Evaluation of Treatments for Homeless Youths
Primary Purpose
Substance Abuse
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Community Reinforcement Approach (CRA) + HIV prevention
Case Management + HIV Prevention
Motivational Enhancement Therapy (MET) + HIV prevention
Sponsored by
About this trial
This is an interventional treatment trial for Substance Abuse focused on measuring Substance abuse, Homelessness, HIV risk behavior
Eligibility Criteria
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).
Sites / Locations
- The Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
CRA + HIV prevention
Case Management + HIV prevention
MET + HIV prevention
Arm Description
Outcomes
Primary Outcome Measures
Substance Use
Percentage of substance use days in prior three months.
Substance Use
Percentage of substance use days in prior three months
Substance Use
Percentage of substance use days in prior six months
Secondary Outcome Measures
HIV Risk
Frequency of condoms use in prior three months.
HIV Risk
Frequency of condoms use in prior three months.
HIV Risk
Frequency of condoms use in prior six months.
Depressive Symptoms
Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)
Depressive Symptoms
Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
Depressive Symptoms
Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)
Full Information
NCT ID
NCT01143792
First Posted
June 11, 2010
Last Updated
April 12, 2013
Sponsor
Ohio State University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01143792
Brief Title
Evaluation of Treatments for Homeless Youths
Official Title
Evaluation of Treatments for Homeless Youth: CRA, MET and Case Management
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
Substance abuse, Homelessness, HIV risk behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRA + HIV prevention
Arm Type
Experimental
Arm Title
Case Management + HIV prevention
Arm Type
Active Comparator
Arm Title
MET + HIV prevention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Community Reinforcement Approach (CRA) + HIV prevention
Intervention Description
12 sessions of the CRA and 2 sessions of HIV prevention.
Intervention Type
Behavioral
Intervention Name(s)
Case Management + HIV Prevention
Intervention Description
12 sessions of case management and 2 sessions of HIV prevention.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy (MET) + HIV prevention
Intervention Description
2 sessions of MET and 2 sessions of HIV prevention.
Primary Outcome Measure Information:
Title
Substance Use
Description
Percentage of substance use days in prior three months.
Time Frame
Three months
Title
Substance Use
Description
Percentage of substance use days in prior three months
Time Frame
Six months
Title
Substance Use
Description
Percentage of substance use days in prior six months
Time Frame
Twelve months
Secondary Outcome Measure Information:
Title
HIV Risk
Description
Frequency of condoms use in prior three months.
Time Frame
Three months
Title
HIV Risk
Description
Frequency of condoms use in prior three months.
Time Frame
Six months
Title
HIV Risk
Description
Frequency of condoms use in prior six months.
Time Frame
Twelve months
Title
Depressive Symptoms
Description
Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)
Time Frame
Three months
Title
Depressive Symptoms
Description
Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
Time Frame
Six months
Title
Depressive Symptoms
Description
Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)
Time Frame
Twelve months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natasha Slesnick, Ph.D.
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Treatments for Homeless Youths
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