Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Trauma Therapy for Weight-Based Bullying in Children

1 de julio de 2026 actualizado por: Marina Ybarra, Western University

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Marina Ybarra, MD, MSc
  • Número de teléfono: 75689/75751 519-685-8500
  • Correo electrónico: Marina.Ybarra@lhsc.on.ca

Copia de seguridad de contactos de estudio

  • Nombre: Anu N James, MSW, RSW
  • Número de teléfono: 55235 519-685-8500
  • Correo electrónico: anu.james@lhsc.on.ca

Ubicaciones de estudio

    • Ontario
      • London, Ontario, Canadá, N6A5W9
        • London Health Sciences Centre

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

Otros nombres:
  • TF-CBT-Informed Trauma Therapy
  • Trauma Therapy for Weight-Based Bullying

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Outcome Measure 1: Recruitment Rate
Periodo de tiempo: Throughout the recruitment period- up to 24 months
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
Periodo de tiempo: Week 1 through Week 12
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
Periodo de tiempo: Week 0 through Week 14
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
Periodo de tiempo: Week 1 through Week 12
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
Periodo de tiempo: 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.
Week 14
Outcome Measure 6: Caregiver Acceptability and Satisfaction
Periodo de tiempo: 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.
Week 14

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Outcome Measure 7: Trauma-Related Symptoms
Periodo de tiempo: Week 0 and Week 14
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.
Week 0 and Week 14
Outcome Measure 8: Anxiety Symptoms
Periodo de tiempo: Week 0 and Week 14
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.
Week 0 and Week 14
Outcome Measure 9: Depressive Symptoms
Periodo de tiempo: Week 0 and Week 14
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.
Week 0 and Week 14
Outcome Measure 10: Weight Bias Internalization
Periodo de tiempo: Week 0 and Week 14
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.
Week 0 and Week 14
Outcome Measure 11: Eating-Related Psychopathology
Periodo de tiempo: Week 0 and Week 14
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.
Week 0 and Week 14
Outcome Measure 12: Self-Esteem
Periodo de tiempo: Week 0 and Week 14
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.
Week 0 and Week 14
Outcome Measure 13: Self-Compassion
Periodo de tiempo: Week 0 and Week 14
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.
Week 0 and Week 14
Outcome Measure 14: Psychosocial Impairment
Periodo de tiempo: Week 0 and Week 14
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.
Week 0 and Week 14

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Marina Ybarra, MD, MSc, Division of Paediatric Endocrinology - Department of Paediatrics

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

30 de junio de 2028

Finalización del estudio (Estimado)

30 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

12 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de julio de 2026

Publicado por primera vez (Actual)

6 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir