Substance Abuse Clinical Trial
Official title:
Evaluation of Treatments for Homeless Youth: CRA, MET and Case Management
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 |
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.
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University | National Institute on Drug Abuse (NIDA) |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04070521 -
EEG Monitoring in the Emergency Department
|
||
Completed |
NCT00729391 -
Women-Focused HIV Prevention in the Western Cape
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT03129334 -
Preventing Prescription Drug Abuse in Middle School Students
|
N/A | |
Completed |
NCT02733003 -
Implementation Research for Vulnerable Women in South Africa
|
N/A | |
Completed |
NCT02282306 -
Phone Interview to Prevent Recurring Opioid Overdoses
|
N/A | |
Completed |
NCT02573948 -
Feasibility of Interventions on People Who Inject Drugs in Vietnam
|
||
Withdrawn |
NCT01523444 -
Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings
|
Phase 3 | |
Withdrawn |
NCT01847300 -
cSBI-M for Young Military Personnel
|
N/A | |
Completed |
NCT01481428 -
Reducing High Risk Behavior in Treatment Court
|
Phase 1 | |
Completed |
NCT01601743 -
Exercise as a Behavioral Treatment for Cocaine Dependence
|
N/A | |
Completed |
NCT01591239 -
Home-Based Program to Help Parents of Drug Abusing Adolescents
|
N/A | |
Active, not recruiting |
NCT00847548 -
Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting
|
N/A | |
Withdrawn |
NCT01228890 -
Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)
|
Phase 3 | |
Completed |
NCT01614015 -
Building Outcomes With Observation-Based Supervision: An FFT Effectiveness Trial
|
Phase 2 | |
Completed |
NCT01621334 -
The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use
|
Phase 1 | |
Completed |
NCT00841711 -
Transitions: Linkages From Jail To Community
|
N/A | |
Completed |
NCT00717444 -
Healthy Activities for Prize Incentives
|
N/A | |
Completed |
NCT01465490 -
Monitoring and Feedback in Substance Abuse Treatment
|
Phase 1/Phase 2 | |
Completed |
NCT01188434 -
Integrating Interventions for Maternal Substance Abuse
|
Phase 1 | |
Completed |
NCT00685074 -
Computer-based Brief Intervention for Perinatal Substance Abuse
|
Phase 1/Phase 2 |