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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Treatment of PTSD in Sexually Abused Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000383
• Other study ID #: R10MH055963
• Secondary ID: 1R10MH0559631R10
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: March 27, 2015
• Start date: September 1997
• Est. completion date: September 2002

Study information

• Verified date: March 2015
• Source: Allegheny Singer Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: September 2002
• Est. primary completion date: September 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Trauma-Focused CBT
Structured skills, exposure, trauma-specific interventions
• Child-Centered Therapy
Client-directed supportive interventions

Locations

Country	Name	City	State
United States	Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents	Pittsburgh	Pennsylvania
United States	Center for Traumatic Stress in Children & Adolescents, Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Center for Children's Support, University of Medicine and Dentistry - New Jersey	Stratford	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute	National Institute of Mental Health (NIMH), University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cohen JA, Deblinger E, Mannarino AP, Steer RA. A multisite, randomized controlled trial for children with sexual abuse-related PTSD symptoms. J Am Acad Child Adolesc Psychiatry. 2004 Apr;43(4):393-402. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD	Change in child PTSD total PTSD symptoms, PTSD cluster symptoms, PTSD diagnosis as measured by the K-SADS-PL	12 weeks; 6- and 12- month follow-up	No
Secondary	Depression	Change in child depressive symptoms measured by the Child Depression Inventory	12 weeks; 6- and 12-month follow up	No
Secondary	Anxiety	Change in child anxiety symptoms measured by State Trait Anxiety Inventory	12 weeks; 6 and 12-month follow-up	No
Secondary	Maldaptive Cognitions	Change in maladaptive trauma-related cognitions measured by the Children'sAttributions and Perceptions Scale	12 weeks; 6 and 12 month follow-up	No
Secondary	Shame	Change in child shame measured by SHAME scale	12 weeks; 6 and 12 month follow up	No
Secondary	Parent depression	Change in parental depression measured by Beck Depression Inventory	12 weeks; 6 and 12 month follow up	No
Secondary	Parent Emotional Distress	Change in parental distress related to child's abuse measured by Parental Emotional Reaction Questionnaire	12 weeks; 6 and 12 month follow up	No
Secondary	Parental Support	Change in parental support of child measured by Parental Support Questionnaire	12 weeks; 6 and 12 month follow up	No
Secondary	Positive Parenting Practices	Change in positive parenting measured by Parenting Practices Questionnaire	12 weeks; 6 and 12 month follow up