London Health Sciences Centre
London, Ontario, N6A5W9, Canada
NCT Number: NCT07685990
The goal of this feasibility study is to learn whether a trauma therapy intervention for children and adolescents who have experienced weight-based bullying can be successfully delivered within a pediatric weight management program. The intervention is informed by Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) principles and is designed to address trauma-related distress, body image concerns, emotional difficulties, and eating-related challenges associated with weight-based bullying. The main questions this study aims to answer are:
* Can this trauma therapy intervention be feasibly implemented within the HEAL Program at Children's Hospital, London Health Sciences Centre? * Is the intervention acceptable and helpful for participating children, adolescents, and caregivers? * Are exploratory changes observed in trauma symptoms, emotional well-being, self-esteem, eating-related concerns, and weight-related distress following participation in the intervention?
Participants will:
* Participate in approximately 12 weekly virtual therapy sessions, with flexibility for additional sessions if clinically needed * Complete questionnaires before and after treatment related to emotional well-being, trauma symptoms, eating-related concerns, and body image * Participate in selected caregiver-supported sessions during treatment * Optionally complete a brief feedback interview about their experience in the program after treatment is completed
The study will also examine recruitment, attendance, treatment completion, and participant satisfaction to help determine whether this intervention can be implemented in routine clinical care settings.
Trial opening soon.
Get Notified10 year–17 year
All sexes
Interventional
Not applicable
London, Ontario, N6A5W9, Canada
Weight-based bullying is increasingly recognized as a significant contributor to psychological distress among children and adolescents living with obesity. Youth who experience bullying related to body size are at increased risk for anxiety, depression, low self-esteem, social withdrawal, disordered eating behaviours, and trauma-related symptoms, including shame, avoidance, hypervigilance, and emotional distress. Repeated experiences of weight-based victimization may function as a form of interpersonal trauma for some youth and may negatively affect emotional well-being, family functioning, and engagement in obesity treatment programs. Despite growing recognition of these impacts, there are currently no established trauma therapies specifically designed to address the psychological consequences of weight-based bullying in pediatric populations.
This study is a single-arm mixed-methods feasibility study evaluating a trauma therapy intervention for weight-based bullying informed by Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) principles. The intervention is adapted to address trauma-related distress associated with weight-based bullying, body image concerns, maladaptive eating behaviours, emotional dysregulation, and avoidance patterns among children and adolescents living with obesity. The intervention retains the core principles and components of TF-CBT while tailoring psychoeducation, coping skills, cognitive processing, and trauma narrative work to experiences related to weight-based bullying and stigma.
The study will take place within the Paediatric Healthy Eating, Activity and Lifestyle (HEAL) Program at Children's Hospital, London Health Sciences Centre in London, Ontario, Canada. Approximately 30 children and adolescents between the ages of 10 and 17 years who report distress related to weight-based bullying experiences will be recruited from the HEAL Program. One caregiver will also participate in selected components of treatment and study assessments. Recruitment will occur through routine clinical care within the HEAL Program.
The primary objectives of this study are to evaluate the feasibility and acceptability of implementing the intervention within a real-world pediatric weight management setting. Feasibility outcomes include recruitment and enrollment rates, participant retention, session attendance, caregiver participation, treatment completion, intervention delivery, and completion of study measures. The study will also assess implementation feasibility by tracking the number of eligible participants approached and the proportion who express interest and enroll in the intervention. Acceptability outcomes include participant and caregiver satisfaction, perceived helpfulness of the intervention, and engagement with treatment content.
Exploratory clinical outcomes will also be examined using standardized self-report measures completed before and after treatment. These measures assess trauma-related symptoms, anxiety, depression, self-esteem, eating-related psychopathology, weight bias internalization, self-compassion, and psychosocial impairment. Participants and caregivers may also complete optional qualitative feedback interviews following treatment completion to provide additional insight into participant experiences, perceived benefits, challenges, and recommendations for future implementation.
The intervention will typically consist of approximately 12 weekly virtual therapy sessions delivered through secure virtual care platforms used within London Health Sciences Centre, with flexibility for additional sessions based on clinical need. Sessions will be delivered by a trained Registered Social Worker (MSW/RSW). Therapy content includes psychoeducation regarding trauma and bullying, emotional regulation and coping skills, cognitive coping strategies, trauma narrative development and processing, body image and stigma-related cognitive restructuring, caregiver support strategies, and safety planning as clinically indicated.
Given the use of trauma-focused intervention content and standardized mental health screening measures, any indication of elevated suicide risk or risk of harm to self or others identified during participation will be managed according to existing clinical protocols and standard of care within the HEAL Program. Appropriate risk assessment, safety planning, consultation, and referrals will occur as clinically indicated.
The findings from this feasibility study will help determine whether this trauma therapy intervention can be successfully integrated into routine pediatric obesity care settings and will inform the development of future larger-scale implementation and effectiveness studies.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention is a trauma therapy program for children and adolescents experiencing distress related to weight-based bullying. The intervention is informed by the core principles and components of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and is adapted to address bullying-related trauma, body image concerns, emotional distress, maladaptive eating behaviours, and weight-related stigma.
The intervention includes psychoeducation, emotional regulation and coping skills, cognitive coping strategies, trauma narrative development and processing, body image and stigma-related cognitive restructuring, caregiver support strategies, and safety planning as clinically indicated. Treatment is developmentally tailored and delivered virtually within the HEAL Program at Children's Hospital, London Health Sciences Centre.
Participants will complete approximately 12 weekly therapy sessions delivered by a trained MSW/RSW clinician.
Other names: TF-CBT-Informed Trauma Therapy, Trauma Therapy for Weight-Based Bullying
Time frame: Throughout the recruitment period- up to 24 months
Recruitment rate, defined as the proportion of eligible participants who consent and enroll in the study.
Time frame: Week 1 through Week 12
Session attendance, defined as the number and proportion of intervention sessions attended by each participant during the intervention period.
Time frame: Week 0 through Week 14
Retention rate, defined as the proportion of enrolled participants who complete the post-treatment assessment.
Time frame: Week 1 through Week 12
Treatment completion rate, defined as the proportion of participants who complete at least 10 of the 12 intervention sessions.
Time frame: Week 14
Acceptability and satisfaction will be assessed using the study-specific Child Acceptability and Satisfaction Survey. Scores range from 1 to 5, with higher scores indicating greater acceptability and satisfaction. Participants will also be invited to provide optional qualitative feedback regarding their experiences with the intervention and suggestions for improvement.
Time frame: Week 14
Acceptability and satisfaction will be assessed using the study-specific Caregiver Acceptability and Satisfaction Survey. Scores range from 1 to 5, with higher scores indicating greater acceptability and satisfaction. Caregivers will also be invited to provide optional qualitative feedback regarding their experiences with the intervention and suggestions for improvement.
Time frame: Week 0 and Week 14
Exploratory changes in trauma-related symptoms will be assessed using the Children's Revised Impact of Event Scale-13 (CRIES-13). Total scores range from 0 to 65, with higher scores indicating greater trauma-related symptom severity.
Time frame: Week 0 and Week 14
Exploratory changes in anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7). Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Time frame: Week 0 and Week 14
Exploratory changes in depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Time frame: Week 0 and Week 14
Exploratory changes in weight bias internalization will be assessed using the Weight Bias Internalization Scale-Modified (WBIS-M). Mean scores range from 1 to 7, with higher scores indicating greater internalized weight bias.
Time frame: Week 0 and Week 14
Exploratory changes in eating-related psychopathology will be assessed using the Eating Disorder Examination Questionnaire (EDE-Q). Global scores range from 0 to 6, with higher scores indicating greater eating disorder psychopathology.
Time frame: Week 0 and Week 14
Exploratory changes in self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES). Total scores range from 10 to 40, with higher scores indicating greater self-esteem.
Time frame: Week 0 and Week 14
Exploratory changes in self-compassion will be assessed using the Self-Compassion Scale (SCS). Mean scores range from 1 to 5, with higher scores indicating greater self-compassion.
Time frame: Week 0 and Week 14
Exploratory changes in psychosocial impairment will be assessed using the Clinical Impairment Assessment (CIA). Total scores range from 0 to 48, with higher scores indicating greater psychosocial impairment related to eating, weight, and shape concerns.
Contact information is provided by the study sponsor or research team.
Anu N James, MSW, RSW
CONTACT
519-685-8500 ext. 55235
Marina Ybarra, MD, MSc
CONTACT
519-685-8500 ext. 75689/75751
Western University
Other
Trauma Therapy for Weight-Based Bullying in Children Informed by TF-CBT Principles: A Feasibility Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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