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Clinical Trials/NCT00000383
NCT00000383
Completed
N/A

Treatment of PTSD in Sexually Abused Children

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)3 sites in 1 country229 target enrollmentSeptember 1997

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stress Disorders, Post-Traumatic
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Enrollment
229
Locations
3
Primary Endpoint
PTSD
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 1997
End Date
September 2002
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Responsible Party
Principal Investigator
Principal Investigator

Judith Cohen

Principal Investigator

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Study Sites (3)

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