Trauma Therapy for Weight-Based Bullying in Children Informed by TF-CBT Principles: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Outcome Measure 1: Recruitment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Outcome Measure 1: Recruitment Rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Outcome Measure 12: Self-Esteem(Week 0 and Week 14)
- Outcome Measure 13: Self-Compassion(Week 0 and Week 14)
- Outcome Measure 14: Psychosocial Impairment(Week 0 and Week 14)