Viewing Study NCT00000383



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Last Modification Date: 2024-10-26 @ 9:01 AM
Study NCT ID: NCT00000383
Status: COMPLETED
Last Update Posted: 2015-03-30
First Post: 1999-11-02

Brief Title: Treatment of Post-Traumatic Stress Disorder PTSD in Sexually Abused Children
Sponsor: Allegheny Singer Research Institute also known as Allegheny Health Network Research Institute
Organization: Allegheny Singer Research Institute also known as Allegheny Health Network Research Institute

Study Overview

Official Title: Treatment of PTSD in Sexually Abused Children
Status: COMPLETED
Status Verified Date: 2015-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 hisher 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 heshe

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 subjects 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1R10MH056224 NIH None httpsreporternihgovquickSearch1R10MH056224
1R10MH055963 NIH None None