Substance Use, Violence
Conditions
Brief summary
This is a randomized clinical trial to study ways of helping justice-involved people change to more healthy behavior.
Interventions
BEHAVIORALBMI
Four 45-minute, brief motivational sessions for substance use
BEHAVIORALStadard Care (SC)
Standard procedures at pretrial program + assessement
Sponsors
National Institute on Drug Abuse (NIDA)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* In Monroe County Pretrial Services Program
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Days Abstinent | 6 months | Percent Days not using alcohol or drugs |
| Substance Use Consequences (SIP-AD) | 6 months | Short Inventory of Problems with Alcohol or Drugs (SIP-AD) Range 0-45 higher = more problems |
| Violent Charges | 2 years | Number of violent charges during follow-up from Statewide Database |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Brief Motivational Intervention (BMI) BMI: Four 45-minute, brief motivational sessions for substance use
Stadard Care (SC): Standard procedures at pretrial program + assessement | 70 |
| Standard Care (SC) Stadard Care (SC): Standard procedures at pretrial program + assessement | 62 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 32 | 28 |
Baseline characteristics
| Characteristic | Brief Motivational Intervention (BMI) | Standard Care (SC) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 62 Participants | 132 Participants |
| Age, Continuous | 37.68 years STANDARD_DEVIATION 11.7 | 36.06 years STANDARD_DEVIATION 11.41 | 36.90 years STANDARD_DEVIATION 11.54 |
| Alcohol use disorder identification test (AUDIT) | 14.23 units on a scale STANDARD_DEVIATION 11.84 | 12.03 units on a scale STANDARD_DEVIATION 11.53 | 13.19 units on a scale STANDARD_DEVIATION 11.69 |
| Psychopathy Checklist Revised - total score | 22.49 units on a scale STANDARD_DEVIATION 7.15 | 21.14 units on a scale STANDARD_DEVIATION 8.51 | 21.85 units on a scale STANDARD_DEVIATION 7.79 |
| Race/Ethnicity, Customized Race/Ethnicity Black | 35 Participants | 29 Participants | 64 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 12 Participants | 15 Participants | 27 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 23 Participants | 18 Participants | 41 Participants |
| Readiness Ruler (readiness to change) | 6.71 units on a scale STANDARD_DEVIATION 2.92 | 6.24 units on a scale STANDARD_DEVIATION 2.78 | 6.49 units on a scale STANDARD_DEVIATION 2.85 |
| Region of Enrollment United States | 70 participants | 62 participants | 132 participants |
| Self-regulation Questionnaire | 214.23 units on a scale STANDARD_DEVIATION 25.07 | 211.37 units on a scale STANDARD_DEVIATION 29.02 | 212.88 units on a scale STANDARD_DEVIATION 26.94 |
| Sex: Female, Male Female | 17 Participants | 45 Participants | 62 Participants |
| Sex: Female, Male Male | 53 Participants | 17 Participants | 70 Participants |
| Timeline Followback; percent days abstinent | 34 percent days abstinent from alcohol/drug STANDARD_DEVIATION 33 | 32 percent days abstinent from alcohol/drug STANDARD_DEVIATION 40 | 33 percent days abstinent from alcohol/drug STANDARD_DEVIATION 36 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 62 |
| other Total, other adverse events | 19 / 70 | 15 / 62 |
| serious Total, serious adverse events | 0 / 70 | 0 / 62 |
Outcome results
Primary
Percent Days Abstinent
Percent Days not using alcohol or drugs
Time frame: 6 months
Population: Those who completed 6-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Motivational Intervention (BMI) | Percent Days Abstinent | 44 percentage of days abstinent | Standard Deviation 42 |
| Standard Care (SC) | Percent Days Abstinent | 42 percentage of days abstinent | Standard Deviation 41 |
Comparison: Hypothesis 1: Affective psychopathy scores will moderate response to a BMI such that individuals with lower scores will benefit relative to controls, but individuals with higher psychopathy scores will not benefit from the intervention in terms of percent days abstinent.p-value: 0.07Regression, Linear
Comparison: Sensitivity analysis: proximal follow-up (3 months following BMI or SC)p-value: 0.02Regression, Linear
Comparison: Increased readiness to change will be associated with decreased substance use.p-value: <0.0195% CI: [0.007, 0.156]Regression, Linear
Primary
Substance Use Consequences (SIP-AD)
Short Inventory of Problems with Alcohol or Drugs (SIP-AD) Range 0-45 higher = more problems
Time frame: 6 months
Population: Individuals who completed the 6-month follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Motivational Intervention (BMI) | Substance Use Consequences (SIP-AD) | 14.55 units on a scale | Standard Deviation 13.38 |
| Standard Care (SC) | Substance Use Consequences (SIP-AD) | 15.24 units on a scale | Standard Deviation 13.79 |
p-value: 0.74Regression, Linear
Primary
Violent Charges
Number of violent charges during follow-up from Statewide Database
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Motivational Intervention (BMI) | Violent Charges | .48 violent charges during 2-year follow up | Standard Deviation 0.97 |
| Standard Care (SC) | Violent Charges | .43 violent charges during 2-year follow up | Standard Deviation 0.92 |
p-value: 0.88Regression, Logistic