Pediatric ObesityNCT07685990
Trauma Therapy for Weight-Based Bullying in Children
A study testing Trauma Therapy for Weight-Based Bullying Informed by TF-CBT in people with Pediatric Obesity and Weight-based Bullying, run by Western University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Pediatric Obesity, Weight-based Bullying, Psychological Trauma
- What is being tested?
- Trauma Therapy for Weight-Based Bullying Informed by TF-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Trauma Therapy for Weight-Based Bullying in Children Informed by TF-CBT Principles: A Feasibility Study
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?
Read more
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.
Read the 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.
- Being tested
- Trauma Therapy for Weight-Based Bullying Informed by TF-CBT
- Keywords
- weight-based bullying, TF-CBT, Pediatric obesity, trauma, feasibility study, Trauma Focused-Cognitive Behaviour Therapy
- Medical subject headings
- Pediatric Obesity, Psychological Trauma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Therapy for Weight-Based Bullying Informed by TF-CBTBehavioural
Also called TF-CBT-Informed Trauma Therapy, Trauma Therapy for Weight-Based Bullying
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Trauma Therapy for Weight-Based Bullying Informed by TF-CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure 1: Recruitment Rate
Recruitment rate, defined as the proportion of eligible participants who consent and enroll in the study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 14
Secondary outcomes (8)
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.
Measured: Week 0 and Week 14
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.
Measured: Week 0 and Week 14
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.
Measured: Week 0 and Week 14
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.
Measured: Week 0 and Week 14
Outcome Measure 11: Eating-Related Psychopathology
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.
Measured: Week 0 and Week 14
Outcome Measure 12: Self-Esteem
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.
Measured: Week 0 and Week 14
Outcome Measure 13: Self-Compassion
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.
Measured: Week 0 and Week 14
Outcome Measure 14: Psychosocial Impairment
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.
Measured: Week 0 and Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Ybarra, Western University
- Investigators
- Marina Ybarra, MD, MSc, Principal investigator, Division of Paediatric Endocrinology - Department of Paediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685990
- Sponsor's protocol ID
- HSREB#129267
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
Bohn, K., & Fairburn, C. G. (2008). Clinical Impairment Assessment Questionnaire (CIA 3.0). In C. G. Fairburn, Cognitive behavior therapy and eating disorders. Guilford Press.
Wolke D, Lereya ST. Long-term effects of bullying. Arch Dis Child. 2015 Sep;100(9):879-85. doi: 10.1136/archdischild-2014-306667. Epub 2015 Feb 10.
PubMed 25670406Whitaker RC, Wright JA, Pepe MS, Seidel KD, Dietz WH. Predicting obesity in young adulthood from childhood and parental obesity. N Engl J Med. 1997 Sep 25;337(13):869-73. doi: 10.1056/NEJM199709253371301.
PubMed 9302300Wang J, Iannotti RJ, Nansel TR. School bullying among adolescents in the United States: physical, verbal, relational, and cyber. J Adolesc Health. 2009 Oct;45(4):368-75. doi: 10.1016/j.jadohealth.2009.03.021. Epub 2009 Jun 11.
PubMed 19766941Takizawa R, Maughan B, Arseneault L. Adult health outcomes of childhood bullying victimization: evidence from a five-decade longitudinal British birth cohort. Am J Psychiatry. 2014 Jul;171(7):777-84. doi: 10.1176/appi.ajp.2014.13101401.
PubMed 24743774Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Puhl RM, Luedicke J, Heuer C. Weight-based victimization toward overweight adolescents: observations and reactions of peers. J Sch Health. 2011 Nov;81(11):696-703. doi: 10.1111/j.1746-1561.2011.00646.x.
PubMed 21972990
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Therapy for Weight-Based Bullying in Children Informed by TF-CBT Principles: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07685990
- Acronym / sponsor ID
- HSREB#129267
- Keywords
- weight-based bullying, TF-CBT, Pediatric obesity, trauma, feasibility study, Trauma Focused-Cognitive Behaviour Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Western UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Trauma Therapy Intervention for Weight-Based Bullying | Experimental | Behavioral: Trauma Therapy for Weight-Based Bullying Informed by TF-CBTParticipants 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma Therapy for Weight-Based Bullying Informed by TF-CBTAlso: TF-CBT-Informed Trauma Therapy, Trauma Therapy for Weight-Based BullyingThis 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. | Behavioural | Trauma Therapy Intervention for Weight-Based Bullying |
Primary outcome
Outcome Measure 1: Recruitment Rate
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.
Outcome Measure 2: Session Attendance
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.
Outcome Measure 3: Retention Rate
Time frame: Week 0 through Week 14
Retention rate, defined as the proportion of enrolled participants who complete the post-treatment assessment.
Outcome Measure 4: Treatment Completion Rate
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.
Outcome Measure 5: Child Acceptability and Satisfaction
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.
Outcome Measure 6: Caregiver Acceptability and Satisfaction
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- BackgroundStatistics Canada. (2017). Overweight and obesity based on measured body mass index among children and youth.
- BackgroundRosenberg, M. (1965). Society and the adolescent self-image. Princeton University Press.
- BackgroundPerrin, 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.
- BackgroundNeff, K. D. (2003). The development and validation of a scale to measure self-compassion. Self and Identity, 2(3), 223-250.
- BackgroundHEAL Research Database. (2024). Internal clinical dataset. Children's Hospital, London Health Sciences Centre.
- BackgroundFairburn, C. G. (2008). Cognitive behavior therapy and eating disorders. Guilford Press.
- BackgroundFairburn, 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
- BackgroundCohen, J. A., Mannarino, A. P., & Deblinger, E. (2017). Treating trauma and traumatic grief in children and adolescents (2nd ed.). Guilford Press.
- BackgroundBohn, K., & Fairburn, C. G. (2008). Clinical Impairment Assessment Questionnaire (CIA 3.0). In C. G. Fairburn, Cognitive behavior therapy and eating disorders. Guilford Press.
- Background: PubMed 25670406Wolke D, Lereya ST. Long-term effects of bullying. Arch Dis Child. 2015 Sep;100(9):879-85. doi: 10.1136/archdischild-2014-306667. Epub 2015 Feb 10.
- Background: PubMed 9302300Whitaker RC, Wright JA, Pepe MS, Seidel KD, Dietz WH. Predicting obesity in young adulthood from childhood and parental obesity. N Engl J Med. 1997 Sep 25;337(13):869-73. doi: 10.1056/NEJM199709253371301.
- Background: PubMed 19766941Wang J, Iannotti RJ, Nansel TR. School bullying among adolescents in the United States: physical, verbal, relational, and cyber. J Adolesc Health. 2009 Oct;45(4):368-75. doi: 10.1016/j.jadohealth.2009.03.021. Epub 2009 Jun 11.
- Individual participant dataSharing planned: No
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Obesity, Adolescent, Oxytocin
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marina Ybarra, MD, MSc principal investigator
Division of Paediatric Endocrinology - Department of Paediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Therapy for Weight-Based Bullying Informed by TF-CBT in people with Pediatric Obesity and Weight-based Bullying, run by Western University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Ybarra, MD, MSc (519-685-8500 ext. 75689/75751, Marina.Ybarra@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Measure 1: Recruitment Rate (time frame: Throughout the recruitment period- up to 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07685990, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.