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Not yet recruiting NCT07685990

Trauma Therapy for Weight-Based Bullying in Children

No phase Interventional Pediatric Obesity Weight-based Bullying Psychological Trauma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trauma Therapy for Weight-Based Bullying Informed by TF-CBT.
Who it may be relevant to
Registry conditions: Pediatric Obesity, Weight-based Bullying, Psychological Trauma. Basic parameters: 10 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Trauma Therapy for Weight-Based Bullying in Children Informed by TF-CBT Principles: A Feasibility Study

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Trauma Therapy for Weight-Based Bullying Informed by TF-CBT
    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 co

Primary outcome measures

  • Outcome Measure 1: Recruitment Rate [Time frame: Throughout the recruitment period- up to 24 months]
  • Outcome Measure 2: Session Attendance [Time frame: Week 1 through Week 12]
  • Outcome Measure 3: Retention Rate [Time frame: Week 0 through Week 14]
  • Outcome Measure 4: Treatment Completion Rate [Time frame: Week 1 through Week 12]
  • Outcome Measure 5: Child Acceptability and Satisfaction [Time frame: Week 14]
  • Outcome Measure 6: Caregiver Acceptability and Satisfaction [Time frame: Week 14]
Secondary outcome measures (8)
  • Outcome Measure 7: Trauma-Related Symptoms [Time frame: Week 0 and Week 14]
  • Outcome Measure 8: Anxiety Symptoms [Time frame: Week 0 and Week 14]
  • Outcome Measure 9: Depressive Symptoms [Time frame: Week 0 and Week 14]
  • Outcome Measure 10: Weight Bias Internalization [Time frame: Week 0 and Week 14]
  • Outcome Measure 11: Eating-Related Psychopathology [Time frame: Week 0 and Week 14]
  • Outcome Measure 12: Self-Esteem [Time frame: Week 0 and Week 14]
  • Outcome Measure 13: Self-Compassion [Time frame: Week 0 and Week 14]
  • Outcome Measure 14: Psychosocial Impairment [Time frame: Week 0 and Week 14]

Eligibility criteria

Inclusion criteria

  • Children and adolescents aged 10-17 years enrolled in the HEAL Program at Children's Hospital, London Health Sciences Centre
  • Self-reported experiences of weight-based bullying or weight-related teasing associated with emotional distress
  • Clinically appropriate for outpatient trauma therapy participation as determined by the study team
  • Ability to participate in virtual therapy sessions in English
  • Willingness of both participant and caregiver to participate in study procedures and intervention components
  • Ability of the participant and caregiver to provide informed assent/consent

Exclusion criteria

  • Acute psychiatric risk requiring a higher level of care (e.g.: active suicidal ideation with intent or plan, recent suicide attempt requiring crisis intervention, psychosis or loss of reality testing, severe psychiatric instability);
  • Severe eating disorder requiring specialized or intensive treatment;
  • Uncontrolled or medically unstable conditions requiring urgent or intensive intervention;
  • Developmental or cognitive conditions that significantly impair participation in TF-CBT;
  • Concurrent participation in other trauma-focused psychotherapy or interventions targeting trauma symptoms;
  • Pregnancy;
  • Lack of caregiver availability for treatment participation.
  • Not able to do virtual sessions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • London Health Sciences Centre — London

Publications

  • Statistics Canada. (2017). Overweight and obesity based on measured body mass index among children and youth.
  • Rosenberg, M. (1965). Society and the adolescent self-image. Princeton University Press.
  • Perrin, S., Meiser-Stedman, R., & Smith, P. (2005). The Children's Revised Impact of Event Scale (CRIES): Validity as a screening instrument for PTSD. Behavioural and Cognitive Psychotherapy, 33(4), 487-498.
  • Neff, K. D. (2003). The development and validation of a scale to measure self-compassion. Self and Identity, 2(3), 223-250.
  • HEAL Research Database. (2024). Internal clinical dataset. Children's Hospital, London Health Sciences Centre.
  • Fairburn, C. G. (2008). Cognitive behavior therapy and eating disorders. Guilford Press.
  • Fairburn, C. G., & Cooper, Z. (1993). The Eating Disorder Examination. In C. G. Fairburn & G. T. Wilson (Eds.), Binge eating: Nature, assessment, and treatment (pp. 317-360). Guilford Press
  • Cohen, J. A., Mannarino, A. P., & Deblinger, E. (2017). Treating trauma and traumatic grief in children and adolescents (2nd ed.). Guilford Press.

Identifiers

NCT: NCT07685990 · HSREB#129267

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