- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01143792
Evaluation of Treatments for Homeless Youths
April 12, 2013 updated by: Natasha Slesnick, Ohio State University
Evaluation of Treatments for Homeless Youth: CRA, MET and Case Management
Youth who leave home for the streets are at significantly more risk for a multitude of problems, yet little research is available to guide treatment intervention efforts with this population.
Studies document high rates of substance use, HIV risk, mental health problems, teenage pregnancy and criminality.
Research to date examining homeless, street living youth has been primarily descriptive; less effort has been directed towards developing and evaluating treatment interventions for this group.
The majority of homeless youth do not receive substance abuse treatment, with one study reporting that only 15% of street living youth report ever receiving mental health services.
The effectiveness of the Community Reinforcement Approach (CRA) with street living youth was studied in our recently completed Stage 1 trial.
The proposed study is a Stage II clinical trial examining outcome of CRA individual therapy as compared to two interventions commonly employed, yet little researched, with this group.
All clients will be randomized to one of three theoretically distinct interventions: (1) CRA therapy, (2) Motivational Enhancement Therapy (MET), or (3) Case Management (CM).
The relative effectiveness of these interventions will be evaluated at 3, 6, and 12 months post-baseline.
The Social Ecology Theory of Development (Bronfenbrenner, 1979) guides our change hypotheses and intervention.
Proposed change mechanisms (mediators) for each intervention will be evaluated.
Differential treatment response as a function of ethnicity, gender, age, sexual orientation and abuse (moderators) will be investigated to better understand the interventions.
The study will also examine how, if at all, treatment engagement, retention and expectations impact youth response to the three treatments.
Information gained through this project may help address the gap in our understanding of how best to effectively intervene with a group at high risk for continuing health and psychological problems.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
270
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 20 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Youth are between the ages of 14-20.
- Youth have plans to remain in the Columbus areas for at least 12 months.
- Youth meets abuse or dependence DSM-IV criteria for Psychoactive Substance Use or Alcohol disorder, as assessed by the computerized diagnostic interview schedule for children (CDISC, Shaffer, 1992).
- Youth agrees to participate in the assessment and treatment intervention.
- Youth meets criteria for homelessness as defined by DHHS.
Exclusion Criteria:
1. Evidence of unremitted psychosis or other condition which would impair their ability to understand and participate in the intervention or consent for research participation (as determined by CDISC).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: CRA + HIV prevention
|
12 sessions of the CRA and 2 sessions of HIV prevention.
|
|
ACTIVE_COMPARATOR: Case Management + HIV prevention
|
12 sessions of case management and 2 sessions of HIV prevention.
|
|
ACTIVE_COMPARATOR: MET + HIV prevention
|
2 sessions of MET and 2 sessions of HIV prevention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Substance Use
Time Frame: Three months
|
Percentage of substance use days in prior three months.
|
Three months
|
|
Substance Use
Time Frame: Six months
|
Percentage of substance use days in prior three months
|
Six months
|
|
Substance Use
Time Frame: Twelve months
|
Percentage of substance use days in prior six months
|
Twelve months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HIV Risk
Time Frame: Three months
|
Frequency of condoms use in prior three months.
|
Three months
|
|
HIV Risk
Time Frame: Six months
|
Frequency of condoms use in prior three months.
|
Six months
|
|
HIV Risk
Time Frame: Twelve months
|
Frequency of condoms use in prior six months.
|
Twelve months
|
|
Depressive Symptoms
Time Frame: Three months
|
Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)
|
Three months
|
|
Depressive Symptoms
Time Frame: Six months
|
Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
|
Six months
|
|
Depressive Symptoms
Time Frame: Twelve months
|
Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)
|
Twelve months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (ACTUAL)
December 1, 2010
Study Completion (ACTUAL)
June 1, 2012
Study Registration Dates
First Submitted
June 11, 2010
First Submitted That Met QC Criteria
June 11, 2010
First Posted (ESTIMATE)
June 14, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
April 16, 2013
Last Update Submitted That Met QC Criteria
April 12, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005B0078
- R01DA013549 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.