_____________________________________________________________________________________________________________

Fam Proc 30:85-99, 1991

A Randomized Clinical Trial of Inpatient Family Intervention: VI. Mediating Variables and Outcome IRA D. GLICK, M.D. JOHN F. CLARKIN, Ph.D. GRETCHEN L. HAAS, Ph.D. JAMES H. SPENCER, JR., M.D. CLARENCE L. CHEN, M.D. In a randomized clinical trial of Inpatient Family Intervention (IFI) for 169 inpatients with schizophrenia, affective disorder, and a residual group of other diagnoses, results suggested significant effects favoring IFI for patients and their families. The treatment effects were limited to females and to two diagnostic groups: chronic schizophrenia patients and the bipolar subgroup of affective disorders. Using analysis of variance and correlational analyses, we examined three variables that mediate between family treatment and outcome: 1) posthospital medication compliance, 2) posthospital psychosocial treatment compliance, and 3) patient rejection by the family. Results showed robust correlations between these variables and outcomes for all diagnostic subgroups. The pattern of associations between the mediating variables and outcome was more prominent for patients treated with IFI. These results were seen most clearly in the total sample, and for the subgroups of "all females" and "poor prehospital functioning females with schizophrenia." Finally, family achievement of the goals of the family intervention were positively associated with better patient outcome, while increased family burden at discharge was associated with shorter length of time posthospital to rehospitalization. Fam Proc 30:85-99, 1991 We have recently completed a study whose principal objective was to test the efficacy of family intervention in a hospital setting (1, 3, 5, 9). The specific study questions were: Does adding inpatient family intervention (IFI) to medication and standard hospital multimodal treatment result in increased efficacy? If so, for whom, patients or families, and for which diagnostic groups? A key related question was: How does it work? This report focuses on the last question, that is, on the process by which the outcomes were accomplished. We will identify and discuss the distinction between moderating and mediating variables. Moderating variables are those that influence whether a therapy is effective. In this study, there are two critical moderating effects: gender of patient and diagnosis. In contrast, mediating variables are those that intervene between the administration of a treatment and the ultimate outcome. These variables can help explain how a therapy works. In our manual for family treatment of patients hospitalized with diagnoses of schizophrenia, affective disorder, and the other Axis-I disorders, we specified key treatment foci for the family intervention. These foci contain hypotheses about how the family might alter or maintain certain patient behaviors, particularly through the influence of three mediating variables: 1) increasing their support for medication, 2) increasing their support for other treatment compliance, and 3) decreasing rejecting behavior toward the patient.

OUTCOME RESULTS To provide background for these process results, let us first summarize the treatment outcome results (1, 3, 5, 9). Results for the full sample of 169 psychiatric patients suggested that adding family treatment to standard hospital treatment was effective, but not uniformly so for all patient groups. At discharge, there was a positive effect of IFI that was largely restricted to female patients with affective disorder and their families, although it was present to a lesser extent in good pre-hospital functioning schizophrenics and "others." At followup, the statistical interactions indicated that this therapeutic effect was largely restricted to female patients with schizophrenia or major affective disorder. The effect of family treatment on male patients with these diagnoses was minimal or slightly negative. Also, of note, the IFI effect on schizophrenia did not appear until the 18-month, post-admission followup point; and, in contrast to our discharge results, the effect was most striking in the poor prehospital functioning group. Similarly (in contrast to the discharge results), for patients with affective disorder, the followup results revealed positive findings favoring the inpatient family intervention, but only in the bipolar subgroup. As for the outcome for families, followup results showed that family treatment was more efficacious for the families of patients (primarily females) with the major psychoses.

