CClinicalTrials.gg
CompletedNCT02148484Updated Aug 19, 2016

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

A Phase 2 interventional study of Prolonged Exposure for Adolescents and Client Centered Therapy in PTSD, sponsored by University of Pennsylvania. Completed. Open to female participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-08-19.

Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
13 Years to 18 Years
Sex
Female
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Study 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.

02

Conditions studied

  • PTSD

Keywords

  • PTSD
  • Cognitive Behavioral Treatment
  • Child Sexual Abuse
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In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 90 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years to 18 Years
Sexes eligible
Female
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

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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    1

    Prolonged exposure for adolescents

    Behavioral: Prolonged Exposure for Adolescents

  • Active comparator
    2

    Client centered therapy

    Behavioral: Client Centered Therapy

Interventions

  • BehavioralProlonged Exposure for Adolescents
  • BehavioralClient Centered Therapy
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What researchers measure

Primary outcomes

  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

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 28682105 ↗
  • 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. PubMed 27459380 ↗
  • 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. PubMed 24368465 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02148484
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
May 28, 2014
Start date
Feb 2006
Primary completion
Mar 2012
Completion
Mar 2013
Last update
Aug 19, 2016

Study contacts

Edna B Foa, Ph.D.
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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