Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse
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| ClinicalTrials.gov Identifier: NCT00417300 |
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Recruitment Status
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Completed
First Posted
: January 1, 2007
Last Update Posted
: June 27, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Post-Traumatic Stress Disorder | Behavioral: Prolonged exposure (PE) therapy for adolescents Behavioral: Client centered therapy (CCT) | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 90 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Treating Adolescents With CSA Related PTSD |
| Study Start Date : | February 2006 |
| Actual Primary Completion Date : | March 2012 |
| Actual Study Completion Date : | March 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Participants will receive prolonged exposure for adolescents
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Behavioral: Prolonged exposure (PE) therapy for adolescents
PE is an individual therapy. The treatment involves talking about thoughts and feelings about the assault and confronting the memory of the assault. The therapy also involves doing homework outside of session.
Other Name: PE-A
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Active Comparator: 2
Participants will receive client centered therapy
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Behavioral: Client centered therapy (CCT)
CCT is an individual therapy. The therapist will talk to the adolescent and help her to discuss all of the thoughts and feelings she wishes to talk about. The therapist is an active listener and helps the child to clarify and understand her feelings and offer non-directive problem solving.
Other Name: CCT
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- Child PTSD Symptom Scale (CPSS) [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ]
- Beck Depression Inventory [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ]
- Child Post-Trauma Attitudes Scale [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ]
- Children's Attributions and Perceptions Scale [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ]
- Speilberger State Trait Anger Expression Inventory [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ]
- Child Global Assessment Scale, Child Behavior Checklist [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ]
- Negative Mood Regulation Scale [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ]
- Personal Experiences Screening Questionnaire [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ]
- CD Inventory [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ]
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| Ages Eligible for Study: | 13 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Primary diagnosis of PTSD or subthreshold PTSD related to CSA or rape
- Adolescent and parent/guardian are literate in English
- If currently on psychotropic medication, dose is stable
Exclusion Criteria:
- Suicidal ideation with intent
- Pervasive developmental disorder or Aspergers disorder
- Mental retardation
- Psychotic disorder
- Thought disorder or conduct disorder
- Alcohol or substance dependence disorder
- Primary diagnosis other than PTSD
- Concurrent trauma-focused therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417300
| United States, Pennsylvania | |
| Women Organized Against Rape | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Center for the Treatment and Study of Anxiety, University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Edna B. Foa, PhD | University of Pennsylvania Center for the Treatment and Study of Anxiety |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00417300 History of Changes |
| Other Study ID Numbers: |
R01MH074505 ( U.S. NIH Grant/Contract ) DSIR CT-C |
| First Posted: | January 1, 2007 Key Record Dates |
| Last Update Posted: | June 27, 2013 |
| Last Verified: | June 2013 |
Keywords provided by University of Pennsylvania:
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PTSD Cognitive Behavioral Treatment Child Sexual Abuse |
Additional relevant MeSH terms:
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Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders |