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| Descriptive Information Fields | |||||||||
| Brief Title † | Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse | ||||||||
| Official Title † | Treating Adolescents With CSA Related PTSD | ||||||||
| Brief Summary | This study will evaluate the comparative effectiveness of prolonged exposure therapy and supportive counseling 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 supportive counseling (SC). PE-A will involve three phases: psychoeducation and planning; exposure; and relapse prevention and graduation. 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. 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. 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 SC 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. Participants assigned to SC will also attend 14 sessions over 18 weeks. 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 Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | 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 ] | ||||||||
| Secondary Outcome Measure † | Beck Depression Inventory [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: Yes ] Child Post-Trauma Attitudes Scale [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ] Children's Attributions and Perceptions Scale [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ] Speilberger State Trait Anger Expression Inventory [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ] Child Global Assessment Scale, Child Behavior Checklist [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ] Negative Mood Regulation Scale [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ] Personal Experiences Screening Questionnaire [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: Yes ] |
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| Condition † | Post-Traumatic Stress Disorder | ||||||||
| Intervention † | Behavioral: Prolonged exposure (PE) therapy for adolescents Behavioral: Client centered therapy (CCT) |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 90 | ||||||||
| Start Date † | January 2007 | ||||||||
| Completion Date | June 2011 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 13 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00417300 | ||||||||
| Organization ID | R01 MH74505 | ||||||||
| Secondary IDs †† | DSIR CT-C | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2008 | ||||||||
| First Received Date † | December 28, 2006 | ||||||||
| Last Updated Date | March 4, 2008 | ||||||||
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