Trauma Therapy for Weight-Based Bullying in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorWestern University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Trauma Therapy for Weight-Based Bullying Informed by TF-CBT
BehavioralThis 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Trauma Therapy Intervention for Weight-Based BullyingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Outcome Measure 1: Recruitment Rate
Recruitment rate, defined as the proportion of eligible participants who consent and enroll in the study.
Time frame
Throughout the recruitment period- up to 24 months2
Outcome Measure 2: Session Attendance
Session attendance, defined as the number and proportion of intervention sessions attended by each participant during the intervention period.
Time frame
Week 1 through Week 123
Outcome Measure 3: Retention Rate
Retention rate, defined as the proportion of enrolled participants who complete the post-treatment assessment.
Time frame
Week 0 through Week 144
Outcome Measure 4: Treatment Completion Rate
Treatment completion rate, defined as the proportion of participants who complete at least 10 of the 12 intervention sessions.
Time frame
Week 1 through Week 12Secondary outcomes
1
Outcome Measure 7: Trauma-Related Symptoms
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 142
Outcome Measure 8: Anxiety Symptoms
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 143
Outcome Measure 9: Depressive Symptoms
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 144
Outcome Measure 10: Weight Bias Internalization
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 14Sponsors and contacts
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Source ClinicalTrials.gov
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