- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07685990
Trauma Therapy for Weight-Based Bullying in Children
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?
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Marina Ybarra, MD, MSc
- Telefonní číslo: 75689/75751 519-685-8500
- E-mail: Marina.Ybarra@lhsc.on.ca
Studijní záloha kontaktů
- Jméno: Anu N James, MSW, RSW
- Telefonní číslo: 55235 519-685-8500
- E-mail: anu.james@lhsc.on.ca
Studijní místa
-
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Ontario
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London, Ontario, Kanada, N6A5W9
- London Health Sciences Centre
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Trauma Therapy Intervention for Weight-Based Bullying
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.
|
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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Outcome Measure 1: Recruitment Rate
Časové okno: Throughout the recruitment period- up to 24 months
|
Recruitment rate, defined as the proportion of eligible participants who consent and enroll in the study.
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Throughout the recruitment period- up to 24 months
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Outcome Measure 2: Session Attendance
Časové okno: Week 1 through Week 12
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Session attendance, defined as the number and proportion of intervention sessions attended by each participant during the intervention period.
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Week 1 through Week 12
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Outcome Measure 3: Retention Rate
Časové okno: Week 0 through Week 14
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Retention rate, defined as the proportion of enrolled participants who complete the post-treatment assessment.
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Week 0 through Week 14
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Outcome Measure 4: Treatment Completion Rate
Časové okno: Week 1 through Week 12
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Treatment completion rate, defined as the proportion of participants who complete at least 10 of the 12 intervention sessions.
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Week 1 through Week 12
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Outcome Measure 5: Child Acceptability and Satisfaction
Časové okno: Week 14
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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.
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Week 14
|
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Outcome Measure 6: Caregiver Acceptability and Satisfaction
Časové okno: 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.
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Week 14
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Outcome Measure 7: Trauma-Related Symptoms
Časové okno: Week 0 and Week 14
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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.
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Week 0 and Week 14
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Outcome Measure 8: Anxiety Symptoms
Časové okno: Week 0 and Week 14
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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.
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Week 0 and Week 14
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Outcome Measure 9: Depressive Symptoms
Časové okno: Week 0 and Week 14
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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.
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Week 0 and Week 14
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Outcome Measure 10: Weight Bias Internalization
Časové okno: Week 0 and Week 14
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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.
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Week 0 and Week 14
|
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Outcome Measure 11: Eating-Related Psychopathology
Časové okno: Week 0 and Week 14
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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.
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Week 0 and Week 14
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Outcome Measure 12: Self-Esteem
Časové okno: Week 0 and Week 14
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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.
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Week 0 and Week 14
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Outcome Measure 13: Self-Compassion
Časové okno: Week 0 and Week 14
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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.
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Week 0 and Week 14
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Outcome Measure 14: Psychosocial Impairment
Časové okno: Week 0 and Week 14
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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.
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Week 0 and Week 14
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Marina Ybarra, MD, MSc, Division of Paediatric Endocrinology - Department of Paediatrics
Publikace a užitečné odkazy
Obecné publikace
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- Spitzer 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.
- Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
- Whitaker 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.
- Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
- Pearl RL, Puhl RM. Measuring internalized weight attitudes across body weight categories: validation of the modified weight bias internalization scale. Body Image. 2014 Jan;11(1):89-92. doi: 10.1016/j.bodyim.2013.09.005. Epub 2013 Oct 4.
- Takizawa 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.
- Freedman DS, Khan LK, Dietz WH, Srinivasan SR, Berenson GS. Relationship of childhood obesity to coronary heart disease risk factors in adulthood: the Bogalusa Heart Study. Pediatrics. 2001 Sep;108(3):712-8. doi: 10.1542/peds.108.3.712.
- 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.
- Bohn K, Doll HA, Cooper Z, O'Connor M, Palmer RL, Fairburn CG. The measurement of impairment due to eating disorder psychopathology. Behav Res Ther. 2008 Oct;46(10):1105-10. doi: 10.1016/j.brat.2008.06.012. Epub 2008 Jul 2.
- Guo SS, Roche AF, Chumlea WC, Gardner JD, Siervogel RM. The predictive value of childhood body mass index values for overweight at age 35 y. Am J Clin Nutr. 1994 Apr;59(4):810-9. doi: 10.1093/ajcn/59.4.810.
- Fairburn, C. G. (2008). Cognitive behavior therapy and eating disorders. Guilford Press.
- Rosenberg, M. (1965). Society and the adolescent self-image. Princeton University Press.
- Durso LE, Latner JD. Understanding self-directed stigma: development of the weight bias internalization scale. Obesity (Silver Spring). 2008 Nov;16 Suppl 2:S80-6. doi: 10.1038/oby.2008.448.
- Statistics Canada. (2017). Overweight and obesity based on measured body mass index among children and youth.
- 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., & 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.
- Wang 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.
- Puhl 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.
- Puhl RM, Latner JD. Stigma, obesity, and the health of the nation's children. Psychol Bull. 2007 Jul;133(4):557-80. doi: 10.1037/0033-2909.133.4.557.
- Pearl RL, Puhl RM. Weight bias internalization and health: a systematic review. Obes Rev. 2018 Aug;19(8):1141-1163. doi: 10.1111/obr.12701. Epub 2018 May 22.
- Lydecker JA, Ozbardakci EV, Lou R, Grilo CM. Trauma-Focused Cognitive-Behavioral Therapy for Adolescents Bullied Because of Weight: A Feasibility Study. Int J Eat Disord. 2024 Oct;57(10):2117-2127. doi: 10.1002/eat.24257. Epub 2024 Jul 15.
- Hunger JM, Tomiyama AJ. Weight labeling and obesity: a longitudinal study of girls aged 10 to 19 years. JAMA Pediatr. 2014 Jun;168(6):579-80. doi: 10.1001/jamapediatrics.2014.122. No abstract available.
- Haines J, Neumark-Sztainer D, Eisenberg ME, Hannan PJ. Weight teasing and disordered eating behaviors in adolescents: longitudinal findings from Project EAT (Eating Among Teens). Pediatrics. 2006 Feb;117(2):e209-15. doi: 10.1542/peds.2005-1242.
- Eisenberg ME, Neumark-Sztainer D, Story M. Associations of weight-based teasing and emotional well-being among adolescents. Arch Pediatr Adolesc Med. 2003 Aug;157(8):733-8. doi: 10.1001/archpedi.157.8.733.
- Copeland WE, Wolke D, Angold A, Costello EJ. Adult psychiatric outcomes of bullying and being bullied by peers in childhood and adolescence. JAMA Psychiatry. 2013 Apr;70(4):419-26. doi: 10.1001/jamapsychiatry.2013.504.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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