Evaluation of Treatments for Homeless Youths

Substance Abuse Clinical Trial

Official title:

Evaluation of Treatments for Homeless Youth: CRA, MET and Case Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143792
• Other study ID #: 2005B0078
• Secondary ID: R01DA013549
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2010
• Last updated: April 12, 2013
• Start date: September 2006
• Est. completion date: June 2012

Study information

• Verified date: April 2013
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: June 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 20 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance Abuse

Intervention

Behavioral:
• Community Reinforcement Approach (CRA) + HIV prevention
12 sessions of the CRA and 2 sessions of HIV prevention.
• Case Management + HIV Prevention
12 sessions of case management and 2 sessions of HIV prevention.
• Motivational Enhancement Therapy (MET) + HIV prevention
2 sessions of MET and 2 sessions of HIV prevention.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance Use	Percentage of substance use days in prior three months.	Three months	No
Primary	Substance Use	Percentage of substance use days in prior three months	Six months	No
Primary	Substance Use	Percentage of substance use days in prior six months	Twelve months	No
Secondary	HIV Risk	Frequency of condoms use in prior three months.	Three months	No
Secondary	HIV Risk	Frequency of condoms use in prior three months.	Six months	No
Secondary	HIV Risk	Frequency of condoms use in prior six months.	Twelve months	No
Secondary	Depressive Symptoms	Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)	Three months	No
Secondary	Depressive Symptoms	Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)	Six months	No
Secondary	Depressive Symptoms	Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)	Twelve months	No