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

June 11, 2010
April 12, 2013
September 2006
December 2010   (final data collection date for primary outcome measure)
  • 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
Substance use [ Time Frame: 3, 6 and 12 months post-baseline ] [ Designated as safety issue: No ]
Percentage of substance use days in prior 90 days
Complete list of historical versions of study NCT01143792 on ClinicalTrials.gov Archive Site
  • 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)
  • HIV risk [ Time Frame: 3, 6, and 12 months post-baseline ] [ Designated as safety issue: No ]
    Number of HIV risk behaviors in prior 3 months
  • Depressive symptoms [ Time Frame: 3, 6, and 12 months post-baseline ] [ Designated as safety issue: No ]
    Beck Depression Inventory total score
Not Provided
Not Provided
 
Evaluation of Treatments for Homeless Youths
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Substance Abuse
  • Behavioral: Community Reinforcement Approach (CRA) + HIV prevention
    12 sessions of the CRA and 2 sessions of HIV prevention.
  • Behavioral: Case Management + HIV Prevention
    12 sessions of case management and 2 sessions of HIV prevention.
  • Behavioral: Motivational Enhancement Therapy (MET) + HIV prevention
    2 sessions of MET and 2 sessions of HIV prevention.
  • Experimental: CRA + HIV prevention
    Intervention: Behavioral: Community Reinforcement Approach (CRA) + HIV prevention
  • Active Comparator: Case Management + HIV prevention
    Intervention: Behavioral: Case Management + HIV Prevention
  • Active Comparator: MET + HIV prevention
    Intervention: Behavioral: Motivational Enhancement Therapy (MET) + HIV prevention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
June 2012
December 2010   (final data collection date for primary outcome measure)

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).

Both
14 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01143792
2005B0078, R01DA013549
No
Natasha Slesnick, Ohio State University
Ohio State University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Natasha Slesnick, Ph.D. Ohio State University
Ohio State University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP