Evaluating Effectiveness of Dyadic Prolonged Exposure Treatment on 2-4 Years Old vs. Toddler-parent Focused Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change from baseline in post traumatic symptoms: clinical assessment and Young child ptsd checklist (YCPC, Scheeringa & Haslett, 2010).
研究概览
简要总结
Traumatic events have potentially debilitating long-lasting effects on the child's normal development and, therefore, should be effectively treated. Prolonged Exposure (PE) therapy has been found to be effective in reducing posttraumatic stress disorder symptoms in adults and in adolescents. It has not yet been tested in toddlers.
The purpose of this study is to examine the treatment efficacy of 2 methods of treatment for toddlers with PTSD and their parents. A randomized control trial could examine the efficacy of PE versus dyadic play therapy (TP-CT). Exploration of these questions under more rigorous conditions would help broaden our knowledge about developmentally sensitive treatment tools for this age group.
Our research hypotheses are:
- PE would more effective than TP-CT in reducing post-traumatic symptoms in toddlers.
- PE would more effective than TP-CT in reducing post-traumatic symptoms of the toddlers' parents.
- These results will be preserved in a follow-up of 3-6 months post treatment. Following psychiatric assessment, 100 toddlers will be randomly assigned to PE and TP-CT (50 participants in each group).
详细描述
Beyond what was detailed in the previous section of the brief summary, it should be noted that the toddlers will be assessed and treated at least 1 month post-trauma and at least 1 month after discharge from hospital in order to avoid acute reaction either to the traumatic event or to the medical procedures during their hospitalization and adjustment problems.
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
- 18 Months 至 66 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hebrew speaking toddlers with PTSD related to traumatic experience that occured at least 1 month prior to the study enrollment
- •Toddlers whose parents are living together
排除标准
- •Toddlers which are still dealing with an active life threatening illness and are hence going through medical procedures.
- •Toddlers with intelectual developmental disorder
- •Toddlers with an active psychosis
- •Toddlers with blindness or deafness
- •Toddlers who are currently taking psychotropic medication
- •Toddlers and parents that receive psycotherapy outside of the study for their PTSD symptoms
- •Toddlers diagnozed with autism spectrum disorder
- •Toddlers who were exposed to domestic or sexual violence
结局指标
主要结局
Change from baseline in post traumatic symptoms: clinical assessment and Young child ptsd checklist (YCPC, Scheeringa & Haslett, 2010).
时间窗: Parents' pre-treatment, post treatment and follow-up 3,6,12 months post treatment
Change from baseline in post traumatic symptoms will be assessed using the Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood) and the Young Child PTSD Checklist (YCPC, Scheeringa \& Haslett, 2010). The YCPC assesses probable diagnosis formed the basis for the new DSM-5 disorder for posttraumatic stress disorder for children 6 years and younger.
次要结局
- The Posttraumatic Stress Symptom Scale-Self report (PSS-SR; Foa, Riggs, Dancu & Rothbaum, 1993)(Parents' pre-treatment, during treatment (every 2 sessions), post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment)
- Posttraumatic Stress Cognitions Inventory (PTCI)(Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment)
- Parenting Sense of Competence Scale )PSOC; Gibaud -Wallstton & Wandersman, 1978)(Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment)
- Beck Depression Inventory (BDI)(Parents' pre-treatment, post treatment (after 12-15 sessions) and follow-up 3-6 months post treatment)