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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA043660 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This is a randomized clinical trial to study ways of helping justice-involved people change to more healthy behavior.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Motivational Intervention (BMI) | Experimental |
| |
| Standard Care (SC) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMI | Behavioral | Four 45-minute, brief motivational sessions for substance use |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Days Abstinent | Percent Days not using alcohol or drugs | 6 months |
| Substance Use Consequences (SIP-AD) | Short Inventory of Problems with Alcohol or Drugs (SIP-AD) Range 0-45 higher = more problems | 6 months |
| Violent Charges | Number of violent charges during follow-up from Statewide Database | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pretrial Services, Inc. | Rochester | New York | 14642 | United States | ||
| University of Rochester Medical Center |
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Adults were recruited from Pretrial Services subsequent to being charged with a crime. They were eligible for the trial if they had a Drug Abuse Screening Test (DAST) score at or above 3, indicating harmful substance use and provided informed consent to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brief Motivational Intervention (BMI) | BMI: Four 45-minute, brief motivational sessions for substance use Stadard Care (SC): Standard procedures at pretrial program + assessement |
| FG001 | Standard Care (SC) | Stadard Care (SC): Standard procedures at pretrial program + assessement |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brief Motivational Intervention (BMI) | BMI: Four 45-minute, brief motivational sessions for substance use Stadard Care (SC): Standard procedures at pretrial program + assessement |
| BG001 | Standard Care (SC) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Percent Days Abstinent | Percent Days not using alcohol or drugs | Those who completed 6-month follow-up | Posted | Mean | Standard Deviation | percentage of days abstinent | 6 months |
|
6 months
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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 | Brief Motivational Intervention (BMI) | BMI: Four 45-minute, brief motivational sessions for substance use Stadard Care (SC): Standard procedures at pretrial program + assessement |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrest; new criminal charges | Social circumstances | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc T. Swogger, Associate Professor, Psychiatry and Medicine | University of Rochester Medical Center | 585-301-7738 | marc_swogger@urmc.rochester.edu |
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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 | Apr 1, 2017 | Mar 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2017 | Feb 24, 2025 | 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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| Stadard Care (SC) | Behavioral | Standard procedures at pretrial program + assessement |
|
| Rochester |
| New York |
| 14642 |
| United States |
Stadard Care (SC): Standard procedures at pretrial program + assessement
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Timeline Followback; percent days abstinent | Mean | Standard Deviation | percent days abstinent from alcohol/drug |
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| Self-regulation Questionnaire | upper limit (high regulation) = 315; lower limit = 63 | Mean | Standard Deviation | units on a scale |
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| Alcohol use disorder identification test (AUDIT) | Upper limit (heavy drinking) = 40, lower limit = 0 | Mean | Standard Deviation | units on a scale |
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| Psychopathy Checklist Revised - total score | upper limit (high psychopathy)= 40, lower limit= 0 | Mean | Standard Deviation | units on a scale |
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| Readiness Ruler (readiness to change) | 1 (low readiness to change) to 10 | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Substance Use Consequences (SIP-AD) | Short Inventory of Problems with Alcohol or Drugs (SIP-AD) Range 0-45 higher = more problems | Individuals who completed the 6-month follow up. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
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| Primary | Violent Charges | Number of violent charges during follow-up from Statewide Database | Posted | Mean | Standard Deviation | violent charges during 2-year follow up | 2 years |
|
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 19 |
| 70 |
| EG001 | Standard Care (SC) | Stadard Care (SC): Standard procedures at pretrial program + assessement | 0 | 62 | 0 | 62 | 15 | 62 |
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