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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA013549 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRA + HIV prevention | Experimental |
| |
| Case Management + HIV prevention | Active Comparator |
| |
| MET + HIV prevention | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Reinforcement Approach (CRA) + HIV prevention | Behavioral | 12 sessions of the CRA and 2 sessions of HIV prevention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Risk | Frequency of condoms use in prior three months. | Three months |
| HIV Risk | Frequency of condoms use in prior three months. | Six months |
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Inclusion Criteria:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Natasha Slesnick, Ph.D. | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
intent to treat design used.
recruitment ended on time, recruitment completed as proposed.
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| ID | Title | Description |
|---|---|---|
| FG000 | CRA + HIV Prevention | Description of CRA: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions. |
| FG001 | MET + HIV Prevention | Description of MET: Treatment included two 1-hour sessions in addition to two HIV prevention sessions. |
| FG002 | Case Management + HIV Prevention | Description of CM: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of participants in each group varies because the urn randomization program didn't balance the groups equally.
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| ID | Title | Description |
|---|---|---|
| BG000 | CRA + HIV Prevention | Treatment included twelve 1-hour sessions for a total of 14 sessions. |
| BG001 | MET + HIV Prevention | Treatment included two 1-hour MI sessions for a total of 4 sessions |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Substance Use | Percentage of substance use days in prior three months. | The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis. | Posted | Mean | Standard Deviation | percent days of drug use | Three months |
|
Overall Study
Adverse events were monitored but none were observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CRA + HIV Prevention | Treatment included twelve 1-hour sessions for a total of 14 sessions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natasha Slesnick | The Ohio State University | 614 247-8469 | slesnick.5@osu.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019090 | Case Management |
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D010347 | Patient Care Planning |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Case Management + HIV Prevention | Behavioral | 12 sessions of case management and 2 sessions of HIV prevention. |
|
| Motivational Enhancement Therapy (MET) + HIV prevention | Behavioral | 2 sessions of MET and 2 sessions of HIV prevention. |
|
| HIV Risk | Frequency of condoms use in prior six months. | Twelve months |
| Depressive Symptoms | Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression) | Three months |
| Depressive Symptoms | Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression) | Six months |
| Depressive Symptoms | Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression) | Twelve months |
| BG002 | Case Management + HIV Prevention | Treatment included twelve 1-hour sessions for a total of 14 sessions. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Case Management + HIV Prevention | The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. |
|
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| Secondary | HIV Risk | Frequency of condoms use in prior three months. | The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis. | Posted | Number | participants who always used condom | Three months |
|
|
|
| Secondary | HIV Risk | Frequency of condoms use in prior three months. | The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis. | Posted | Number | participants who always used condoms | Six months |
|
|
|
| Secondary | HIV Risk | Frequency of condoms use in prior six months. | The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis. | Posted | Number | participants who always used condoms | Twelve months |
|
|
|
| Secondary | Depressive Symptoms | Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression) | The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Three months |
|
|
|
| Secondary | Depressive Symptoms | Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression) | The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Six months |
|
|
|
| Secondary | Depressive Symptoms | Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression) | The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Twelve months |
|
|
|
| Primary | Substance Use | Percentage of substance use days in prior three months | The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis. | Posted | Mean | Standard Deviation | percent days of drug use | Six months |
|
|
|
| Primary | Substance Use | Percentage of substance use days in prior six months | The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis. | Posted | Mean | Standard Deviation | percent days of drug use | Twelve months |
|
|
|
| 0 |
| 93 |
| 0 |
| 93 |
| EG001 | MET + HIV Prevention | Treatment included two 1-hour MI sessions for a total of 4 sessions | 0 | 86 | 0 | 86 |
| EG002 | Case Management + HIV Prevention | Treatment included twelve 1-hour sessions for a total of 14 sessions. | 0 | 91 | 0 | 91 |
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| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |