Trial Outcomes & Findings for Improving Attendance in Community Wise (NCT NCT05934591)
NCT ID: NCT05934591
Last Updated: 2025-07-02
Results Overview
We will test if different intervention delivery strategies will result in a clinically and statistically important intervention attendance with a minimum of 50% of participants attending at least 50% of the intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
166 participants
Primary outcome timeframe
nine weeks
Results posted on
2025-07-02
Participant Flow
Participant milestones
| Measure |
Supervision/Paid/Open Group
People under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend open format groups of the Community Wise intervention.
|
Supervision/Paid/Closed Group
People under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend closed format groups of the Community Wise intervention.
|
Supervision/Not Paid/Open Group
People under supervision (those on parole, drug court, probation, or methadone maintenance) will attend open groups of the Community Wise intervention without an incentive.
|
Supervision/Not Paid/Closed Group
People under supervision (those on parole, drug court, probation, or methadone maintenance) will attend closed groups of the Community Wise intervention without an incentive.
|
Not Under Supervision/Paid/Open Group
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend open groups of the Community Wise intervention.
|
Not Under Supervision/Paid/Closed Group
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend closed groups of the Community Wise intervention.
|
Not Under Supervision/Not Paid/Open Group
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will attend open groups of the Community Wise intervention without receiving an incentive.
|
Not Under Supervision/Not Paid/Closed Group
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will attend closed groups of the Community Wise intervention without receiving an incentive.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
20
|
25
|
22
|
32
|
22
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
20
|
23
|
22
|
31
|
22
|
12
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
1
|
0
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Attendance in Community Wise
Baseline characteristics by cohort
| Measure |
Supervision/Paid/Open Group
n=15 Participants
People under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend open format groups of the Community Wise intervention.
|
Supervision/Paid/Closed Group
n=20 Participants
People under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend closed format groups of the Community Wise intervention.
|
Supervision/Not Paid/Open Group
n=25 Participants
People under supervision (those on parole, drug court, probation, or methadone maintenance) will attend open groups of the Community Wise intervention without an incentive.
|
Supervision/Not Paid/Closed Group
n=22 Participants
People under supervision (those on parole, drug court, probation, or methadone maintenance) will attend closed groups of the Community Wise intervention without an incentive.
|
Not Under Supervision/Paid/Open Group
n=32 Participants
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend open groups of the Community Wise intervention.
|
Not Under Supervision/Paid/Closed Group
n=22 Participants
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend closed groups of the Community Wise intervention.
|
Not Under Supervision/Not Paid/Open Group
n=15 Participants
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will attend open groups of the Community Wise intervention without receiving an incentive
|
Not Under Supervision/Not Paid/Closed Group
n=15 Participants
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will attend closed groups of the Community Wise intervention without receiving an incentive.
Period Title: Overall Study
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
14 Participants
n=6 Participants
|
162 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
49 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
10 Participants
n=6 Participants
|
117 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black/Caribbean
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
42 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
63 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
52 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Alaskan/Native American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
20 participants
n=7 Participants
|
25 participants
n=5 Participants
|
22 participants
n=4 Participants
|
32 participants
n=21 Participants
|
22 participants
n=10 Participants
|
15 participants
n=115 Participants
|
15 participants
n=6 Participants
|
166 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: nine weeksWe will test if different intervention delivery strategies will result in a clinically and statistically important intervention attendance with a minimum of 50% of participants attending at least 50% of the intervention
Outcome measures
| Measure |
Supervision/Paid/Open Group
n=15 Participants
People under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend open format groups of the Community Wise intervention.
|
Supervision/Paid/Closed Group
n=20 Participants
People under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend closed format groups of the Community Wise intervention.
|
Supervision/Not Paid/Open Group
n=25 Participants
People under supervision (those on parole, drug court, probation, or methadone maintenance) will attend open groups of the Community Wise intervention without an incentive.
