Adverse Events in Cognitive Behavioral Therapy and Relaxation Training for Children and Adolescents with Obsessive-Compulsive Disorder: A Mixed Methods Study and Analysis Plan for the TECTO Trial
20 Pages Posted: 7 Feb 2023
Abstract
Background: No official guidelines or validated instruments exist for defining or monitoring adverse events in psychotherapy for children and adolescents. This study aims to investigate if and how adverse events relate to family-based cognitive behavioral therapy (FCBT) versus family-based psychoeducation and relaxation therapy (FPRT) for youth (<18 years) with obsessive-compulsive disorder (OCD). We outline a mixed methods analysis plan of adverse events in a randomized clinical trial.
Methods: This is a convergent mixed methods study within the TECTO trial. We include at least 128 youth aged 8 to 17 years with OCD. Participants are randomized to either FCBT or FPRT and adverse events are monitored quantitatively with the Negative Effects Questionnaire. Further, we assess psychiatric symptoms, global functioning, quality of life, and family factors to investigate predictors for adverse events. We conduct semi-structured interviews with all youths and their parents on their experience of FCBT or FPRT. For the mixed methods analysis, we will merge 1) a qualitative content analysis with descriptive statistics comparing the types, frequencies, and severity of adverse events, 2) a qualitative content analysis of the perceived causes for adverse events with prediction models for adverse events, and 3) a thematic analysis of the participants’ treatment evaluation with a correlational analysis of adverse events and OCD severity.
Discussion: The in-depth mixed methods analysis can inform 1) safer and more effective CBT; 2) instruments and guidelines for monitoring adverse events; and 3) patient information on potential adverse events. The main limitation is risk of missing data.
Note:
Funding Declaration: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. This TECTO sub-study is financed by the Research Unit at the Child and Adolescent Mental Health Centre in the Capital Region of Denmark. Funding for the entire TECTO trial is published in the study protocol [33].
Conflict of Interest: No authors have declared competing financial or non-financial interests.
Ethical Information: Data collection for the mixed methods study received approval from The Ethics Committee of the Capital
Region of Denmark (H-18010607) and The Knowledge Centre on Data Protection Compliance in The
Capital Region of Denmark (VD-2018-263, I-Suite no.: 6502) as part of the TECTO trial protocol [33].
Participants consent to participate in this sub-study when entering the TECTO trial and can withdraw
consent to participate at any time.
Trial Registration: ClinicalTrials.gov identifier: NCT03595098. Registered on July 23, 2018.
Keywords: adverse effects, obsessive-compulsive disorder, cognitive behavioral therapy, Child, Adolescent
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