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

Treatment of PTSD in Sexually Abused Children

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.

Study Overview

• Status: Completed
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Behavioral: Trauma-Focused CBT; Behavioral: Child-Centered Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Stratford, New Jersey, United States, 08084
      • Center for Children's Support, University of Medicine and Dentistry - New Jersey
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: CCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Change in child depressive symptoms measured by the Child Depression Inventory	12 weeks; 6- and 12-month follow up
Anxiety	Change in child anxiety symptoms measured by State Trait Anxiety Inventory	12 weeks; 6 and 12-month follow-up
Maldaptive Cognitions	Change in maladaptive trauma-related cognitions measured by the Children'sAttributions and Perceptions Scale	12 weeks; 6 and 12 month follow-up
Shame	Change in child shame measured by SHAME scale	12 weeks; 6 and 12 month follow up
Parent depression	Change in parental depression measured by Beck Depression Inventory	12 weeks; 6 and 12 month follow up
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
Parental Support	Change in parental support of child measured by Parental Support Questionnaire	12 weeks; 6 and 12 month follow up
Positive Parenting Practices	Change in positive parenting measured by Parenting Practices Questionnaire	12 weeks; 6 and 12 month follow up

Collaborators and Investigators

• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Collaborators: National Institute of Mental Health (NIMH); University of Medicine and Dentistry of New Jersey
• Investigators: Principal Investigator: Esther Deblinger, PhD, University of Medicine and Dentistry of New Jersey

Publications and helpful links

General Publications

• 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. doi: 10.1097/00004583-200404000-00005.

Study record dates

Study Major Dates

• Study Start: September 1, 1997
• Primary Completion (ACTUAL): September 1, 2001
• Study Completion (ACTUAL): September 1, 2002

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: November 2, 1999
• First Posted (ESTIMATE): November 3, 1999

Study Record Updates

• Last Update Posted (ESTIMATE): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 27, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Child; Female; Human; Male; Stress Disorders, Post-Traumatic; Adolescence; Cognitive Therapy; Comparative Study; Stress Disorders, Post-Traumatic -- *therapy; Child Abuse, Sexual; Child Abuse, Sexual -- *psychology
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: R10MH055963 (NIH); 1R10MH055963 (NIH); 1R10MH056224 (NIH)