Post-Traumatic Stress DisorderPhase 1/2NCT01560728
Bringing What Works to Youth in Corrections: A Trauma Intervention
A Phase 1/2 study testing Trauma-Focused Cognitive Behavioral Therapy in people with Post-Traumatic Stress Disorder, run by University of Texas at Austin at 3 sites in United States.
Trial summary
Youth with mental illnesses are disproportionately represented in juvenile correctional facilities and limited evidence exists about effective treatments in this setting. This study will adapt Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a treatment found to be efficacious in community settings, to the… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Trauma-Focused Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2012to Jul 2015
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Evidence of one or more significant traumatic life events
- Current diagnosis of one of the following:
- Post Traumatic Stress Disorder
- Major Depressive Disorder
- Dysthymia
- Generalized Anxiety Disorder
Show all 9Show fewer
- Social Phobia
- Panic Disorder
- Trauma symptom severity scores of 25 or greater.
Who cannot join
- Expected release date or transfer date within 5 months from study enrollment date
- Current inclusion in the Sex Offender Treatment Program
- Intellectual Quotient (IQ) less than 70
- Current high risk of suicidality
- Current symptoms of active psychosis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ron Jackson State Juvenile Correctional Facility
Brownwood, Texas, 76804
Giddings State School
Giddings, Texas, 78942
McClennan County State Juvenile Correctional Facility
Mart, Texas, 76664
About this study
Official title: Bringing What Works to Youth in Prison: An Evidence-Based Trauma Intervention
Youth with mental illnesses are disproportionately represented in juvenile correctional facilities and limited evidence exists about effective treatments in this setting. This study will adapt Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a treatment found to be efficacious in community settings, to the correctional setting and study the feasibility of its implementation. Conducted within Texas youth correctional facilities, the findings will be rapidly disseminated in the state. The goal is to enhance the TF-CBT approach to meet the unique needs of incarcerated youth and the correctional system, one of the priorities outlined in the National Institute of Mental Health Strategic Plan.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Trauma-Focused Cognitive Behavioral Therapy
- Keywords
- Post Traumatic Stress Disorder, Major Depressive Disorder, Dysthymia, Generalized Anxiety Disorder, Social Phobia, Panic Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Major, Dysthymic Disorder, Generalized Anxiety Disorder, Phobia, Social, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Focused Cognitive Behavioral TherapyBehavioural
Individual psychotherapeutic approach occurring once per week for 12 to 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| Trauma-Focused CBT | Experimental | Adapted or modified Trauma-Focused Cognitive Behavioral Therapy Receives: Behavioral: Trauma-Focused Cognitive Behavioral Therapy |
| Wait list | No intervention | Monitored while waiting for intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in UCLA PTSD Reaction Index (UCLA PTSD RI) Trauma Symptom Severity
Reduction in traumatic stress symptom severity
Measured: Participants will be assessed at baseline and every 2 weeks for an average of 6 months
Secondary outcomes (1)
Rate of change in Child Behavioral Checklist Youth Self-Report Total Score
Reduction in self-reported emotional and behavioral problem scores
Measured: Participants will be assessed at baseline and every 2 weeks for an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Molly M Lopez, Ph.D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560728
- Sponsor's protocol ID
- 1R34MH095210-01
- Other IDs
- 1R34MH095210-01
- Status last verified
- Mar 2016
- First submitted
- 19 Mar 2012
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bringing What Works to Youth in Prison: An Evidence-Based Trauma Intervention
- ClinicalTrials.gov ID
- NCT01560728
- Acronym / sponsor ID
- 1R34MH095210-01
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Post Traumatic Stress Disorder, Major Depressive Disorder, Dysthymia, Generalized Anxiety Disorder, Social Phobia, Panic Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Mar 2012 (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.
Youth with mental illnesses are disproportionately represented in juvenile correctional facilities and limited evidence exists about effective treatments in this setting. This study will adapt Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a treatment found to be efficacious in community settings, to the correctional setting and study the feasibility of its implementation. Conducted within Texas youth correctional facilities, the findings will be rapidly disseminated in the state. The goal is to enhance the TF-CBT approach to meet the unique needs of incarcerated youth and the correctional system, one of the priorities outlined in the National Institute of Mental Health Strategic Plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma-Focused CBT | Experimental | Behavioral: Trauma-Focused Cognitive Behavioral TherapyAdapted or modified Trauma-Focused Cognitive Behavioral Therapy |
| Wait list | No intervention | –Monitored while waiting for intervention |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Evidence of one or more significant traumatic life events
- Current diagnosis of one of the following:
- Trauma symptom severity scores of 25 or greater.
Key exclusion criteria (5 listed)
- Expected release date or transfer date within 5 months from study enrollment date
- Current inclusion in the Sex Offender Treatment Program
- Intellectual Quotient (IQ) less than 70
- Current high risk of suicidality
- Current symptoms of active psychosis
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 |
|---|---|---|
| Trauma-Focused Cognitive Behavioral TherapyIndividual psychotherapeutic approach occurring once per week for 12 to 20 weeks | Behavioural | Trauma-Focused CBT |
Primary outcome
Rate of change in UCLA PTSD Reaction Index (UCLA PTSD RI) Trauma Symptom Severity
Time frame: Participants will be assessed at baseline and every 2 weeks for an average of 6 months
Reduction in traumatic stress symptom severity
1 secondary outcome
Rate of change in Child Behavioral Checklist Youth Self-Report Total Score
Time frame: Participants will be assessed at baseline and every 2 weeks for an average of 6 months
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 17 Mar 2016.
Related trials for Post-Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
Molly M Lopez, Ph.D. principal investigator
University of Texas at Austin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Trauma-Focused Cognitive Behavioral Therapy in people with Post-Traumatic Stress Disorder, run by University of Texas at Austin at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. 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 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Rate of change in UCLA PTSD Reaction Index (UCLA PTSD RI) Trauma Symptom Severity (time frame: Participants will be assessed at baseline and every 2 weeks for an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2016.