NCT02148484

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2013

Completed
10 months until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

6.1 years

First QC Date

July 18, 2013

Last Update Submit

August 18, 2016

Conditions

PTSD

Keywords

PTSDCognitive Behavioral TreatmentChild Sexual Abuse

Outcome Measures

Primary Outcomes (1)

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

    Baseline, mid-treatment, post-treatment, 3-, 6-, and 12-month follow-ups

Study Arms (2)

1

EXPERIMENTAL

Prolonged exposure for adolescents

Behavioral: Prolonged Exposure for Adolescents

2

ACTIVE COMPARATOR

Client centered therapy

Behavioral: Client Centered Therapy

Interventions

Prolonged Exposure for AdolescentsBEHAVIORAL
1
Client Centered TherapyBEHAVIORAL
2

Eligibility Criteria

Age13 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 28682105DERIVED

  • 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.

    PMID: 27459380DERIVED

  • 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.

    PMID: 24368465DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Person-Centered Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Edna B Foa, Ph.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2013

First Posted

May 28, 2014

Study Start

February 1, 2006

Primary Completion

March 1, 2012

Study Completion

March 1, 2013

Last Updated

August 19, 2016

Record last verified: 2016-08