Evaluation of Treatments for Homeless Youths

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Natasha Slesnick, Ohio State University
ClinicalTrials.gov Identifier:
NCT01143792
First received: June 11, 2010
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Substance Abuse
Behavioral: Community Reinforcement Approach (CRA) + HIV prevention
Behavioral: Case Management + HIV Prevention
Behavioral: Motivational Enhancement Therapy (MET) + HIV prevention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Treatments for Homeless Youth: CRA, MET and Case Management

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Substance Use [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Percentage of substance use days in prior three months.

  • Substance Use [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Percentage of substance use days in prior three months

  • Substance Use [ Time Frame: Twelve months ] [ Designated as safety issue: No ]
    Percentage of substance use days in prior six months


Secondary Outcome Measures:
  • HIV Risk [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Frequency of condoms use in prior three months.

  • HIV Risk [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Frequency of condoms use in prior three months.

  • HIV Risk [ Time Frame: Twelve months ] [ Designated as safety issue: No ]
    Frequency of condoms use in prior six months.

  • Depressive Symptoms [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)

  • Depressive Symptoms [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)

  • Depressive Symptoms [ Time Frame: Twelve months ] [ Designated as safety issue: No ]
    Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)


Enrollment: 270
Study Start Date: September 2006
Study Completion Date: June 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CRA + HIV prevention Behavioral: Community Reinforcement Approach (CRA) + HIV prevention
12 sessions of the CRA and 2 sessions of HIV prevention.
Active Comparator: Case Management + HIV prevention Behavioral: Case Management + HIV Prevention
12 sessions of case management and 2 sessions of HIV prevention.
Active Comparator: MET + HIV prevention Behavioral: Motivational Enhancement Therapy (MET) + HIV prevention
2 sessions of MET and 2 sessions of HIV prevention.

  Eligibility

Ages Eligible for Study:   14 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Youth are between the ages of 14-20.
  2. Youth have plans to remain in the Columbus areas for at least 12 months.
  3. 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).
  4. Youth agrees to participate in the assessment and treatment intervention.
  5. 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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143792

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Natasha Slesnick, Ph.D. Ohio State University
  More Information

No publications provided

Responsible Party: Natasha Slesnick, Ph.D., Ohio State University
ClinicalTrials.gov Identifier: NCT01143792     History of Changes
Other Study ID Numbers: 2005B0078, R01DA013549
Study First Received: June 11, 2010
Results First Received: December 13, 2012
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Substance abuse
Homelessness
HIV risk behavior

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 25, 2014