Clinical trial NCT00000383: Treatment of Post-Traumatic Stress Disorder (PTSD) in Sexually Abused Children
Official title: Treatment of PTSD in Sexually Abused Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: 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
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Medicine and Dentistry of New Jersey
First posted: 1999-11-03
Enrollment: 229
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: PTSD
timeFrame: 12 weeks; 6- and 12- month follow-up
Secondary outcomes:
measure: Depression
timeFrame: 12 weeks; 6- and 12-month follow up
measure: Anxiety
timeFrame: 12 weeks; 6 and 12-month follow-up
measure: Maldaptive Cognitions
timeFrame: 12 weeks; 6 and 12 month follow-up
measure: Shame
timeFrame: 12 weeks; 6 and 12 month follow up
measure: Parent depression
timeFrame: 12 weeks; 6 and 12 month follow up
measure: Parent Emotional Distress
timeFrame: 12 weeks; 6 and 12 month follow up
measure: Parental Support
timeFrame: 12 weeks; 6 and 12 month follow up
measure: Positive Parenting Practices
timeFrame: 12 weeks; 6 and 12 month follow up
Other outcomes:
Locations:
city: Stratford
country: United States
facility: Center for Children's Support, University of Medicine and Dentistry - New Jersey
state: New Jersey
city: Pittsburgh
country: United States
facility: Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Center for Traumatic Stress in Children & Adolescents, Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
name: Judith A. Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Medicine and Dentistry of New Jersey
name: Esther Deblinger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.