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Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00417300
First Posted: January 1, 2007
Last Update Posted: June 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania
December 28, 2006
January 1, 2007
June 27, 2013
February 2006
March 2012   (Final data collection date for primary outcome measure)
Child PTSD Symptom Scale (CPSS) [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ]
Child PTSD Symptom Scale (CPSS) (measured post-treatment and at 3-, 6-, and 12-month follow-up visits)
Complete list of historical versions of study NCT00417300 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Beck Depression Inventory
  • Child Post-Trauma Attitudes Scale
  • Children's Attributions and Perceptions Scale
  • Speilberger State Trait Anger Expression Inventory
  • Child Global Assessment Scale, Child Behavior Checklist
  • Negative Mood Regulation Scale
  • Personal Experiences Screening Questionnaire (all measured post-treatment and at 3-, 6-, and 12-month follow-up visits)
Not Provided
Not Provided
 
Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse
Treating Adolescents With CSA Related PTSD
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
  • 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
  • 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
  • Experimental: 1
    Participants will receive prolonged exposure for adolescents
    Intervention: Behavioral: Prolonged exposure (PE) therapy for adolescents
  • Active Comparator: 2
    Participants will receive client centered therapy
    Intervention: Behavioral: Client centered therapy (CCT)
Foa EB, McLean CP, Capaldi S, Rosenfield D. Prolonged exposure vs supportive counseling for sexual abuse-related PTSD in adolescent girls: a randomized clinical trial. JAMA. 2013 Dec 25;310(24):2650-7. doi: 10.1001/jama.2013.282829.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
March 2013
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
13 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00417300
R01MH074505( U.S. NIH Grant/Contract )
R01MH074505 ( U.S. NIH Grant/Contract )
DSIR CT-C
Yes
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
National Institute of Mental Health (NIMH)
Principal Investigator: Edna B. Foa, PhD University of Pennsylvania Center for the Treatment and Study of Anxiety
University of Pennsylvania
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP