Clinical trial NCT01143792: Evaluation of Treatments for Homeless Youths
Official title: Evaluation of Treatments for Homeless Youth: CRA, MET and Case Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance Abuse
Keywords: Substance abuse
Homelessness
HIV risk behavior
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-06-14
Enrollment: 270
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Substance Use
timeFrame: Three months
measure: Substance Use
timeFrame: Six months
measure: Substance Use
timeFrame: Twelve months
Secondary outcomes:
measure: HIV Risk
timeFrame: Three months
measure: HIV Risk
timeFrame: Six months
measure: HIV Risk
timeFrame: Twelve months
measure: Depressive Symptoms
timeFrame: Three months
measure: Depressive Symptoms
timeFrame: Six months
measure: Depressive Symptoms
timeFrame: Twelve months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Natasha Slesnick, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: