PTSDPhase 2NCT02148484
Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse
A Phase 2 study testing Prolonged Exposure for Adolescents and Client Centered Therapy in people with PTSD, run by University of Pennsylvania.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years, women only
- Conditions the study is for
- PTSD
- What is being tested?
- Prolonged Exposure for Adolescents and Client Centered Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
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
About this study
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.
- Conditions
- PTSD
- Being tested
- Prolonged Exposure for Adolescents, Client Centered Therapy
- Keywords
- PTSD, Cognitive Behavioral Treatment, Child Sexual Abuse
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure for AdolescentsBehavioural
Client Centered TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Prolonged exposure for adolescents Receives: Behavioral: Prolonged Exposure for Adolescents |
| 2 | Active comparator | Client centered therapy Receives: Behavioral: Client Centered Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on PTSD symptoms utilizing the Child PTSD Symptom Scale-Interview (CPSS-I)
Measured: Baseline, mid-treatment, post-treatment, 3-, 6-, and 12-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startFeb 2006
- Primary completionMar 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edna B Foa, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148484
- Sponsor's protocol ID
- 804439
- Status last verified
- Aug 2016
- First submitted
- 18 Jul 2013
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 28682105Kaczkurkin 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 27459380Foa 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse
- ClinicalTrials.gov ID
- NCT02148484
- Acronym / sponsor ID
- 804439
- Conditions
- PTSD
- Keywords
- PTSD, Cognitive Behavioral Treatment, Child Sexual Abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Prolonged Exposure for AdolescentsProlonged exposure for adolescents |
| 2 | Active comparator | Behavioral: Client Centered TherapyClient centered therapy |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Exposure for Adolescents | Behavioural | 1 |
| Client Centered Therapy | Behavioural | 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Derived from this study: PubMed 28682105Chang 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.
- Derived from this study: PubMed 27459380Kaczkurkin 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.
- Derived from this study: PubMed 24368465Foa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edna B Foa, Ph.D. principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prolonged Exposure for Adolescents and Client Centered Therapy in people with PTSD, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02148484, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.