Social Connections for Preventing Opioid Use Disorder in Homeless Youth

Recruiting at 1 trial location

Overseen By Natasha Slesnick, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Stable housing, Non-English speaker

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 24 months

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find effective ways to prevent opioid use disorder among homeless youth by testing different support methods. It will explore three approaches: Motivational Interviewing with the Community Reinforcement Approach, Strengths-Based Outreach and Advocacy, and standard services. The goal is to determine which combination best supports mental health and reduces substance misuse. Youth aged 14 to 24 who currently lack stable housing, as defined by the McKinney-Vento Act, may be eligible to participate. Researchers will assess participants over two years to measure the impact of these interventions.

As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could shape future support strategies for vulnerable youth.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the Motivational Interviewing/Community Reinforcement Approach (MI/CRA) and Strengths-Based Outreach and Advocacy (SBOA) are safe and well-received methods. MI/CRA effectively treats substance use issues without major safety concerns. Participants generally respond well to this therapy, which focuses on increasing motivation to change behavior.

Research also supports Strengths-Based Outreach and Advocacy (SBOA). Studies have found it effective in helping homeless youth connect to services with minimal risk. This approach builds on individual strengths and provides support while ensuring basic needs are met.

In summary, both treatments have been tested and are considered safe for participants. They focus on supporting positive change and helping youth access needed services. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for preventing opioid use disorder in homeless youth because they offer a fresh, comprehensive approach. Unlike traditional methods that often focus solely on substance use, these treatments combine motivational interviewing and community reinforcement to enhance motivation and support behavior change. Additionally, the strengths-based outreach and advocacy model emphasizes helping youth access essential services and support, ensuring their basic needs are met while fostering independence. By integrating these approaches, the treatments aim to address both immediate needs and long-term well-being, providing a holistic framework that goes beyond typical substance use interventions.

What evidence suggests that this trial's treatments could be effective for preventing opioid use disorder in homeless youth?

Research shows that the Motivational Interviewing/Community Reinforcement Approach (MI/CRA), one of the treatment arms in this trial, effectively reduces substance misuse, including opioid use. Studies have found that this method helps young people, especially those who have been homeless, avoid substances and manage related issues. It combines boosting motivation with structured support to encourage positive behavioral changes.

Another treatment arm in this trial, the Strengths-Based Outreach and Advocacy (SBOA) approach, has demonstrated effectiveness in reducing hard drug use among homeless youth. This method connects young people to essential services and support, enhancing their well-being without solely focusing on their problems. Both MI/CRA and SBOA, as separate treatment arms in this trial, show promise in helping youth avoid opioid misuse by addressing their needs comprehensively. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for English-speaking youth aged 14-24 who are experiencing homelessness, as defined by the McKinney-Vento Act. It's aimed at those without a stable nighttime residence or living in temporary accommodations due to economic hardship.

Inclusion Criteria

Youth must meet the criteria for homelessness as defined by the McKinney-Vento Act: children and youth who lack a fixed, regular, and adequate nighttime residence; or live in a welfare hotel, or place without regular sleeping accommodations, or live in a shared residence with other persons due to the loss of one's housing or economic hardship

Exclusion Criteria

Non-English speaker

Youth who have a stable housing situation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to different intervention conditions including MI/CRA + SAU, SBOA + SAU, MI/CRA + SBOA + SAU, or SAU

24 months

Baseline and follow-up assessments at 3, 6, 12, 18, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Assessments at 3, 6, 12, 18, and 24 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• Motivational Interviewing/Community Reinforcement Approach
• Services as Usual
• Strengths-Based Outreach and Advocacy

Trial Overview The study tests interventions for preventing opioid misuse among homeless youth: Motivational Interviewing/Community Reinforcement Approach (MI/CRA), Strengths-Based Outreach and Advocacy (SBOA), both with and without standard services, compared to just standard services.

How Is the Trial Designed?

Group I: Strengths-Based Outreach and Advocacy + Services As Usual (SBOA +SAU) Experimental Treatment 2 Interventions

Some research suggests that engagement with an advocate is key to success when linking those experiencing homelessness to available services and supports in the community. The strengths model is based on the premise that the purpose of advocacy "is to assist consumers in identifying, securing, and preserving the range of resources, both external and internal, needed to live in a normal, independent way in the community". Strengths-based interventions focus on enhancing well-being and happiness rather than attempting to correct deficits or pathology. The advocate takes responsibility for securing needed services for the youth and remains a support as they traverse the system of care. The focus of the first several weeks of advocacy is on obtaining identification and ensuring basic needs are met (food, safety, medical care, housing, etc.). As basic needs are addressed, youth and advocates focus on other high need areas including education, employment, mental health and substance use.

