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

This study has been completed.
Sponsor:
Collaborators:
University of Medicine and Dentistry of New Jersey
Information provided by (Responsible Party):
Judith Cohen, Allegheny Singer Research Institute
ClinicalTrials.gov Identifier:
NCT00000383
First received: November 2, 1999
Last updated: March 27, 2015
Last verified: March 2015
  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: 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 Intervention
Stress Disorders, Post-Traumatic
Behavioral: Trauma-Focused CBT
Behavioral: Child-Centered Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
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:

Primary Outcome Measures:
  • PTSD [ Time Frame: 12 weeks; 6- and 12- month follow-up ] [ Designated as safety issue: No ]
    Change in child PTSD total PTSD symptoms, PTSD cluster symptoms, PTSD diagnosis as measured by the K-SADS-PL


Secondary Outcome Measures:
  • Depression [ Time Frame: 12 weeks; 6- and 12-month follow up ] [ Designated as safety issue: No ]
    Change in child depressive symptoms measured by the Child Depression Inventory

  • Anxiety [ Time Frame: 12 weeks; 6 and 12-month follow-up ] [ Designated as safety issue: No ]
    Change in child anxiety symptoms measured by State Trait Anxiety Inventory

  • Maldaptive Cognitions [ Time Frame: 12 weeks; 6 and 12 month follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in child shame measured by SHAME scale

  • Parent depression [ Time Frame: 12 weeks; 6 and 12 month follow up ] [ Designated as safety issue: No ]
    Change in parental depression measured by Beck Depression Inventory

  • Parent Emotional Distress [ Time Frame: 12 weeks; 6 and 12 month follow up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Enrollment: 229
Study Start Date: September 1997
Study Completion Date: September 2002
Primary Completion Date: September 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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:

  1. Post-Traumatic Stress Disorder (PTSD) symptoms (at least 5 with at least one symptom in each of 3 PTSD clusters) related to sexual abuse
  2. Confirmed child sexual abuse history
  3. Speak English
  4. Parent willing to participate in treatment

Exclusion Criteria:

  1. Active psychotic disorder resulting in inability to participate in CBT
  2. Active substance abuse disorder that resulted in significant impairment 3 Serious developmental disorder precluding participation in CBT

4) If on psychotropic medication, not on stable dose for at least 4 weeks 5) Receiving ongoing psychotherapy outside of study

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 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
Sponsors and Collaborators
Allegheny Singer Research Institute
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Judith A. Cohen, MD Allegheny Singer Research Institute
Principal Investigator: Esther Deblinger, PhD University of Medicine and Dentistry of New Jersey
  More Information

Publications:
Responsible Party: Judith Cohen, Principal Investigator, Allegheny Singer Research Institute
ClinicalTrials.gov Identifier: NCT00000383     History of Changes
Other Study ID Numbers: R10 MH55963, 1R10MH055963, 1R10MH056224
Study First Received: November 2, 1999
Last Updated: March 27, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Allegheny Singer Research Institute:
Adolescence
Child
Child Abuse, Sexual
Child Abuse, Sexual -- *psychology
Cognitive Therapy
Comparative Study
Female
Human
Male
Stress Disorders, Post-Traumatic
Stress Disorders, Post-Traumatic -- *therapy

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

ClinicalTrials.gov processed this record on April 16, 2015