Family-based cognitive behavioral therapy versus family-based psychoeducation and relaxation training for obsessive-compulsive disorder in children and adolescents: a randomized clinical trial (TECTO).

Few randomized clinical trials (RCTs) have compared cognitive behavioral therapy (CBT) versus active control interventions for pediatric obsessive-compulsive disorder (OCD), and the range of investigated outcomes has been limited. We investigated benefits and harms of family-based CBT with exposure and response prevention (FCBT) versus family-based psychoeducation and relaxation training (FPRT) in pediatric OCD. This single-center RCT was investigator-initiated, independently funded, including participants with OCD aged 8-17 years with a Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) entry score ≥ 16. We randomized participants 1:1 to 14 sessions of FCBT versus FPRT. Allocation was masked to assessors and statisticians. The primary outcome was CY-BOCS end-of-treatment-score (week-16) analyzed by intention-to-treat. Adverse events were reported by the Negative Effects Questionnaire (NEQ-20). One-hundred-and-thirty participants were randomized, 52.3% females; mean age 13.3 (SD = 2.9) years; mean CY-BOCS total score 25.8 (SD = 4.9); n = 64 to FCBT versus n = 66 to FPRT. Sixteen participants dropped out (four from FCBT, 12 from FPRT). The mean CY-BOCS total score at end-of-treatment was significantly lower for FCBT (15.9, SD = 8.7) versus FPRT (19.9, SD = 8.1), estimate - 3.89, 95%CI [-6.83, - 0.96), p = 0.01, effect size = 0.47, 95% CI [0.09, 0.85]. This difference was below our predefined minimal clinically important difference of four points. The average weekly NEQ frequency score showed no significant group differences. FCBT was associated with significantly larger symptom reduction than FPRT, but with a modest effect. FCBT and FPRT appeared comparably tolerable. A rigorous methodology enabled the counteraction of several biases. Limitations included missing self-reported data and inability of masking participants and treatment providers.