Treatment of Post-Traumatic Stress Disorder (PTSD) in Sexually Abused Children
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|ClinicalTrials.gov Identifier: NCT00000383|
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : March 30, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic||Behavioral: Trauma-Focused CBT Behavioral: Child-Centered Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||229 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Treatment of PTSD in Sexually Abused Children|
|Study Start Date :||September 1997|
|Actual Primary Completion Date :||September 2001|
|Actual Study Completion Date :||September 2002|
Experimental: Trauma-Focused CBT
Trauma -Focused CBT provides 12 sessions (45 minutes child, 45 minutes parent) of CBT treatment. This includes therapist-directed trauma-focused skills training, exposure, parenting, conjoint parent-child sessions, and safety component provided to child and parent.
Behavioral: Trauma-Focused CBT
Structured skills, exposure, trauma-specific interventions
Other Name: TF-CBT
Active Comparator: Child Centered Therapy
Child Centered Therapy provides 12 sessions (45 minutes child, 45 minutes parent) of supportive interventions. This includes client-directed activities focused on the needs and interests of the child or parent, respectively.
Behavioral: Child-Centered Therapy
Client-directed supportive interventions
Other Name: CCT
- PTSD [ Time Frame: 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
- Depression [ Time Frame: 12 weeks; 6- and 12-month follow up ]Change in child depressive symptoms measured by the Child Depression Inventory
- Anxiety [ Time Frame: 12 weeks; 6 and 12-month follow-up ]Change in child anxiety symptoms measured by State Trait Anxiety Inventory
- Maldaptive Cognitions [ Time Frame: 12 weeks; 6 and 12 month follow-up ]Change in maladaptive trauma-related cognitions measured by the Children'sAttributions and Perceptions Scale
- Shame [ Time Frame: 12 weeks; 6 and 12 month follow up ]Change in child shame measured by SHAME scale
- Parent depression [ Time Frame: 12 weeks; 6 and 12 month follow up ]Change in parental depression measured by Beck Depression Inventory
- Parent Emotional Distress [ Time Frame: 12 weeks; 6 and 12 month follow up ]Change in parental distress related to child's abuse measured by Parental Emotional Reaction Questionnaire
- Parental Support [ Time Frame: 12 weeks; 6 and 12 month follow up ]Change in parental support of child measured by Parental Support Questionnaire
- Positive Parenting Practices [ Time Frame: 12 weeks; 6 and 12 month follow up ]Change in positive parenting measured by Parenting Practices Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000383
|United States, New Jersey|
|Center for Children's Support, University of Medicine and Dentistry - New Jersey|
|Stratford, New Jersey, United States, 08084|
|United States, Pennsylvania|
|Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents|
|Pittsburgh, Pennsylvania, United States, 15212|
|Center for Traumatic Stress in Children & Adolescents, Allegheny General Hospital|
|Pittsburgh, Pennsylvania, United States, 15212|
|Principal Investigator:||Judith A. Cohen, MD||Allegheny Singer Research Institute|
|Principal Investigator:||Esther Deblinger, PhD||University of Medicine and Dentistry of New Jersey|