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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00000383 |
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: Sexual Abuse-Specific Cognitive Behavioral Therapy (SAS-CBT) vs nondirective supportive therapy (NST).
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 | Intervention | Phase |
---|---|---|
Child Abuse, Sexual Sexual Abuse Stress Disorders, Post-Traumatic |
Behavioral: Nondirective supportive therapy Behavioral: Cognitive Behavior Therapy Behavioral: Parent therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Treatment of PTSD in Sexually Abused Children |
Study Start Date: | September 1997 |
Estimated Study Completion Date: | July 2002 |
To evaluate the comparative efficacy of Sexual Abuse-Specific Cognitive Behavioral Therapy (SAS-CBT) vs nondirective supportive therapy (NST) 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 SAS-CBT or NST 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.
Ages Eligible for Study: | 8 Years to 14 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Patients must have:
Post-Traumatic Stress Disorder (PTSD) as a result of sexual abuse.
United States, New Jersey | |
Center for Children's Support, University of Medicine and Dentistry - New Jersey | |
Stratford, New Jersey, United States | |
United States, Pennsylvania | |
Center for Traumatic Stress in Children & Adolescents, Allegheny General Hospital | |
Pittsburgh, Pennsylvania, United States |
Principal Investigator: | Judith A. Cohen, MD | |
Principal Investigator: | Esther Deblinger, PhD |
Study ID Numbers: | R10 MH55963, R10 MH56224, DSIR CT-S |
Study First Received: | November 2, 1999 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00000383 |
Health Authority: | United States: Federal Government |
Adolescence Child Cognitive Therapy Comparative Study Female Human |
Male Stress Disorders, Post-Traumatic Child Abuse, Sexual Stress Disorders, Post-Traumatic -- *therapy Child Abuse, Sexual -- *psychology |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Pathologic Processes Disease |