584054
research-article2015
JADXXX10.1177/1087054715584054Journal of Attention DisordersJournal of Attention DisordersSciberras et al.
Article
Managing Anxiety in Children With ADHD Using Cognitive-Behavioral Therapy: A Pilot Randomized Controlled Trial
Journal of Attention Disorders 1–7 © 2015 SAGE Publications Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1087054715584054 jad.sagepub.com
Emma Sciberras1,2,3, Melissa Mulraney1, Vicki Anderson1,2,3, Ronald M. Rapee4, Jan M. Nicholson1,5, Daryl Efron1,2,3, Katherine Lee1,3, Zoe Markopoulos1, and Harriet Hiscock1,2,3
Abstract Objective:This pilot randomized controlled trial examined the acceptability and feasibility of a cognitive-behavioral therapy (CBT) intervention for children with ADHD and anxiety, and provided preliminary information on child and family outcomes. Method: Children with ADHD and anxiety (8-12 years) were randomized to receive an adapted version of the Cool Kids CBT program or usual clinical care. Key outcomes included feasibility and acceptability of the intervention (participant enrollment, drop-out, intervention session attendance), remission of anxiety assessed via diagnostic interview, ADHD symptom severity, quality of life (QoL), and parent mental health. Results: Twelve children participated (67% uptake). Most families attended all 10 intervention sessions, with no drop-outs. Intervention participants had marked improvements in both child and family well-being by parent and teacher report, including anxiety, ADHD symptom severity, QoL, and parent mental health. Conclusion: Non-pharmacological interventions may improve important domains of functioning for children with ADHD and anxiety, including ADHD symptom severity. (J. of Att. Dis. XXXX; XX(X) XX-XX) Keywords ADHD, anxiety, cognitive-behavioral therapy, randomized controlled trial, children Approximately 25% of children with ADHD meet criteria for at least one anxiety disorder (Jarrett & Ollendick, 2008), and there is growing evidence that anxiety exacerbates impairments for these children (Bowen, Chavira, Bailey, Stein, & Stein, 2008; Pfiffner & McBurnett, 2006; Sciberras et al., 2014). Children with both ADHD and anxiety have more severe executive and school functioning difficulties including school absenteeism, poorer quality of life (QoL), and more strained family relationships (Bowen et al., 2008; Pfiffner & McBurnett, 2006; Sciberras et al., 2014). Managing anxiety may be one way of improving the broader functioning of children with ADHD; however, anxiety is often under-detected in this population (Efron, Davies, & Sciberras, 2012). Non-pharmacological treatments for managing anxiety in children with ADHD are desirable given parent preferences for psychological treatments (Dosreis et al., 2003) and the potential side effects and drug interactions when multiple psychotropic medications are prescribed (Efron et al., 2003). Cognitive-behavioral therapy (CBT) has the strongest empirical support for the management of pediatric anxiety (Rapee, Schniering, & Hudson, 2009). A small number of pre- and post-test studies have reported that CBT improves anxiety in children with ADHD (Houghton, Alsalmi, Tan, Taylor, &
Durkin, 2013; Jarrett & Ollendick, 2012); however, existing studies use non-randomized designs, do not include blinded outcomes, and have not examined benefits to broader areas of functioning including QoL, school-based functioning, and family functioning. Improvements observed in pre- and posttest studies may merely reflect natural resolution of anxiety rather than true treatment effects. This pilot randomized controlled trial (RCT) aimed to (trial number: ISRCTN33930984) (a) examine the acceptability and feasibility of a CBT program to treat anxiety in children with ADHD (primary outcome), and (b) explore associated improvements in child and parent outcomes assessed using multi-source assessment.
1
Murdoch Childrens Research Institute, Parkville, Australia The Royal Children’s Hospital, Parkville, Australia 3 The University of Melbourne, Parkville, Australia 4 Macquarie University, Sydney, Australia 5 La Trobe University, Melbourne, Australia 2
Corresponding Author: Emma Sciberras, Murdoch Childrens Research Institute, The Royal Children’s Hospital, Flemington Road, Parkville, Victoria 3052, Australia. Email: [email protected]
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Journal of Attention Disorders
Method Study Design and Sample Children aged 8 to 12 years with ADHD were recruited from an ADHD Assessment Clinic and previous research studies at The Royal Children’s Hospital, Melbourne. Ethics approval was granted by the Human Research Ethics Committees of the Royal Children’s Hospital (#33186), the Victorian Department of Education and Early Childhood Development (#2013_002150), and the Catholic Education Office Melbourne (#1943). To be eligible, children needed to (a) meet full criteria for ADHD assessed using the ADHD Rating Scale IV (DuPaul, Power, Anastopoulos, & Reid, 1998) and (b) meet criteria for generalized, social, or separation anxiety disorder assessed using the Anxiety Disorders Interview Schedule for Children IV (ADIS-C; Lyneham & Rapee, 2005). Children were excluded if they were already receiving specialist help to manage anxiety. Children taking medication for anxiety were not excluded provided they were still experiencing significant anxiety and had been on a stable dose for a minimum of 6 weeks prior to enrollment. Interested and eligible families were mailed consent forms and baseline surveys for the primary caregiver and child to complete.
Randomization On receipt of the completed consent forms and baseline surveys, families were randomized to the “intervention” or “usual care” group. Children in the usual care group continued to receive treatment as usual for their ADHD from their treating pediatrician. At this point, teachers were emailed a survey to complete about the child’s baseline functioning. An independent statistician generated a randomization schedule using a computerized random number sequence. Assignment was in a ratio of 1:1 “intervention” to “usual care.” Allocation was concealed from families and researchers using sealed opaque envelopes until parent consent was obtained. Children in the usual care group continued to access care from their pediatrician for the management of ADHD along with any other health concerns that arose during the study.
Intervention The intervention group received the Cool Kids CBT program designed for the treatment of pediatric anxiety (Rapee et al., 2013), consisting of eight 60-min weekly sessions, followed by two 60-min biweekly sessions (total of 10 sessions). The program aims to help families and children learn about anxiety and worries and develop the skills to be able to manage child anxiety. Trained facilitators (E.S., M.M.) conducted each session, which included time with the child
and parent(s) alone and time with the child and parent together. An individual as opposed to group format was used to cater to the needs of children with ADHD. Adaptations were made to the program to make it more acceptable for children with ADHD and their parents including (a) use of an activity schedule and positive reinforcement to promote on-task behavior, (b) 1-min “brain breaks” between activities, (c) shortening and repetition of key concepts, and (d) use of visual aids in the sessions and at home to promote skills practice.
Measures The primary outcome was the feasibility and acceptability of the intervention assessed via rates of participant enrollment, drop-out, and intervention session attendance. Secondary child outcome measures were the parentcompleted ADIS-C administered by a blinded interviewer, the Spence Children’s Anxiety Scale (Nauta et al., 2004; child and parent report), the Child Anxiety Life Interference Scale (Lyneham et al., 2013; child and parent report), School Anxiety Scale (Lyneham, Street, Abbott, & Rapee, 2008; teacher report), ADHD Rating Scale IV (DuPaul et al., 1998; parent and teacher report), the Strengths and Difficulties Questionnaire (Goodman, 2001; parent and teacher report), the Pediatric Quality of Life Inventory 4.0 (Varni, Limbers, & Burwinkle, 2007; parent and child report), child school attendance (Sung, Hiscock, Sciberras, & Efron, 2008; parent report), and sleep problems (Sung et al., 2008; parent report) assessed at baseline and 5 months post randomization (~6 weeks post intervention). Parent outcomes included the Depression Anxiety Stress Scales (Lovibond & Lovibond, 1995), parenting anger and consistency (Zubrick, Lucas, Westrupp, & Nicholson, 2014), and work attendance (Sung et al., 2008).
Statistical Analysis Analyses were conducted on an intention-to-treat basis. Descriptive statistics were used to summarize the acceptability and feasibility of the intervention. The mean difference in secondary outcomes between the usual care and intervention group was examined using logistic and linear regression. All analyses were re-run adjusting for baseline functioning, and Cohen’s d effect sizes were reported for adjusted findings. Given the proof-of-principle nature of this study, it focused on effect sizes rather than statistical significance testing. Effect size differences of 0.20 to 0.49 were considered small, 0.50 to 0.79 medium, and above 0.80 large (Cohen, 1992). No adjustment for baseline was used for teacher-reported outcomes, as 10 of the 12 participants changed teachers between baseline and follow-up. All analyses were conducted using Stata Version 13.0.
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Sciberras et al.
Opt out letters sent n = 64
Excluded Opted out n = 12 Uncontactable n = 14
Screening calls made n = 38
Excluded Not meeting ADHD criteria n = 4 Not meeting anxiety criteria n = 7 Receiving specialist help for anxiety n=7 Intellectual disability n = 1 Opted out n = 1
ADHD and anxiety disorder n = 18
Excluded Not interested n = 5 Too busy n = 1
Randomised n = 12
Allocated to intervention n=6
Allocated to usual care n=6
Received intervention n=5
Lost to follow-up n =0
Lost to follow-up n =0
Figure 1. Summary of participant flow. Table 1. Sample Characteristics. Characteristics Child Male, n Age, M (SD), range ADHD subtype, n Combined Inattentive Medication use, n Methylphenidate Clonidine Melatonin Anxiety diagnoses, M (SD), range Parent Mother, n Age, M (SD), range Education status, n Did not complete high school College/postgraduate degree Employed, n
Results Sixty-seven percent of eligible families approached agreed to be enrolled in the trial (n = 12, see Figure 1; see Table 1 for sample characteristics). Five of the 6
Intervention (n = 6)
Usual care (n = 6)
5 10.4 (1.3), 8.4-12.2
6 11.6 (0.6), 10.6-12.2
3 3 5 4 1 1 2.3 (0.8), 1-3
3 3 4 4 0 0 2.0 (0.6), 1-3
6 48 (3.3), 43.4-52.6
6 45.5 (4.9), 41.6-53.4
2 4 5
3 3 6
intervention families attended all 10 sessions. The other family only attended three sessions before follow-up but continued to be engaged with the study. All intervention families reported the program was helpful and would
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Table 2. Mean Difference in Parent- and Child-Reported Outcomes at 5 Months Post Randomization. Study group
N
Child outcomes Parent report SCAS Baseline 6 5 months 6 CALIS impact on parent Baseline 6 5 months 6 CALIS impact on child Baseline 6 5 months 6 ADHD Rating Scale IV Baseline 6 5 months 5 PedsQL psychosocial Baseline 6 5 months 5 SDQ total Baseline 6 5 months 5 Child report SCAS Baseline 6 5 months 5 CALIS impact on child Baseline 6 5 months 5 PedsQL Baseline 6 5 months 5 Parent outcomes DASS total Baseline 6 5 months 5 Consistent parenting Baseline 6 5 months 5 Irritable parenting Baseline 6 5 months 4
Adjusted effect sizea
M (SD)
N
M (SD)
33.0 (18.0) 21.3 (17.0)
6 5
29.0 (4.6) 25.4 (3.8)
— −7.7 [−18.0, 2.6]
— −6.9 [−17.2, 3.4]
— −0.6
18.7 (12.8) 12.2 (12.1)
6 5
9.7 (6.1) 8.8 (5.6)
— −6.1 [−11.4, −0.8]
— −4.8 [−10.6, 1.1]
— −0.5
15.3 (8.2) 9.8 (8.7)
6 5
11.8 (4.2) 10.0 (4.0)
— −4.7 [−9.7, 0.3]
−4.3 [−10.1, 1.4]
−0.6
35.5 (11.9) 30.0 (12.5)
6 4
29.3 (9.2) 27.3 (2.9)
— −6.4 [−16.7, 4.0]
— −3.6 [−14.5, 7.3]
— −0.4
49.0 (14.9) 64.0 (17.9)
6 5
55.6 (8.8) 61.3 (8.3)
— 10.9 [−6.6, 28.4]
21.3 (7.4) 15.8 (5.8)
6 5
17.7 (2.6) 16.6 (4.6)
— −3.4 [−8.9, 2.3]
40.7 (20.6) 25.4 (14.3)
6 5
25.2 (10.8) 17.2 (12.4)
— −1.4 [−18.5, 15.7]
— 2.4 [−15.1, 20.0]
— 0.2
12.5 (7.9) 12.6 (8.6)
6 5
6.5 (5.4) 4.6 (5.0)
— 0.4 [−8.2, 9.0]
— 2.8 [−7.9, 13.6]
— 0.4
52.5 (14.6) 61.0 (13.3)
6 5
66.4 (13.1) 73.7 (15.3)
— −2.2 [−22.4, 17.9]
— −0.1
11.0 (4.6) 6.4 (2.7)
6 5
13.7 (7.0) 14.8 (7.7)
— −3.2 [−13.2, 6.8]
— −7.1 [−17.5, 3.2]
— −1.0
18.2 (2.3) 19.2 (2.2)
6 5
16.8 (3.0) 17.8 (1.3)
— −0.8 [−5.0, 3.4]
— 0.9 [−1.9, 3.7]
— 0.5
8.2 (4.7) 6.5 (2.1)
6 5
6.7 (2.2) 14.8 (3.1)
— −2.0 [−8.5, 4.5]
— −1.4 [−5.6, 2.8]
— −0.4
Intervention Outcome
Adjusted M differencea, intervention control [95% CI]
M difference, intervention control [95% CI]
Usual care
— 3.0 [−14.1, 20.2]
— 8.0 [−10.9, 27.0] — −2.6 [−7.9, 2.8]
— 0.6 — −0.5
Note. CI = confidence interval; SCAS = Spence Child Anxiety Scale; CALIS = Child Anxiety Life Interference Scale; SDQ = Strengths and Difficulties Questionnaire; PedsQL = Pediatric Quality of Life Inventory; DASS = Depression, Anxiety, and Stress Scale. a Adjusted for baseline score.
recommend it to others. There were no participant drop-outs. At follow-up, three intervention children were free of an anxiety diagnosis compared with none in the usual care group. The total number of anxiety disorders decreased
from 14 at baseline to 7 at follow-up (50% reduction) for intervention children and from 12 at baseline to 11 at follow-up for the usual care group (8% reduction). There were substantial improvements across secondary outcome measures by parent and teacher report (see Tables 2 and 3), but
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Sciberras et al. Table 3. Mean Teacher-Reported Outcomes at Baseline and 5 Months Post Randomization. Study group Intervention Outcome SAS Baseline 5 months ADHD Rating Scale IV Baseline 5 months SDQ total Baseline 5 months
Usual care
N
M (SD)
N
M (SD)
4 4
15.3 (11.9) 8.5 (2.3)
4 5
18.3 (10.7) 16.8 (1.8)
4 4
23.0 (16.9) 16.3 (16.1)
5 5
17.1 (10.3) 29.6 (11.5)
4 4
15.0 (7.9) 6.5 (2.1)
4 5
16.8 (7.4) 14.8 (3.1)
Note. Mean differences were not calculated as only six children had teacher data available at both baseline and follow-up. SAS = School Anxiety Scale; SDQ = Strengths and Difficulties Questionnaire.
little improvement in terms of school or work attendance or child sleep (data not shown). Intervention parents also had improvements in parent mental health and reported less irritable and more consistent parenting at follow-up. Both intervention and usual care children reported improved anxiety and QoL from baseline to 5 months. There was little change in child-reported impairment due to anxiety for intervention children, while there were slight improvements for controls.
Discussion Consistent with previous research, the findings suggest it is feasible and acceptable to manage anxiety in children with ADHD using standard CBT for anxious children with only minor modifications (Houghton et al., 2013; Jarrett & Ollendick, 2012). To the best of our knowledge, this is the first RCT to report that a CBT intervention for children with ADHD may be associated with improved child and parent well-being, including child anxiety, QoL, ADHD symptom severity and behavior, and improved parent mental health and parenting. Importantly, potential benefits were observed by multiple informants including parents and teachers. The minimal group differences reported by children are consistent with other studies (Rapee et al., 2009). Usual care children had worsening teacher-reported ADHD symptoms over time. This could suggest that comorbid anxiety exacerbates ADHD symptoms if left untreated. This pilot RCT extends previous research through inclusion of a broad battery of outcome measures, including diagnostic interviews administered by blinded interviewers and blinded teacher-reported outcomes. Although the sample size was small, our use of a randomized design builds on the results of previous studies and provides greater confidence that observed differences reflect intervention effects
rather than the natural resolution of anxiety over time. It is possible that benefits observed may have been due to the therapeutic effect of attending sessions, rather than the intervention content itself. Most intervention children (five out of six) were taking medication to manage their ADHD; therefore, future research should examine the suitability of this intervention in children not taking medication to manage ADHD. These results now need to be replicated in an adequately powered RCT with a longer follow-up period. In conclusion, this study supports the feasibility of managing anxiety in children with ADHD using CBT. We report preliminary evidence suggesting that non-pharmacological interventions may improve important areas of functioning for children with ADHD and anxiety, including ADHD symptom severity. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by the Murdoch Childrens Research Institute (MCRI) and the Besen Family Trust. Dr. Sciberras is funded by an Australian National Health and Medical Research Council (NHMRC) Early Career Fellowship in Population Health 1037159 (2012-2015). Dr. Efron is funded by a MCRI Career Development Award. Professor Anderson is funded by an NHMRC Practitioner Fellowship 607333 (2010-2014). Professor Nicholson is funded through the Roberta Holmes Chair for the Transition to Contemporary Parenthood Program. Associate Professor Hiscock’s position is funded by an NHMRC Career Development Award (No. 607351). This research was supported by the Victorian Government’s Operational Infrastructure Support Program to the MCRI.
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References Bowen, R., Chavira, D. A., Bailey, K., Stein, M. T., & Stein, M. B. (2008). Nature of anxiety comorbid with attention deficit hyperactivity disorder in children from a pediatric primary care setting. Psychiatry Research, 157, 201-209. Cohen, J. (1992). A power primer. Psychological Bulletin, 112, 155-159. Dosreis, S., Zito, J. M., Safer, D., Soeken, K. L., Mitchell, J. W., Jr., & Ellwood, L. C. (2003). Parental perceptions and satisfaction with stimulant medication for Attention-Deficit Hyperactivity Disorder. Journal of Developmental & Behavioral Pediatrics, 24, 155-162. DuPaul, G. J., Power, T. J., Anastopoulos, A. D., & Reid, R. (1998). ADHD Rating Scale–IV (for children and adolescents): Checklists, norms, and clinical interpretation. New York, NY: Guilford Press. Efron, D., Davies, S., & Sciberras, E. (2012). Current Australian paediatric practice in the assessment and treatment of attention deficit hyperactivity disorder. Academic Pediatrics, 13, 328-333. Efron, D., Sewell, J., Cranswick, N., Hiscock, H., Vance, A., & Luk, E. (2003). The prescribing of psychotropic medications for children by Australian pediatricians and child psychiatrists. Pediatrics, 111, 372-375. Goodman, R. (2001). Psychometric properties of the Strengths and Difficulties Questionnaire. Journal of the American Academy of Child & Adolescent Psychiatry, 40, 1337-1345. Houghton, S., Alsalmi, N., Tan, C., Taylor, M., & Durkin, K. (2013). Treating comorbid anxiety in adolescents with ADHD using a cognitive behavior therapy program approach. Journal of Attention Disorders. Advance online publication. doi:10.1177/1087054712473182 Jarrett, M. A., & Ollendick, T. H. (2008). A conceptual review of the comorbidity of attention-deficit/hyperactivity disorder and anxiety: Implications for future research and practice. Clinical Psychology Review, 28, 1266-1280. Jarrett, M. A., & Ollendick, T. H. (2012). Treatment of comorbid attention-deficit/hyperactivity disorder and anxiety in children: A multiple baseline design analysis. Journal of Consulting and Clinical Psychology, 80, 239-244. Lovibond, P. F., & Lovibond, S. H. (1995). The structure of negative emotional states: Comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behaviour Research and Therapy, 33, 335-343. Lyneham, H. J., & Rapee, R. M. (2005). Agreement between telephone and in-person delivery of a structured interview for anxiety disorders in children. Journal of the American Academy of Child & Adolescent Psychiatry, 44, 274-282. Lyneham, H. J., Sburlati, E. S., Abbott, M. J., Rapee, R. M., Hudson, J. L., Tolin, D. F., & Carlson, S. E. (2013). Psychometric properties of the Child Anxiety Life Interference Scale (CALIS). Journal of Anxiety Disorders, 27, 711-719. Lyneham, H. J., Street, A. K., Abbott, M. J., & Rapee, R. M. (2008). Psychometric properties of the School Anxiety Scale– Teacher report (SAS-TR). Journal of Anxiety Disorders, 22, 292-300.
Nauta, M. H., Scholing, A., Rapee, R. M., Abbott, M., Spence, S. H., & Water, A. (2004). A parent-report measure of children’s anxiety: Psychometric properties and comparison with childreport in a clinic and normal sample. Behaviour Research and Therapy, 42, 813-839. Pfiffner, L. J., & McBurnett, K. (2006). Family correlates of comorbid anxiety disorders in children with attention deficit/hyperactivity disorder. Journal of Abnormal Child Psychology, 34, 725-735. Rapee, R. M., Lyneham, H. J., Hudson, J. L., Kangas, M., Wuthrich, V. M., & Schniering, C. A. (2013). Effect of comorbidity on treatment of anxious children and adolescents: Results from a large, combined sample. Journal of the American Academy of Child & Adolescent Psychiatry, 52, 48-58. Rapee, R. M., Schniering, C. A., & Hudson, J. L. (2009). Anxiety disorders during childhood and adolescence: Origins and treatment. Annual Review of Clinical Psychology, 5, 311341. Sciberras, E., Lycett, K., Efron, D., Mensah, F., Gerner, B., & Hiscock, H. (2014). Anxiety in children with attention-deficit/ hyperactivity disorder. Pediatrics, 133, 801-808. Sung, V., Hiscock, H., Sciberras, E., & Efron, D. (2008). Sleep problems in children with attention-deficit/hyperactivity disorder: Prevalence and the effect on the child and family. Archives of Pediatrics & Adolescent Medicine, 162, 336-342. doi:10.1001/archpedi.162.4.336 Varni, J. W., Limbers, C. A., & Burwinkle, T. M. (2007). Parent proxy-report of their children’s health-related quality of life: An analysis of 13,878 parents’ reliability and validity across age subgroups using the PedsQL™ 4.0 Generic Core Scales. Health and Quality of Life Outcomes, 5, 1043-1051. Zubrick, S. R., Lucas, N., Westrupp, E. M., & Nicholson, J. M. (2014). Parenting measures in the Longitudinal Study of Australian children: Construct validity and measurement quality, Waves 1 to 4. Canberra, Australia: Department of Social Services.
Author Biographies Emma Sciberras is a post-doctoral research fellow and clinical psychologist at the Murdoch Childrens Research Institute and The Royal Children’s Hospital, Melbourne, Australia. She is also an honorary research fellow at the Department of Pediatrics, the University of Melbourne. Melissa Mulraney completed her PhD in psychology at Monash University, Australia. She is involved in research at the Murdoch Childrens Research Institute investigating ways to improve outcomes for children with ADHD. Vicki Anderson is the clinical sciences theme director at the Murdoch Childrens Research Institute and director of psychology at The Royal Children’s Hospital, Melbourne, Australia. Ronald M. Rapee is distinguished professor in the Department of Psychology and director of the Center for Emotional Health at Macquarie University, Sydney, Australia. Jan M. Nicholson is the Inaugural Roberta Holmes Professorial Chair at the Judith Lumley Center, Latrobe University, Melbourne.
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Sciberras et al. Daryl Efron is a developmental-behavioral pediatrician at The Royal Children’s Hospital, Melbourne, Australia; a senior lecturer in the Department of Pediatrics, at the University of Melbourne; and a senior research fellow at the Murdoch Childrens Research Institute. Katherine Lee is a senior biostatistician at the Murdoch Childrens Research Institute, Melbourne, Australia. She also holds an honorary appointment at the Department of Pediatrics, the University of Melbourne.
Zoe Markopoulos is a Master’s of educational psychology student from the Melbourne Graduate School of Education, the University of Melbourne. Harriet Hiscock is a pediatrician and senior research fellow at the Murdoch Childrens Research Institute and The Royal Children’s Hospital, Melbourne, Australia. She has a keen interest in designing and evaluating interventions to improve outcomes for children with behavioral problems.
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research-article2015
JADXXX10.1177/1087054715584054Journal of Attention DisordersJournal of Attention DisordersSciberras et al.
Article
Managing Anxiety in Children With ADHD Using Cognitive-Behavioral Therapy: A Pilot Randomized Controlled Trial
Journal of Attention Disorders 1–7 © 2015 SAGE Publications Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1087054715584054 jad.sagepub.com
Emma Sciberras1,2,3, Melissa Mulraney1, Vicki Anderson1,2,3, Ronald M. Rapee4, Jan M. Nicholson1,5, Daryl Efron1,2,3, Katherine Lee1,3, Zoe Markopoulos1, and Harriet Hiscock1,2,3
Abstract Objective:This pilot randomized controlled trial examined the acceptability and feasibility of a cognitive-behavioral therapy (CBT) intervention for children with ADHD and anxiety, and provided preliminary information on child and family outcomes. Method: Children with ADHD and anxiety (8-12 years) were randomized to receive an adapted version of the Cool Kids CBT program or usual clinical care. Key outcomes included feasibility and acceptability of the intervention (participant enrollment, drop-out, intervention session attendance), remission of anxiety assessed via diagnostic interview, ADHD symptom severity, quality of life (QoL), and parent mental health. Results: Twelve children participated (67% uptake). Most families attended all 10 intervention sessions, with no drop-outs. Intervention participants had marked improvements in both child and family well-being by parent and teacher report, including anxiety, ADHD symptom severity, QoL, and parent mental health. Conclusion: Non-pharmacological interventions may improve important domains of functioning for children with ADHD and anxiety, including ADHD symptom severity. (J. of Att. Dis. XXXX; XX(X) XX-XX) Keywords ADHD, anxiety, cognitive-behavioral therapy, randomized controlled trial, children Approximately 25% of children with ADHD meet criteria for at least one anxiety disorder (Jarrett & Ollendick, 2008), and there is growing evidence that anxiety exacerbates impairments for these children (Bowen, Chavira, Bailey, Stein, & Stein, 2008; Pfiffner & McBurnett, 2006; Sciberras et al., 2014). Children with both ADHD and anxiety have more severe executive and school functioning difficulties including school absenteeism, poorer quality of life (QoL), and more strained family relationships (Bowen et al., 2008; Pfiffner & McBurnett, 2006; Sciberras et al., 2014). Managing anxiety may be one way of improving the broader functioning of children with ADHD; however, anxiety is often under-detected in this population (Efron, Davies, & Sciberras, 2012). Non-pharmacological treatments for managing anxiety in children with ADHD are desirable given parent preferences for psychological treatments (Dosreis et al., 2003) and the potential side effects and drug interactions when multiple psychotropic medications are prescribed (Efron et al., 2003). Cognitive-behavioral therapy (CBT) has the strongest empirical support for the management of pediatric anxiety (Rapee, Schniering, & Hudson, 2009). A small number of pre- and post-test studies have reported that CBT improves anxiety in children with ADHD (Houghton, Alsalmi, Tan, Taylor, &
Durkin, 2013; Jarrett & Ollendick, 2012); however, existing studies use non-randomized designs, do not include blinded outcomes, and have not examined benefits to broader areas of functioning including QoL, school-based functioning, and family functioning. Improvements observed in pre- and posttest studies may merely reflect natural resolution of anxiety rather than true treatment effects. This pilot randomized controlled trial (RCT) aimed to (trial number: ISRCTN33930984) (a) examine the acceptability and feasibility of a CBT program to treat anxiety in children with ADHD (primary outcome), and (b) explore associated improvements in child and parent outcomes assessed using multi-source assessment.
1
Murdoch Childrens Research Institute, Parkville, Australia The Royal Children’s Hospital, Parkville, Australia 3 The University of Melbourne, Parkville, Australia 4 Macquarie University, Sydney, Australia 5 La Trobe University, Melbourne, Australia 2
Corresponding Author: Emma Sciberras, Murdoch Childrens Research Institute, The Royal Children’s Hospital, Flemington Road, Parkville, Victoria 3052, Australia. Email: [email protected]
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Journal of Attention Disorders
Method Study Design and Sample Children aged 8 to 12 years with ADHD were recruited from an ADHD Assessment Clinic and previous research studies at The Royal Children’s Hospital, Melbourne. Ethics approval was granted by the Human Research Ethics Committees of the Royal Children’s Hospital (#33186), the Victorian Department of Education and Early Childhood Development (#2013_002150), and the Catholic Education Office Melbourne (#1943). To be eligible, children needed to (a) meet full criteria for ADHD assessed using the ADHD Rating Scale IV (DuPaul, Power, Anastopoulos, & Reid, 1998) and (b) meet criteria for generalized, social, or separation anxiety disorder assessed using the Anxiety Disorders Interview Schedule for Children IV (ADIS-C; Lyneham & Rapee, 2005). Children were excluded if they were already receiving specialist help to manage anxiety. Children taking medication for anxiety were not excluded provided they were still experiencing significant anxiety and had been on a stable dose for a minimum of 6 weeks prior to enrollment. Interested and eligible families were mailed consent forms and baseline surveys for the primary caregiver and child to complete.
Randomization On receipt of the completed consent forms and baseline surveys, families were randomized to the “intervention” or “usual care” group. Children in the usual care group continued to receive treatment as usual for their ADHD from their treating pediatrician. At this point, teachers were emailed a survey to complete about the child’s baseline functioning. An independent statistician generated a randomization schedule using a computerized random number sequence. Assignment was in a ratio of 1:1 “intervention” to “usual care.” Allocation was concealed from families and researchers using sealed opaque envelopes until parent consent was obtained. Children in the usual care group continued to access care from their pediatrician for the management of ADHD along with any other health concerns that arose during the study.
Intervention The intervention group received the Cool Kids CBT program designed for the treatment of pediatric anxiety (Rapee et al., 2013), consisting of eight 60-min weekly sessions, followed by two 60-min biweekly sessions (total of 10 sessions). The program aims to help families and children learn about anxiety and worries and develop the skills to be able to manage child anxiety. Trained facilitators (E.S., M.M.) conducted each session, which included time with the child
and parent(s) alone and time with the child and parent together. An individual as opposed to group format was used to cater to the needs of children with ADHD. Adaptations were made to the program to make it more acceptable for children with ADHD and their parents including (a) use of an activity schedule and positive reinforcement to promote on-task behavior, (b) 1-min “brain breaks” between activities, (c) shortening and repetition of key concepts, and (d) use of visual aids in the sessions and at home to promote skills practice.
