Substance Use Disorders
Conditions
Brief summary
The current project seeks to implement the Multiphase Optimization Strategy (MOST) and Community Based Participatory Research (CBPR) principles to identify the most efficient, scalable, and sustainable combination of Community Wise components. Community Wise is a manualized multi-level intervention aimed at reducing health inequalities related to alcohol and illicit drug use (AIDU).This 2x2x2x2 factorial design will be fully powered to detect change in AIDU in a sample of 528 men with substance use disorders and a history of incarceration residing in distressed communities with predominantly Black populations. Participants will be randomly assigned to one of sixteen experimental conditions.
Detailed description
The current project seeks to implement the Multiphase Optimization Strategy (MOST) and Community Based Participatory Research (CBPR) principles to identify the most efficient, scalable, and sustainable combination of Community Wise components. Community Wise is a manualized multi-level intervention aimed at reducing health inequalities related to alcohol and illicit drug use (AIDU). The research will be conducted by the Newark Community Collaborative Board (NCCB), a network that developed and pilot-tested the original Community Wise. NCCB members include the principal investigators (PIs), co-investigators (Co-Is), service providers, consumers of AIDU, and community members. Specific aims include: Aim 1: Use a highly efficient experimental design to estimate the unique contribution of key components of Community Wise in: a) reducing AIDU frequency and b) increasing the percentage of participants abstinent over five months. Components tested are the presence or absence of: (a) Critical Dialogue; (b) Quality-of-Life-Wheel; (c) Capacity Building Project; and (d) group facilitation by a peer versus a licensed clinician. A factorial experiment will be used to detect effects of individual components and three-way interactions. Aim 2: Informed by MOST, Community Wise will be optimized for scalability and sustainability-- the most efficacious combination of components that can be delivered for less than $2000 per intervention cycle serving up to eleven individuals simultaneously (as per recommendations by the Substance Abuse and Mental Health Services Administration (SAMHSA). This 2x2x2x2 factorial design will be fully powered to detect change in AIDU in a sample of 528 men with substance use disorders and a history of incarceration residing in distressed communities with predominantly Black populations. Participants will be randomly assigned to one of sixteen experimental conditions. The first eight conditions will be facilitated by a licensed facilitator. The remaining conditions will be facilitated by a peer facilitator. Each set of eight conditions will include the following components: (1) Critical Dialogue (CD) only; (2) Quality-of-Life-Wheel (QLW) only; (3) Capacity Building Project (CBP) only; (4) CD+QLW; (5) CD+CBP; (6) QLW+CBP; (7) CD+QLW+CBP; and (8) no components. Data will be collected at baseline plus five post-baseline monthly follow-ups. This study has potential to impact public health; the use of CBPR and MOST will generate action-oriented implications and an optimized multi-level intervention adaptable to address different health inequalities.
Interventions
BEHAVIORALCritical Dialogue
Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
BEHAVIORALCapacity Building Project
Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
BEHAVIORALQuality of Life Wheel
Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
BEHAVIORALPF
Whether the intervention is delivered by a peer facilitator.
BEHAVIORALLC
Whether the intervention is delivered by a licensed clinician.
Sponsors
National Development and Research Institutes, Inc.
University of Michigan
National Institute on Minority Health and Health Disparities (NIMHD)
North Jersey Community Research Initiative
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for the factorial experiment participants in the study will include: * Men age 18 or older * Residence in Essex County, NJ * Willingness to be voice recorded during group sessions * Ability to speak English * Having a substance use disorder measured by the Global Appraisal of Individual Needs-Substance Problem Scale (GAIN-SPS). * Having been released from incarceration in the past 4 years. This is due to research that shows that people are more likely to be re-incarcerated within the first 4 years of release from incarceration.
Exclusion criteria
* Severe psychiatric disorders in the prior 6 months not stabilized (schizophrenia, depression with psychotic features, bipolar disorder, any psychosis), as measured by the MINI International Neuropsychiatric Interview 6 psychoticism and suicidality modules * Gross cognitive impairment as measured by the Mini Mental State Exam. * Sexual identification as female
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 5 months | The primary outcome was the percentage of ASM (i.e., the percentage of days each substance was used in the past month) as operationalized by the Global Assessment of Individual needs. At each time point (baseline, five follow-ups), percentage ASM was calculated by dividing the reported number of days in the past month that participants used cannabis, heroin, alcohol, opioids, or cocaine by the number of days in the month (data were collected with the Timeline Follow-Back measure), multiplied by 100. Next, mean ASM frequency per month during 5 months of follow-up was calculated by adding the percentages for each substance and dividing by 5.31 We conducted correlations for self-reported ASM in the past 30 days with toxicology urine screens to assess validity of self-reported data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of People Abstinent From Alcohol and Drug Use | 5 months | Number of people abstinent from alcohol and drug use, which is assessed via the timeline follow back scale |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CD-LC Group behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Licensed Clinician (LC).
Critical Dialogue: Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
LC: Whether the intervention is delivered by a licensed clinician. | 37 |
| CBP- LC Group community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Licensed Clinician (LC)
Capacity Building Project: Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
LC: Whether the intervention is delivered by a licensed clinician. | 37 |
| QLW- LC Group intervention where participants learn to develop and implement personal goals that are measurable, attainable, realistic, and time bound. Intervention includes 9 sessions. Quality of Life Wheel, Licensed Clinician (LC)
Quality of Life Wheel: Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
LC: Whether the intervention is delivered by a licensed clinician. | 39 |
| CD & CBP- LC Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Critical Dialogue: Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
Capacity Building Project: Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
LC: Whether the intervention is delivered by a licensed clinician. | 39 |
| CD & QLW- LC Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Critical Dialogue: Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
Quality of Life Wheel: Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
LC: Whether the intervention is delivered by a licensed clinician. | 36 |
| QLW & Capacity Building ProjectCBP- LC Combination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks. Licensed Clinician (LC)
Capacity Building Project: Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
Quality of Life Wheel: Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
LC: Whether the intervention is delivered by a licensed clinician. | 37 |
| QLW & CD & CBP-LC Combination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Critical Dialogue: Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
Capacity Building Project: Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
Quality of Life Wheel: Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
LC: Whether the intervention is delivered by a licensed clinician. | 39 |
| Core LC This condition will include 3 core sessions that are not a part of the components being tested. These are support sessions to the components being tested and is hypothesized to have the smallest impact on substance use outcomes.Licensed Clinician (LC)
LC: Whether the intervention is delivered by a licensed clinician. | 37 |
| CD- PF Group behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Peer Facilitator (PF)
Critical Dialogue: Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
PF: Whether the intervention is delivered by a peer facilitator. | 39 |
| CBP- PF Group community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Peer Facilitator (PF)
Capacity Building Project: Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
PF: Whether the intervention is delivered by a peer facilitator. | 37 |
| QLW-PF Group intervention where participants learn to develop and implement personal goals that are measurable, attainable, realistic, and time bound. Intervention includes 9 sessions. Quality of Life wheel, Peer Facilitator (PF)
Quality of Life Wheel: Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
PF: Whether the intervention is delivered by a peer facilitator. | 37 |
| CD & CBP- PF Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions. Peer Facilitator (PF)
Critical Dialogue: Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
Capacity Building Project: Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
PF: Whether the intervention is delivered by a peer facilitator. | 39 |
| CD & QLW- PF Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF)
Critical Dialogue: Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
Quality of Life Wheel: Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
PF: Whether the intervention is delivered by a peer facilitator. | 37 |
| QLW & CBP- PF Combination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks.Peer Facilitator (PF)
Capacity Building Project: Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
Quality of Life Wheel: Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
PF: Whether the intervention is delivered by a peer facilitator. | 37 |
| CD & QLW & CBP- PF Combination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF)
Critical Dialogue: Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
Capacity Building Project: Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
Quality of Life Wheel: Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
PF: Whether the intervention is delivered by a peer facilitator. | 39 |
| Core PF This condition will include 3 core sessions that are not a part of the components being tested. These are support sessions to the components being tested and is hypothesized to have the smallest impact on substance use outcomes. Peer Facilitator (PF)
PF: Whether the intervention is delivered by a peer facilitator. | 36 |
| Total | 602 |
Baseline characteristics
| Characteristic | CBP- LC | Total | Core PF | CD & QLW & CBP- PF | QLW & CBP- PF | CD & QLW- PF | CD & CBP- PF | QLW-PF | CBP- PF | CD- PF | Core LC | QLW & CD & CBP-LC | QLW & Capacity Building ProjectCBP- LC | CD & QLW- LC | CD & CBP- LC | QLW- LC | CD-LC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 8 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 594 Participants | 36 Participants | 38 Participants | 37 Participants | 37 Participants | 38 Participants | 37 Participants | 36 Participants | 39 Participants | 37 Participants | 37 Participants | 37 Participants | 35 Participants | 37 Participants | 39 Participants | 37 Participants |
| Employment status Employed | 6 Participants | 102 Participants | 6 Participants | 1 Participants | 5 Participants | 6 Participants | 9 Participants | 9 Participants | 4 Participants | 7 Participants | 4 Participants | 13 Participants | 6 Participants | 6 Participants | 5 Participants | 8 Participants | 7 Participants |
| Employment status Unemployed | 31 Participants | 500 Participants | 30 Participants | 38 Participants | 32 Participants | 31 Participants | 30 Participants | 28 Participants | 33 Participants | 32 Participants | 33 Participants | 26 Participants | 31 Participants | 30 Participants | 34 Participants | 31 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 66 Participants | 2 Participants | 4 Participants | 2 Participants | 6 Participants | 4 Participants | 4 Participants | 6 Participants | 4 Participants | 3 Participants | 5 Participants | 4 Participants | 3 Participants | 4 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 533 Participants | 34 Participants | 35 Participants | 35 Participants | 31 Participants | 35 Participants | 33 Participants | 31 Participants | 35 Participants | 34 Participants | 34 Participants | 32 Participants | 32 Participants | 35 Participants | 34 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Marital Status Married | 5 Participants | 58 Participants | 2 Participants | 5 Participants | 3 Participants | 2 Participants | 4 Participants | 5 Participants | 6 Participants | 3 Participants | 2 Participants | 9 Participants | 5 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants |
| Marital Status Not married | 32 Participants | 544 Participants | 34 Participants | 34 Participants | 34 Participants | 35 Participants | 35 Participants | 32 Participants | 31 Participants | 36 Participants | 35 Participants | 30 Participants | 32 Participants | 33 Participants | 38 Participants | 38 Participants | 35 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 15 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 6 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 499 Participants | 27 Participants | 32 Participants | 31 Participants | 33 Participants | 36 Participants | 29 Participants | 30 Participants | 33 Participants | 32 Participants | 34 Participants | 30 Participants | 27 Participants | 34 Participants | 31 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 27 Participants | 0 Participants | 3 Participants | 3 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 8 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 47 Participants | 8 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 3 Participants | 3 Participants | 6 Participants | 3 Participants | 2 Participants | 2 Participants | 4 Participants | 1 Participants | 6 Participants | 2 Participants |
| Religion Christian | 20 Participants | 299 Participants | 22 Participants | 18 Participants | 19 Participants | 22 Participants | 19 Participants | 22 Participants | 15 Participants | 20 Participants | 16 Participants | 19 Participants | 23 Participants | 14 Participants | 16 Participants | 21 Participants | 13 Participants |
| Religion Muslim | 9 Participants | 150 Participants | 7 Participants | 12 Participants | 11 Participants | 7 Participants | 8 Participants | 9 Participants | 7 Participants | 7 Participants | 14 Participants | 14 Participants | 5 Participants | 11 Participants | 11 Participants | 4 Participants | 14 Participants |
| Religion Other | 8 Participants | 154 Participants | 7 Participants | 9 Participants | 7 Participants | 8 Participants | 12 Participants | 6 Participants | 15 Participants | 12 Participants | 7 Participants | 7 Participants | 9 Participants | 11 Participants | 12 Participants | 14 Participants | 10 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 37 Participants | 602 Participants | 36 Participants | 39 Participants | 37 Participants | 37 Participants | 39 Participants | 37 Participants | 37 Participants | 39 Participants | 37 Participants | 39 Participants | 37 Participants | 36 Participants | 39 Participants | 39 Participants | 37 Participants |
| Sexual Preference/Orientation Heterosexual | 36 Participants | 542 Participants | 33 Participants | 36 Participants | 35 Participants | 35 Participants | 34 Participants | 31 Participants | 36 Participants | 32 Participants | 33 Participants | 34 Participants | 30 Participants | 33 Participants | 33 Participants | 37 Participants | 34 Participants |
| Sexual Preference/Orientation LGBTQ+ | 1 Participants | 54 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 5 Participants | 6 Participants | 1 Participants | 7 Participants | 4 Participants | 5 Participants | 0 Participants | 3 Participants | 7 Participants | 2 Participants | 3 Participants |
| Substance Use | 0.24 %days past 30 days used substances STANDARD_DEVIATION 0.21 | 0.20 %days past 30 days used substances STANDARD_DEVIATION 0.16 | 0.17 %days past 30 days used substances STANDARD_DEVIATION 0.15 | 0.20 %days past 30 days used substances STANDARD_DEVIATION 0.13 | 0.21 %days past 30 days used substances STANDARD_DEVIATION 0.16 | 0.25 %days past 30 days used substances STANDARD_DEVIATION 0.16 | 0.20 %days past 30 days used substances STANDARD_DEVIATION 0.15 | 0.16 %days past 30 days used substances STANDARD_DEVIATION 0.16 | 0.24 %days past 30 days used substances STANDARD_DEVIATION 0.21 | 0.17 %days past 30 days used substances STANDARD_DEVIATION 0.13 | 0.19 %days past 30 days used substances STANDARD_DEVIATION 0.18 | 0.19 %days past 30 days used substances STANDARD_DEVIATION 0.19 | 0.23 %days past 30 days used substances STANDARD_DEVIATION 0.18 | 0.17 %days past 30 days used substances STANDARD_DEVIATION 0.15 | 0.18 %days past 30 days used substances STANDARD_DEVIATION 0.15 | 0.21 %days past 30 days used substances STANDARD_DEVIATION 0.16 | 0.18 %days past 30 days used substances STANDARD_DEVIATION 0.12 |
| Time since release from Incarceration | 5.20 Years STANDARD_DEVIATION 1.26 | 5.43 Years STANDARD_DEVIATION 1.52 | 5.61 Years STANDARD_DEVIATION 1.86 | 5.14 Years STANDARD_DEVIATION 1.18 | 5.53 Years STANDARD_DEVIATION 1.19 | 5.56 Years STANDARD_DEVIATION 1.31 | 5.00 Years STANDARD_DEVIATION 1.21 | 5.82 Years STANDARD_DEVIATION 2.7 | 5.65 Years STANDARD_DEVIATION 1.32 | 5.29 Years STANDARD_DEVIATION 1.5 | 5.85 Years STANDARD_DEVIATION 1.92 | 5.51 Years STANDARD_DEVIATION 1.44 | 5.08 Years STANDARD_DEVIATION 1.13 | 5.62 Years STANDARD_DEVIATION 1.74 | 5.75 Years STANDARD_DEVIATION 1.45 | 4.95 Years STANDARD_DEVIATION 0.83 | 5.36 Years STANDARD_DEVIATION 1.34 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 | 0 / 39 | 0 / 39 | 0 / 36 | 0 / 37 | 0 / 39 | 0 / 37 | 0 / 39 | 0 / 37 | 0 / 37 | 0 / 39 | 0 / 37 | 0 / 37 | 0 / 39 | 0 / 36 |
| other Total, other adverse events | 0 / 37 | 0 / 37 | 0 / 39 | 0 / 39 | 0 / 36 | 0 / 37 | 0 / 39 | 0 / 37 | 0 / 39 | 0 / 37 | 0 / 37 | 0 / 39 | 0 / 37 | 0 / 37 | 0 / 39 | 0 / 36 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 | 0 / 39 | 0 / 39 | 0 / 36 | 0 / 37 | 0 / 39 | 0 / 37 | 0 / 39 | 0 / 37 | 0 / 37 | 0 / 39 | 0 / 37 | 0 / 37 | 0 / 39 | 0 / 36 |
Outcome results
Primary
Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days
The primary outcome was the percentage of ASM (i.e., the percentage of days each substance was used in the past month) as operationalized by the Global Assessment of Individual needs. At each time point (baseline, five follow-ups), percentage ASM was calculated by dividing the reported number of days in the past month that participants used cannabis, heroin, alcohol, opioids, or cocaine by the number of days in the month (data were collected with the Timeline Follow-Back measure), multiplied by 100. Next, mean ASM frequency per month during 5 months of follow-up was calculated by adding the percentages for each substance and dividing by 5.31 We conducted correlations for self-reported ASM in the past 30 days with toxicology urine screens to assess validity of self-reported data.
Time frame: 5 months
Population: Participants who completed 5 months post baseline follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD-LC | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.15 % days misusing substances past 30 days | Standard Deviation 0.12 |
| CBP- LC | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.16 % days misusing substances past 30 days | Standard Deviation 0.1 |
| QLW- LC | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.21 % days misusing substances past 30 days | Standard Deviation 0.12 |
| CD & CBP- LC | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.16 % days misusing substances past 30 days | Standard Deviation 0.12 |
| CD & QLW- LC | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.14 % days misusing substances past 30 days | Standard Deviation 0.11 |
| QLW & Capacity Building ProjectCBP- LC | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.22 % days misusing substances past 30 days | Standard Deviation 0.25 |
| QLW & CD & CBP-LC | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.18 % days misusing substances past 30 days | Standard Deviation 0.13 |
| Core LC | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.17 % days misusing substances past 30 days | Standard Deviation 0.13 |
| CD- PF | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.14 % days misusing substances past 30 days | Standard Deviation 0.15 |
| CBP- PF | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.21 % days misusing substances past 30 days | Standard Deviation 0.11 |
| QLW-PF | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.16 % days misusing substances past 30 days | Standard Deviation 0.12 |
| CD & CBP- PF | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.15 % days misusing substances past 30 days | Standard Deviation 0.13 |
| CD & QLW- PF | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.19 % days misusing substances past 30 days | Standard Deviation 0.12 |
| QLW & CBP- PF | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.14 % days misusing substances past 30 days | Standard Deviation 0.11 |
| CD & QLW & CBP- PF | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.19 % days misusing substances past 30 days | Standard Deviation 0.16 |
| Core PF | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | 0.14 % days misusing substances past 30 days | Standard Deviation 0.1 |
Secondary
Number of People Abstinent From Alcohol and Drug Use
Number of people abstinent from alcohol and drug use, which is assessed via the timeline follow back scale
Time frame: 5 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CD-LC | Number of People Abstinent From Alcohol and Drug Use | 1 Participants |
| CBP- LC | Number of People Abstinent From Alcohol and Drug Use | 1 Participants |
| QLW- LC | Number of People Abstinent From Alcohol and Drug Use | 0 Participants |
| CD & CBP- LC | Number of People Abstinent From Alcohol and Drug Use | 2 Participants |
| CD & QLW- LC | Number of People Abstinent From Alcohol and Drug Use | 3 Participants |
| QLW & Capacity Building ProjectCBP- LC | Number of People Abstinent From Alcohol and Drug Use | 0 Participants |
| QLW & CD & CBP-LC | Number of People Abstinent From Alcohol and Drug Use | 1 Participants |
| Core LC | Number of People Abstinent From Alcohol and Drug Use | 3 Participants |
| CD- PF | Number of People Abstinent From Alcohol and Drug Use | 4 Participants |
| CBP- PF | Number of People Abstinent From Alcohol and Drug Use | 2 Participants |
| QLW-PF | Number of People Abstinent From Alcohol and Drug Use | 3 Participants |
| CD & CBP- PF | Number of People Abstinent From Alcohol and Drug Use | 4 Participants |
| CD & QLW- PF | Number of People Abstinent From Alcohol and Drug Use | 0 Participants |
| QLW & CBP- PF | Number of People Abstinent From Alcohol and Drug Use | 7 Participants |
| CD & QLW & CBP- PF | Number of People Abstinent From Alcohol and Drug Use | 3 Participants |
| Core PF | Number of People Abstinent From Alcohol and Drug Use | 5 Participants |