J Head Trauma Rehabil Vol. 30, No. 4, pp. 249–260 c 2015 Wolters Kluwer Health, Inc. All rights reserved. Copyright
Efficacy of the Brain Injury Family Intervention: Impact on Family Members Jeffrey S. Kreutzer, PhD; Jennifer H. Marwitz, MA; Adam P. Sima, PhD; Emilie E. Godwin, PhD Objective: Examine the effectiveness of an intervention (Brain Injury Family Intervention) for family caregivers after acquired brain injury. Research Design: Prospective, controlled repeated-measures design. Methods: The Brain Injury Family Intervention was designed as a whole family approach to addressing needs, emphasizing education, skill building, and psychological support. One hundred eight families of outpatients were assigned to either a treatment or wait list control group. The manualized treatment focused on highly relevant topics (eg, common injury effects, coping with loss and change, communication, and stress management) and was composed of five 2-hour sessions with outcome measurement pretreatment, posttreatment, and at 3 months following. Outcome measures included the Family Needs Questionnaire, the Service Obstacles Scale, and the Zarit Burden Interview. Results: Treatment group caregivers showed an increase in met needs, greater satisfaction with services, and reduced burden relative to pretesting, whereas controls did not. Between-group differences for Professional Support needs were identified. Conclusions: Investigation provided evidence that a curriculum-based education, skill-building, and support intervention can benefit caregivers for up to 3 months. Additional research is needed to ascertain the longer-term benefits of intervention and the efficacy of alternative delivery methods (eg, via telephone and the Internet). Key words: caregiver, family intervention, family needs, support systems
D
URING THE PAST SEVERAL DECADES, rehabilitation programs have placed a greater emphasis on involving families in patients’ care. Despite professionals’ best efforts, family members, especially those in a caregiving role, often report feeling poorly equipped and emotionally overwhelmed in trying to provide for survivor’s long-term needs.1–3 Researchers have documented that a family’s ability to cope with stress affects the quality of support provided to
Author Affiliations: Departments of Physical Medicine and Rehabilitation, Neurological Surgery, and Psychiatry (Dr Kreutzer), Department of Physical Medicine and Rehabilitation (Ms Marwitz, Dr Godwin), and Department of Biostatistics (Dr Sima), Virginia Commonwealth University, Richmond, Virginia. Supported by grants H133A070036 and H133A120031 from the National Institute on Disability and Rehabilitation Research (NIDRR) of the US Department of Education. However, these contents do not necessarily reflect the opinions or views of NIDRR or the US Department of Education. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.headtraumarehab.com). The authors declare no conflicts of interest. Corresponding Author: Jennifer H. Marwitz, MA, Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, 1200 E Broad St, Rm 3-109, Box 980542, Richmond, VA 23298 (jhmarwit@ vcu.edu). DOI: 10.1097/HTR.0000000000000144
the survivor and, consequently, the extent of neurobehavioral recovery.4,5 Some would assert that customarily short hospital stays6 leave family members with insufficient time to personally adjust and recover from the emotional trauma elicited by the initial injury. A number of researchers have documented the impact of traumatic brain injury (TBI) on families. High rates of psychological distress, especially depression and anxiety, have been reported.7–15 Family functioning is often disrupted as indicated by deficiencies in problem solving, coping, and communication skills.16–19 A number of studies have focused on delineating family members’ needs. Often ranked highest are needs for information, emotional support, and professional support.20,21 Clearly support systems are inadequate as many needs rated as important are also rated as unmet.21–23 Several studies have identified dramatic role changes and substantially increased caregiver burden.24–26 Caregiving family members frequently help survivors manage activities of daily living, transportation, appointments, finances, and medications. Family members also strain to arrange for appropriate recreational and social activities. The myriad of new roles may include serving as a survivor’s primary support system. Many family members would agree that the system of care is inadequate to provide for survivors’ needs 249
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as well as those of family members. The ideal system of care would provide for the needs of caregivers as well as survivors. Concern for the needs of families has inspired a small number of clinical researchers to develop interventions for families.27–33 Boschen34 was among the first to review the literature. She and her colleagues expressed concern for the lack of methodological rigor and the absence of support for intervention efficacy. At the same time, Brereton and colleagues35 offered the same criticisms in their systematic review of interventions for caregivers after stroke. Several years later, Kreutzer and colleagues33 arrived at a similar conclusion upon reviewing the literature on family interventions after brain injury. The authors noted that survivors were most often not included in the interventions. The structure of interventions was highly variable with some conducted by telephone or the Internet,28,29,36 and others conducted inperson with individual family members or groups of family members.27,30–32 Interventions varied in their focus with differing emphasis on skills (eg, problem solving and behavior management)31,36 versus providing widely varying educational and psychological support components.27,28,30,32 Findings were often equivocal, but with some evidence of improved problem solving and diminished psychological distress posttreatment.
A review of the current literature substantiates the critical need for systematic research on the efficacy of interventions designed to address family member’s needs remains. In a preliminary investigation, Kreutzer et al33 used a pretest-posttest design to characterize the efficacy of the Brain Injury Family Intervention (BIFI). Analysis indicated that families reported more met needs and fewer obstacles to receiving services after participating in the intervention. An extension of previous work, the present investigation was a controlled trial. Families receiving the intervention were compared with a wait list control group, in regard to perceived family needs, caregiver burden, and quality and accessibility of brain injury resources. The research hypotheses were as follows: (1) participants in the treatment group will show an increase in met needs, reduced burden, and a more positive perception of community-based services in comparison to controls; and (2) gains apparent at completion of treatment will remain apparent at 3-month follow-up. METHODS Participants Of the 108 families enrolled in the treatment group, 80 completed the intervention program and the baseline and posttreatment assessments (see Figure 1). Of the 46
Figure 1. Consolidated Standards of Reporting Trials diagram.