1

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METHOD This research was done on an acute care unit of the Payne Whitney Clinic. Its methodology is described elsewhere in detail (1, 3, 5, 9) and is summarized here. One hundred eighty-six subjects and their families met inclusion criteria and signed informed consent forms. The patients were classified by DSM-III, Axis-I criteria into four diagnostic groups: 1) schizophrenic/schizophreniform disorder with good prehospital functioning over the preceding 18 months, 2) schizophrenic/schizophreniform disorder with poor pre-hospital functioning over the preceding 18 months, 3) major affective disorder, and 4) other DSM-III, Axis-I diagnoses. Within each of these groups, patients were randomly assigned to either standard hospital treatment with family intervention or standard hospital treatment without family intervention (comparison group). The two treatments have been previously described by Haas and colleagues (5).To summarize, IFI was a brief45-60 minutes/session, 1-2 times/week (mean 8.6 sessions, mode 6)psychoeducational and problem-focused family intervention designed structure to help the patient and family cope with hospitalization and to lay the groundwork for better posthospital adjustment. The goals of IFI were: 1) patient/family acceptance of the reality of the illness and development of an understanding of the current episode; 2) identification of possible precipitating stresses in the current episode; 3) identification of likely future stresses inside and outside the family; 4) elucidation of family interactions that produce stress on the patient; 5) planning of strategies for managing and/or minimizing future stresses; and 6) acceptance by patient and family of the patient's need for continued treatment after hospital discharge. IFI was added to the standard hospital treatment for the experimental group; mean length of stay was 51 days. Because compliance with medication and psychotherapy were important variables to be evaluated, we describe (see Table 1) the general characteristics of the hospital treatment program for the two groups. Medication was partially controlled to insure that the patients in both groups received about equal amounts of the medications appropriate to their diagnoses. Posthospital treatment, including family treatment, was not controlled, that is, it was prescribed as clinically indicated. Table 1 Description of Treatment Program for Inpatient Family Intervention (IFI) and Comparison Groups* Factors Specific to Treatment Modality Type of Treatment

Description of Treatment

IFI

Comparison

Includes all patients; conducted by primary therapist (resident, psychology intern, or medical student)

Integrated into family sessions with primary therapist and social worker

Patient and family seen by primary therapist at time of admission, integrated into individual therapy sessions

Integrated into family sessions with primary therapist and social worker

Staff social worker consultation with primary therapist who works with patient individually around discharge planning issues

Includes IFI patients only; conducted by staff social workers with co-therapist (resident, psychology intern, or medical student); frequency: 1-2 times/wk, mean = 8.6, mode = 6 (45-60 minutes per session); type: heavy psychoeducation component with systemic-dynamic interventions as indicated

Included

Not included

Includes all patients; prescribed by MD

Somatic treatment plus Somatic treatment issues discussed at admission patient and family compliance issues always and discharge discussed in family sessions in context of family issues

Family intervention History-gathering

Disposition planning Includes all patients; conducted by staff social worker and primary therapist

Family sessions

Somatic treatments

Medication

For schizophrenia: antipsychotics prescribed for all patients in standard doses for at least 3-week trials For affective disorders: for unipolars, mostly

2

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tricyclics; and for bipolars, lithium carbonate (for acute manic stages or as adjunct antipsychotic) Electroconvulsive therapy Milieu therapy

Included for severe delusional, and medication-refractory, unipolar depressives Includes all patients; adapted to meet the patient's specific need for: (1) environmental structure, (2) modification of external stimulation, (3) support for expression of feelings, (4) confrontation and limit setting, (5) problem-solving/conflict resolution (6) social skills learning Frequency: ongoing throughout the patients's stay on unit

Therapeutic activities Includes all patients; conducted by members of the therapeutic activities department (occupational, vocational and recreational therapists) Frequency: approximately 2h/d Individual psychotherapy

Includes all patients; conducted by primary therapists (mostly psychiatric residents but occasionally psychology interns or medical students) [2.3 hrs/wk]y

Frequency: Group therapy

[1.7 hrs/wk]y

Includes all patients; conducted by staff nurses and supervised by attending psychologist Frequency: 2 times/wk

* Used with permission of the Archives

of General Psychiatry 45 (March 1988): 220, Haas et al. (5), Copyright 1988, American

Medical Association. y Modified from original article.

The family treatment and comparison groups were compared on certain demographic variables and on pretreatment baseline measures. The two groups were equivalent, except that the comparison group had more people who were married or had been previously married. To the extent that this difference may have affected outcome results, we would expect it to contribute to better outcome in the comparison groups. Patients were assessed at admission, at discharge, after 6 months, and after 18 months, from the vantage points of the patient, a significant other, and an independent assessor, on measures of global outcome, symptoms, and role functioning (work, family, social, and leisure time). Family attitudes toward treatment, social support, and the patient, as well as perceived family burden were also measured. We have previously described (1, 3, 5, 9) the scales that were used and their functions: the Global Assessment Scale (GAS), the Psychiatric Evaluation Form, the Family Attitude Inventory (which included the Patient Rejection Scale (see 9) items on family burden and additional items), the Goals of IFI Rating Scale, and the Role Performance Treatment Scale. We now describe in more detail two instruments that were central to the process analysis. We hypothesized that achievement of specific IFI treatment goals by the IFI families during the course of treatment would correlate with patient outcome. Individualized goals were set by the family therapist for each IFI family early in the hospitalization and were classified according to the six major goals of IFI. Achievement of each specific goal and the overall achievement of all treatment goals were rated at the point of hospital discharge by the family therapist using an instrument called the Goals of IFI Rating Scale. One of the six scales measured family support of the patient's compliance with treatment. For a variety of administrative reasons, this measure was completed on only 80% of the patients in the IFI treatment group. Compliance with treatment was assessed using an instrument developed for this study: the Treatment and Medication Compliance Data Scale (TMCDS) measured the degree of the patient's adherence to prescribed psychiatric treatments. The scale consists of a series of detailed questions about the patient's compliance to both medication and nonmedication (such as psychotherapy) forms of treatment. Information was collected about the exact nature and regimen of prescribed treatment as well as the patient's degree of compliance. It was administered to patients and their families by trained raters at time of admission in order to evaluate compliance with treatment before hospitalization, and at 6 and 18 months followup in order 3

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to evaluate compliance with posthospital treatment. The data obtained were then used in rating both medication and nonmedication treatment compliance on a 6-point scale ranging from complete noncompliance to total compliance. Inter-rater reliability for members of the assessment team was good: r = .94 for medication compliance ratings and r = .90 for nonmedication compliance ratings, using the TMCDS; the intraclass correlations were based on four raters rating 17 (10%) of the patients. Data gathered for the TMCDS were based on both the patient's self-report and the family member's report about outpatient treatments and adherence behavior. For cases in which the reliability of the report was questionable, the followup interviewer contacted the outpatient treating clinician. For all patients in the study, the initial assignment to diagnostic group was made with information available at admission, using DSM-III criteria. Since longitudinal course is crucial for a correct diagnosis, we made a diagnostic "update" at the end of the index episode to reach a final research diagnosis for each patient at 18 months, using all information then available. All data analyses are based on these research diagnoses. The focus was on a clearer delineation (than could be obtained at admission) of onset and course of illness, rather than on results of treatment. Results when analyzed using admission diagnosis versus followup diagnosis were not essentially different in either the direction or the magnitude of the effect. Seventeen of the original 186 patients (13 family treatment and 4 comparison) were dropped from the study during the course of hospitalization because their stays were too short for the requisite minimum of treatment. At 6-month followup, we obtained data on 168 of the 169 patients who had completed treatment (79 family intervention patients and 89 comparison patients). At 18-month followup, we obtained data on 158 patients (77 family treatment and 81 comparison). In a few cases (5 at 6 months and 9 at 18 months), we were unsuccessful in obtaining a portion of the family data. The low attrition rate (6.5%, 11/169) and the characteristics of the family treatment and comparison group dropouts indicated that differential attrition did not reduce the comparability of the two groups. The study design included several independent variables (treatment assignment, diagnosis, and sex) and several dependent (outcome) variables for the patients and the families. We reduced the dependent variables to composite outcome measures using principal-components analysis, a form of factor analysis, and regression procedures. This produced two patient outcome composite measures, one derived from the measures of global functioning and symptoms and the other derived from the measures of role functioning (which accounted for 44% and 11% of the variance in patient outcome, respectively, at 18 months). An independent principal-components analysis of the family measures yielded two family outcome composite measures, one derived from the Family Attitude Inventory scales for attitude toward treatment and openness to social support, and one derived from the Patient Rejection Scale and the family burden scales (which accounted for 26% and 43% of the variance in family outcome, respectively, at 18 months). These composite measure variables were then included in two sets of three-way (treatment by symptom by diagnosis) analyses of covariance (ANCOVA) with the composite measure at baseline as the covariate and the composite measure at followup as the dependent variable. We tested the main effect of treatment assignment on each composite at each followup point, along with the two-way and three-way interaction effects with sex and diagnosis (see Tables 2 and 4). These "higher order" analyses with composite outcome measures provided stastical protection against chance findings. Table 2 The Effect of Treatment Assignment on the Association of Mediating Variables with Outcome for Various Patient Groups (on the Global/Symptomatology Composite) Treatment Assignment IFI Mediating Variables

Comparison

6 mos

18 mos

6 mos

18 mos

(r)

(r)

(r)

(r)

All Patients (n = 169) Posthospital compliance with medication:

0.20*

0.18y

0.07

0.12

with psychosocial treatment:

0.24*

0.01

0.20*

0.19

-0.49**

-0.45**

-0.32**

-0.35**

Family rejection of patient1

All Female Patients(n = 91) Posthospital compliance with medication:

0.30*

0.25*

0.00

0.06

with psychosocial treatment:

0.25*

0.02

0.21y

0.27*

-0.53**

-0.55**

-0.42**

-0.27*

Family rejection of patient

4

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Poor Functioning Schizophrenic Females (n = 25) Posthospital compliance with medication:

0.76**

0.04

0.15

0.19

with psychosocial treatment:

0.60**

0.37y

0.22

0.25

-0.52*

-0.61**

-0.62*

-0.21

Family rejection of patient

Bipolar Disorder Patients (n = 21) Posthospital compliance with medication:

0.10

0.04

with psychosocial treatment:

0.36

0.44y

0.11

0.27

-0.65**

-0.52*

-0.17

-0.22

Family rejection of patient

0.76**

0.07

p < 0.10 < 0.05 ** p < 0.01 1 As measured on the Patient Rejection Scale (D. E. Kreisman, 1987; see reference 9).

y

*p

Table 3 The Effect of Treatment Assignment on the Association of Mediating Variables with Outcome for Bipolar Patients (on the Role Functioning Composite) Treatment Assignment IFI Mediating Variables

Comparison

6 mos

18 mos

6 mos

18 mos

(r)

(r)

(r)

(r)

0.10

0.02

0.11

0.38

0.42y

0.56*

0.18

0.14

-0.26

-0.49y

-0.37

-0.35

Posthospital compliance with medication: with psychosocial treatment: Family rejection of patient1 p < 0.10 < 0.05 ** p < 0.01 1 As measured on the Patient Rejection Scale

y

*p

Table 4 Analysis of Variance Results Testing Effects of Treatment Assignment on the "Mediating" Variables Medication Compliance Psychosocial TX Compliance Family Rejection of Patient Patient Group

6 mos

18 mos

6 mos

18 mos

6 mos

18 mos

All patient (N = 169)

NS

NS

NS

NS

NS

NS

All females1(n

NS

NS

+

NS

NS

NS

Poor prehospital functioning females with schizophrenia2 (n = 25)

NS

NS

+

NS

NS

NS

Bipolar patients (n = 21)

NS

NS

NS

NS

NS

NS

= 91)

1 IFI > Comp, F = 2 IFI > Comp, F = +=

3.20, df = 1,88; p < 0.08 2.93, df = 1.24; p < 0.10

p < .10

Evaluation of Mediating Variables As for the "process" analyses, we should first note that the study was originally designed and carried out as an outcome,

5

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not a process, study, and there are many potential post hoc hypotheses as to process variables that could have contributed to the observed outcomes. In this process study, we limited hypothesis testing to two moderating variables: sex and diagnosis (and, in the case of schizophrenia, two levels of previous functioning), and to the three hypothesized mediating variables: treatment compliance to medication and to nonmedication, and family rejection of patient. We had included measures of the mediating variables in the outcome study because we had a priori hypothesized that the IFI treatment would have its effect on patient outcome via enhancement of treatment compliance and family attitudes toward patient. We have tested our hypotheses on the sample as a whole and on only those subgroups of patients who showed overall significant results of treatment. We have tried to specify a model for how the process might work (see Figure 1). In short, we asked two main questions: 1) Taking into account prehospital compliance patterns, how did hospital treatment with IFI affect the mediating variables? 2) How did the mediating variables affect outcome for both patients and their families? We were also interested in whether IFI would enhance the linkage of the mediating variables and outcome. We also asked if family burden as well as family achievement of the goals of IFI were associated with outcome.

Figure 1. A model for understanding process and outcome results.

Data Analysis To assess the association between the hypothesized "mediating" IFI treatment variables and patient outcome, we examined the correlations between the three specified mediating variables (that is, posthospital medication compliance, posthospital psychosocial treatment compliance, and family rejection of patient) and the composite measures of outcome. Due to limited sample size, such methods as path analysis1 and structural modeling could not be used. Instead, we used analyses of variance and covariance to test treatment effects of the mediating variables. To identify factors that might "explain" the differential treatment outcomes and help to illuminate something of the "process" or "mechanism of change," we compared the magnitude of the correlations between mediating variables and patient outcome across the two treatment groups (IFI and comparison). We used the correlation coefficients to examine the relationship between the clinician's rating of the family's achievement of the goals of IFI and patient outcome. Finally, we used chi-square and t-tests to compare differences between groups on the amount of posthospital treatment received.