Measures The primary outcome was the feasibility and acceptability of the intervention assessed via rates of participant enrollment, drop-out, and intervention session attendance. Secondary child outcome measures were the parentcompleted ADIS-C administered by a blinded interviewer, the Spence Children’s Anxiety Scale (Nauta et al., 2004; child and parent report), the Child Anxiety Life Interference Scale (Lyneham et al., 2013; child and parent report), School Anxiety Scale (Lyneham, Street, Abbott, & Rapee, 2008; teacher report), ADHD Rating Scale IV (DuPaul et al., 1998; parent and teacher report), the Strengths and Difficulties Questionnaire (Goodman, 2001; parent and teacher report), the Pediatric Quality of Life Inventory 4.0 (Varni, Limbers, & Burwinkle, 2007; parent and child report), child school attendance (Sung, Hiscock, Sciberras, & Efron, 2008; parent report), and sleep problems (Sung et al., 2008; parent report) assessed at baseline and 5 months post randomization (~6 weeks post intervention). Parent outcomes included the Depression Anxiety Stress Scales (Lovibond & Lovibond, 1995), parenting anger and consistency (Zubrick, Lucas, Westrupp, & Nicholson, 2014), and work attendance (Sung et al., 2008).
Statistical Analysis Analyses were conducted on an intention-to-treat basis. Descriptive statistics were used to summarize the acceptability and feasibility of the intervention. The mean difference in secondary outcomes between the usual care and intervention group was examined using logistic and linear regression. All analyses were re-run adjusting for baseline functioning, and Cohen’s d effect sizes were reported for adjusted findings. Given the proof-of-principle nature of this study, it focused on effect sizes rather than statistical significance testing. Effect size differences of 0.20 to 0.49 were considered small, 0.50 to 0.79 medium, and above 0.80 large (Cohen, 1992). No adjustment for baseline was used for teacher-reported outcomes, as 10 of the 12 participants changed teachers between baseline and follow-up. All analyses were conducted using Stata Version 13.0.
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Sciberras et al.
Opt out letters sent n = 64
Excluded Opted out n = 12 Uncontactable n = 14
Screening calls made n = 38
Excluded Not meeting ADHD criteria n = 4 Not meeting anxiety criteria n = 7 Receiving specialist help for anxiety n=7 Intellectual disability n = 1 Opted out n = 1
ADHD and anxiety disorder n = 18
Excluded Not interested n = 5 Too busy n = 1
Randomised n = 12
Allocated to intervention n=6
Allocated to usual care n=6
Received intervention n=5
Lost to follow-up n =0
Lost to follow-up n =0
Figure 1. Summary of participant flow. Table 1. Sample Characteristics. Characteristics Child Male, n Age, M (SD), range ADHD subtype, n Combined Inattentive Medication use, n Methylphenidate Clonidine Melatonin Anxiety diagnoses, M (SD), range Parent Mother, n Age, M (SD), range Education status, n Did not complete high school College/postgraduate degree Employed, n
Results Sixty-seven percent of eligible families approached agreed to be enrolled in the trial (n = 12, see Figure 1; see Table 1 for sample characteristics). Five of the 6
Intervention (n = 6)
Usual care (n = 6)
5 10.4 (1.3), 8.4-12.2
6 11.6 (0.6), 10.6-12.2
3 3 5 4 1 1 2.3 (0.8), 1-3
3 3 4 4 0 0 2.0 (0.6), 1-3
6 48 (3.3), 43.4-52.6
6 45.5 (4.9), 41.6-53.4
2 4 5
3 3 6
intervention families attended all 10 sessions. The other family only attended three sessions before follow-up but continued to be engaged with the study. All intervention families reported the program was helpful and would
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Journal of Attention Disorders
Table 2. Mean Difference in Parent- and Child-Reported Outcomes at 5 Months Post Randomization. Study group
N
Child outcomes Parent report SCAS Baseline 6 5 months 6 CALIS impact on parent Baseline 6 5 months 6 CALIS impact on child Baseline 6 5 months 6 ADHD Rating Scale IV Baseline 6 5 months 5 PedsQL psychosocial Baseline 6 5 months 5 SDQ total Baseline 6 5 months 5 Child report SCAS Baseline 6 5 months 5 CALIS impact on child Baseline 6 5 months 5 PedsQL Baseline 6 5 months 5 Parent outcomes DASS total Baseline 6 5 months 5 Consistent parenting Baseline 6 5 months 5 Irritable parenting Baseline 6 5 months 4
Adjusted effect sizea
M (SD)
N
M (SD)
33.0 (18.0) 21.3 (17.0)
6 5
29.0 (4.6) 25.4 (3.8)
— −7.7 [−18.0, 2.6]
— −6.9 [−17.2, 3.4]
— −0.6
18.7 (12.8) 12.2 (12.1)
6 5
9.7 (6.1) 8.8 (5.6)
— −6.1 [−11.4, −0.8]
— −4.8 [−10.6, 1.1]
— −0.5
15.3 (8.2) 9.8 (8.7)
6 5
11.8 (4.2) 10.0 (4.0)
— −4.7 [−9.7, 0.3]
−4.3 [−10.1, 1.4]
−0.6
35.5 (11.9) 30.0 (12.5)
6 4
29.3 (9.2) 27.3 (2.9)
— −6.4 [−16.7, 4.0]
— −3.6 [−14.5, 7.3]
— −0.4
49.0 (14.9) 64.0 (17.9)
6 5
55.6 (8.8) 61.3 (8.3)
— 10.9 [−6.6, 28.4]
21.3 (7.4) 15.8 (5.8)
6 5
17.7 (2.6) 16.6 (4.6)
— −3.4 [−8.9, 2.3]
40.7 (20.6) 25.4 (14.3)
6 5
25.2 (10.8) 17.2 (12.4)
— −1.4 [−18.5, 15.7]
— 2.4 [−15.1, 20.0]
— 0.2
12.5 (7.9) 12.6 (8.6)
6 5
6.5 (5.4) 4.6 (5.0)
— 0.4 [−8.2, 9.0]
— 2.8 [−7.9, 13.6]
— 0.4
52.5 (14.6) 61.0 (13.3)
6 5
66.4 (13.1) 73.7 (15.3)
— −2.2 [−22.4, 17.9]
— −0.1
11.0 (4.6) 6.4 (2.7)
6 5
13.7 (7.0) 14.8 (7.7)
— −3.2 [−13.2, 6.8]
— −7.1 [−17.5, 3.2]
— −1.0
18.2 (2.3) 19.2 (2.2)
6 5
16.8 (3.0) 17.8 (1.3)
— −0.8 [−5.0, 3.4]
— 0.9 [−1.9, 3.7]
— 0.5
8.2 (4.7) 6.5 (2.1)
6 5
6.7 (2.2) 14.8 (3.1)
— −2.0 [−8.5, 4.5]
— −1.4 [−5.6, 2.8]
— −0.4
Intervention Outcome
Adjusted M differencea, intervention control [95% CI]
M difference, intervention control [95% CI]
Usual care
— 3.0 [−14.1, 20.2]
— 8.0 [−10.9, 27.0] — −2.6 [−7.9, 2.8]
— 0.6 — −0.5
Note. CI = confidence interval; SCAS = Spence Child Anxiety Scale; CALIS = Child Anxiety Life Interference Scale; SDQ = Strengths and Difficulties Questionnaire; PedsQL = Pediatric Quality of Life Inventory; DASS = Depression, Anxiety, and Stress Scale. a Adjusted for baseline score.