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Efficacy of the Brain Injury Family Intervention families in the control group, 29 completed the baseline assessment and 24 completed both assessments. Transportation difficulties, residential relocation, illness, divorce, and separation were the most commonly cited reasons for discontinuation. Active substance abuse, psychosis, or suicidal intent was not evidenced by any participants, and consequently no families were excluded from the study. The present investigation was funded over a 10-year period. During the first 5 years of funding, controls were not recruited. During the second 5 years, the investigators planned to accrue an equal number of control and treatment participants but were unable to do so. Many families (n = 17) randomized to the control group were unwilling to wait 10 weeks before receiving the intervention. The intervention was only available to persons willing to participate in the study. Upon their request, reluctant families were given contact information for community-based family support services. Included in the intervention were parents, spouses, partners, significant others, or close friends of individuals with acquired brain injury (ABI). When more than 1 person was available to participate, data were obtained from the individual identified by the survivor as providing the majority of care. Participants ranged in age from 20 to 81 years with a mean of 52.23 (SD = 13.08) years. With regard to education, 9% had less than a high school education and 40% were college graduates. Roughly two thirds (68%) were competitively employed, 3% were students, and 8% were retired due to age. Eleven percent labeled themselves as homemakers and caregivers. The remaining 10% labeled themselves as unemployed. Most survivors were male (58%), 47% were married, and 77% were Caucasian. The vast majority of survivors had sustained a TBI (85%). With regard to TBI severity, nearly half (47%) had sustained a severe injury (Glasgow Coma Scale, GCS 3-8). The remaining survivors sustained mild (13%; GCS 13-15) or moderate (40%; GCS 9-12) injuries. About half of the injuries were caused by motor vehicle accidents (51%) with a smaller number caused by motorcycle or bicycle accidents (11%), falls (12%), and blunt objects (9%). The remainder of the group (15%) included persons who had sustained an aneurysm, brain abscess, stroke, or hypoxia. Mean time post ABI was 37.98 months (SD = 61.08) with 3 months postinjury set as a minimum. Table 1 provides additional descriptive information regarding survivors and family participants. Intervention structure and content The BIFI is a structured treatment program designed to enhance family functioning after ABI via family education, skill building, and psychological support. The intervention was conceived to meet the needs most com-
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monly identified by family members,20,37,38 improve access to services, and reduce caregiver burden.33,39 The BIFI is manualized to maximize treatment fidelity. The program is implemented over the course of five 2-hour sessions. As detailed in Kreutzer et al,33 the themes of each session are (1) effects of brain injury on the survivor and family; (2) understanding recovery; (3) solving problems and setting goals; (4) managing stress and intense emotions; and (5) strategies for optimal recovery. During each session, 2 or 3 topics are addressed. For example, “What is normal after brain injury?” and “Brain injury happens to the whole family” are topics covered in the first session. Topics covered in the final session include, “Taking care of yourself,” “Focusing on gains and accomplishments,” and “Most important lessons learned and where to go from here.” Family systems theory is a foundation of the BIFI and postulates that families are interconnected systems.33,40,41 Theoretically, the actions, feelings, and communications of each family member influence those of other family members and the family as a whole. The BIFI relies heavily on family therapy techniques including reframing, normalization, validation, and empathic reflection. Principles of Cognitive-Behavioral Therapy also underlie the BIFI, especially the notion that cognition influences emotions and actions. A number of recent studies have successfully incorporated CognitiveBehavioral Therapy approaches to improve neurobehavioral functioning after brain injury.33,42–44 A more detailed description of the BIFI is provided in a previous publication by the authors.33 The previous publication used a single-group, pretest-posttest design and focused on 53 family members. Measures The Family Needs Questionnaire (FNQ) was selected as the primary outcome measure with the Service Obstacles Scale (SOS) and Zarit Burden Inventory (ZBI) serving as secondary outcomes. A description of each measure is provided in the following section. Although statistical significance was set at .05, clinical significance was defined as a pre-/posttreatment difference of 10% or more of the respective scale value. Specifically, a clinically meaningful difference for the FNQ was 1.0 point or greater. Clinical differences for the SOS and ZBI were 2.4 and 4.8 points or greater, respectively. Family Needs Questionnaire The FNQ is a 37-item self-report questionnaire measuring family members’ perceived needs after brain injury.38 Respondents rate the degree to which each need has been met (not met, partly met, or met). Research has provided evidence of content and construct validity, as well as internal consistency and reliability.20 Factor www.headtraumarehab.com
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Frequencies, percentages, medians, and P values associated with covariates and outcome measures for control and treatment group participants TABLE 1
Characteristic Relationship to survivor Participant’s sex Minority status of participant Marital status of participant Time postinjury
Characteristic Age (survivor), y Age (participant), y Acute care length of stay FNQ: Health Information (baseline) FNQ: Emotional Support (baseline) FNQ: Instrumental Support (baseline) FNQ: Professional Support (baseline) FNQ: Community Support (baseline) FNQ: Care Involvement (baseline) SOS ZBI
Na (%)
Treatment (N = 108) Median [IQR]
Control (N = 29) Median [IQR]
Spouse Parent Other Male Female Minority
56 (40.9%) 51 (37.2%) 30 (21.9%) 38 (27.7%) 99 (72.3%) 34 (25.4%)
49 (45.4%) 37 (34.3%) 22 (20.4%) 34 (31.5%) 74 (68.5%) 26 (24.8%)
7 (24.1%) 14 (48.3%) 8 (27.6%) 4 (13.8%) 25 (86.2%) 8 (27.6%)
Nonminority Married
100 (74.6%) 101 (73.7%)
79 (75.2%) 81 (75.0%)
21 (72.4%) 20 (69.0%)
Not married 5 y
36 (26.3%) 50 (36.8%) 85 (63.2%)
27 (25.0%) 42 (39.6%) 64 (60.4%)
9 (31.0%) 8 (27.6%) 21 (72.4%)
Median [IQR]
Treatment (N = 108) Median [IQR]
Control (N = 29) Median [IQR]
P
42.6 [29.4, 50.8] 51.4 [40.8, 59.6] 13.5 [3.0, 25.0]
42.9 [31.6, 52.3] 51.5 [40.6, 58.9] 14.0 [2.0, 25.0]
36.2 [25.6, 50.1] 50.2 [41.8, 62.1] 12.0 [6.0, 24.0]
.1895 .4835 .4786
6.0 [3.0, 9.0]
6.8 [3.0, 9.0]
6.0 [3.0, 9.0]
.5586
2.5 [0.0, 5.0]
2.5 [0.0, 5.0]
2.5 [0.0, 6.3]
.7703
2.0 [0.0, 6.7]
2.0 [0.0, 6.7]
1.7 [0.0, 8.3]
.4382
2.0 [0.0, 8.0]
2.0 [0.0, 8.0]
2.5 [2.0, 6.0]
.6876
2.0 [0.0, 8.0]
2.5 [2.0, 7.8]
2.0 [0.0, 8.0]
.3777
6.7 [0.0, 10.0]
6.7 [0.0, 10.0]
3.3 [0.0, 10.0]
.2834
15.0 [10.0, 18.0] 14.0 [7.0, 25.0]
15.0 [9.0, 17.0] 16.0 [10.0, 25.0]
16.0 [13.5, 20.5] 10.0 [6.0, 20.0]
.0221 .1852
Level
P .1182 .0589 .7570 .5121 .2343
Abbreviations: FNQ, Family Needs Questionnaire; IQR, interquartile range values; SOS, Service Obstacles Scale; ZBI, Zarit Burden Inventory. a Sample sizes vary slightly due to missing values.
