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 -