recommend it to others. There were no participant drop-outs. At follow-up, three intervention children were free of an anxiety diagnosis compared with none in the usual care group. The total number of anxiety disorders decreased
from 14 at baseline to 7 at follow-up (50% reduction) for intervention children and from 12 at baseline to 11 at follow-up for the usual care group (8% reduction). There were substantial improvements across secondary outcome measures by parent and teacher report (see Tables 2 and 3), but
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Sciberras et al. Table 3. Mean Teacher-Reported Outcomes at Baseline and 5 Months Post Randomization. Study group Intervention Outcome SAS Baseline 5 months ADHD Rating Scale IV Baseline 5 months SDQ total Baseline 5 months
Usual care
N
M (SD)
N
M (SD)
4 4
15.3 (11.9) 8.5 (2.3)
4 5
18.3 (10.7) 16.8 (1.8)
4 4
23.0 (16.9) 16.3 (16.1)
5 5
17.1 (10.3) 29.6 (11.5)
4 4
15.0 (7.9) 6.5 (2.1)
4 5
16.8 (7.4) 14.8 (3.1)
Note. Mean differences were not calculated as only six children had teacher data available at both baseline and follow-up. SAS = School Anxiety Scale; SDQ = Strengths and Difficulties Questionnaire.
little improvement in terms of school or work attendance or child sleep (data not shown). Intervention parents also had improvements in parent mental health and reported less irritable and more consistent parenting at follow-up. Both intervention and usual care children reported improved anxiety and QoL from baseline to 5 months. There was little change in child-reported impairment due to anxiety for intervention children, while there were slight improvements for controls.
Discussion Consistent with previous research, the findings suggest it is feasible and acceptable to manage anxiety in children with ADHD using standard CBT for anxious children with only minor modifications (Houghton et al., 2013; Jarrett & Ollendick, 2012). To the best of our knowledge, this is the first RCT to report that a CBT intervention for children with ADHD may be associated with improved child and parent well-being, including child anxiety, QoL, ADHD symptom severity and behavior, and improved parent mental health and parenting. Importantly, potential benefits were observed by multiple informants including parents and teachers. The minimal group differences reported by children are consistent with other studies (Rapee et al., 2009). Usual care children had worsening teacher-reported ADHD symptoms over time. This could suggest that comorbid anxiety exacerbates ADHD symptoms if left untreated. This pilot RCT extends previous research through inclusion of a broad battery of outcome measures, including diagnostic interviews administered by blinded interviewers and blinded teacher-reported outcomes. Although the sample size was small, our use of a randomized design builds on the results of previous studies and provides greater confidence that observed differences reflect intervention effects
rather than the natural resolution of anxiety over time. It is possible that benefits observed may have been due to the therapeutic effect of attending sessions, rather than the intervention content itself. Most intervention children (five out of six) were taking medication to manage their ADHD; therefore, future research should examine the suitability of this intervention in children not taking medication to manage ADHD. These results now need to be replicated in an adequately powered RCT with a longer follow-up period. In conclusion, this study supports the feasibility of managing anxiety in children with ADHD using CBT. We report preliminary evidence suggesting that non-pharmacological interventions may improve important areas of functioning for children with ADHD and anxiety, including ADHD symptom severity. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by the Murdoch Childrens Research Institute (MCRI) and the Besen Family Trust. Dr. Sciberras is funded by an Australian National Health and Medical Research Council (NHMRC) Early Career Fellowship in Population Health 1037159 (2012-2015). Dr. Efron is funded by a MCRI Career Development Award. Professor Anderson is funded by an NHMRC Practitioner Fellowship 607333 (2010-2014). Professor Nicholson is funded through the Roberta Holmes Chair for the Transition to Contemporary Parenthood Program. Associate Professor Hiscock’s position is funded by an NHMRC Career Development Award (No. 607351). This research was supported by the Victorian Government’s Operational Infrastructure Support Program to the MCRI.
