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

NCT ID: NCT02148484

Last Updated: 2016-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Prolonged exposure for adolescents

Group Type EXPERIMENTAL

Prolonged Exposure for Adolescents

Intervention Type BEHAVIORAL

2

Client centered therapy

Group Type ACTIVE_COMPARATOR

Client Centered Therapy

Intervention Type BEHAVIORAL

Interventions

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Prolonged Exposure for Adolescents

Intervention Type BEHAVIORAL

Client Centered Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edna B Foa, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

References

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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.

Reference Type DERIVED
PMID: 28682105 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27459380 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24368465 (View on PubMed)

Other Identifiers

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804439

Identifier Type: -

Identifier Source: org_study_id

NCT00417300

Identifier Type: -

Identifier Source: nct_alias

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