RESULTS Which, if any, of the mediating variables (posthospital compliance with medication, posthospital compliance with psychosocial treatments, and patient rejection) correlated with clinical status at followup? Examination of Tables 2 and 3 reveals a number of significant correlations for each of the mediating variables and outcome, depending on the patient group examined. For example, Table 2 shows that when all patient diagnostic groups are combined, lessened family rejection of the patient was significantly correlated with improved patient outcome for both the IFI group r = -.49 and -.45 at 6 and 18 months), as well as for the comparison treatment group (r = .32 and -.35). Does assignment to IFI (versus the comparison treatment) enhance treatment compliance and family attitudes at

6

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followup (that is, does treatment assignment influence scores on the mediating variables at followup)? To evaluate this question, we performed three sets of analysis of covariance procedures, one for each of the three mediating variables (see Table 4). We included treatment assignment as the independent variable, the measure of the mediating variable at 6 and 18 months followup as the dependent variables, and baseline values of the compliance measures as the covariate. We found, in general, our hypothesis that assignment to IFI would enhance compliance and family attitudes at followup was not confirmedwith the exception of a few trends. Treatment assignment did not predict posthospital compliance with either medication or psychosocial treatment, nor did it predict family rejection of the patient at either 6 or 18 months. The sole exception was for female patientswe found a trend for treatment assignment to IFI to be weakly (p < .10) associated with posthospital psychosocial treatment compliance (which included individual, group, and family therapy). Does the association between these mediating variables and patient status at followup differ for the IFI versus the comparison patients? What does this suggest about the mechanism of change? We found a general trend for more numerous, significant associations between mediating variables and patient status at followup (see Table 2), favoring IFI over the comparison group. For all patients, and all females, the magnitude of the correlations between medication compliance and outcome at 6 months are near 0.0 for the comparison treatment group, whereas they are significant for the IFI treatment group. Tests of significance on the differences between correlations revealed a trend (p < .09) for a stronger association between compliance and outcome at 6 months for the "poor prehospital functioning schizophrenic females," and a trend (p < .08) for a stronger association between medication compliance and outcome at 18 months (on the global symptomatology composite) for the bipolar disorder patients. For the bipolar disorder patients, results presented in Tables 2 and 3 reveal that the association between medication compliance and outcome did not hold. For this group, we examined the association between mediating variables and role functioning (see Table 3) because it was the role-functioning measure on which the treatment effects were found. Compliance with psychosocial treatments correlated with role functioning at both 6 and 18 months, while patient rejection correlated only weakly with role functioning at 18 months. Which mediating variables account for superior outcome for patients treated with IFI (see Table 2)? Six-month followup results indicate that during the first 4 to 5 months following discharge from the hospital, posthospital medication complianceparticularly in combination with IFIwas found to be an important correlate of clinical outcome not only for the "all-patients" subgroup but (specifically) for females and for all poor prehospital functioning schizophrenic females. The other hypothesized mediating variables, although correlated with outcome, were not differentially correlated with the two treatment groups. In summary, with the exception of the bipolar patients, the linkage between medication compliance and global outcome was stronger for patients assigned to IFI than for those assigned to the comparison group. For the bipolar patients, our results were somewhat different. Among the comparison patients, global clinical outcome at 18 months was associated with medication compliance. IFI outcome was not associated with medication compliance; rather, it was associated with both psychosocial treatment compliance and patient rejection. Patient rejection was correlated with global outcome at 6 and 18 months for the IFI group but not for the comparison groupsuggesting that the family's lessened rejection of their patient-family member was a key correlate of improved clinical outcome for IFI patients. As for role functioning, the dimension that showed the strongest treatment effects for the bipolar disorder patients, psychosocial treatment compliance, was most strongly correlated with outcome (see Table 3). Did the family's overall achievement of the goals of IFI correlate with patient outcome? In general, Table 5 reveals that there were significant, and consistent, correlations for all groupsfor all patients, for all females (at 6 months only), for poor prehospital functioning schizophrenic females, and for the bipolar patients (at 6 months only). This indicates a positive association between patient outcome and the clinical global rating of the family's overall achievement of the goals of IFI. A related question was: Did the family's achievement of the goal of supporting patient compliance with medication and psychosocial treatment correlate with the actual patient outcome? Examination of the support of patient compliance goal in Table 5 reveals virtually parallel results to the above, except that they are less robust and are not present in the bipolar subgroup. Because of that finding (see Table 6), we examined the relationship between actual posthospital patient medication compliance and family support of compliance; we did not find that the family support of medication compliance strongly correlated with the actual patient compliance. Table 5 Association between Family Achievement of the Goals of IFI and Patient Clinical Status at Followup (IFI Patients Only) Family Achievement of Goals of IFI Overall Achievement1 Patient Group

