Trial Outcomes & Findings for A Social Network AOD Intervention for Homeless Youth Transitioning to Housing (NCT NCT04637815)
NCT ID: NCT04637815
Last Updated: 2024-10-22
Results Overview
Count of days that respondent used cannabis in the past 30 days
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
39 participants
Primary outcome timeframe
30 days
Results posted on
2024-10-22
Participant Flow
Participants were recruited through a nonprofit agency in Los Angeles County that provides a comprehensive continuum of care to transitional age youth experiencing homelessness. The agency's case managers offered eligibility screening to all residents who had been at the facility for less than one year. Residents who consented to be contacted by the study team completed an eligibility screener and provided contact information and informed consent if eligible and willing to participate.
Recruitment was delayed throughout the project due to COVID-19 social-distancing restrictions and frequent resident quarantines. These restrictions also limited the number of MNI sessions that could be scheduled and completed. During the final year of the project, the project team ended randomization and assigned all study participants to the CONNECT arm to adjust for recruitment/session delivery shortfalls.
Participant milestones
| Measure |
Intervention
The intervention will consist of four sessions spaced two weeks apart that will last approximately 30 minutes each and consist of two parts: a network interview to capture network data about the time period since their last interview and a discussion of a resulting network visualization conducted in a motivational interviewing style. Participants will receive the intervention as part of existing case management.
Motivational Network Intervention: See earlier description
|
Usual Care
As part of residency, participants receive regular case management meetings. Since we are interested in evaluating the added benefit of the MNI over usual case management, residents in the control condition will be asked to meet with their case manager four times (once every two weeks) during their participation in the study. These meetings are anticipated to last approximately 30-60 minutes and will be customized to the residents' needs.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
13
|
|
Overall Study
COMPLETED
|
20
|
11
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Intervention
The intervention will consist of four sessions spaced two weeks apart that will last approximately 30 minutes each and consist of two parts: a network interview to capture network data about the time period since their last interview and a discussion of a resulting network visualization conducted in a motivational interviewing style. Participants will receive the intervention as part of existing case management.
Motivational Network Intervention: See earlier description
|
Usual Care
As part of residency, participants receive regular case management meetings. Since we are interested in evaluating the added benefit of the MNI over usual case management, residents in the control condition will be asked to meet with their case manager four times (once every two weeks) during their participation in the study. These meetings are anticipated to last approximately 30-60 minutes and will be customized to the residents' needs.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
Baseline Characteristics
A Social Network AOD Intervention for Homeless Youth Transitioning to Housing
Baseline characteristics by cohort
| Measure |
Intervention
n=24 Participants
The intervention will consist of four sessions spaced two weeks apart that will last approximately 30 minutes each and consist of two parts: a network interview to capture network data about the time period since their last interview and a discussion of a resulting network visualization conducted in a motivational interviewing style. Participants will receive the intervention as part of existing case management.
Motivational Network Intervention: See earlier description
|
Usual Care
n=12 Participants
As part of residency, participants receive regular case management meetings.
Usual Care: See earlier description
|
Total
n=36 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
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21.2 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
21.7 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
21.3 years
STANDARD_DEVIATION 2.17 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unspecified
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Number of Days Cannabis Used
|
4.79 days
STANDARD_DEVIATION 5.76 • n=5 Participants
|
5.67 days
STANDARD_DEVIATION 8.67 • n=7 Participants
|
5.08 days
STANDARD_DEVIATION 6.75 • n=5 Participants
|
|
Proportion of Risky Network Members
|
.24 proportion
STANDARD_DEVIATION .27 • n=5 Participants
|
.05 proportion
STANDARD_DEVIATION .07 • n=7 Participants
|
.164 proportion
STANDARD_DEVIATION .222 • n=5 Participants
|
|
Number of Drinks Consumed on Drinking Days
|
3.75 drinks per day
STANDARD_DEVIATION 5.45 • n=5 Participants
|
3.58 drinks per day
STANDARD_DEVIATION 2.78 • n=7 Participants
|
3.69 drinks per day
STANDARD_DEVIATION 4.68 • n=5 Participants
|
|
Number of Drinking Days
|
4.79 days
STANDARD_DEVIATION 5.76 • n=5 Participants
|
5.67 days
STANDARD_DEVIATION 8.67 • n=7 Participants
|
5.08 days
STANDARD_DEVIATION 6.75 • n=5 Participants
|
|
Number of Days Consumed 5 (for Men) or 4 (for Women) Drinks on a Single Occasion
|
2.63 days
STANDARD_DEVIATION 5.24 • n=5 Participants
|
4.17 days
STANDARD_DEVIATION 8.33 • n=7 Participants
|
3.14 days
STANDARD_DEVIATION 6.36 • n=5 Participants
|
|
Proportion of Supportive Network Members
|
.56 proportion
STANDARD_DEVIATION .31 • n=5 Participants
|
.60 proportion
STANDARD_DEVIATION .30 • n=7 Participants
|
.59 proportion
STANDARD_DEVIATION .30 • n=5 Participants
|
|
Average network centrality - risky alters
|
.328 average connections
STANDARD_DEVIATION .401 • n=5 Participants
|
.167 average connections
STANDARD_DEVIATION .30 • n=7 Participants
|
.271 average connections
STANDARD_DEVIATION .372 • n=5 Participants
|
|
Average network centrality - supportive alters
|
1.50 average connections
STANDARD_DEVIATION 1.31 • n=5 Participants
|
2.24 average connections
STANDARD_DEVIATION 2.65 • n=7 Participants
|
1.77 average connections
STANDARD_DEVIATION 1.89 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysCount of days that respondent used cannabis in the past 30 days
Outcome measures
| Measure |
Intervention
n=20 Participants
The intervention will consist of four sessions spaced two weeks apart that will last approximately 30 minutes each and consist of two parts: a network interview to capture network data about the time period since their last interview and a discussion of a resulting network visualization conducted in a motivational interviewing style. Participants will receive the intervention as part of existing case management.
Motivational Network Intervention: See earlier description
|
Usual Care
n=11 Participants
As part of residency, participants receive regular case management meetings.
Usual Care: See earlier description
|
|---|---|---|
|
Number of Days Cannabis Used
|
23.7 days
Standard Deviation 10.5
|
7.36 days
Standard Deviation 11.2
|
PRIMARY outcome
Timeframe: 4 weeksProportion of network members who engaged in substance use or the participant used more substances when they were with the network member.
Outcome measures
| Measure |
Intervention
n=20 Participants
The intervention will consist of four sessions spaced two weeks apart that will last approximately 30 minutes each and consist of two parts: a network interview to capture network data about the time period since their last interview and a discussion of a resulting network visualization conducted in a motivational interviewing style. Participants will receive the intervention as part of existing case management.
Motivational Network Intervention: See earlier description
|
Usual Care
n=11 Participants
As part of residency, participants receive regular case management meetings.
Usual Care: See earlier description
|
|---|---|---|
|
Proportion of Risky Network Members
|
.242 proportion of network members
Standard Deviation .342
|
.0797 proportion of network members
Standard Deviation .106
|
PRIMARY outcome
Timeframe: 30 daysParticipants reported on the typical number of drinks they consumed on drinking days in the past month.
Outcome measures
| Measure |
Intervention
n=20 Participants
The intervention will consist of four sessions spaced two weeks apart that will last approximately 30 minutes each and consist of two parts: a network interview to capture network data about the time period since their last interview and a discussion of a resulting network visualization conducted in a motivational interviewing style. Participants will receive the intervention as part of existing case management.
Motivational Network Intervention: See earlier description
|
Usual Care
n=11 Participants
As part of residency, participants receive regular case management meetings.
Usual Care: See earlier description
|
|---|---|---|
|
Number of Drinks Consumed on Drinking Days
|
2.30 drinks per day
Standard Deviation 2.25
|
3.64 drinks per day
Standard Deviation 5.54
|
PRIMARY outcome
Timeframe: 30 daysNumber of days in the past month (0-30) that participants reported engaging in any alcohol use.
Outcome measures
| Measure |
Intervention
n=20 Participants
The intervention will consist of four sessions spaced two weeks apart that will last approximately 30 minutes each and consist of two parts: a network interview to capture network data about the time period since their last interview and a discussion of a resulting network visualization conducted in a motivational interviewing style. Participants will receive the intervention as part of existing case management.
Motivational Network Intervention: See earlier description
|
Usual Care
n=11 Participants
As part of residency, participants receive regular case management meetings.
Usual Care: See earlier description
|
|---|---|---|
|
Number of Drinking Days
|
7.45 days
Standard Deviation 8.47
|
6.09 days
Standard Deviation 9.35
|
PRIMARY outcome
Timeframe: 30 daysNumber of days in the past month (0-30) that participants reported engaging in heavy alcohol use (5 or more drinks for men and four or more drinks for women on a single occasion).
Outcome measures
| Measure |
Intervention
n=20 Participants
The intervention will consist of four sessions spaced two weeks apart that will last approximately 30 minutes each and consist of two parts: a network interview to capture network data about the time period since their last interview and a discussion of a resulting network visualization conducted in a motivational interviewing style. Participants will receive the intervention as part of existing case management.
Motivational Network Intervention: See earlier description
|
Usual Care
n=11 Participants
As part of residency, participants receive regular case management meetings.
Usual Care: See earlier description
|
|---|---|---|
|
Number of Days Consumed 5 (for Men) or 4 (for Women) Drinks on a Single Occasion
|
1.95 days
Standard Deviation 2.89
|
2.91 days
Standard Deviation 8.35
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place