Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (Subclinical) PTSD: a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Changes in Posttraumatic stress symptoms (KJTS)
研究概览
简要总结
The primary objective of this study is to examine the effectiveness of a Brief Intensive Trauma Treatment (BITT) for adolescents with (s)PTSD.
详细描述
This study is a multi-center, single-blinded RCT. Adolescents (12-18 years old) with (s)PTSD will be randomly allocated by an independent researcher to the BITT (n=50) versus a waitlist control group (WLCG; n=50), stratified by center. Measurements are done at comparable time intervals for both groups: at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up. The WLCG receives BITT after the 3 months follow-up.
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
- Double (Investigator, Outcomes Assessor)
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
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •12-18 years of age;
- •with a history of psychological trauma (conform the Life Events Checklist of the Clinician Administered PTSD Scale for Children and Adolescents DSM-5 (CAPS-CA DSM-5) (Nader, 2004; van Meijel et al., 2019);
- •at least subthreshold PTSD criteria, conform the CAPS-CA DSM-5, i.e.;
- •fully meeting criterion A, F and G and at least one symptom of criteria B, C, D and E;
- •or fully meeting criterion A, F, G and at least the B, C, D or E symptom clusters;
- •and written informed consent must be provided by the adolescent and, for adolescents aged 12-15 years, all legal guardians.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study in case of:
- •inability to speak and write Dutch;
- •estimated or determined mental retardation (IQ <70);
- •suffering from ongoing trauma by a parent who is part of the adolescent's current primary-care system.
研究组 & 干预措施
Brief Intensive Trauma Treatment
If allocated to the intervention group, participants follow the Brief Intensive Trauma Treatment (BITT).
干预措施: Brief Intensive Trauma Treatment (Behavioral)
Waitlist control group
When allocated to the WLCG, participants receive BITT after a 3 months waiting period. The WLCG receives no care during the treatment phase (one week) of the intervention group. Besides this week the WLCG can undergo every treatment including EMDR and TF-CBT during the 3 months waiting period.
结局指标
主要结局
Changes in Posttraumatic stress symptoms (KJTS)
时间窗: PTSD symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
The primary objective of this study is to test the effectiveness of BITT versus a WLCG on adolescents (12-18 years) with (s)PTSD. PTSD symptoms will be assessed by the Child and Adolescent Trauma Screening (In Dutch: Kind en Jeugd Trauma Screener (KJTS; Kooij \& Lindauer, 2019). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) on (s)PTSD symptoms will be tested.
Changes in Posttraumatic stress symptoms (CAPS-CA)
时间窗: PTSD symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.
The primary objective of this study is to test the effectiveness of BITT versus a WLCG on adolescents (12-18 years) with (s)PTSD. PTSD symptoms will be assessed by the Clinician Administered PTSD Scale for Children and Adolescents DSM-5 (CAPS-CA DSM 5; Van Meijel et al., 2013). Additionally, the effectiveness of BITT versus regular trauma treatment (i.e., TF-CBT and EMDR) on (s)PTSD symptoms will be tested.
次要结局
- Changes in Anxiety symptoms (SCID-5-Junior)(Anxiety symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.)
- Changes in Quality of life(Quality of life is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.)
- Changes in Depression symptoms (SCID-5-Junior)(Depression symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.)
- Dropout rates(Dropout is measures at each day of the BITT week (in total 5 days).)
- Changes in Anxiety symptoms (PROMIS)(Anxiety symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.)
- Changes in Depression symptoms (PROMIS)(Depression symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.)
- Changes in Risk-behavior and safety(Risk-behavior and safety is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.)
- Cost-effectiveness(Cost-effectiveness is measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.)
- Changes in Anger symptoms (PROMIS)(Anger symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.)
- Changes in Anger symptoms (SCID-5 Junior)(Anger symptoms are measured at pre-treatment (T0), directly after BITT or WLCG (T1) and at 3 (T2), 6 (T3) and 9 (T4) months follow-up.)
研究者
Prof. dr. R.J.L. (Ramón) Lindauer
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)