A Phase 1 interventional study of Motivational Network Intervention and Usual Care in Substance Use, sponsored by RAND. Completed at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by RAND · Phase 1, Interventional, and Prevention
This project will pilot test a computer-assisted social network intervention, using motivational interviewing techniques, that can help case managers work with formerly homeless young adults who recently transitioned to supportive housing to reduce substance use and increase permanent supportive connections during this critical transitional period.
The goal of this study is to conduct a pilot evaluation of a motivational network intervention (MNI) to reduce substance use and strengthen supportive connections for recently homeless 18-25 year-olds who have transitioned to a housing program. The goal of this pilot study is to evaluate, through a small randomized controlled trial (Stage 1b), the added benefit of incorporating the MNI into case management for transitional age youth (TAY) residents of housing programs. We hypothesized that residents receiving the MNI as part of case management would show more positive changes in their substance use behaviors and the composition and structure of their personal networks (i.e., greater proportion of network members who are low-risk) over a 3-month follow-up period compared to residents receiving usual case management only.
2,181 studies on the registry are indexed under Substance-Related Disorders; 399 are open to participants now.
This study's enrollment of 39 is below the median of 108 across 1,770 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →RAND is the lead sponsor of 114 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Motivational Network Intervention
As part of residency, participants receive regular case management meetings.
Other: Usual Care
Every 2 weeks, residents attend meetings with their case manager. These meetings are customized to the needs of the resident at the time of the meeting. Participants randomized into the Motivational Network Intervention arm are offered an additional discussion about their social networks. Case managers ask participants to answer a series of standardized questions about people they know. After these questions are answered, case managers show participants a series of images representing these answers. While showing these images, case mangers engage the participant in discussions about what they notice using Motivational Interviewing techniques. The goal is to discuss what the participant wants to change and state strategies about achieving these changes.
Residents attend regular case management meetings with their case managers as a condition of their residency in the housing program. These sessions are customized do the needs of the resident at the time of the meeting. Participants randomized into the usual care arm will be offered these sessions every 2 weeks.
Number of Days Cannabis Used
Count of days that respondent used cannabis in the past 30 days
Time frame: 30 days
Proportion of Risky Network Members
Proportion of network members who engaged in substance use or the participant used more substances when they were with the network member.
Time frame: 4 weeks
Number of Drinks Consumed on Drinking Days
Participants reported on the typical number of drinks they consumed on drinking days in the past month.
Time frame: 30 days
Number of Drinking Days
Number of days in the past month (0-30) that participants reported engaging in any alcohol use.
Time frame: 30 days
Number of Days Consumed 5 (for Men) or 4 (for Women) Drinks on a Single Occasion
Number 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).
Time frame: 30 days
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.
| Milestone | Intervention | Usual Care |
|---|---|---|
| Started | 26 | 13 |
| Completed | 20 | 11 |
| Not completed | 6 | 2 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 5 | 2 |
Count of days that respondent used cannabis in the past 30 days
| days | Intervention | Usual Care |
|---|---|---|
| Number of Days Cannabis Used | 23.7 ± 10.5 | 7.36 ± 11.2 |
Proportion of network members who engaged in substance use or the participant used more substances when they were with the network member.
| proportion of network members | Intervention | Usual Care |
|---|---|---|
| Proportion of Risky Network Members | .242 ± .342 | .0797 ± .106 |
Participants reported on the typical number of drinks they consumed on drinking days in the past month.
| drinks per day | Intervention | Usual Care |
|---|---|---|
| Number of Drinks Consumed on Drinking Days | 2.30 ± 2.25 | 3.64 ± 5.54 |
Number of days in the past month (0-30) that participants reported engaging in any alcohol use.
| days | Intervention | Usual Care |
|---|---|---|
| Number of Drinking Days | 7.45 ± 8.47 | 6.09 ± 9.35 |
Number 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).
| days | Intervention | Usual Care |
|---|---|---|
| Number of Days Consumed 5 (for Men) or 4 (for Women) Drinks on a Single Occasion | 1.95 ± 2.89 | 2.91 ± 8.35 |
Collected over 3 months, from the time they are screened / recruited by case managers until they complete the follow-up assessment. Each participant is offered 4 sessions separated by 2 weeks each. After they complete the final session with their case manager, they are contacted about completing their final assessment. During this time, project staff discuss any adverse events for participants who have been screened until they complete follow-up interviews with case managers during weekly project meetings.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 1/24 (4.2%) | 0/24 (0%) | 0/24 (0%) |
| Usual Care | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
Baseline analysis participants include all those who completed baseline surveys. Case managers recruited and provided informed consent to 39 eligible and interested participants. A separate interviewer subsequently contacted and completed the baseline interview with the participant by telephone. 3 eligible participants never completed the baseline interview and are not part of the analysis population because they never provided any responses to any questions necessary for measures.
| Age, Categorical(Participants) | Intervention | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 12 | 36 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 21.2 ± 2.4 | 21.7 ± 1.7 | 21.3 ± 2.17 |
| Sex/Gender, Customized(Participants) | Intervention | Usual Care | Total |
|---|---|---|---|
| Female | 10 | 5 | 15 |
| Male | 12 | 6 | 18 |
| Unspecified | 2 | 1 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 4 | 17 |
| Not Hispanic or Latino | 11 | 8 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 2 | 9 |
| White | 2 | 3 | 5 |
| More than one race | 4 | 5 | 9 |
| Unknown or Not Reported | 11 | 2 | 13 |
| Number of Days Cannabis Used(days) | Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 4.79 ± 5.76 | 5.67 ± 8.67 | 5.08 ± 6.75 |
| Proportion of Risky Network Members(proportion) | Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | .24 ± .27 | .05 ± .07 | .164 ± .222 |
| Number of Drinks Consumed on Drinking Days(drinks per day) | Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 3.75 ± 5.45 | 3.58 ± 2.78 | 3.69 ± 4.68 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Ran from Feb 2021 to primary completion in Sep 2023, 30 months.
Results were first posted in Oct 2024, 1 year 1 month after primary completion.
Of 34 non-industry phase 1 interventional studies under Substance-Related Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's 30 months is close to that.
Counting every sponsor, half of 57 studies reached it within 12 months; a quarter within 4 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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