Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents: protocol for a randomised clinical trial (the TECTO trial)

Abstract

Background Cognitive behavioural therapy (CBT) is the recommended first-line treatment for children and adolescents with obsessive-compulsive disorder (OCD), but evidence concerning treatment-specific benefits and harms compared with other interventions is limited. Furthermore, high risk-of-bias in most trials prevent firm conclusions regarding the efficacy of CBT. We investigate the benefits and harms of family-based CBT (FCBT) versus family-based psychoeducation and relaxation training (FPRT) in youth with OCD in a trial designed to reduce risk-of-bias. Methods This is an investigator-initiated, independently funded, single-centre, parallel group superiority randomised clinical trial (RCT). Outcome assessors, data managers, statisticians, and conclusion drawers are blinded. From child and adolescent mental health services we include patients aged 8–17 years with a primary OCD diagnosis and an entry score of ≥16 on the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). We exclude patients with comorbid illness contraindicating trial participation; intelligence quotient < 70; or treatment with CBT, PRT, antidepressant or antipsychotic medication within the last 6 months prior to trial entry. Participants are randomised 1:1 to the experimental intervention (FCBT) versus the control intervention (FPRT) each consisting of 14 75-min sessions. All therapists deliver both interventions. Follow-up assessments occur in week 4, 8 and 16 (end-of-treatment). The primary outcome is OCD symptom severity assessed with CY-BOCS at end-of-trial. Secondary outcomes are quality-of-life and adverse events. Based on sample size estimation, a minimum of 128 participants (64 in each intervention group) are included. Discussion In our trial design we aim to reduce risk-of-bias, enhance generalisability, and broaden the outcome measures by: 1) conducting an investigator-initiated, independently funded RCT; 2) blinding investigators; 3) investigating a representative sample of OCD patients; 3) using an active control intervention (FPRT) to tease apart general and specific therapy effects; 4) using equal dosing of interventions and therapist supervision in both intervention groups; 5) having therapists perform both interventions decided by randomisation; 6) rating fidelity of both interventions; 7) assessing a broad range of benefits and harms with repeated measures. The primary study limitations are the risk of missing data and the inability to blind participants and therapists to the intervention. Trial registration ClinicalTrials.gov: NCT03595098, registered July 23, 2018.

Associations Between the Severity of Obsessive-Compulsive Disorder and Vocal Features in Children and Adolescents: Protocol for a Statistical and Machine Learning Analysis

“…We will include audio recordings from a total of 64 youths aged 8 to 17 years (47 with OCD and 17 healthy controls). The audio recordings of diagnostic interviews stem from a large randomized clinical trial and case-control study of OCD, called TECTO [ 17 ]—TECTO runs at a public hospital in Denmark.…”

Early Identification and Intervention in Pediatric Obsessive-Compulsive Disorder

“…Psychoeducation is one of the available forms; it can be conducted for parents alone or as part of family-based CBT (FCBT) treatment for different purposes, such as increasing parents’ knowledge of mental health, helping create a more supportive family environment, improving their parenting styles and raising parents’ awareness of FA [ 20 ]. Furthermore, FCBT interventions include teaching parents to reduce FA, training them to assist their children with homework and ERP therapy and helping parents identify and cope with the pain and anxiety they feel when facing their child’s OCD [ 145 , 146 , 147 , 148 ]. Studies have shown that these FCBT techniques have similar effects on parents and OCD children [ 145 ].…”

Speech Detection For Child-Clinician Conversations In Danish For Low-Resource In-The-Wild Conditions: A Case Study

“…The interview generally lasts 30 to 90 minutes. We used audio from a randomized clinical trial and case-control study of obsessive-compulsive disorder (OCD), the TECTO trial [7] . Thus, the participants in this cohort included 8-17 year old children with OCD and children with no psychiatric diagnoses.…”