Substance UsePhase 1NCT04637815

A Social Network AOD Intervention for Homeless Youth Transitioning to Housing

A Phase 1 study testing Motivational Network Intervention in people with Substance Use, run by RAND at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Substance Use
What is being tested?: Motivational Network Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: 9 Feb 2021to 1 Sep 2023
Phase: Phase 1
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 to 25 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age 18-25
In a housing program for homeless transition age youth
Past month substance use
Screen positive for past-year harmful substance use

Who cannot join

Not able to speak/understand English

Trial locations and contacts

1 site in 1 country.

United States1 site

The Village Family Services
Burbank, California, 90512

Other trials in United States

About this study

Read the detailed description

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.

Conditions: Substance Use
Being tested: Motivational Network Intervention, Usual Care
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.

Motivational Network InterventionBehavioural
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.
Usual CareOther
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.

Study groups in NCT04637815
Study group	Role	What they receive
Intervention	Experimental	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. Receives: Behavioral: Motivational Network Intervention
Usual Care	Active comparator	As part of residency, participants receive regular case management meetings. Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Days Cannabis Used
Count of days that respondent used cannabis in the past 30 days
Measured: 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.
Measured: 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.
Measured: 30 days
Number of Drinking Days
Number of days in the past month (0-30) that participants reported engaging in any alcohol use.
Measured: 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).
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Feb 20211 Sep 2023

First posted20 Nov 2020
Study start9 Feb 2021
Primary completion1 Sep 2023
Study completion1 Sep 2023

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 UseStudies 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04637815
Sponsor's protocol ID: RHINO Study ID: 2018-0539
Other IDs: R34DA047502
Status last verified: Sep 2024
First submitted: 10 Nov 2020
Last updated: 22 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Kennedy DP, Osilla KC, Tucker JS. Feasibility of a computer-assisted social network motivational interviewing intervention to reduce substance use and increase supportive connections among emerging adults transitioning from homelessness to housing. Addict Sci Clin Pract. 2022 May 3;17(1):26. doi: 10.1186/s13722-022-00307-4.
PubMed 35505383
Tucker JS, Kennedy DP, Osilla KC, Golinelli D. Motivational network intervention to reduce substance use and increase supportive connections among formerly homeless emerging adults transitioning to housing: study protocol for a pilot randomized controlled trial. Addict Sci Clin Pract. 2021 Mar 16;16(1):18. doi: 10.1186/s13722-021-00227-9.
PubMed 33726809

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All Substance Use trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Social Network AOD Intervention for Homeless Youth Transitioning to Housing
ClinicalTrials.gov ID: NCT04637815
Acronym / sponsor ID: RHINO Study ID: 2018-0539
Conditions: Substance Use
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: RANDUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 9 Feb 2021 (actual)
Primary completion: 1 Sep 2023 (actual)
Study completion: 1 Sep 2023 (actual)
First posted: 20 Nov 2020 (actual)
Results: Posted 22 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: Motivational Network InterventionThe 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.
Usual Care	Active comparator	Other: Usual CareAs part of residency, participants receive regular case management meetings.

Who may qualify

Ages: 18 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age 18-25
In a housing program for homeless transition age youth
Past month substance use
Screen positive for past-year harmful substance use

Key exclusion criteria (1 listed)

Not able to speak/understand English

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
Motivational Network InterventionEvery 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.	Behavioural	Intervention
Usual CareResidents 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.	Other	Usual Care

Primary outcome

Number of Days Cannabis Used
Time frame: 30 days
Count of days that respondent used cannabis in the past 30 days
Proportion of Risky Network Members
Time frame: 4 weeks
Proportion of network members who engaged in substance use or the participant used more substances when they were with the network member.
Number of Drinks Consumed on Drinking Days
Time frame: 30 days
Participants reported on the typical number of drinks they consumed on drinking days in the past month.
Number of Drinking Days
Time frame: 30 days
Number of days in the past month (0-30) that participants reported engaging in any alcohol use.
Number of Days Consumed 5 (for Men) or 4 (for Women) Drinks on a Single Occasion
Time frame: 30 days
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).

Results and safety

Results posted to the registry on 22 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	26	20
Usual Care	13	11

Primary outcome: Number of Days Cannabis Used

Time frame: 30 days. Mean (Standard Deviation). Unit: days

Measure	Intervention n = 20	Usual Care n = 11
Value	23.7 (10.5)	7.36 (11.2)

Intervention vs Usual Care: t-test, 2 sided

Primary outcome: Proportion of Risky Network Members

Time frame: 4 weeks. Mean (Standard Deviation). Unit: proportion of network members

Measure	Intervention n = 20	Usual Care n = 11
Value	.242 (.342)	.0797 (.106)

Intervention vs Usual Care: t-test, 2 sided

Primary outcome: Number of Drinks Consumed on Drinking Days

Time frame: 30 days. Mean (Standard Deviation). Unit: drinks per day

Measure	Intervention n = 20	Usual Care n = 11
Value	2.30 (2.25)	3.64 (5.54)

Intervention vs Usual Care: t-test, 2 sided

Primary outcome: Number of Drinking Days

Time frame: 30 days. Mean (Standard Deviation). Unit: days

Measure	Intervention n = 20	Usual Care n = 11
Value	7.45 (8.47)	6.09 (9.35)

Intervention vs Usual Care: t-test, 2 sided

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 24 (0%)	0 of 24 (0%)	1 of 24
Usual Care	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): 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. The resulting study sample was underpowered to detect intervention effects.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35505383Kennedy DP, Osilla KC, Tucker JS. Feasibility of a computer-assisted social network motivational interviewing intervention to reduce substance use and increase supportive connections among emerging adults transitioning from homelessness to housing. Addict Sci Clin Pract. 2022 May 3;17(1):26. doi: 10.1186/s13722-022-00307-4.
Derived from this study: PubMed 33726809Tucker JS, Kennedy DP, Osilla KC, Golinelli D. Motivational network intervention to reduce substance use and increase supportive connections among formerly homeless emerging adults transitioning to housing: study protocol for a pilot randomized controlled trial. Addict Sci Clin Pract. 2021 Mar 16;16(1):18. doi: 10.1186/s13722-021-00227-9.

Related trials for Substance Use

RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Motivational Network Intervention in people with Substance Use, run by RAND 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 4 inclusion and 1 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 22 Oct 2024. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2024). 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?

Number of Days Cannabis Used (time frame: 30 days). The study lists 5 primary outcomes in all. 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 NCT04637815, 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 22 Oct 2024.