7

6 mos

18 mos

Patient Compliance2 6 mos

18 mos

_____________________________________________________________________________________________________________

All patients (N = 79)

0.35**

0.26*

0.30**

0.21

All females (n = 47)

0.28*

0.17

0.24y

0.10

0.41y

0.50*

0.40y

0.48y

0.60*

0.11

0.45

0.01

Poor prehospital functioning females with schizophrenia (n = 14) Bipolar patients (n = 12)

1 Overall = Overall achievement of the goals of the IFI treatment, as rated by the family clinician at time of discharge from treatment. 2 Goal 6 = "Family Support of Posthospital Patient Compliance," as rated by family clinican at time of discharge from treatment. ** p

< 0.01 < 0.05 y p < 0.10 *p

Table 6 Association between Family's Achievement of the Goal 6 "Support for Patient Compliance" & Actual Patient Compliance at 6 and 18 Months (IFI Patients Only) Medication Compliance Psychosocial Compliance 6 mos

18 mos

6 mos

18 mos

(r)

(r)

(r)

(r)

All patients (N = 79)

0.20y

0.10

0.09

-0.12

All females (n = 47)

0.10

0.10

0.01

-0.22

0.10

-0.41y

0.36

-0.43y

0.01

0.47y

0.10

0.03

Poor prehospital functioning females (n = 14) Bipolar disorder (n = 12) y

p < .10

Does assignment to IFI increase the amount of posthospital treatment received (see Table 7)? Table 7 Summary of Posthospital Treatment for All Subjects at Followup Followup 6 Months Type

Measure

IFI

Comp

p

IFI

Comp

p

Hospitalization

% Patients hospitalized

14

16

NS

24

20

NS

Medication

% Patients in medication review

44

59

0.08

56

56

NS

Family Threrapy

% Patients in family therapy

23

9

0.02

15

10

NS

Length of time in family treatment (mean N of weeks per patientthose in family Therapy)

10.9

10.6

NS

30.0

18.0

0.04

Length of time in treatment (mean N of weekks per patientonly

11.5

20.5

0.07

32.0

52.0

NS

Self-help Support Group

8

18 Months

_____________________________________________________________________________________________________________

those in Support Group) Vocational Rehabilitation Length of time in treatment (mean N of weeks per patientonly those in Vocational Rehabilitation)

10.6

5.6

0.05

12.7

13.8

NS

For all patients, treatment with IFI results in a greater likelihood of both entering into (p < .02) and spending more time in (p < .04) posthospital family therapy, as well as more time in self-help support groups (p < .07) and vocational rehabilitation (p < .05). For all schizophrenics, the IFI effect on posthospital family therapy is seen at 6 months in both the good prehospital functioning (more patients in the therapy, p < .005) and the poor prehospital functioning (greater length of time in treatment, p < .06) subgroups. Finally, we examined two other related issues. We performed a survival analysis using Cox's proportional hazards model to evaluate the impact of family intervention on rehospitalization. We did not find a significant effect of IFI (p = 0.70, ns)see Figure 2. On the other hand, we did find a negative association between level of family burden at discharge with time to patient rehospitalization (p < .004).

Figure 2. Survival curves: IFI versus Comparison group.

DISCUSSION Previous reports from this study have presented data that suggest modest effects of an inpatient family intervention on outcome for both patients and families, but these effects varied as to subgroup and outcome points examined. Our intent in this report was to examine the relationship between hypothesized process variables and outcome. More specifically, we have examined the relative strength of hypothesized mediating factors for various patient subgroups.

9

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As reported in our articles on outcome results, we found two moderating factorsgender and diagnosisthat interacted with treatment assignment to produce variable outcomes. We had anticipated variable effects across diagnostic groups but not across gender groupsalthough the gender finding was consistent with previous research that interpersonal interventions have been found somewhat more effective with females than males (2, 6, 7, 8). We hypothesized a priori that mediating variables of 1) posthospitalization medication compliance, 2) posthospitalization psychosocial treatment compliance, 3) decreased family rejection of patient, and 4) family achievement of the goals of IFI would promote better outcome for both patients and family. We found the following: 1) With respect to what extent the mediating variable correlated with outcome, we found relatively strong correlations between the first three mediating variables and outcomes for all groups. This is gratifying as it was consistent with prior research emphasizing the importance of medication, psychosocial treatment, and reducing high expressed emotion. 2) In response to whether IFI affected the mediating variables, the answer is a qualified nothat is, we found only a few suggestive trends reflecting IFI effect on these variables. Given the brevity (68 sessions) of our intervention, the acute nature of the illness, and the stress of the family at this point, this is not surprising. In addition, it is difficult to show an incremental effect, that is, an effect that significantly augments or increases the demonstrated effectiveness of other hospital interventions, such as medication. The arguments may also be relevant to the effect of IFI on the mediating variables. This brings us to the most important process question, namely, 3) was there a relationship among the treatment, the mediating variables, and outcome? To our surprise, the most potentially important finding of the study was that IFI resulted in significant enhancement of the linkage between the mediating variables and outcome. This finding, although requiring replication, has important clinical implications. Examination of the data in Tables 2 and 3 shows an interesting contrast between the bipolar and other groups. Posthospital compliance with medication is associated almost exclusively with outcome in the IFI treatment groups. The sole exception is found in the data for the bipolar patients, for whom posthospital medication compliance correlates with outcome in the comparison group (only at 18 months). Role functioning for the bipolar patients treated with IFI is significantly correlated with posthospital compliance with psychosocial treatment, rather than medication. One might speculate that psychosocial treatment, involving as it does a stronger focus on interpersonal relations, may have a more direct and therefore effective influence on role functioning (including social, family, and work roles), thus contributing to the superior 18-month outcome on role-functioning parameters in the IFI group. Alternatively, compliance with psychosocial treatments may merely reflect patient skills in dealing with interpersonal role function (and, in this case, meeting with a clinician for treatment). Hence, a secondary effect of improved patient role-functioning outcome would be improved patient compliance. The pattern of our findings, however, would tend to argue against the latter explanation. The fact that the link between posthospital compliance and role-functioning outcome is relatively exclusive to IFI, would suggest that there is something about the treatment that has influenced this link rather than something more generic about the patient role functioning that has influenced posthospital compliance. Our major finding, and what is perhaps most interesting, is that although IFI does not directly affect the mediating variables, it does seem to enhance (or make possible) the effect these variables have on outcome. What we have shown here is that the effects of IFI intervention may be observed in terms of the impact of compliance on outcome. In effect, only in the presence of IFI does variation in levels of patient compliance lead to the expected variations in clinical outcome. Previous studies of outpatient family treatments, including the work of Falloon (2), Goldstein (4), Leff (7), Hogarty (6) and their colleagues, which are also consistent with the rationale for the ongoing NIMH Collaborative Study of Treatment Strategies in Schizophrenia (8), have demonstrated that drug therapy and family therapy are additive. Results of this study suggest an interesting additive effect of an inpatient family intervention used in combination with other hospital (including somatic) treatments. Adding IFI may reduce the influence of extraneous (non-controlled) factors, that is, the "noise" in the system, and thereby enhance the linkage between medication compliance and outcome in at least some patient groups. Many clinicians believe that the more a particular family achieves its goals during the hospitalization, the better the patient outcome after hospitalization. Accordingly, our data showing robust correlations between patient outcome and both the achievement of the family goals as well as increased family support for posthospital compliance, may suggest clinical implications (even though we do not know the actual family dynamics responsible). That is, given the limited resources available for inpatient family work, for some families, especially those who are doing poorly in achieving the prescribed goals, a particular family intervention may need to be changed or, in some cases, discontinued altogether. A few caveats in closing. This was the first randomized clinical trial of an inpatient family intervention, therefore, the findings need replication. As such, we view the outcome results as suggestive, not definitive. Since, however, these were positive effects of IFI on outcome, we believed it important to attempt to understand the treatment process as it related to outcome. Furthermore, we did not examine all possible process variablesonly a few that the literature on family factors suggested, and which we believed were relevant to patient outcome. Finally, we recognize that correlational data provide

