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

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  • Markus Harboe Olsen
  • Nicole Nadine Lønfeldt
  • Valdemar Uhre
  • Linea Pretzmann
  • Sofie Heidenheim Christensen
  • Nicoline Løcke Jepsen Korsbjerg
  • Anna Rosa Cecilie Mora-Jensen
  • Melanie Ritter
  • Janus Engstrøm
  • Jane Lindschou
  • Frank Verhulst
  • Jens Richardt Møllegaard Jepsen
  • Per Hove Thomsen
  • Katja Hybel
  • Line Katrine Harder Clemmesen
  • Christian Gluud
  • Kerstin Jessica Plessen
  • Janus Christian Jakobsen

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.

Original languageEnglish
Article number854
JournalTrials
Volume23
ISSN1745-6215
DOIs
Publication statusPublished - 2022

Bibliographical note

Publisher Copyright:
© 2022, The Author(s).

    Research areas

  • Cognitive behavioural therapy, Family-based psychoeducation/relaxation training, Obsessive-compulsive disorder, Randomised clinical trial, Statistical analysis plan

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