Substance Abuse
Conditions
Keywords
Substance abuse, Homelessness, HIV risk behavior
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.
Interventions
BEHAVIORALCommunity Reinforcement Approach (CRA) + HIV prevention
12 sessions of the CRA and 2 sessions of HIV prevention.
BEHAVIORALCase Management + HIV Prevention
12 sessions of case management and 2 sessions of HIV prevention.
BEHAVIORALMotivational Enhancement Therapy (MET) + HIV prevention
2 sessions of MET and 2 sessions of HIV prevention.
Sponsors
National Institute on Drug Abuse (NIDA)
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 20 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Substance Use | Three months | Percentage of substance use days in prior three months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Risk | Three months | Frequency of condoms use in prior three months. |
| Depressive Symptoms | Three months | Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression) |
Countries
United States
Participant flow
Recruitment details
recruitment ended on time, recruitment completed as proposed.
Pre-assignment details
intent to treat design used.
Participants by arm
| Arm | Count |
|---|---|
| CRA + HIV Prevention Treatment included twelve 1-hour sessions for a total of 14 sessions. | 93 |
| MET + HIV Prevention Treatment included two 1-hour MI sessions for a total of 4 sessions | 86 |
| Case Management + HIV Prevention Treatment included twelve 1-hour sessions for a total of 14 sessions. | 91 |
| Total | 270 |
Baseline characteristics
| Characteristic | MET + HIV Prevention | Case Management + HIV Prevention | CRA + HIV Prevention | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 10 Participants | 17 Participants | 43 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 81 Participants | 76 Participants | 227 Participants |
| Age Continuous | 18.69 years STANDARD_DEVIATION 1.32 | 18.84 years STANDARD_DEVIATION 1.11 | 18.70 years STANDARD_DEVIATION 1.34 | 18.7 years STANDARD_DEVIATION 1.3 |
| Region of Enrollment United States | 86 participants | 91 participants | 93 participants | 270 participants |
| Sex: Female, Male Female | 37 Participants | 47 Participants | 43 Participants | 127 Participants |
| Sex: Female, Male Male | 49 Participants | 44 Participants | 50 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 93 | 0 / 86 | 0 / 91 |
| serious Total, serious adverse events | 0 / 93 | 0 / 86 | 0 / 91 |
Outcome results
Primary
Substance Use
Percentage of substance use days in prior three months.
Time frame: Three months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MET + HIV Prevention | Substance Use | 45.67 percent days of drug use | Standard Deviation 43.24 |
| CRA + HIV Prevention | Substance Use | 53.60 percent days of drug use | Standard Deviation 40.76 |
| Case Management + HIV Prevention | Substance Use | 49.38 percent days of drug use | Standard Deviation 40.66 |
Primary
Substance Use
Percentage of substance use days in prior three months
Time frame: Six months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MET + HIV Prevention | Substance Use | 39.10 percent days of drug use | Standard Deviation 38.83 |
| CRA + HIV Prevention | Substance Use | 48.88 percent days of drug use | Standard Deviation 41.43 |
| Case Management + HIV Prevention | Substance Use | 42.64 percent days of drug use | Standard Deviation 40.74 |
Primary
Substance Use
Percentage of substance use days in prior six months
Time frame: Twelve months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MET + HIV Prevention | Substance Use | 49.25 percent days of drug use | Standard Deviation 41.55 |
| CRA + HIV Prevention | Substance Use | 44.33 percent days of drug use | Standard Deviation 39.31 |
| Case Management + HIV Prevention | Substance Use | 38.46 percent days of drug use | Standard Deviation 39.84 |
Secondary
Depressive Symptoms
Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)
Time frame: Three months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MET + HIV Prevention | Depressive Symptoms | 9.63 units on a scale | Standard Deviation 9.57 |
| CRA + HIV Prevention | Depressive Symptoms | 14.78 units on a scale | Standard Deviation 14.83 |
| Case Management + HIV Prevention | Depressive Symptoms | 10.97 units on a scale | Standard Deviation 12.2 |
Secondary
Depressive Symptoms
Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
Time frame: Six months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MET + HIV Prevention | Depressive Symptoms | 10.02 units on a scale | Standard Deviation 9.94 |
| CRA + HIV Prevention | Depressive Symptoms | 11.97 units on a scale | Standard Deviation 14.13 |
| Case Management + HIV Prevention | Depressive Symptoms | 8.76 units on a scale | Standard Deviation 10.09 |
Secondary
Depressive Symptoms
Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)
Time frame: Twelve months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MET + HIV Prevention | Depressive Symptoms | 8.70 units on a scale | Standard Deviation 11.09 |
| CRA + HIV Prevention | Depressive Symptoms | 12.07 units on a scale | Standard Deviation 12.13 |
| Case Management + HIV Prevention | Depressive Symptoms | 8.48 units on a scale | Standard Deviation 10.93 |
Secondary
HIV Risk
Frequency of condoms use in prior six months.
Time frame: Twelve months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MET + HIV Prevention | HIV Risk | 17 participants who always used condoms |
| CRA + HIV Prevention | HIV Risk | 18 participants who always used condoms |
| Case Management + HIV Prevention | HIV Risk | 24 participants who always used condoms |
Secondary
HIV Risk
Frequency of condoms use in prior three months.
Time frame: Three months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MET + HIV Prevention | HIV Risk | 19 participants who always used condom |
| CRA + HIV Prevention | HIV Risk | 26 participants who always used condom |
| Case Management + HIV Prevention | HIV Risk | 25 participants who always used condom |
Secondary
HIV Risk
Frequency of condoms use in prior three months.
Time frame: Six months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MET + HIV Prevention | HIV Risk | 25 participants who always used condoms |
| CRA + HIV Prevention | HIV Risk | 29 participants who always used condoms |
| Case Management + HIV Prevention | HIV Risk | 25 participants who always used condoms |