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only limited information about an association, in these cases, between hypothesized "mediating" variables and treatment outcome. Correlations cannot tell us about the direction of influence, nor the causal relationship between mediating variables and outcome. However, on clinical grounds, a priori hypotheses postulated 1) that the most likely direction of effect was a unilateral impact on outcomes of the mediating variables (so-called, to reflect their presumed influence in mediating the effects of treatment), and 2) that the tendency for these correlations to appear almost exclusively in the case of the IFI treatment groups indicates a possible treatment effect on these correlations. Further investigation is needed to assess whether IFI acts indirectly, by reducing the potential influence of extraneous, uncontrolled factors on treatment outcome, or directly, by augmenting the influence of mediating variables (posthospital treatment compliance and critical family attitudes toward patient). In spite of these limitations, the data from this unique, large-N, random assignment, clinical trial do provide "leads" concerning both process and outcome of inpatient family treatmentsleads that should guide us in further refining future investigations of family treatments in hospital settings.

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Clarkin, J. F., Glick, I. D., Haas, G. L., Spencer, J. H., Lewis, A. B., Peyser, J., DeMane, N., Good-Ellis, M., Harris, E. and Lestelle, V., A randomized clinical trial of inpatient family intervention, V: Results for affective disorders. Journal of Affective Disorders, 18, 17-28, 1990. Faloon, I.R. H., Boyd, J. L., McGill, C. W., Williamson, M., Razani, J., Moss, H. B., Gilderman, A. M., Alexander, M. and Simpson, G. M., Family management in the prevention of morbidity of schizophrenia: Clinical outcome of a two-year longitudinal study. Archives of General Psychiatry, 42, 887-896, 1985. Glick, I. D., Spencer, J. H., Jr., Clarkin, J. F., Haas, G. L., Lewis, A. B., Peyser, J., DeMane, N., Good-Ellis, M., Harris, E. and Lestelle, V., A randomized clinical trial of inpatient family intervention. IV. Followup results for subjects with schizophrenics. Schizophrenia Research, 3, 187-200, 1990. Goldstein, M. J., Rodnik, E. H., Evans, J. R., May, P.R. A. and Steinberg, M. R., Drug and family therapy in the aftercare of acute schizophrenics. Archives of General Psychiatry, 35, 1169-1177, 1978. Haas, G. L., Glick, I. D., Clarkin, J. F., Spencer, J. H., Lewis, A. B., Peyser, J., DeMane, N., Good-Ellis, M., Harris, E. and Lestelle, V., Inpatient family intervention: A randomized clinical trial, II: Results at hospital discharge. Archives of General Psychiatry, 45, 217-224, 1988. Hogarty, G. E., Anderson, C. M., Reiss, D. J., Kornblith, S. J., Greenwald, D. P., Javna, C. D. and Madonia, M. J., The EPICS Schizophrenia Research Group. Family psychoeducation, social skills training, and maintenance chemotherapy in the aftercare treatment of schizophrenia: I. One-year effects of a controlled study on relapse and expressed emotion. Archives of General Psychiatry, 43, 633-642, 1986. Leff, J., Kuipers, L., Berkowitz, R., EberleinVries, R. and Surgeon, D., A controlled trial of social intervention in the families of schizophrenic patients. British Journal of Psychiatry, 141, 121-134, 1982. Schooler, N. R., Keith, S. J. and Severe, J. B., the Treatment Strategies and Schizophrenia Collaborative Study Group. Acute treatment response and short term outcome in schizophrenia: First results of the NIMH treatment strategies in schizophrenia study. Psychopharmacology Bulletin, 25, 331-334, 1990. Spencer, J. H., Glick, I. D., Haas, G. L., Clarkin, J. F., Lewis, A. B., Peyser, J., DeMane, N., Good-Ellis, M., Harris, E. and Lestelle, V., A randomized clinical trial of inpatient family intervention, III: Effects at 6-month and 18-month follow-ups. American Journal of Psychiatry, 145, 1115-1121, 1988.

Manuscript received November 30, 1989; Revisions submitted August 16, 1990; Accepted October 15, 1990. 1We realized that the number of variables involved in path analysis (drawing as it does on measures at multiple time points as

well as the three hypothesized mediating variables under study) would greatly exceed the number supported with our sample sizes. Thus, we elected to present the correlational data as we have, treating it as suggestive. We recognize the need for cross-validation and/or enlargement of the sample to permit the more complex path analyses.

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A randomized clinical trial of inpatient family intervention: VI. Mediating variables and outcome.

In a randomized clinical trial of Inpatient Family Intervention (IFI) for 169 inpatients with schizophrenia, affective disorder, and a residual group ...
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