NCT07685990

Brief Summary

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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
28mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

July 6, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

June 12, 2026

Last Update Submit

July 1, 2026

Conditions

Keywords

weight-based bullyingTF-CBTPediatric obesitytraumafeasibility studyTrauma Focused-Cognitive Behaviour Therapy

Outcome Measures

Primary Outcomes (6)

  • Outcome Measure 1: Recruitment Rate

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

    Throughout the recruitment period- up to 24 months

  • Outcome Measure 2: Session Attendance

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

    Week 1 through Week 12

  • Outcome Measure 3: Retention Rate

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

    Week 0 through Week 14

  • 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.

    Week 1 through Week 12

  • Outcome Measure 5: Child Acceptability and Satisfaction

    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.

    Week 14

  • Outcome Measure 6: Caregiver Acceptability and Satisfaction

    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.

    Week 14

Secondary Outcomes (8)

  • Outcome Measure 7: Trauma-Related Symptoms

    Week 0 and Week 14

  • Outcome Measure 8: Anxiety Symptoms

    Week 0 and Week 14

  • Outcome Measure 9: Depressive Symptoms

    Week 0 and Week 14

  • Outcome Measure 10: Weight Bias Internalization

    Week 0 and Week 14

  • Outcome Measure 11: Eating-Related Psychopathology

    Week 0 and Week 14

  • +3 more secondary outcomes

Study Arms (1)

Trauma Therapy Intervention for Weight-Based Bullying

EXPERIMENTAL

Participants in this single-arm feasibility study will receive a trauma therapy intervention for weight-based bullying informed by Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) principles. The intervention is delivered virtually within the HEAL Program at Children's Hospital, London Health Sciences Centre and consists of approximately 12 weekly therapy sessions. Treatment focuses on trauma-related distress associated with weight-based bullying, including emotional regulation, coping skills, cognitive processing, trauma narrative work, body image concerns, and caregiver support strategies. Sessions are delivered by a trained MSW/RSW clinician.

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

Interventions

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.

Also known as: TF-CBT-Informed Trauma Therapy, Trauma Therapy for Weight-Based Bullying
Trauma Therapy Intervention for Weight-Based Bullying

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

Related Publications (30)

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    PMID: 22193671BACKGROUND
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    PMID: 24100004BACKGROUND
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    PMID: 29788533BACKGROUND
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    PMID: 39007703BACKGROUND
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MeSH Terms

Conditions

Pediatric ObesityPsychological TraumaWounds and Injuries

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Marina Ybarra, MD, MSc

    Division of Paediatric Endocrinology - Department of Paediatrics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Ybarra, MD, MSc

CONTACT

Anu N James, MSW, RSW

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single-arm mixed-methods feasibility study using a single group assignment design. All enrolled participants will receive a trauma therapy intervention for weight-based bullying informed by Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) principles within the HEAL Program at Children's Hospital, London Health Sciences Centre. The study will evaluate the feasibility, acceptability, and preliminary clinical outcomes of implementing the intervention within a real-world pediatric weight management setting. There is no randomization or comparison group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

June 12, 2026

First Posted

July 6, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

July 6, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations