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Trial NCT00000383

Resource URI: http://static.linkedct.org/resource/trials/NCT00000383
PropertyValue
linkedct:brief_title Treatment of Post-Traumatic Stress Disorder (PTSD) in Sexually Abused Children
linkedct:condition <http://static.linkedct.org/resource/condition/12028>
linkedct:condition <http://static.linkedct.org/resource/condition/12581>
linkedct:condition <http://static.linkedct.org/resource/condition/2577>
linkedct:criteria Inclusion Criteria: - Patients must have: Post-Traumatic Stress Disorder (PTSD) as a result of sexual abuse.
linkedct:description To evaluate the comparative efficacy of Sexual Abuse-Specific Cognitive Behavioral Therapy (SAS-CBT) vs nondirective supportive therapy (NST) 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 SAS-CBT or NST 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 14 Years
linkedct:eligibility_minimum_age 8 Years
linkedct:end_date July 2002
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000383
rdfs:label Trial NCT00000383
linkedct:lastchanged_date February 12, 2008
linkedct:lead_sponsor_agency National Institute of Mental Health (NIMH)
linkedct:location <http://static.linkedct.org/resource/location/141289>
linkedct:location <http://static.linkedct.org/resource/location/144057>
linkedct:nct_id NCT00000383
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Treatment of PTSD in Sexually Abused Children
linkedct:org_study_id R10 MH55963
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/17073>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/30868>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000383>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/22587>
linkedct:secondary_id DSIR CT-S
linkedct:secondary_id R10 MH56224
linkedct:source National Institute of Mental Health (NIMH)
linkedct:start_date September 1997
linkedct:study_design Treatment, Randomized
linkedct:study_type Interventional
linkedct: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: Sexual Abuse-Specific Cognitive Behavioral Therapy (SAS-CBT) vs nondirective supportive therapy (NST). 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.
rdf:type linkedct:trials
linkedct:verification_date February 2008