Evaluation of Treatments for Homeless Youths

NCT01143792 | Completed Phase 2 Results

• 2 other identifiers: 2005B0078R01DA013549
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Abuse

Keywords

Substance abuse; Homelessness; HIV risk behavior

Outcome Measures

Primary Outcomes (3)

• Substance Use

  Percentage of substance use days in prior three months.

  Three months

• Substance Use

  Percentage of substance use days in prior three months

  Six months

• Substance Use

  Percentage of substance use days in prior six months

  Twelve months

Secondary Outcomes (6)

• HIV Risk

  Three months

• HIV Risk

  Six months

• HIV Risk

  Twelve months

• Depressive Symptoms

  Three months

• Depressive Symptoms

  Six months

Study Arms (3)

CRA + HIV prevention

EXPERIMENTAL

Behavioral: Community Reinforcement Approach (CRA) + HIV prevention

Case Management + HIV prevention

ACTIVE COMPARATOR

Behavioral: Case Management + HIV Prevention

MET + HIV prevention

ACTIVE COMPARATOR

Behavioral: Motivational Enhancement Therapy (MET) + HIV prevention

Interventions

Community Reinforcement Approach (CRA) + HIV prevention BEHAVIORAL

12 sessions of the CRA and 2 sessions of HIV prevention.

CRA + HIV prevention

Case Management + HIV Prevention BEHAVIORAL

12 sessions of case management and 2 sessions of HIV prevention.

Case Management + HIV prevention

Motivational Enhancement Therapy (MET) + HIV prevention BEHAVIORAL

2 sessions of MET and 2 sessions of HIV prevention.

MET + HIV prevention

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• Ohio State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Case Management; Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Natasha Slesnick
• Organization: The Ohio State University

slesnick.5@osu.edu

614 247-8469

Study Officials

• Natasha Slesnick, Ph.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 14, 2010
• Study Start: September 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2012
• Last Updated: April 16, 2013
• Results First Posted: April 16, 2013

Record last verified: 2013-04

Locations

US (1)