|
Supervision/Not Paid/Closed Group
n=22 Participants
People under supervision (those on parole, drug court, probation, or methadone maintenance) will attend closed groups of the Community Wise intervention without an incentive.
|
Not Under Supervision/Paid/Open Group
n=32 Participants
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend open groups of the Community Wise intervention.
|
Not Under Supervision/Paid/Closed Group
n=22 Participants
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend closed groups of the Community Wise intervention.
|
Not Under Supervision/Not Paid/Open Group
n=15 Participants
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will attend open groups of the Community Wise intervention without receiving an incentive.
|
Not Under Supervision/Not Paid/Closed Group
n=15 Participants
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will attend closed groups of the Community Wise intervention without receiving an incentive.
Period Title: Overall Study
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Attending at Least 50% of Sessions
|
8 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
19 Participants
|
12 Participants
|
5 Participants
|
4 Participants
|
Adverse Events
Supervision/Paid/Open Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Supervision/Paid/Closed Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Supervision/Not Paid/Open Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Supervision/Not Paid/Closed Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Not Under Supervision/Paid/Open Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Not Under Supervision/Paid/Closed Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Not Under Supervision/Not Paid/Open Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Not Under Supervision/Not Paid/Closed Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Supervision/Paid/Open Group
n=15 participants at risk
People under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend open format groups of the Community Wise intervention
|
Supervision/Paid/Closed Group
n=20 participants at risk
People under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend closed format groups of the Community Wise intervention
|
Supervision/Not Paid/Open Group
n=25 participants at risk
People under supervision (those on parole, drug court, probation, or methadone maintenance) will attend open groups of the Community Wise intervention without an incentive.
|
Supervision/Not Paid/Closed Group
n=22 participants at risk
People under supervision (those on parole, drug court, probation, or methadone maintenance) will attend closed groups of the Community Wise intervention without an incentive.
|
Not Under Supervision/Paid/Open Group
n=32 participants at risk
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend open groups of the Community Wise intervention.
|
Not Under Supervision/Paid/Closed Group
n=22 participants at risk
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend closed groups of the Community Wise intervention.
|
Not Under Supervision/Not Paid/Open Group
n=15 participants at risk
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will attend open groups of the Community Wise intervention without receiving an incentive.
|
Not Under Supervision/Not Paid/Closed Group
n=15 participants at risk
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will attend closed groups of the Community Wise intervention without receiving an incentive.
|
|---|---|---|---|---|---|---|---|---|
|
Social circumstances
Threat
|
0.00%
0/15 • 6 months
In addition to the clinicaltrials.gov definition of an adverse event, the University of Illinois Urbana Champaign's definition of an adverse event includes "Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio".
|
0.00%
0/20 • 6 months
In addition to the clinicaltrials.gov definition of an adverse event, the University of Illinois Urbana Champaign's definition of an adverse event includes "Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio".
|
0.00%
0/25 • 6 months
In addition to the clinicaltrials.gov definition of an adverse event, the University of Illinois Urbana Champaign's definition of an adverse event includes "Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio".
|
0.00%
0/22 • 6 months
In addition to the clinicaltrials.gov definition of an adverse event, the University of Illinois Urbana Champaign's definition of an adverse event includes "Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio".
|
6.2%
2/32 • Number of events 2 • 6 months
In addition to the clinicaltrials.gov definition of an adverse event, the University of Illinois Urbana Champaign's definition of an adverse event includes "Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio".
|
0.00%
0/22 • 6 months
In addition to the clinicaltrials.gov definition of an adverse event, the University of Illinois Urbana Champaign's definition of an adverse event includes "Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio".
|
0.00%
0/15 • 6 months
In addition to the clinicaltrials.gov definition of an adverse event, the University of Illinois Urbana Champaign's definition of an adverse event includes "Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio".
|
0.00%
0/15 • 6 months
In addition to the clinicaltrials.gov definition of an adverse event, the University of Illinois Urbana Champaign's definition of an adverse event includes "Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio".
|
Additional Information
Dr. Liliane Windsor
University of Illinois Urbana Champaign
Phone: 2173001782
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place