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Original Investigation |

Family-Based Treatment of Early Childhood Obsessive-Compulsive Disorder:  The Pediatric Obsessive-Compulsive Disorder Treatment Study for Young Children (POTS Jr)—A Randomized Clinical Trial

Jennifer Freeman, PhD1; Jeffrey Sapyta, PhD2; Abbe Garcia, PhD1; Scott Compton, PhD2; Muniya Khanna, PhD3; Chris Flessner, PhD1; David FitzGerald, PhD2; Christian Mauro, PhD2; Rebecca Dingfelder, PhD2; Kristen Benito, PhD1; Julie Harrison, BA3; John Curry, PhD2; Edna Foa, PhD3; John March, MD2; Phoebe Moore, PhD2; Martin Franklin, PhD3
[+] Author Affiliations
1Alpert Medical School of Brown University; Bradley-Hasbro Children’s Research Center, Providence, Rhode Island
2Duke University School of Medicine, Durham, North Carolina
3University of Pennsylvania School of Medicine, Philadelphia
JAMA Psychiatry. 2014;71(6):689-698. doi:10.1001/jamapsychiatry.2014.170.
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Importance  Cognitive behavior therapy (CBT) has been established as efficacious for obsessive-compulsive disorder (OCD) among older children and adolescents, yet its effect on young children has not been evaluated sufficiently.

Objective  To examine the relative efficacy of family-based CBT (FB-CBT) involving exposure plus response prevention vs an FB relaxation treatment (FB-RT) control condition for children 5 to 8 years of age.

Design, Setting, and Participants  A 14-week randomized clinical trial (Pediatric Obsessive-Compulsive Disorder Treatment Study for Young Children [POTS Jr]) conducted at 3 academic medical centers between 2006 and 2011, involving 127 pediatric outpatients 5 to 8 years of age who received a primary diagnosis of OCD and a Children’s Yale-Brown Obsessive Compulsive Scale total score of 16 or higher.

Interventions  Participants were randomly assigned to 14 weeks of (1) FB-CBT, including exposure plus response prevention, or (2) FB-RT.

Main Outcomes and Measures  Responder status defined as an independent evaluator–rated Clinical Global Impression–Improvement scale score of 1 (very much improved) or 2 (much improved) and change in independent evaluator–rated continuous Children’s Yale-Brown Obsessive Compulsive Scale total score.

Results  Family-based CBT was superior to FB-RT on both primary outcome measures. The percentages of children who were rated as 1 (very much improved) or 2 (much improved) on the Clinical Global Impression–Improvement scale at 14 weeks were 72% for FB-CBT and 41% for FB-RT. The effect size difference between FB-CBT and FB-RT on the Clinical Global Impression–Improvement scale was 0.31 (95% CI, 0.17-0.45). The number needed to treat (NNT) with FB-CBT vs FB-RT was estimated as 3.2 (95% CI, 2.2-5.8). The effect size difference between FB-CBT and FB-RT on the Children’s Yale-Brown Obsessive Compulsive Scale at week 14 was 0.84 (95% CI, 0.62-1.06).

Conclusions and Relevance  A comprehensive FB-CBT program was superior to a relaxation program with a similar format in reducing OCD symptoms and functional impairment in young children (5-8 years of age) with OCD.

Trial Registration  clinicaltrials.gov Identifier: NCT00533806

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Figure 1.
Trial Flow Diagram

ADHD indicates attention-deficit/hyperactivity disorder; ADIS, Anxiety Disorder Interview Schedule; CY-BOCS, Children’s Yale-Brown Obsessive Compulsive Scale; FB-CBT, family-based cognitive behavior therapy; FB-RT, family-based relaxation treatment; IE, independent evaluator; ITT, intention-to-treat; MR, mental retardation; OCD, obsessive-compulsive disorder; PANDAS, pediatric autoimmune neuropsychiatric disorders associated with strep infection; and PDD, pervasive developmental disorder.

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Figure 2.
Results of Fitting Longitudinal Model

The circles indicate mean values, and the error bars indicate SD. CY-BOCS indicates Children’s Yale-Brown Obsessive Compulsive Scale; FB-CBT, family-based cognitive behavior therapy; and FB-RT, family-based relaxation treatment.

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