Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse
Recruitment status was Recruiting
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| First Received Date ICMJE | December 28, 2006 | ||||||||
| Last Updated Date | March 10, 2009 | ||||||||
| Start Date ICMJE | January 2007 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Child PTSD Symptom Scale (CPSS) [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Child PTSD Symptom Scale (CPSS) (measured post-treatment and at 3-, 6-, and 12-month follow-up visits) | ||||||||
| Change History | Complete list of historical versions of study NCT00417300 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse | ||||||||
| Official Title ICMJE | Treating Adolescents With CSA Related PTSD | ||||||||
| Brief Summary | This study will evaluate the comparative effectiveness of prolonged exposure therapy and client centered therapy in treating adolescents with post-traumatic stress disorder related to childhood sexual abuse or assault. |
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| Detailed Description | Adolescents who have experienced childhood sexual abuse (CSA) frequently develop post-traumatic stress disorder (PTSD), substance abuse problems, and re-victimization during their teenage years. PTSD is a type of anxiety disorder that often occurs following a traumatic event, such as violent personal assault, natural or human-caused disasters, accidents, or military combat. PTSD is characterized by persistent frightening thoughts and memories of the traumatic ordeal, emotional numbness, sleep problems, and anxiousness. Because of the high prevalence of CSA and the association between CSA, PTSD, and other serious mental disorders, it is essential that efficient, effective, and readily available treatments are developed for adolescents with PTSD brought on by sexual assault. This study will evaluate the comparative effectiveness of prolonged exposure therapy and supportive counseling in treating adolescents with PTSD that is related to childhood sexual abuse or assault. Participants in this 1-year study will be randomly assigned to receive one of the following two treatments: prolonged exposure therapy for adolescents (PE-A) or client centered therapy (CCT). PE-A will involve three phases: psychoeducation and planning; exposure; and relapse prevention and graduation. PE-A and CCT participants will attend 14 sessions over 18 weeks, including up to 5 hours with their parents or guardians. During the first three sessions, participants will briefly discuss the CSA and learn breathing techniques. For PE-A participants, sessions 4 through 12 will focus on repeatedly confronting the trauma memory to allow participants to thoroughly process the trauma and reduce fear and anxiety. PE-A participants will also complete homework assignments designed to expose them to experiences that are safe but may remind them of past traumatic events or trigger anxiety. In CCT sessions, the therapist will help participants identify daily stresses and will discuss them in a supportive, non-directive way, with a focus on problem solving. Topics may include everyday life difficulties, directly or indirectly related to CSA, or discussion of the CSA itself. All participants will attend follow-up visits at Week 19 (immediately post-treatment) and 3, 6, and 12 months post-treatment. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Post-Traumatic Stress Disorder | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 90 | ||||||||
| Estimated Completion Date | June 2011 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 13 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00417300 | ||||||||
| Other Study ID Numbers ICMJE | R01 MH074505, DSIR CT-C | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Joel Sherrill, National Institute of Mental Health | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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