BLAME-LESS STUDY: a Two-arm Randomized Controlled Trial Evaluating the Effects of an Online Psycho-education Program for Adolescents Who Experienced (sexual) Violence.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Primary outcome: Changes in Feelings of Shame and Guilt
研究概览
简要总结
The primary objective of the BLAME-LESS study is to examine the effectiveness of an online psychoeducation program in reducing trauma-related feelings of shame and guilt in adolescents who experienced sexual or physical abuse .
详细描述
The study follows a two-arm RCT (n=34). The effects of a brief online psychoeducation program will be compared, with a waiting-list control group. The intervention aims to reduce feelings of trauma-related shame and guilt that adolescents experience regarding their own defense responses during and after (sexual) violence. Assessments take place after screening, at baseline, two weeks after allocation to the intervention or waiting-list, and, only for the waiting-list participants, seven weeks after allocation to the intervention.
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
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the participant experienced one or more traumatic life events, including (sexual) violence as indicated by the CTSQ;
- •the participant reported one or more feelings of guilt and/or shame on the CERQ (items 1 and/or 10 and/or 19 and/or 28)
- •the participant being fluent in written and spoken Dutch;
- •the participant is motivated and available for a period of seven weeks to engage in the study, including the psychoeducation program BLAME-LESS, and commit to the assessments.
排除标准
- •acute suicidal behavior or suicidal ideations requiring immediate hospitalization;
- •the participant has already read the book that this program is based upon: "Paralyzed with Fear" (In Dutch: Verlamd van Angst, van Minnen 2017), or has been intensively informed otherwise in the past 12 months by a psychologist about common defense responses during and after trauma;
- •Cognitive Impairments (IQ < 70);
- •the participant has a brother or sister in the present study;
- •the participant is already involved in trauma-focused treatment.
结局指标
主要结局
Primary outcome: Changes in Feelings of Shame and Guilt
时间窗: The SGATS will be assessed at before treatment (T1 = Week 1), after treatment (T2 = Week 4, T3 = week 7)
The primary objective of the BLAME-LESS study is to examine the effectiveness of an online psychoeducation program, BLAME-LESS, compared to a waiting-list control group of adolescents (12 - 18 years) who experienced sexual or physical abuse in reducing trauma-related feelings of shame and guilt. The Shame and Guilt After Trauma Scale (SGATS) (Aakvaag et al., 2016) measures trauma-related shame and guilt. The SGATS consists of nine items, four on trauma-related feelings of shame and five on trauma-related feelings of guilt (Aakvaag et al., 2016). Each question can be answered on a 3-point Likert scale (0 = no, 1 = yes, a little, 2 = yes, a lot).
次要结局
- Secondary outcome: Changes in Depression and Anxiety Symptoms(The PROMIS will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7))
- Secondary outcome: Changes in Posttraumatic Cognition(The CPTCI will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7))
- Secondary outcome: Changes in motivation and disclosure(The TPEQ will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7))
- Secondary outcome: Changes in Posttraumatic Stress Symptoms(The KJTS will be assessed before treatment (T1 = Week 1) and after treatment (T2 = Week 4, T3 = Week 7).)