Substance Use DisordersNCT02951455
Community Wise: An Innovative Multi-level Intervention to Reduce Alcohol and Illegal Drug Use
A study testing Critical Dialogue, Capacity Building Project and Quality of Life Wheel in people with Substance Use Disorders, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Critical Dialogue, Capacity Building Project and Quality of Life Wheel
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2017to 20 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- Critical Dialogue, Capacity Building Project, Quality of Life Wheel, PF, LC
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical DialogueBehavioural
Also called CD
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 ProjectBehavioural
Also called CBP
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 WheelBehavioural
Also called QLW
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).
PFBehavioural
Whether the intervention is delivered by a peer facilitator.
LCBehavioural
Whether the intervention is delivered by a licensed clinician.
| Study group | Role | What they receive |
|---|---|---|
| CD-LC | Experimental | Group behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Licensed Clinician (LC). Receives: Behavioral: Critical Dialogue; Behavioral: LC |
| CBP- LC | Experimental | Group community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Licensed Clinician (LC) Receives: Behavioral: Capacity Building Project; Behavioral: LC |
| QLW- LC | Experimental | 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) Receives: Behavioral: Quality of Life Wheel; Behavioral: LC |
| CD & CBP- LC | Experimental | Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC) Receives: Behavioral: Critical Dialogue; Behavioral: Capacity Building Project; Behavioral: LC |
| CD & QLW- LC | Experimental | Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC) Receives: Behavioral: Critical Dialogue; Behavioral: Quality of Life Wheel; Behavioral: LC |
| QLW & Capacity Building ProjectCBP- LC | Experimental | Combination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks. Licensed Clinician (LC) Receives: Behavioral: Capacity Building Project; Behavioral: Quality of Life Wheel; Behavioral: LC |
| QLW & CD & CBP-LC | Experimental | Combination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC) Receives: Behavioral: Critical Dialogue; Behavioral: Capacity Building Project; Behavioral: Quality of Life Wheel; Behavioral: LC |
| LC | Experimental | 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) Receives: Behavioral: LC |
| CD- PF | Experimental | Group behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Peer Facilitator (PF) Receives: Behavioral: Critical Dialogue; Behavioral: PF |
| CBP- PF | Experimental | Group community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Peer Facilitator (PF) Receives: Behavioral: Capacity Building Project; Behavioral: PF |
| QLW-PF | Experimental | 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) Receives: Behavioral: Quality of Life Wheel; Behavioral: PF |
| CD & CBP- PF | Experimental | Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions. Peer Facilitator (PF) Receives: Behavioral: Critical Dialogue; Behavioral: Capacity Building Project; Behavioral: PF |
| CD & QLW- PF | Experimental | Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF) Receives: Behavioral: Critical Dialogue; Behavioral: Quality of Life Wheel; Behavioral: PF |
| QLW & CBP- PF | Experimental | Combination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks.Peer Facilitator (PF) Receives: Behavioral: Capacity Building Project; Behavioral: Quality of Life Wheel; Behavioral: PF |
| CD & QLW & CBP- PF | Experimental | Combination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF) Receives: Behavioral: Critical Dialogue; Behavioral: Capacity Building Project; Behavioral: Quality of Life Wheel; Behavioral: PF |
| PF | Experimental | 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) Receives: Behavioral: PF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (1)
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
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start17 Jan 2017
- Primary completion20 Jan 2020
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- National Development and Research Institutes, Inc., University of Michigan, National Institute on Minority Health and Health Disparities (NIMHD), North Jersey Community Research Initiative
- Responsible party
- Principal investigator, Liliane Cambraia Windsor, University of Illinois at Urbana-Champaign
- Investigators
- Liliane Windsor, PhD, Principal investigator, University of Illinois Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951455
- Sponsor's protocol ID
- 1U01MD010629-01
- Other IDs
- 1U01MD010629-01
- Status last verified
- Nov 2022
- First submitted
- 27 Oct 2016
- Last updated
- 23 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Investigators will require a data- sharing agreement that provides for the following conditions at minimum: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate tools and computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. All data will be stripped of personal identifiers so as to be suitable for use by other investigators. Even though the database will be stripped of identifiers prior to any sharing, however, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for the above-stated commitments.
Publications
Windsor LC, Benoit E, Pinto RM, Gwadz M, Thompson W. Enhancing behavioral intervention science: using community-based participatory research principles with the multiphase optimization strategy. Transl Behav Med. 2021 Aug 13;11(8):1596-1605. doi: 10.1093/tbm/ibab032.
PubMed 33837786Windsor LC, Benoit E, Smith D, Pinto RM, Kugler KC; Newark Community Collaborative Board (NCCB). Optimizing a community-engaged multi-level group intervention to reduce substance use: an application of the multiphase optimization strategy. Trials. 2018 Apr 27;19(1):255. doi: 10.1186/s13063-018-2624-5.
PubMed 29703237
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Wise: An Innovative Multi-level Intervention to Reduce Alcohol and Illegal Drug Use
- ClinicalTrials.gov ID
- NCT02951455
- Acronym / sponsor ID
- 1U01MD010629-01
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- National Development and Research Institutes, Inc., University of Michigan, National Institute on Minority Health and Health Disparities (NIMHD), North Jersey Community Research Initiative
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Posted 23 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| CD-LC | Experimental | Behavioral: Critical Dialogue, Behavioral: LCGroup behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Licensed Clinician (LC). |
| CBP- LC | Experimental | Behavioral: Capacity Building Project, Behavioral: LCGroup community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Licensed Clinician (LC) |
| QLW- LC | Experimental | Behavioral: Quality of Life Wheel, Behavioral: LCGroup 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) |
| CD & CBP- LC | Experimental | Behavioral: Critical Dialogue, Behavioral: Capacity Building Project, Behavioral: LCCombination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC) |
| CD & QLW- LC | Experimental | Behavioral: Critical Dialogue, Behavioral: Quality of Life Wheel, Behavioral: LCCombination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC) |
| QLW & Capacity Building ProjectCBP- LC | Experimental | Behavioral: Capacity Building Project, Behavioral: Quality of Life Wheel, Behavioral: LCCombination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks. Licensed Clinician (LC) |
| QLW & CD & CBP-LC | Experimental | Behavioral: Critical Dialogue, Behavioral: Capacity Building Project, Behavioral: Quality of Life Wheel, Behavioral: LCCombination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC) |
| LC | Experimental | Behavioral: LCThis 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) |
| CD- PF | Experimental | Behavioral: Critical Dialogue, Behavioral: PFGroup behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Peer Facilitator (PF) |
| CBP- PF | Experimental | Behavioral: Capacity Building Project, Behavioral: PFGroup community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Peer Facilitator (PF) |
| QLW-PF | Experimental | Behavioral: Quality of Life Wheel, Behavioral: PFGroup 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) |
| CD & CBP- PF | Experimental | Behavioral: Critical Dialogue, Behavioral: Capacity Building Project, Behavioral: PFCombination of group behavioral intervention and community mobilization intervention including 15 weekly sessions. Peer Facilitator (PF) |
| CD & QLW- PF | Experimental | Behavioral: Critical Dialogue, Behavioral: Quality of Life Wheel, Behavioral: PFCombination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF) |
| QLW & CBP- PF | Experimental | Behavioral: Capacity Building Project, Behavioral: Quality of Life Wheel, Behavioral: PFCombination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks.Peer Facilitator (PF) |
| CD & QLW & CBP- PF | Experimental | Behavioral: Critical Dialogue, Behavioral: Capacity Building Project, Behavioral: Quality of Life Wheel, Behavioral: PFCombination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF) |
| PF | Experimental | Behavioral: PFThis 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critical DialogueAlso: CDPrompted 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. | Behavioural | CD & CBP- LC, CD & CBP- PF, CD & QLW & CBP- PF, CD & QLW- LC, CD & QLW- PF, CD- PF, CD-LC, QLW & CD & CBP-LC |
| Capacity Building ProjectAlso: CBPDesigned 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. | Behavioural | CBP- LC, CBP- PF, CD & CBP- LC, CD & CBP- PF, CD & QLW & CBP- PF, QLW & CBP- PF, QLW & CD & CBP-LC, QLW & Capacity Building ProjectCBP- LC |
| Quality of Life WheelAlso: QLWAims 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). | Behavioural | CD & QLW & CBP- PF, CD & QLW- LC, CD & QLW- PF, QLW & CBP- PF, QLW & CD & CBP-LC, QLW & Capacity Building ProjectCBP- LC, QLW- LC, QLW-PF |
| PFWhether the intervention is delivered by a peer facilitator. | Behavioural | CBP- PF, CD & CBP- PF, CD & QLW & CBP- PF, CD & QLW- PF, CD- PF, PF, QLW & CBP- PF, QLW-PF |
| LCWhether the intervention is delivered by a licensed clinician. | Behavioural | CBP- LC, CD & CBP- LC, CD & QLW- LC, CD-LC, LC, QLW & CD & CBP-LC, QLW & Capacity Building ProjectCBP- LC, QLW- LC |
Primary outcome
Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days
Time frame: 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.
1 secondary outcome
Number of People Abstinent From Alcohol and Drug Use
Time frame: 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33837786Windsor LC, Benoit E, Pinto RM, Gwadz M, Thompson W. Enhancing behavioral intervention science: using community-based participatory research principles with the multiphase optimization strategy. Transl Behav Med. 2021 Aug 13;11(8):1596-1605. doi: 10.1093/tbm/ibab032.
- Derived from this study: PubMed 29703237Windsor LC, Benoit E, Smith D, Pinto RM, Kugler KC; Newark Community Collaborative Board (NCCB). Optimizing a community-engaged multi-level group intervention to reduce substance use: an application of the multiphase optimization strategy. Trials. 2018 Apr 27;19(1):255. doi: 10.1186/s13063-018-2624-5.
- Individual participant dataSharing planned: Yes. Investigators will require a data- sharing agreement that provides for the following conditions at minimum: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate tools and computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. All data will be stripped of personal identifiers so as to be suitable for use by other investigators. Even though the database will be stripped of identifiers prior to any sharing, however, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for the above-stated commitments.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liliane Windsor, PhD principal investigator
University of Illinois Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Critical Dialogue, Capacity Building Project and Quality of Life Wheel in people with Substance Use Disorders, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02951455, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.