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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:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00417300
First received: December 28, 2006
Last updated: June 26, 2013
Last verified: June 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Adolescents With CSA Related PTSD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

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 ]
Enrollment: 90
Study Start Date: February 2006
Study Completion Date: March 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Other Name: PE-A
Active Comparator: 2
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.
Other Name: CCT

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   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Sponsors and Collaborators
University of Pennsylvania
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

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  DSIR CT-C 
Study First Received: December 28, 2006
Last Updated: June 26, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
PTSD
Cognitive Behavioral Treatment
Child Sexual Abuse

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2016