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临床试验/NCT06172452
NCT06172452招募中不适用

Testing a Single-Session Online Body Image and Mood Program for Sexual and Gender Minority (SGM) Adolescents

Northwestern University2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
2
主要终点
Eating Disorder Examination Questionnaire - 10 item, 3 factor version (EDE-Q; Fairburn & Beglin, 2008; Habashy et al., 2023)

研究概览

简要总结

This study tests a single-session intervention (SSI) targeting risk factors for depression and eating disorders among sexual and gender minority (SGM) adolescents. Youth ages 13-17 who identify as sexual or gender minorities will be randomized to the intervention condition (Project Body Neutrality SSI) or a control (supportive therapy SSI). Participants will complete questionnaires before the intervention, immediately after the intervention, and 3-months after completing the intervention so that the study team can investigate if Project Body Neutrality leads to reductions in depression and eating disorder symptoms compared to the control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Identify as a sexual or gender minority individual per self-report
  • 13-17 years old at the time of enrollment
  • English proficiency per self-report
  • Report having body image concerns per self-report
  • Score of ≥ 2 on the Patient Health Questionnaire-2 (PHQ-2; Kroenke et al., 2003), - indicating elevated depressive symptoms
  • Did not participate in a past study involving Project Body Neutrality per self-report
  • Residing within the United States per IP address
  • Passes comprehension of consent language assessment

排除标准

  • Fail to meet the above-listed inclusion criteria
  • Exit the study prior to condition randomization
  • Failure to pass the data integrity measures
  • Duplicate responses from the same individual in baseline or follow-up surveys

结局指标

主要结局

Eating Disorder Examination Questionnaire - 10 item, 3 factor version (EDE-Q; Fairburn & Beglin, 2008; Habashy et al., 2023)

时间窗: Pre-Intervention to 3-month follow-up

A 10-item questionnaire designed to assess the range and severity of features associated with a diagnosis of eating disorder. The original measure's factor structure has failed to replicate across many samples, especially for diverse populations. This version has achieved strict invariance by gender and race/ethnicity. Higher global scores indicate greater eating disorder severity (primary outcome). Outcomes for the three subscales (Dietary Restaurant, Preoccupation with Eating Concern, and Shape/Weight Overvaluation) will also be reported. Each item is on a 0 to 6 scale and the scores are computed as means.

Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995)

时间窗: Pre-Intervention to 3-month follow-up

A 13-item questionnaire designed to assess depressive symptoms in youth. Total scores range from 0 to 26, with higher scores indicating greater depression severity (primary outcome).

次要结局

  • State Hope Scale - 3 item Pathways subscale (SHS; Snyder et al., 1996)(Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up)
  • Beck Hopelessness Scale - 4 item version (BHS; Perczel Forintos et al., 2013)(Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up)
  • Body Image States Scale (BISS; Cash et al., 2002)(Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up)
  • Functionality Appreciation Scale (FAS; Alleva et al., 2017)(Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Schleider

Associate Professor

Northwestern University

研究点 (2)

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