Girls In Recovery From Life Stress (GIRLS) Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 14
- 主要终点
- Interview (CAPS-CA) assessing posttraumatic stress disorder and questionnaires (PTCI, IPSI, TMQ, TSCC) and clinician ratings (SOTS) assessing posttraumatic stress symptom severity.
研究概览
简要总结
This study will compare treatment outcomes of 90 adolescent girls who are (a) at high risk for delinquency and/or are juvenile justice involved, and (b) who are experiencing symptoms of PTSD: 45 of the girls will receive Trauma Affect Regulation: Guide for Education and Therapy (TARGET, Frisman, Ford, Lin, Mallon, & Chang, in press), and their outcomes will be compared to 45 girls who receive Enhanced Treatment as Usual (ETAU). As part of their involvement, participants will make phone calls to provide data via an interactive voice response system (IVR), meet 3 times for a research interview, and be invited to participate in a cognitive assessment substudy at the Olin Neuropsychiatric Research Center at Hartford Hospital.
详细描述
Hypotheses, Objectives and Aims:
The purpose of the GIRLS study is to provide counseling to adolescent girls who are (a) at high risk for delinquency and/or are juvenile justice involved and (b) are experiencing symptoms of PTSD, in order to help them regulate their emotions, planning, decision-making, and actions/ interactions in ways that will reduce PTSD and enhance their safety, responsible civic involvement, learning, peer, family, and adult relationships, and physical and psychological well-being. The study will be the first randomized clinical trial of a therapeutic intervention for complex post-traumatic stress disorder (PTSD)with girls: 1) Trauma Affect Regulation: Guide for Education and Therapy (TARGET; Frisman, Ford, Lin, Mallon, & Chang, in press), compared to Enhanced Treatment as Usual (ETAU). Both interventions will provide 12 one-to-one manualized, educational and therapeutic sessions that teach coping skills and stress reduction techniques.
The aims of the study are:
Aim 1) To test if participation in TARGET results in clinically and statistically significant improvements in PTSD symptoms, psychosocial functioning, and emotion/impulse regulation.
Aim 2) To compare the differential affects of TARGET and ETAU on affect regulation, social support, stress-related information processing and cognitive coping, and the reduction of impulsive or aggressive thinking/behavior.
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
- 13 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 13-17 years old
- •Past and/or current juvenile justice involvement AND/OR past and/or current delinquent behavior
- •Able to obtain assent from youth
- •Able to obtain consent from legal guardian
- •Willing to assent/consent to be audiotaped for research purposes in assessment and intervention sessions
- •Currently experiencing negative reactions to past traumas (PTSD symptoms)
排除标准
- •Imminently suicidal
- •Past 30 days inpatient psychiatric treatment
- •IF meetings take place at a school or group facility and the girl/participant is NOT willing to schedule appointments through the school or group facility staff
结局指标
主要结局
Interview (CAPS-CA) assessing posttraumatic stress disorder and questionnaires (PTCI, IPSI, TMQ, TSCC) and clinician ratings (SOTS) assessing posttraumatic stress symptom severity.
时间窗: Post-treatment, 4-6 months post-treatment
次要结局
- Questionnaires assessing problems with externalizing behaviors (Weinberger Adjustment Survey) and socioemotional strengths (Hope, NMR, Weinberger Adjustment Survey)(Post-treatment and 4-6 months post-treatment)