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

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.
 
ClinicalTrials.gov Identifier: NCT02148484
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
Posttraumatic stress disorder (PTSD) is the most common disorder among childhood sexual abuse survivors and is associated with substantial psychosocial and medical problems, but evidence-based treatment for PTSD in adolescents is lacking. This study aims to examine the efficacy and effectiveness of prolonged exposure therapy for adolescents with client-centered therapy.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: Prolonged Exposure for Adolescents Behavioral: Client Centered Therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse
Study Start Date : February 2006
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Prolonged exposure for adolescents
Behavioral: Prolonged Exposure for Adolescents
Active Comparator: 2
Client centered therapy
Behavioral: Client Centered Therapy



Primary Outcome Measures :
  1. Change from baseline on PTSD symptoms utilizing the Child PTSD Symptom Scale-Interview (CPSS-I) [ Time Frame: Baseline, mid-treatment, post-treatment, 3-, 6-, and 12-month follow-ups ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: female gender, age 13-18, and a primary DSM-IV-TR diagnosis of chronic or subthreshold PTSD related to sexual assault

Exclusion Criteria: current suicidal ideation with intent, uncontrolled bipolar disorder, schizophrenia, other thought disorders, or conduct disorder, the presence of a pervasive developmental disorder, initiation of treatment with psychotropic medication within the previous 12 weeks, and current inpatient psychiatric treatment


Information from the National Library of Medicine

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): NCT02148484


Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Edna B Foa, Ph.D. University of Pennsylvania
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02148484    
Obsolete Identifiers: NCT00417300
Other Study ID Numbers: 804439
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Keywords provided by University of Pennsylvania:
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