Treatment of PTSD in Sexually Abused Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 229
- 试验地点
- 6
- 主要终点
- PTSD
研究概览
简要总结
The purpose of this study is to compare the effectiveness of two psychological therapies used to treat PTSD in children who have recently been sexually abused: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) vs Child Centered Therapy (CCT).
Child sexual abuse is a common experience that has serious mental health consequences, including the development of PTSD and other abuse-related problems.
All children will be assigned randomly (like tossing a coin) to receive either SAS-CBT or NST at each of two sites. In addition, the parents and the child will receive individual therapy for 12 weeks. The child will be monitored to evaluate his/her response to therapy. Assessments will take place before and just following treatment, and then 6 and 12 months post-treatment.
A child may be eligible for this study if he/she:
Has been sexually abused, is suffering from PTSD as a result of the abuse, and is 8 to 14 years old.
详细描述
To evaluate the comparative efficacy of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) vs Child Centered Therapy (CCT) in decreasing symptoms of Post-Traumatic Stress Disorder (PTSD) following recent sexual abuse.
Child sexual abuse is a common experience that has serious mental health consequences, including the development of PTSD and other abuse-related and general psychopathological symptoms.
Patients are randomly assigned to receive either TF-CBT or CCT at each of two sites, and will be provided with 12 weeks of individual therapy for children and parents. Treatment is monitored for compliance with the respective treatment models through intensive supervision, audiotaping of sessions, rating of sessions with use of adherence checklists, and independent blind rating of audiotapes. Treatment outcome is evaluated through the use of several self-, parent-, and teacher-report standardized instruments, administered at pre- and post-treatment, and follow-up evaluations at 6 and 12 months. The project also assesses differential treatment impact by gender and ethnicity, and attempts to evaluate the impact of specific components of the treatment process in mediating treatment outcome. Specifically, the project evaluates the differential effectiveness of the two treatment modalities in improving the subject's abuse-related attributions and perceptions, parenting practices, familial adaptability and cohesiveness, parent support, and parental emotional reaction to the abuse, and the impact of improving these variables on treatment outcome.
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
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Post-Traumatic Stress Disorder (PTSD) symptoms (at least 5 with at least one symptom in each of 3 PTSD clusters) related to sexual abuse
- •Confirmed child sexual abuse history
- •Speak English
- •Parent willing to participate in treatment
排除标准
- •Active psychotic disorder resulting in inability to participate in CBT
- •Active substance abuse disorder that resulted in significant impairment 3 Serious developmental disorder precluding participation in CBT
- •If on psychotropic medication, not on stable dose for at least 4 weeks 5) Receiving ongoing psychotherapy outside of study
结局指标
主要结局
PTSD
时间窗: 12 weeks; 6- and 12- month follow-up
Change in child PTSD total PTSD symptoms, PTSD cluster symptoms, PTSD diagnosis as measured by the K-SADS-PL
次要结局
- Maldaptive Cognitions(12 weeks; 6 and 12 month follow-up)
- Depression(12 weeks; 6- and 12-month follow up)
- Shame(12 weeks; 6 and 12 month follow up)
- Positive Parenting Practices(12 weeks; 6 and 12 month follow up)
- Anxiety(12 weeks; 6 and 12-month follow-up)
- Parent depression(12 weeks; 6 and 12 month follow up)
- Parent Emotional Distress(12 weeks; 6 and 12 month follow up)
- Parental Support(12 weeks; 6 and 12 month follow up)
研究者
Judith Cohen
Principal Investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)