Stepped Care for Young Children After Trauma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Posttraumatic stress symptoms
研究概览
简要总结
The aim of this R34 study is to develop and test the feasibility of a Stepped Care intervention for young children with Posttraumatic Stress Disorder (PTSD). Phase I will focus on developing and testing the feasibility of Stepped Care Trauma-Focused Cognitive Behavioral Therapy (SC-TF-CBT) in a small open trial (N=10). Phase II will consist of a randomized controlled trial (N=54) examining the efficacy of SC-TF-CBT relative to standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)on a number of outcome measures, treatment acceptability and satisfaction, and costs of treatment delivery. Findings from this pilot study will establish the feasibility and preliminary efficacy (see Kraemer et al., 2006) of SC-TF-CBT before progressing to a larger, randomized R01 to examine the effectiveness of SC-TF-CBT for early childhood PTSD.
详细描述
Young children who are exposed to traumatic events such as abuse, disasters, accidents, illnesses, injury and the death of a person close to them are at risk for developing PTSD. While effective treatments for childhood PTSD exist, novel interventions that are more accessible, efficient, and cost-effective are needed to improve access to evidence-based treatment. The purpose of this study is to develop and test the feasibility of an intervention called Stepped Care Trauma-Focused Cognitive Behavioral Therapy which has the potential to greatly improve service delivery approaches to make treatment more accessible and less costly, thereby reducing childhood PTSD and related societal impacts and costs.
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
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child must have experienced at least one traumatic event after the age of 36 months.
- •At least five Postttraumatic stress symptoms with one symptom of reexperiencing or one symptom of avoidance.
- •Child must be between 3 and 7 years of age at the time of enrollment.
- •The parent must be willing and able to participate in the treatment and complete informed consent.
排除标准
- •Psychosis, mental retardation, autism, or related pervasive developmental disorders in child or any condition that would limit the caregiver's ability to understand CBT and the child's ability to follow instructions.
- •Parent has had substance use disorder within the past 3 months.
- •Child or parent is suicidal (the DIPA will be used to screen for child suicidal ideation and the SCID-RV will be used to screen for parent suicide ideation; assessed by all available information). A delayed entry once the parent or child is stabilized (at least 6 months post suicidal) and not having suicidal ideation will be allowed.
- •Child or parent is not fluent in English.
- •Child is currently taking psychotropic medication and is not on a stable medication regimen for at least 4 weeks prior to admission to the study. If appropriate, a delayed entry will be allowed so that once a child is on a stable dosage the child may be enrolled in the study.
- •Child is receiving trauma-focused psychotherapy when study treatment is provided.
- •Parent or caregiver who would be treatment participant was the perpetrator, or the child was perpetrated by a person who still lives in the home (e.g. mother's boyfriend, sibling).
结局指标
主要结局
Posttraumatic stress symptoms
时间窗: baseline, week 14, and 3 month follow up
Change from baseline in Diagnostic Preschool Infant Assessment PTSD module (DIPA; Scheeringa, 2010) and in the Trauma Symptom Checklist for Young Children (Briere et al., 2001) at 14 weeks and 3 month follow up
次要结局
- Externalizing behaviors(baseline and week 14 and 3 month follow up)
- Internalizing behaviors(baseline, week 14 and 3 month follow up)
- Independent Evaluator-rated PTSD symptom and impairment severity(baseline, week 14 and 3 month follow up)
- Global improvement(baseline, week 14 and 3 month follow up)