Clinical trial

Trauma Therapy for Weight-Based Bullying in Children

Opening soon · Not applicable · 1 countries · Registry ID NCT07685990

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age10 Years to 17 Years

SexAll

Healthy volunteersNot accepted

ConditionPediatric Obesity, Weight-based Bullying, Psychological Trauma

Full registry 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

Treatments and study arms

Trauma Therapy for Weight-Based Bullying Informed by TF-CBT

Behavioral

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.

Primary outcomes

Outcome Measure 1: Recruitment RateThroughout the recruitment period- up to 24 months

Recruitment rate, defined as the proportion of eligible participants who consent and enroll in the study.

Outcome Measure 2: Session AttendanceWeek 1 through Week 12

Session attendance, defined as the number and proportion of intervention sessions attended by each participant during the intervention period.

Outcome Measure 3: Retention RateWeek 0 through Week 14

Retention rate, defined as the proportion of enrolled participants who complete the post-treatment assessment.

Outcome Measure 4: Treatment Completion RateWeek 1 through Week 12

Treatment completion rate, defined as the proportion of participants who complete at least 10 of the 12 intervention sessions.

Outcome Measure 5: Child Acceptability and SatisfactionWeek 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.

Outcome Measure 6: Caregiver Acceptability and SatisfactionWeek 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.

Study locations

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London Health Sciences Centre🇨🇦 London, Ontario, Canada

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