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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA034973-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The goal of the study is to see if a Motivational Interviewing Case Management (MICM) intervention will improve outcomes for respondents who are on probation or parole, at risk for HIV and have recently entered a Sober Living House. The MICM will help respondents access needed services, adapt to their new living environment, find and maintain work, address HIV risk and treatment, and manage setbacks. The risk for HIV infection among criminal justice offenders is significant, as is the need for stable, drug free housing in this population. Our aim is to see if the MICM intervention in the context of drug free housing will improve health outcomes and reduce recidivism.
This study is based on the premise that probationers and parolees must have access to stable, drug-free housing to reduce HIV risk, access needed services and avoid rearrests and reincarceration. Drug-free housing at the Sober Living Network (SLN) in California are being studied as a way to provide a positive living environment for probationers and parolees. The houses use a sober living house (SLH) model of recovery that includes a communal recovery environment, abstinence from drugs and alcohol, peer support, and encouragement to attend self-help groups such as Alcoholics Anonymous.
The proposed study will improve SLHs for offenders by adding a Motivational Interviewing Case Management (MICM) intervention specifically targeted to the problems presented by each offender. The list of potential problems that MICM can address is extensive: 1) adapting to the SLH environment, 2) complying with parole and probation, 3) finding and maintain work, 4) successfully accessing and maintaining retention in services, 5) addressing HIV risk, testing and treatment, 6) mobilizing personal and informal resources, and 7) managing setbacks (e.g., relapse, loss of housing, loss of work).
Men and women involved with the criminal justice system (N=330) entering SLHs will be assigned to a condition consisting of a provision of a resources manual where residents can seek help for a variety of problems (a control group) or the MICM (intervention).To avoid mixing individuals who receive the intervention with individuals who do not within the same house, houses are randomized at the house level. Once a house is randomized to a study condition, all of the individuals recruited from that house receive the same intervention, MICM or SLH as usual. To avoid contamination of study conditions by gender, randomization procedures are stratified by houses for men, women, and both genders. Research interviews are conducted at baseline (within one month of entering the houses), 6 months, and 12 months. Follow-up interviews are conducted whether or not the participant leaves the SLH and at a site that is the most comfortable for the participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational interviewing case management | Experimental | MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months). |
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| Resource referrals | Other | Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational interviewing case management | Behavioral |
| ||
| Resource referrals |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Criminal Justice Outcomes | Measured by dichotomous measure of whether or not any time spent incarcerated in past 6 months.56 follow-up interviews were conducted in jails, when allowed and the participant was comfortable, but we did not conduct interviews in prison. See participant flow for number of participants in prison. | Baseline, 6 months, and 12 months |
| Change in Alcohol and Drug Use (Timeline Follow Back) | Measured by whether or not the participant reports complete abstinence from all substance use for last 6 months on Timeline Followback (TLFB). | Baseline, 6 months, and 12 months |
| Change in Worries About HIV in Past 6 Months. | Measured by whether or not the participant was worried about HIV in past 6 months. | Baseline, 6 months, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doug Polcin, Ed.D | Alcohol Research Group / Public Health Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcohol Research Group | Emeryville | California | 94608 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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To avoid mixing individuals who received the intervention with individuals who did not within the same house, we randomized at the house level. Once a house was randomized to a study condition, all of the individuals recruited from that house received the same intervention.
The recruitment of 330 study participants followed a two-step process: first we recruited the house, and then we recruited residents that moved in to those houses. The approximately 50 SLHs participating in the study were located in the Los Angeles area and all were members of the Sober Living Network.
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| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Interviewing Case Management | MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months). Motivational interviewing case management |
| FG001 | Resource Referrals | Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems. Resource referrals |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants in the motivational interviewing case management (MICM) would be set up with their MICM therapist at the end of the baseline interview to set up their first appointment. They would continue with MICM for the 12 months in the study, regardless of whether or not they stayed at the house. The control group was given a list of resources.
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| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Interviewing Case Management | MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months). Motivational interviewing case management |
| 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 | Change in Criminal Justice Outcomes | Measured by dichotomous measure of whether or not any time spent incarcerated in past 6 months.56 follow-up interviews were conducted in jails, when allowed and the participant was comfortable, but we did not conduct interviews in prison. See participant flow for number of participants in prison. | 330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews. We were not able to find all of them for follow up interviews. | Posted | Count of Participants | Participants | Baseline, 6 months, and 12 months |
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Data was collected for participants for 1 year that they participated in the study.
This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
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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 | Motivational Interviewing Case Management | MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months). Motivational interviewing case management |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depressive symptoms | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Mahoney | Public Health Institute | (818)310-2684 | lmahoney@bhrsca.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 7, 2016 | Jun 18, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2016 | Jun 18, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Behavioral |
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| Withdrawal by Subject |
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| In prison |
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| BG001 | Control - Resource Referrals | Respondents will receive sober living house services as usual along with a list of resources that can be used to address a variety of problems. control - Resource referrals |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Legal status | Count of Participants | Participants |
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| OG001 | Control/Resource Referrals | Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems. Resource referrals |
|
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| Primary | Change in Alcohol and Drug Use (Timeline Follow Back) | Measured by whether or not the participant reports complete abstinence from all substance use for last 6 months on Timeline Followback (TLFB). | 330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews. | Posted | Count of Participants | Participants | Baseline, 6 months, and 12 months |
|
|
|
| Primary | Change in Worries About HIV in Past 6 Months. | Measured by whether or not the participant was worried about HIV in past 6 months. | 330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews. We were not able to find all of them for follow up interviews. | Posted | Count of Participants | Participants | Baseline, 6 months, and 12 months |
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|
|
| 3 |
| 149 |
| 12 |
| 149 |
| 0 |
| 149 |
| EG001 | Resource Referrals | Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems. Resource referrals | 4 | 181 | 30 | 181 | 0 | 181 |
| Suicidal symptoms | Psychiatric disorders | Non-systematic Assessment | Hospitalizations due to suicidal symptoms |
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| Staph infection | General disorders | Non-systematic Assessment |
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| Contusions and lacerations | General disorders | Non-systematic Assessment |
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| Cardiac arrhythmia, unspecified | Cardiac disorders | Non-systematic Assessment |
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| Alcohol withdrawal | General disorders | Non-systematic Assessment |
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| Unspecified asthma with (acute) exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Fracture | General disorders | Non-systematic Assessment |
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| Cerebral infarction | Nervous system disorders | Non-systematic Assessment |
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| Seizure disorder | Nervous system disorders | Non-systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Unconsciousness NOS | General disorders | Non-systematic Assessment |
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| Gastrointestinal hemorrhage, unspecified | Gastrointestinal disorders | Non-systematic Assessment | Ppt reported they had internal bleeding due to drug use |
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| Acute embolism and thrombosis of unspecified deep veins of lower extremity | Blood and lymphatic system disorders | Non-systematic Assessment | ppt reported hospitalization due to a blood clot in leg |
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| Infarction of spleen | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Biliary acute pancreatitis | Endocrine disorders | Non-systematic Assessment |
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| Contusions | General disorders | Non-systematic Assessment | Ppt was assaulted and hospitalized overnight due to injuries. |
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| Incarcerated in past 6 months |
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| Incarcerated in past 6 months |
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| Abstinent |
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| 6 months |
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| 12 months |
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| Had HIV worry |
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| 6 months |
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| 12 months |
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