analysis has revealed 6 independent factors comprising 6 scales—Health Information, Emotional Support, Instrumental Support, Professional Support, Community Support Network, and Involvement with Care.37 For the present investigation, the proportion of needs rated as met, converted to a 10-point scale, was a primary outcome measure.
through strongly agree, is used to rate items. Higher scores indicate greater dissatisfaction with and more obstacles to receiving services. A regional needs assessment study substantiated the SOS’s validity.46 With a range of 4 to 28, the SOS score served as a secondary outcome measure. Zarit Burden Interview
Service Obstacles Scale The satisfaction with treatment resources scale of the SOS was used to evaluate perceptions of the quality and accessibility of community-based brain injury services.45 A 7-point Likert-type scale, ranging from strongly disagree
The ZBI was designed to quantify caregiving burden.47 Caregivers are asked to describe perceived changes in their emotional or physical health, social life, and financial status as a result of caring for a relative. Items are rated on a 5-point Likert scale, ranging from
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Efficacy of the Brain Injury Family Intervention 0 (never) to 4 (nearly always). A total score is derived, representing the extent of burden, with higher scores denoting greater burden. The measure was initially developed to characterize burden among caregivers of persons with Alzheimer’s disease, dementia, and stroke.48–51 The ZBI has also been used with adult and pediatric TBI populations.52–54 The measure is known to have high internal consistency (0.87-0.93)51 and test-retest reliability, r = 0.76.55 Bachner and O’Rourke47 examined the ZBI’s psychometric properties and found that responses were reliable across populations of caregivers and patients with an average internal consistency of 0.86. The present investigation used the 12-item version. Investigators have found high correlations between scores derived from the 12and 22-item versions, ranging from 0.92 to 0.97.56 Other variables A number of covariates were examined because of their possible relationship to outcomes. Considered were characteristics of the family member including age, sex, marital status (married, not married), relationship to the person with a TBI (spouse, parent, other), and minority status. Additional characteristics relating to the individual with TBI were also assessed, including age, acute care length of stay, and time since injury (≤5 years, >5 years). Procedure From 2003 to 2012, families were recruited from a number of sources and included patients with neurocognitive and behavioral problems referred by healthcare providers, agencies, and advocacy organizations. Screening, assessment, and intervention activities were completed in an outpatient rehabilitation clinic attached to a level I trauma center. At the initial intake meeting, families were given information about the clinical research program and their questions were answered. The investigators ascertained their eligibility and interest in participation. The primary family member was identified, and informed consent was obtained from all participating family members. On giving informed consent, the individual with TBI and the primary family member were given baseline assessment materials to complete. Control group participants were scheduled to return in 10 weeks to complete baseline assessments a second time. For practical reasons, the second baseline assessment is labeled as a posttreatment assessment in later sections of the manuscript. Controls were offered an opportunity to complete the intervention following the second assessment as a courtesy. With regard to the treatment group, a therapist worked with each family individually through the inter-
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vention program. Therapists included clinical psychologists and family therapists with doctoral degrees. All received training and supervision from the first author. The 5 sessions were completed over a 10-week period. Families were asked to complete worksheets and review and discuss materials between sessions. Posttreatment data were collected following the fifth session. Threemonth follow-up data were collected 10 to 14 weeks following the last session. Data analysis Each of the explanatory variables was summarized by frequencies and percentages for categorical variables and medians and interquartile ranges for continuous variables separately for each treatment group. A similar summary was performed for each of the outcome variables at baseline. A Kruskal-Wallis test, to compare medians, or the chi-square test of association, to compare percentages, was used to assess if any of the explanatory variables differed between the treatment and control groups. The 6 FNQ subscales were jointly assessed using a multivariate longitudinal model to determine whether the intervention affected any of the scores. This model is a type of repeated-measures analysis of covariance model that accounts for the longitudinal dependence present in repeated-measures designs while simultaneously incorporating the different relationships between separate outcome variables, all in a single model. Along with each of the survivor and participant characteristics, this model allowed each of the outcomes to vary differently by time and treatment group. The relationship between the covariates and each of the subscales was assumed to be the same for each subscale. The multivariate longitudinal model was used to estimate differences between each treatment over each time point for all of the FNQ subscales. Specifically, differences between baseline and posttreatment, baseline and 3-month follow-up, and posttreatment and 3-month follow-up were estimated for the treatment group. Differences between the 2 baseline assessments were reported for the control group. Standard errors (SEs), 95% confidence intervals (CIs), and P values were reported for each difference. The primary study hypothesis, that the difference in the mean FNQ subscale from baseline to posttreatment would be higher for the treatment group compared with the control group, was tested at the 0.05 level. Comparisons of the individual differences in change in the mean FNQ subscales were assessed, controlling for multiple comparisons using a Bonferroni-corrected type-I error rate of 0.0083. The differences in these means were reported with the SE, Bonferroni-corrected 95% CI, and P values. Mean differences in the FNQ subscales were www.headtraumarehab.com
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reported for each of the covariates. Five-year differences in both the age of the family member and the survivor were considered, as well as 7-day differences in the acute care length of stay. Each of the covariates was tested at the 0.05 level. A similar strategy was used to assess each of the secondary outcomes. Separate repeated-measures models were fit for these outcomes, and each of the respective change in means was calculated. The P value corresponding to the time by group interaction and the mean differences for each of the covariates were reported for each outcome. The mean differences between the covariates and each of the outcomes were reported. Only results that have corresponding P values less than .05 are discussed; information on all others is provided in the online Supplemental Digital Content (http://links.lww.com/JHTR/A142). RESULTS Comparability of control and treatment groups Participant characteristics are presented for the entire sample and for each group in Table 1. There was a higher percentage of male family members (31.5%) in the treatment group than in the control group (13.8%); however, this difference did not reach statistical significance (χ 2 (1) = 3.6; P = .0589). Specifically, survivors in both groups did not differ with regard to age, hospital length of stay, or time postinjury. Family members were comparable with regard to relationship to survivor, minority status, marital status, and age. Comparisons were made between the treatment and control groups at baseline with regard to the outcome measures. Overall, as indicated by the FNQ, relatively few Emotional Support, Instrumental Support, Professional Support, and Community Support needs were reported as met (20%-25%). A higher number of Health Information and Care Involvement needs were rated as met (60%-67%). The proportion of met needs did not differ between the treatment and control groups (P > .05). Similarly, no difference was observed between the treatment and control groups with respect to the baseline ZBI score. However, controls had higher SOS scores (χ 2 (1) = 5.2, P = .0221) than the treatment group at baseline. Family needs Figure 2 shows the profiles of the treatment and control groups over time; a tabular representation of this information is provided in Appendix A of the online Supplemental Digital Content (http://links.lww.com/ JHTR/A142). The change of each mean subscale score over time for the treatment and control groups is shown in Table 2. For the treatment group, baseline to post-
treatment increases in the Health Information (t689 = 2.98, P = .0030; Figure 2a), Emotional Support (t689 = 3.86, P = .0001; Figure 2b), Professional Support (t689 = 4.66, P < .0001; Figure 2d), and Community Support (t689 = 2.37, P = .0179; Figure 2e) subscales of the FNQ were observed. No such differences were observed for the Instrumental Support (t689 = 0.63, P = .5292; Figure 2c) or Care Involvement subscales (t689 = 1.69, P = .0646; Figure 2f). With regard to the control group, no baseline to posttreatment (second baseline) differences were observed (P > .05). Within the treatment group, baseline to follow-up increases were observed for the Emotional Support (t689 = 2.36, P = .0184; Figure 2b) and Professional Support (t689 = 3.08, P = .0022; Figure 2d) subscales. Differences were not observed for the remaining subscales (P > .05). No posttreatment to follow-up differences were found (P > .05). The primary analysis, which consisted of comparing the groups’ mean baseline to posttreatment scores, indicated at least 1 significant difference (F6,689 = 2.2, P = .0397). Adjusted for multiple comparisons using a Bonferroni-corrected type-I error rate of 0.0083, a significant difference of 3.01 (SE = 0.96, adjusted 95% CI: 0.47, 5.54; t689 = 3.13, P = .0018; Figure 2d) for the Professional Support subscale was observed. In other words, on average, the posttreatment Professional Support subscale score for a treatment group participant increased about 3 points compared with a control group participant. The Health Information (t689 = 2.08, P = .0383; Figure 2a) and Community Support (t689 = 2.17, P = .0305; Figure 2e) subscales had P values that were larger than the Bonferroni-adjusted level (0.0083) but smaller than the experiment-wise typeI error (0.05). Compared with the control group, the treatment group rated more needs as met at posttreatment relative to baseline for both the Health Information (Diff = 1.77, SE = 0.85, adjusted 95% CI: −0.49, 4.02; Figure 2a) and Community Support (Diff = 1.97, SE = 0.91, adjusted 95% CI: −0.44, 4.38; Figure 2e) subscales. No significant differences, either at the adjusted or unadjusted experiment-wise type-I error rate, were observed for the Emotional Support (t689 = 1.95, P = .0512; Figure 2b), Instrumental Support (t689 = −0.03, P = .9833; Figure 2c), or Care Involvement (t689 = 0.978, P = .3340; Figure 2f) subscales. There were nominal increases for both the Emotional Support (Diff = 1.76, SE = 0.90, adjusted 95% CI: −0.62, 4.14; Figure 2b) and Community Support (Diff = 1.06, SE = 1.10, adjusted 95% CI: −1.85, 3.97; Figure 2e). Virtually no difference was observed for the Care Involvement subscale (Diff = −0.03, SE = 0.98, adjusted 95% CI: −2.63, 2.57; Figure 2f). The relationship between each of the covariates and each of the FNQ subscales can be seen in Table 3. The
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Efficacy of the Brain Injury Family Intervention
a) Health Information
255
8 6 4
FNQ 4
FNQ
6
8
b) Emotional Support
0
5
10
15
20
Treatment Control
2
2
Treatment Control
22
0
5
Time (wks)
10
15
20
22
Time (wks)
6 4
FNQ 4
FNQ
6
8
d) Professional Support
8
c) Instrumental Support
0
5
10
15
20
Treatment Control
2
2
Treatment Control
22
0
5
Time (wks)
10
15
20
22
Time (wks)
6 4
FNQ 4
FNQ
6
8
f) Care Involvement
8
e) Community Support
0
5
10 Time (wks)
15
20
Treatment Control
2
2
Treatment Control
22
0
5
10
15
20
22
Time (wks)
Figure 2. Family Needs Questionnaire scale values for treatment and control group participants.
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TABLE 2
JOURNAL OF HEAD TRAUMA REHABILITATION/JULY-AUGUST 2015
Temporal differences for all outcome variables Treatment group Mean change
FNQ Health Information Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment FNQ Emotional Support Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment FNQ Instrumental Support Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment FNQ Professional Support Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment FNQ Community Support Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment FNQ Care Involvement Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment SOS Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment ZBI Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment
Control group
P
SE (95% CI)
Mean change
SE (95% CI)
P
1.18 0.79 − 0.39
0.40 (0.40, 1.97) 0.48 (−0.14, 1.73) 0.43 (−1.23, 0.45)
.0030 .0958 .3638
− 0.58
0.75 (−2.06, 0.90)
.4399
1.65 1.20 − 0.46
0.43 (0.81, 2.49) 0.51 (0.20, 2.19) 0.45 (−1.35, 0.43)
.0001 .0184 .3127
− 0.10
0.79 (−1.65, 1.45)
.8967
0.29 0.27 − 0.03
0.47 (−0.62, 1.21) 0.56 (−0.83, 1.36) 0.50 (−1.02, 0.96)
.5292 .6331 .9554
0.32
0.71 (−1.38, 2.02)
.7089
2.10 1.65 − 0.44
0.45 (1.21, 2.98) 0.54 (0.60, 2.71) 0.48 (−1.39, 0.51)
Efficacy of the Brain Injury Family Intervention: Impact on Family Members Jeffrey S. Kreutzer, PhD; Jennifer H. Marwitz, MA; Adam P. Sima, PhD; Emilie E. Godwin, PhD Objective: Examine the effectiveness of an intervention (Brain Injury Family Intervention) for family caregivers after acquired brain injury. Research Design: Prospective, controlled repeated-measures design. Methods: The Brain Injury Family Intervention was designed as a whole family approach to addressing needs, emphasizing education, skill building, and psychological support. One hundred eight families of outpatients were assigned to either a treatment or wait list control group. The manualized treatment focused on highly relevant topics (eg, common injury effects, coping with loss and change, communication, and stress management) and was composed of five 2-hour sessions with outcome measurement pretreatment, posttreatment, and at 3 months following. Outcome measures included the Family Needs Questionnaire, the Service Obstacles Scale, and the Zarit Burden Interview. Results: Treatment group caregivers showed an increase in met needs, greater satisfaction with services, and reduced burden relative to pretesting, whereas controls did not. Between-group differences for Professional Support needs were identified. Conclusions: Investigation provided evidence that a curriculum-based education, skill-building, and support intervention can benefit caregivers for up to 3 months. Additional research is needed to ascertain the longer-term benefits of intervention and the efficacy of alternative delivery methods (eg, via telephone and the Internet). Key words: caregiver, family intervention, family needs, support systems
D
URING THE PAST SEVERAL DECADES, rehabilitation programs have placed a greater emphasis on involving families in patients’ care. Despite professionals’ best efforts, family members, especially those in a caregiving role, often report feeling poorly equipped and emotionally overwhelmed in trying to provide for survivor’s long-term needs.1–3 Researchers have documented that a family’s ability to cope with stress affects the quality of support provided to
Author Affiliations: Departments of Physical Medicine and Rehabilitation, Neurological Surgery, and Psychiatry (Dr Kreutzer), Department of Physical Medicine and Rehabilitation (Ms Marwitz, Dr Godwin), and Department of Biostatistics (Dr Sima), Virginia Commonwealth University, Richmond, Virginia. Supported by grants H133A070036 and H133A120031 from the National Institute on Disability and Rehabilitation Research (NIDRR) of the US Department of Education. However, these contents do not necessarily reflect the opinions or views of NIDRR or the US Department of Education. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.headtraumarehab.com). The authors declare no conflicts of interest. Corresponding Author: Jennifer H. Marwitz, MA, Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, 1200 E Broad St, Rm 3-109, Box 980542, Richmond, VA 23298 (jhmarwit@ vcu.edu). DOI: 10.1097/HTR.0000000000000144
the survivor and, consequently, the extent of neurobehavioral recovery.4,5 Some would assert that customarily short hospital stays6 leave family members with insufficient time to personally adjust and recover from the emotional trauma elicited by the initial injury. A number of researchers have documented the impact of traumatic brain injury (TBI) on families. High rates of psychological distress, especially depression and anxiety, have been reported.7–15 Family functioning is often disrupted as indicated by deficiencies in problem solving, coping, and communication skills.16–19 A number of studies have focused on delineating family members’ needs. Often ranked highest are needs for information, emotional support, and professional support.20,21 Clearly support systems are inadequate as many needs rated as important are also rated as unmet.21–23 Several studies have identified dramatic role changes and substantially increased caregiver burden.24–26 Caregiving family members frequently help survivors manage activities of daily living, transportation, appointments, finances, and medications. Family members also strain to arrange for appropriate recreational and social activities. The myriad of new roles may include serving as a survivor’s primary support system. Many family members would agree that the system of care is inadequate to provide for survivors’ needs 249
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as well as those of family members. The ideal system of care would provide for the needs of caregivers as well as survivors. Concern for the needs of families has inspired a small number of clinical researchers to develop interventions for families.27–33 Boschen34 was among the first to review the literature. She and her colleagues expressed concern for the lack of methodological rigor and the absence of support for intervention efficacy. At the same time, Brereton and colleagues35 offered the same criticisms in their systematic review of interventions for caregivers after stroke. Several years later, Kreutzer and colleagues33 arrived at a similar conclusion upon reviewing the literature on family interventions after brain injury. The authors noted that survivors were most often not included in the interventions. The structure of interventions was highly variable with some conducted by telephone or the Internet,28,29,36 and others conducted inperson with individual family members or groups of family members.27,30–32 Interventions varied in their focus with differing emphasis on skills (eg, problem solving and behavior management)31,36 versus providing widely varying educational and psychological support components.27,28,30,32 Findings were often equivocal, but with some evidence of improved problem solving and diminished psychological distress posttreatment.
A review of the current literature substantiates the critical need for systematic research on the efficacy of interventions designed to address family member’s needs remains. In a preliminary investigation, Kreutzer et al33 used a pretest-posttest design to characterize the efficacy of the Brain Injury Family Intervention (BIFI). Analysis indicated that families reported more met needs and fewer obstacles to receiving services after participating in the intervention. An extension of previous work, the present investigation was a controlled trial. Families receiving the intervention were compared with a wait list control group, in regard to perceived family needs, caregiver burden, and quality and accessibility of brain injury resources. The research hypotheses were as follows: (1) participants in the treatment group will show an increase in met needs, reduced burden, and a more positive perception of community-based services in comparison to controls; and (2) gains apparent at completion of treatment will remain apparent at 3-month follow-up. METHODS Participants Of the 108 families enrolled in the treatment group, 80 completed the intervention program and the baseline and posttreatment assessments (see Figure 1). Of the 46
Figure 1. Consolidated Standards of Reporting Trials diagram.
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Efficacy of the Brain Injury Family Intervention families in the control group, 29 completed the baseline assessment and 24 completed both assessments. Transportation difficulties, residential relocation, illness, divorce, and separation were the most commonly cited reasons for discontinuation. Active substance abuse, psychosis, or suicidal intent was not evidenced by any participants, and consequently no families were excluded from the study. The present investigation was funded over a 10-year period. During the first 5 years of funding, controls were not recruited. During the second 5 years, the investigators planned to accrue an equal number of control and treatment participants but were unable to do so. Many families (n = 17) randomized to the control group were unwilling to wait 10 weeks before receiving the intervention. The intervention was only available to persons willing to participate in the study. Upon their request, reluctant families were given contact information for community-based family support services. Included in the intervention were parents, spouses, partners, significant others, or close friends of individuals with acquired brain injury (ABI). When more than 1 person was available to participate, data were obtained from the individual identified by the survivor as providing the majority of care. Participants ranged in age from 20 to 81 years with a mean of 52.23 (SD = 13.08) years. With regard to education, 9% had less than a high school education and 40% were college graduates. Roughly two thirds (68%) were competitively employed, 3% were students, and 8% were retired due to age. Eleven percent labeled themselves as homemakers and caregivers. The remaining 10% labeled themselves as unemployed. Most survivors were male (58%), 47% were married, and 77% were Caucasian. The vast majority of survivors had sustained a TBI (85%). With regard to TBI severity, nearly half (47%) had sustained a severe injury (Glasgow Coma Scale, GCS 3-8). The remaining survivors sustained mild (13%; GCS 13-15) or moderate (40%; GCS 9-12) injuries. About half of the injuries were caused by motor vehicle accidents (51%) with a smaller number caused by motorcycle or bicycle accidents (11%), falls (12%), and blunt objects (9%). The remainder of the group (15%) included persons who had sustained an aneurysm, brain abscess, stroke, or hypoxia. Mean time post ABI was 37.98 months (SD = 61.08) with 3 months postinjury set as a minimum. Table 1 provides additional descriptive information regarding survivors and family participants. Intervention structure and content The BIFI is a structured treatment program designed to enhance family functioning after ABI via family education, skill building, and psychological support. The intervention was conceived to meet the needs most com-
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monly identified by family members,20,37,38 improve access to services, and reduce caregiver burden.33,39 The BIFI is manualized to maximize treatment fidelity. The program is implemented over the course of five 2-hour sessions. As detailed in Kreutzer et al,33 the themes of each session are (1) effects of brain injury on the survivor and family; (2) understanding recovery; (3) solving problems and setting goals; (4) managing stress and intense emotions; and (5) strategies for optimal recovery. During each session, 2 or 3 topics are addressed. For example, “What is normal after brain injury?” and “Brain injury happens to the whole family” are topics covered in the first session. Topics covered in the final session include, “Taking care of yourself,” “Focusing on gains and accomplishments,” and “Most important lessons learned and where to go from here.” Family systems theory is a foundation of the BIFI and postulates that families are interconnected systems.33,40,41 Theoretically, the actions, feelings, and communications of each family member influence those of other family members and the family as a whole. The BIFI relies heavily on family therapy techniques including reframing, normalization, validation, and empathic reflection. Principles of Cognitive-Behavioral Therapy also underlie the BIFI, especially the notion that cognition influences emotions and actions. A number of recent studies have successfully incorporated CognitiveBehavioral Therapy approaches to improve neurobehavioral functioning after brain injury.33,42–44 A more detailed description of the BIFI is provided in a previous publication by the authors.33 The previous publication used a single-group, pretest-posttest design and focused on 53 family members. Measures The Family Needs Questionnaire (FNQ) was selected as the primary outcome measure with the Service Obstacles Scale (SOS) and Zarit Burden Inventory (ZBI) serving as secondary outcomes. A description of each measure is provided in the following section. Although statistical significance was set at .05, clinical significance was defined as a pre-/posttreatment difference of 10% or more of the respective scale value. Specifically, a clinically meaningful difference for the FNQ was 1.0 point or greater. Clinical differences for the SOS and ZBI were 2.4 and 4.8 points or greater, respectively. Family Needs Questionnaire The FNQ is a 37-item self-report questionnaire measuring family members’ perceived needs after brain injury.38 Respondents rate the degree to which each need has been met (not met, partly met, or met). Research has provided evidence of content and construct validity, as well as internal consistency and reliability.20 Factor www.headtraumarehab.com
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Frequencies, percentages, medians, and P values associated with covariates and outcome measures for control and treatment group participants TABLE 1
Characteristic Relationship to survivor Participant’s sex Minority status of participant Marital status of participant Time postinjury
Characteristic Age (survivor), y Age (participant), y Acute care length of stay FNQ: Health Information (baseline) FNQ: Emotional Support (baseline) FNQ: Instrumental Support (baseline) FNQ: Professional Support (baseline) FNQ: Community Support (baseline) FNQ: Care Involvement (baseline) SOS ZBI
Na (%)
Treatment (N = 108) Median [IQR]
Control (N = 29) Median [IQR]
Spouse Parent Other Male Female Minority
56 (40.9%) 51 (37.2%) 30 (21.9%) 38 (27.7%) 99 (72.3%) 34 (25.4%)
49 (45.4%) 37 (34.3%) 22 (20.4%) 34 (31.5%) 74 (68.5%) 26 (24.8%)
7 (24.1%) 14 (48.3%) 8 (27.6%) 4 (13.8%) 25 (86.2%) 8 (27.6%)
Nonminority Married
100 (74.6%) 101 (73.7%)
79 (75.2%) 81 (75.0%)
21 (72.4%) 20 (69.0%)
Not married 5 y
36 (26.3%) 50 (36.8%) 85 (63.2%)
27 (25.0%) 42 (39.6%) 64 (60.4%)
9 (31.0%) 8 (27.6%) 21 (72.4%)
Median [IQR]
Treatment (N = 108) Median [IQR]
Control (N = 29) Median [IQR]
P
42.6 [29.4, 50.8] 51.4 [40.8, 59.6] 13.5 [3.0, 25.0]
42.9 [31.6, 52.3] 51.5 [40.6, 58.9] 14.0 [2.0, 25.0]
36.2 [25.6, 50.1] 50.2 [41.8, 62.1] 12.0 [6.0, 24.0]
.1895 .4835 .4786
6.0 [3.0, 9.0]
6.8 [3.0, 9.0]
6.0 [3.0, 9.0]
.5586
2.5 [0.0, 5.0]
2.5 [0.0, 5.0]
2.5 [0.0, 6.3]
.7703
2.0 [0.0, 6.7]
2.0 [0.0, 6.7]
1.7 [0.0, 8.3]
.4382
2.0 [0.0, 8.0]
2.0 [0.0, 8.0]
2.5 [2.0, 6.0]
.6876
2.0 [0.0, 8.0]
2.5 [2.0, 7.8]
2.0 [0.0, 8.0]
.3777
6.7 [0.0, 10.0]
6.7 [0.0, 10.0]
3.3 [0.0, 10.0]
.2834
15.0 [10.0, 18.0] 14.0 [7.0, 25.0]
15.0 [9.0, 17.0] 16.0 [10.0, 25.0]
16.0 [13.5, 20.5] 10.0 [6.0, 20.0]
.0221 .1852
Level
P .1182 .0589 .7570 .5121 .2343
Abbreviations: FNQ, Family Needs Questionnaire; IQR, interquartile range values; SOS, Service Obstacles Scale; ZBI, Zarit Burden Inventory. a Sample sizes vary slightly due to missing values.
analysis has revealed 6 independent factors comprising 6 scales—Health Information, Emotional Support, Instrumental Support, Professional Support, Community Support Network, and Involvement with Care.37 For the present investigation, the proportion of needs rated as met, converted to a 10-point scale, was a primary outcome measure.
through strongly agree, is used to rate items. Higher scores indicate greater dissatisfaction with and more obstacles to receiving services. A regional needs assessment study substantiated the SOS’s validity.46 With a range of 4 to 28, the SOS score served as a secondary outcome measure. Zarit Burden Interview
Service Obstacles Scale The satisfaction with treatment resources scale of the SOS was used to evaluate perceptions of the quality and accessibility of community-based brain injury services.45 A 7-point Likert-type scale, ranging from strongly disagree
The ZBI was designed to quantify caregiving burden.47 Caregivers are asked to describe perceived changes in their emotional or physical health, social life, and financial status as a result of caring for a relative. Items are rated on a 5-point Likert scale, ranging from
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Efficacy of the Brain Injury Family Intervention 0 (never) to 4 (nearly always). A total score is derived, representing the extent of burden, with higher scores denoting greater burden. The measure was initially developed to characterize burden among caregivers of persons with Alzheimer’s disease, dementia, and stroke.48–51 The ZBI has also been used with adult and pediatric TBI populations.52–54 The measure is known to have high internal consistency (0.87-0.93)51 and test-retest reliability, r = 0.76.55 Bachner and O’Rourke47 examined the ZBI’s psychometric properties and found that responses were reliable across populations of caregivers and patients with an average internal consistency of 0.86. The present investigation used the 12-item version. Investigators have found high correlations between scores derived from the 12and 22-item versions, ranging from 0.92 to 0.97.56 Other variables A number of covariates were examined because of their possible relationship to outcomes. Considered were characteristics of the family member including age, sex, marital status (married, not married), relationship to the person with a TBI (spouse, parent, other), and minority status. Additional characteristics relating to the individual with TBI were also assessed, including age, acute care length of stay, and time since injury (≤5 years, >5 years). Procedure From 2003 to 2012, families were recruited from a number of sources and included patients with neurocognitive and behavioral problems referred by healthcare providers, agencies, and advocacy organizations. Screening, assessment, and intervention activities were completed in an outpatient rehabilitation clinic attached to a level I trauma center. At the initial intake meeting, families were given information about the clinical research program and their questions were answered. The investigators ascertained their eligibility and interest in participation. The primary family member was identified, and informed consent was obtained from all participating family members. On giving informed consent, the individual with TBI and the primary family member were given baseline assessment materials to complete. Control group participants were scheduled to return in 10 weeks to complete baseline assessments a second time. For practical reasons, the second baseline assessment is labeled as a posttreatment assessment in later sections of the manuscript. Controls were offered an opportunity to complete the intervention following the second assessment as a courtesy. With regard to the treatment group, a therapist worked with each family individually through the inter-
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vention program. Therapists included clinical psychologists and family therapists with doctoral degrees. All received training and supervision from the first author. The 5 sessions were completed over a 10-week period. Families were asked to complete worksheets and review and discuss materials between sessions. Posttreatment data were collected following the fifth session. Threemonth follow-up data were collected 10 to 14 weeks following the last session. Data analysis Each of the explanatory variables was summarized by frequencies and percentages for categorical variables and medians and interquartile ranges for continuous variables separately for each treatment group. A similar summary was performed for each of the outcome variables at baseline. A Kruskal-Wallis test, to compare medians, or the chi-square test of association, to compare percentages, was used to assess if any of the explanatory variables differed between the treatment and control groups. The 6 FNQ subscales were jointly assessed using a multivariate longitudinal model to determine whether the intervention affected any of the scores. This model is a type of repeated-measures analysis of covariance model that accounts for the longitudinal dependence present in repeated-measures designs while simultaneously incorporating the different relationships between separate outcome variables, all in a single model. Along with each of the survivor and participant characteristics, this model allowed each of the outcomes to vary differently by time and treatment group. The relationship between the covariates and each of the subscales was assumed to be the same for each subscale. The multivariate longitudinal model was used to estimate differences between each treatment over each time point for all of the FNQ subscales. Specifically, differences between baseline and posttreatment, baseline and 3-month follow-up, and posttreatment and 3-month follow-up were estimated for the treatment group. Differences between the 2 baseline assessments were reported for the control group. Standard errors (SEs), 95% confidence intervals (CIs), and P values were reported for each difference. The primary study hypothesis, that the difference in the mean FNQ subscale from baseline to posttreatment would be higher for the treatment group compared with the control group, was tested at the 0.05 level. Comparisons of the individual differences in change in the mean FNQ subscales were assessed, controlling for multiple comparisons using a Bonferroni-corrected type-I error rate of 0.0083. The differences in these means were reported with the SE, Bonferroni-corrected 95% CI, and P values. Mean differences in the FNQ subscales were www.headtraumarehab.com
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reported for each of the covariates. Five-year differences in both the age of the family member and the survivor were considered, as well as 7-day differences in the acute care length of stay. Each of the covariates was tested at the 0.05 level. A similar strategy was used to assess each of the secondary outcomes. Separate repeated-measures models were fit for these outcomes, and each of the respective change in means was calculated. The P value corresponding to the time by group interaction and the mean differences for each of the covariates were reported for each outcome. The mean differences between the covariates and each of the outcomes were reported. Only results that have corresponding P values less than .05 are discussed; information on all others is provided in the online Supplemental Digital Content (http://links.lww.com/JHTR/A142). RESULTS Comparability of control and treatment groups Participant characteristics are presented for the entire sample and for each group in Table 1. There was a higher percentage of male family members (31.5%) in the treatment group than in the control group (13.8%); however, this difference did not reach statistical significance (χ 2 (1) = 3.6; P = .0589). Specifically, survivors in both groups did not differ with regard to age, hospital length of stay, or time postinjury. Family members were comparable with regard to relationship to survivor, minority status, marital status, and age. Comparisons were made between the treatment and control groups at baseline with regard to the outcome measures. Overall, as indicated by the FNQ, relatively few Emotional Support, Instrumental Support, Professional Support, and Community Support needs were reported as met (20%-25%). A higher number of Health Information and Care Involvement needs were rated as met (60%-67%). The proportion of met needs did not differ between the treatment and control groups (P > .05). Similarly, no difference was observed between the treatment and control groups with respect to the baseline ZBI score. However, controls had higher SOS scores (χ 2 (1) = 5.2, P = .0221) than the treatment group at baseline. Family needs Figure 2 shows the profiles of the treatment and control groups over time; a tabular representation of this information is provided in Appendix A of the online Supplemental Digital Content (http://links.lww.com/ JHTR/A142). The change of each mean subscale score over time for the treatment and control groups is shown in Table 2. For the treatment group, baseline to post-
treatment increases in the Health Information (t689 = 2.98, P = .0030; Figure 2a), Emotional Support (t689 = 3.86, P = .0001; Figure 2b), Professional Support (t689 = 4.66, P < .0001; Figure 2d), and Community Support (t689 = 2.37, P = .0179; Figure 2e) subscales of the FNQ were observed. No such differences were observed for the Instrumental Support (t689 = 0.63, P = .5292; Figure 2c) or Care Involvement subscales (t689 = 1.69, P = .0646; Figure 2f). With regard to the control group, no baseline to posttreatment (second baseline) differences were observed (P > .05). Within the treatment group, baseline to follow-up increases were observed for the Emotional Support (t689 = 2.36, P = .0184; Figure 2b) and Professional Support (t689 = 3.08, P = .0022; Figure 2d) subscales. Differences were not observed for the remaining subscales (P > .05). No posttreatment to follow-up differences were found (P > .05). The primary analysis, which consisted of comparing the groups’ mean baseline to posttreatment scores, indicated at least 1 significant difference (F6,689 = 2.2, P = .0397). Adjusted for multiple comparisons using a Bonferroni-corrected type-I error rate of 0.0083, a significant difference of 3.01 (SE = 0.96, adjusted 95% CI: 0.47, 5.54; t689 = 3.13, P = .0018; Figure 2d) for the Professional Support subscale was observed. In other words, on average, the posttreatment Professional Support subscale score for a treatment group participant increased about 3 points compared with a control group participant. The Health Information (t689 = 2.08, P = .0383; Figure 2a) and Community Support (t689 = 2.17, P = .0305; Figure 2e) subscales had P values that were larger than the Bonferroni-adjusted level (0.0083) but smaller than the experiment-wise typeI error (0.05). Compared with the control group, the treatment group rated more needs as met at posttreatment relative to baseline for both the Health Information (Diff = 1.77, SE = 0.85, adjusted 95% CI: −0.49, 4.02; Figure 2a) and Community Support (Diff = 1.97, SE = 0.91, adjusted 95% CI: −0.44, 4.38; Figure 2e) subscales. No significant differences, either at the adjusted or unadjusted experiment-wise type-I error rate, were observed for the Emotional Support (t689 = 1.95, P = .0512; Figure 2b), Instrumental Support (t689 = −0.03, P = .9833; Figure 2c), or Care Involvement (t689 = 0.978, P = .3340; Figure 2f) subscales. There were nominal increases for both the Emotional Support (Diff = 1.76, SE = 0.90, adjusted 95% CI: −0.62, 4.14; Figure 2b) and Community Support (Diff = 1.06, SE = 1.10, adjusted 95% CI: −1.85, 3.97; Figure 2e). Virtually no difference was observed for the Care Involvement subscale (Diff = −0.03, SE = 0.98, adjusted 95% CI: −2.63, 2.57; Figure 2f). The relationship between each of the covariates and each of the FNQ subscales can be seen in Table 3. The
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Efficacy of the Brain Injury Family Intervention
a) Health Information
255
8 6 4
FNQ 4
FNQ
6
8
b) Emotional Support
0
5
10
15
20
Treatment Control
2
2
Treatment Control
22
0
5
Time (wks)
10
15
20
22
Time (wks)
6 4
FNQ 4
FNQ
6
8
d) Professional Support
8
c) Instrumental Support
0
5
10
15
20
Treatment Control
2
2
Treatment Control
22
0
5
Time (wks)
10
15
20
22
Time (wks)
6 4
FNQ 4
FNQ
6
8
f) Care Involvement
8
e) Community Support
0
5
10 Time (wks)
15
20
Treatment Control
2
2
Treatment Control
22
0
5
10
15
20
22
Time (wks)
Figure 2. Family Needs Questionnaire scale values for treatment and control group participants.
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TABLE 2
JOURNAL OF HEAD TRAUMA REHABILITATION/JULY-AUGUST 2015
Temporal differences for all outcome variables Treatment group Mean change
FNQ Health Information Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment FNQ Emotional Support Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment FNQ Instrumental Support Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment FNQ Professional Support Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment FNQ Community Support Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment FNQ Care Involvement Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment SOS Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment ZBI Posttreatment—baseline 3-mo follow-up—baseline 3-mo follow-up—posttreatment
Control group
P
SE (95% CI)
Mean change
SE (95% CI)
P
1.18 0.79 − 0.39
0.40 (0.40, 1.97) 0.48 (−0.14, 1.73) 0.43 (−1.23, 0.45)
.0030 .0958 .3638
− 0.58
0.75 (−2.06, 0.90)
.4399
1.65 1.20 − 0.46
0.43 (0.81, 2.49) 0.51 (0.20, 2.19) 0.45 (−1.35, 0.43)
.0001 .0184 .3127
− 0.10
0.79 (−1.65, 1.45)
.8967
0.29 0.27 − 0.03
0.47 (−0.62, 1.21) 0.56 (−0.83, 1.36) 0.50 (−1.02, 0.96)
.5292 .6331 .9554
0.32
0.71 (−1.38, 2.02)
.7089
2.10 1.65 − 0.44
0.45 (1.21, 2.98) 0.54 (0.60, 2.71) 0.48 (−1.39, 0.51)
