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

Primary Purpose

PTSD

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Prolonged Exposure for Adolescents
Client Centered Therapy
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Cognitive Behavioral Treatment, Child Sexual Abuse

Eligibility Criteria

13 Years - 18 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Prolonged exposure for adolescents

    Client centered therapy

    Outcomes

    Primary Outcome Measures

    Change from baseline on PTSD symptoms utilizing the Child PTSD Symptom Scale-Interview (CPSS-I)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 18, 2013
    Last Updated
    August 18, 2016
    Sponsor
    University of Pennsylvania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02148484
    Brief Title
    Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse
    Official Title
    Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Pennsylvania

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PTSD
    Keywords
    PTSD, Cognitive Behavioral Treatment, Child Sexual Abuse

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Prolonged exposure for adolescents
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Client centered therapy
    Intervention Type
    Behavioral
    Intervention Name(s)
    Prolonged Exposure for Adolescents
    Intervention Type
    Behavioral
    Intervention Name(s)
    Client Centered Therapy
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edna B Foa, Ph.D.
    Organizational Affiliation
    University of Pennsylvania
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28682105
    Citation
    Chang C, Kaczkurkin AN, McLean CP, Foa EB. Emotion regulation is associated with PTSD and depression among female adolescent survivors of childhood sexual abuse. Psychol Trauma. 2018 May;10(3):319-326. doi: 10.1037/tra0000306. Epub 2017 Jul 6.
    Results Reference
    derived
    PubMed Identifier
    27459380
    Citation
    Kaczkurkin AN, Asnaani A, Zhong J, Foa EB. The Moderating Effect of State Anger on Treatment Outcome in Female Adolescents With PTSD. J Trauma Stress. 2016 Aug;29(4):325-31. doi: 10.1002/jts.22116. Epub 2016 Jul 26.
    Results Reference
    derived
    PubMed Identifier
    24368465
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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