Treatment of Post-Traumatic Stress Disorder (PTSD) in Sexually Abused Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Allegheny Singer Research Institute
ClinicalTrials.gov Identifier:
NCT00000383
First received: November 2, 1999
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Treatment of PTSD in Sexually Abused Children

Resource links provided by NLM:


Further study details as provided by Allegheny Singer Research Institute:

Study Start Date: September 1997
Estimated Study Completion Date: July 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-

Patients must have:

Post-Traumatic Stress Disorder (PTSD) as a result of sexual abuse.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000383

Locations
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
Sponsors and Collaborators
Allegheny Singer Research Institute
Investigators
Principal Investigator: Judith A. Cohen, MD
Principal Investigator: Esther Deblinger, PhD
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000383     History of Changes
Other Study ID Numbers: R10 MH55963, R10MH055963, R10 MH56224, DSIR CT-S
Study First Received: November 2, 1999
Last Updated: November 20, 2013
Health Authority: United States: Federal Government

Keywords provided by Allegheny Singer Research Institute:
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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014