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

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00417300

Purpose

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.

Condition	Intervention	Phase
Post-Traumatic Stress Disorder	Behavioral: Prolonged exposure (PE) therapy for adolescents Behavioral: Client centered therapy (CCT)	Phase II

MedlinePlus related topics: Anxiety Post-Traumatic Stress Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Treating Adolescents With CSA Related PTSD

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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 Measures:

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 ]
CD Inventory [ Time Frame: Measured at post-treatment and at Months 3, 6, and 12 of follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	January 2007
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive prolonged exposure for adolescents	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.
2: Active Comparator Participants will receive client centered therapy	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.

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.

Eligibility

Ages Eligible for Study:	13 Years to 18 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417300

Contacts

Contact: Alissa B. Worly, BA	215-746-3334	aworly@mail.med.upenn.edu
Contact: Laura Benner, MA	215-985-3315 ext 198	laura@WOAR.org

Locations

United States, Pennsylvania
Center for the Treatment and Study of Anxiety, University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sandy Capaldi, MA, MS 215-746-3327 sandraca@mail.med.upenn.edu
Contact: Alissa B. Worly, BA 215-746-3334 aworly@mail.med.upenn.edu
Principal Investigator: Edna B. Foa, PhD
Sub-Investigator: Elizabeth A. Hembree, PhD
Women Organized Against Rape	Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Laura Benner, MA 215-985-3315 laura@WOAR.org

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Edna B. Foa, PhD

University of Pennsylvania Center for the Treatment and Study of Anxiety

More Information

Responsible Party:	National Institute of Mental Health ( Joel Sherrill )
Study ID Numbers:	R01 MH74505, DSIR CT-C
Study First Received:	December 28, 2006
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00417300
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

PTSD
Cognitive Behavioral Treatment
Child Sexual Abuse

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009