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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Behavioural Therapy | Update

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

Authors: Markus Harboe Olsen, Julie Hagstrøm, Nicole Nadine Lønfeldt, Camilla Uhre, Valdemar Uhre, Linea Pretzmann, Sofie Heidenheim Christensen, Christine Thoustrup, Nicoline Løcke Jepsen Korsbjerg, Anna-Rosa Cecilie Mora-Jensen, Melanie Ritter, Janus Engstrøm, Jane Lindschou, Hartwig Roman Siebner, Frank Verhulst, Pia Jeppesen, Jens Richardt Møllegaard Jepsen, Signe Vangkilde, Per Hove Thomsen, Katja Hybel, Line Katrine Harder Clemmesen, Christian Gluud, Kerstin Jessica Plessen, Anne Katrine Pagsberg, Janus Christian Jakobsen

Published in: Trials | Issue 1/2022

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Abstract

Background

Obsessive-compulsive disorder (OCD) is a debilitating psychiatric disorder which affects up to 3% of children and adolescents. OCD in children and adolescents is generally treated with cognitive behavioural therapy (CBT), which, in more severely affected patients, can be combined with antidepressant medication. The TECTO trial aims to compare the benefits and harms of family-based CBT (FCBT) versus family-based psychoeducation/relaxation training (FPRT) in children and adolescents aged 8 to 17 years. This statistical analysis plan outlines the planned statistical analyses for the TECTO trial.

Methods

The TECTO trial is an investigator-initiated, independently funded, single-centre, parallel-group, superiority randomised clinical trial. Both groups undergo 14 sessions of 75 min each during a period of 16 weeks with either FCBT or FPRT depending on the allocation. Participants are randomised stratified by age and baseline Children’s Yale–Brown Obsessive-Compulsive Scale (CY-BOCS) score. The primary outcome is the CY-BOCS score. Secondary outcomes are health-related quality of life assessed using KIDSCREEN-10 and adverse events assessed by the Negative Effects Questionnaire (NEQ). Primary and secondary outcomes are assessed at the end of the intervention. Continuous outcomes will be analysed using linear regression adjusted for the stratification variables and baseline value of the continuous outcome. Dichotomous outcomes will be analysed using logistic regression adjusted for the stratification variables. The statistical analyses will be carried out by two independent blinded statisticians.

Discussion

This statistical analysis plan includes a detailed predefined description of how data will be analysed and presented in the main publication before unblinding of study data. Statistical analysis plans limit selective reporting bias. This statistical analysis plan will increase the validity of the final trial results.

Trial registration

ClinicalTrials.​gov NCT03595098. July 23, 2018
Appendix
Available only for authorised users
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Metadata
Title
Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents (the TECTO trial): a statistical analysis plan for the randomised clinical trial
Authors
Markus Harboe Olsen
Julie Hagstrøm
Nicole Nadine Lønfeldt
Camilla Uhre
Valdemar Uhre
Linea Pretzmann
Sofie Heidenheim Christensen
Christine Thoustrup
Nicoline Løcke Jepsen Korsbjerg
Anna-Rosa Cecilie Mora-Jensen
Melanie Ritter
Janus Engstrøm
Jane Lindschou
Hartwig Roman Siebner
Frank Verhulst
Pia Jeppesen
Jens Richardt Møllegaard Jepsen
Signe Vangkilde
Per Hove Thomsen
Katja Hybel
Line Katrine Harder Clemmesen
Christian Gluud
Kerstin Jessica Plessen
Anne Katrine Pagsberg
Janus Christian Jakobsen
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06799-4

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