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Journal of Attention Disorders
References Bowen, R., Chavira, D. A., Bailey, K., Stein, M. T., & Stein, M. B. (2008). Nature of anxiety comorbid with attention deficit hyperactivity disorder in children from a pediatric primary care setting. Psychiatry Research, 157, 201-209. Cohen, J. (1992). A power primer. Psychological Bulletin, 112, 155-159. Dosreis, S., Zito, J. M., Safer, D., Soeken, K. L., Mitchell, J. W., Jr., & Ellwood, L. C. (2003). Parental perceptions and satisfaction with stimulant medication for Attention-Deficit Hyperactivity Disorder. Journal of Developmental & Behavioral Pediatrics, 24, 155-162. DuPaul, G. J., Power, T. J., Anastopoulos, A. D., & Reid, R. (1998). ADHD Rating Scale–IV (for children and adolescents): Checklists, norms, and clinical interpretation. New York, NY: Guilford Press. Efron, D., Davies, S., & Sciberras, E. (2012). Current Australian paediatric practice in the assessment and treatment of attention deficit hyperactivity disorder. Academic Pediatrics, 13, 328-333. Efron, D., Sewell, J., Cranswick, N., Hiscock, H., Vance, A., & Luk, E. (2003). The prescribing of psychotropic medications for children by Australian pediatricians and child psychiatrists. Pediatrics, 111, 372-375. Goodman, R. (2001). Psychometric properties of the Strengths and Difficulties Questionnaire. Journal of the American Academy of Child & Adolescent Psychiatry, 40, 1337-1345. Houghton, S., Alsalmi, N., Tan, C., Taylor, M., & Durkin, K. (2013). Treating comorbid anxiety in adolescents with ADHD using a cognitive behavior therapy program approach. Journal of Attention Disorders. Advance online publication. doi:10.1177/1087054712473182 Jarrett, M. A., & Ollendick, T. H. (2008). A conceptual review of the comorbidity of attention-deficit/hyperactivity disorder and anxiety: Implications for future research and practice. Clinical Psychology Review, 28, 1266-1280. Jarrett, M. A., & Ollendick, T. H. (2012). Treatment of comorbid attention-deficit/hyperactivity disorder and anxiety in children: A multiple baseline design analysis. Journal of Consulting and Clinical Psychology, 80, 239-244. Lovibond, P. F., & Lovibond, S. H. (1995). The structure of negative emotional states: Comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behaviour Research and Therapy, 33, 335-343. Lyneham, H. J., & Rapee, R. M. (2005). Agreement between telephone and in-person delivery of a structured interview for anxiety disorders in children. Journal of the American Academy of Child & Adolescent Psychiatry, 44, 274-282. Lyneham, H. J., Sburlati, E. S., Abbott, M. J., Rapee, R. M., Hudson, J. L., Tolin, D. F., & Carlson, S. E. (2013). Psychometric properties of the Child Anxiety Life Interference Scale (CALIS). Journal of Anxiety Disorders, 27, 711-719. Lyneham, H. J., Street, A. K., Abbott, M. J., & Rapee, R. M. (2008). Psychometric properties of the School Anxiety Scale– Teacher report (SAS-TR). Journal of Anxiety Disorders, 22, 292-300.
Nauta, M. H., Scholing, A., Rapee, R. M., Abbott, M., Spence, S. H., & Water, A. (2004). A parent-report measure of children’s anxiety: Psychometric properties and comparison with childreport in a clinic and normal sample. Behaviour Research and Therapy, 42, 813-839. Pfiffner, L. J., & McBurnett, K. (2006). Family correlates of comorbid anxiety disorders in children with attention deficit/hyperactivity disorder. Journal of Abnormal Child Psychology, 34, 725-735. Rapee, R. M., Lyneham, H. J., Hudson, J. L., Kangas, M., Wuthrich, V. M., & Schniering, C. A. (2013). Effect of comorbidity on treatment of anxious children and adolescents: Results from a large, combined sample. Journal of the American Academy of Child & Adolescent Psychiatry, 52, 48-58. Rapee, R. M., Schniering, C. A., & Hudson, J. L. (2009). Anxiety disorders during childhood and adolescence: Origins and treatment. Annual Review of Clinical Psychology, 5, 311341. Sciberras, E., Lycett, K., Efron, D., Mensah, F., Gerner, B., & Hiscock, H. (2014). Anxiety in children with attention-deficit/ hyperactivity disorder. Pediatrics, 133, 801-808. Sung, V., Hiscock, H., Sciberras, E., & Efron, D. (2008). Sleep problems in children with attention-deficit/hyperactivity disorder: Prevalence and the effect on the child and family. Archives of Pediatrics & Adolescent Medicine, 162, 336-342. doi:10.1001/archpedi.162.4.336 Varni, J. W., Limbers, C. A., & Burwinkle, T. M. (2007). Parent proxy-report of their children’s health-related quality of life: An analysis of 13,878 parents’ reliability and validity across age subgroups using the PedsQL™ 4.0 Generic Core Scales. Health and Quality of Life Outcomes, 5, 1043-1051. Zubrick, S. R., Lucas, N., Westrupp, E. M., & Nicholson, J. M. (2014). Parenting measures in the Longitudinal Study of Australian children: Construct validity and measurement quality, Waves 1 to 4. Canberra, Australia: Department of Social Services.
Author Biographies Emma Sciberras is a post-doctoral research fellow and clinical psychologist at the Murdoch Childrens Research Institute and The Royal Children’s Hospital, Melbourne, Australia. She is also an honorary research fellow at the Department of Pediatrics, the University of Melbourne. Melissa Mulraney completed her PhD in psychology at Monash University, Australia. She is involved in research at the Murdoch Childrens Research Institute investigating ways to improve outcomes for children with ADHD. Vicki Anderson is the clinical sciences theme director at the Murdoch Childrens Research Institute and director of psychology at The Royal Children’s Hospital, Melbourne, Australia. Ronald M. Rapee is distinguished professor in the Department of Psychology and director of the Center for Emotional Health at Macquarie University, Sydney, Australia. Jan M. Nicholson is the Inaugural Roberta Holmes Professorial Chair at the Judith Lumley Center, Latrobe University, Melbourne.
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Sciberras et al. Daryl Efron is a developmental-behavioral pediatrician at The Royal Children’s Hospital, Melbourne, Australia; a senior lecturer in the Department of Pediatrics, at the University of Melbourne; and a senior research fellow at the Murdoch Childrens Research Institute. Katherine Lee is a senior biostatistician at the Murdoch Childrens Research Institute, Melbourne, Australia. She also holds an honorary appointment at the Department of Pediatrics, the University of Melbourne.
Zoe Markopoulos is a Master’s of educational psychology student from the Melbourne Graduate School of Education, the University of Melbourne. Harriet Hiscock is a pediatrician and senior research fellow at the Murdoch Childrens Research Institute and The Royal Children’s Hospital, Melbourne, Australia. She has a keen interest in designing and evaluating interventions to improve outcomes for children with behavioral problems.
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