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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Treating Adolescents With CSA Related PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417300
• Other study ID #: R01MH074505
• Secondary ID: R01MH074505DSIR
• Status: Completed
• Phase: Phase 2
• First received: December 28, 2006
• Last updated: June 26, 2013
• Start date: February 2006
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Center for the Treatment and Study of Anxiety, University of Pennsylvania	Philadelphia	Pennsylvania
United States	Women Organized Against Rape	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child PTSD Symptom Scale (CPSS)		Measured at post-treatment and at Months 3, 6, and 12 of follow-up	No
Secondary	Beck Depression Inventory		Measured at post-treatment and at Months 3, 6, and 12 of follow-up	Yes
Secondary	Child Post-Trauma Attitudes Scale		Measured at post-treatment and at Months 3, 6, and 12 of follow-up	No
Secondary	Children's Attributions and Perceptions Scale		Measured at post-treatment and at Months 3, 6, and 12 of follow-up	No
Secondary	Speilberger State Trait Anger Expression Inventory		Measured at post-treatment and at Months 3, 6, and 12 of follow-up	No
Secondary	Child Global Assessment Scale, Child Behavior Checklist		Measured at post-treatment and at Months 3, 6, and 12 of follow-up	No
Secondary	Negative Mood Regulation Scale		Measured at post-treatment and at Months 3, 6, and 12 of follow-up	No
Secondary	Personal Experiences Screening Questionnaire		Measured at post-treatment and at Months 3, 6, and 12 of follow-up	Yes
Secondary	CD Inventory		Measured at post-treatment and at Months 3, 6, and 12 of follow-up	No