TY - JOUR

T1 - Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents (the TECTO trial)

T2 - a statistical analysis plan for the randomised clinical trial

AU - Olsen, Markus Harboe

AU - Hagstrøm, Julie

AU - Lønfeldt, Nicole Nadine

AU - Uhre, Camilla

AU - Uhre, Valdemar

AU - Pretzmann, Linea

AU - Christensen, Sofie Heidenheim

AU - Thoustrup, Christine

AU - Korsbjerg, Nicoline Løcke Jepsen

AU - Mora-Jensen, Anna Rosa Cecilie

AU - Ritter, Melanie

AU - Engstrøm, Janus

AU - Lindschou, Jane

AU - Siebner, Hartwig Roman

AU - Verhulst, Frank

AU - Jeppesen, Pia

AU - Jepsen, Jens Richardt Møllegaard

AU - Vangkilde, Signe

AU - Thomsen, Per Hove

AU - Hybel, Katja

AU - Clemmesen, Line Katrine Harder

AU - Gluud, Christian

AU - Plessen, Kerstin Jessica

AU - Pagsberg, Anne Katrine

AU - Jakobsen, Janus Christian

N1 - Publisher Copyright: © 2022, The Author(s).

PY - 2022

Y1 - 2022

N2 - 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.

AB - 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.

KW - Cognitive behavioural therapy

KW - Family-based psychoeducation/relaxation training

KW - Obsessive-compulsive disorder

KW - Randomised clinical trial

KW - Statistical analysis plan

U2 - 10.1186/s13063-022-06799-4

DO - 10.1186/s13063-022-06799-4

M3 - Journal article

C2 - 36203215

AN - SCOPUS:85139309558

VL - 23

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 854

ER -