Group II: Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU) Experimental Treatment 2 Interventions

The current evidence base recommends integrating treatments targeting both Substance Use Disorder and psychiatric disorders, especially combining Motivational Interviewing with behavioral interventions such as CRA or Cognitive Behaviorial Therapy. Enhancing intrinsic motivation for behavioral change is the central purpose of motivational interviewing (MI), a clinical method built on the insights and strategies described by Carl Rogers as client-centered therapy. MI is also directive, however, in selectively eliciting and reinforcing client "change talk". Typically offered as a brief intervention of 1-2 sessions, MI has a strong record of efficacy in the treatment of alcohol and other drug use disorders, mental health and other problematic behaviors. The Community Reinforcement Approach (CRA) offers an empirically-based multifaceted approach to substance abuse/mental health treatment that also addresses many of the clinical needs of multi-problem homeless individuals.

Group III: Motivational Interviewing/Community Reinforcement Approach (MI/CRA) + SBOA + SAU Experimental Treatment 3 Interventions

This intervention combines all three interventional models: Motivational Interviewing/Community Reinforcement Approach along with Strengths-Based Outreach and Advocacy and the Services as Usual.

Group IV: Services as Usual (SAU) Active Control 1 Intervention

All youth will receive services as usual provided by the drop-in center.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

The article outlines three relationship-oriented behavioral interventions aimed at improving medication adherence for opioid use disorder (MOUD) among youth aged 16-25, focusing on addressing barriers to treatment uptake and enhancing recovery.

These interventions—Relational Orientation, Medication Education and Decision-making Support, and Family Leadership—are designed to be flexible and can be tailored to meet the unique needs of different individuals, as demonstrated through case examples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Launching Relationship-Oriented Behavioral Services for Youth Opioid Use Disorder: Innovations in Medication Decision-Making and Adherence Planning. Hogue, A., Bobek, M., Porter, N., et al.[2023]

A Collaborative Board meeting with Elders, cultural leaders, and individuals with lived experience from over 25 AI/AN communities focused on creating a culturally relevant intervention to improve the delivery of medications for opioid use disorder (OUD).

The discussions emphasized the importance of integrating traditional healing practices and family involvement in recovery strategies, highlighting a strength-based and holistic approach to addressing OUD in AI/AN communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Centering culture in the treatment of opioid use disorder with American Indian and Alaska Native Communities: Contributions from a National Collaborative Board. Hirchak, KA., Nadeau, M., Vasquez, A., et al.[2023]

The study involved 419 young adults aged 18-25 and compared treatment outcomes between those with primary opioid use and those with primary marijuana or alcohol use, both receiving the Adolescent Community Reinforcement Approach (A-CRA).

Both groups showed similar treatment retention and engagement, but the opioid use group had a significant reduction in opioid use at 3 months, although they did not reach the same level of improvement as the marijuana/alcohol use group by the 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Retention and Outcomes with the Adolescent Community Reinforcement Approach in Emerging Adults with Opioid Use. Welsh, JW., Passetti, LL., Funk, RR., et al.[2020]

Collaboration between drug courts and medication for opioid use disorder (MOUD) providers is essential for improving access to treatment, with drug court staff favoring agencies that offer comprehensive services alongside MOUD.

Barriers to effective collaboration include logistical issues like limited provider hours and inadequate communication, as well as concerns about the prescribing practices of MOUD providers, which can hinder referrals and negatively impact participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators and barriers to collaboration between drug courts and community-based medication for opioid use disorder providers. Pivovarova, E., Taxman, FS., Boland, AK., et al.[2023]

The Community Reinforcement Approach (CRA) has been shown to effectively reduce opioid use and improve various aspects of life, such as legal status and social functioning, in patients undergoing methadone maintenance and withdrawal.

Combining CRA with vouchers and medications like buprenorphine and naltrexone can enhance treatment retention and support sustained abstinence from opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the community reinforcement approach in the treatment of opioid dependence. Abbott, PJ.[2019]

The Mobile Community-based Access Team (M-CAT) pilot program successfully provided buprenorphine (BUP) treatment to veterans experiencing homelessness, showing potential to increase treatment engagement in this high-risk population.

While retention in treatment was lower in M-CAT (19.2 months) compared to the usual BUP clinic (36 months), a significant 66.7% of M-CAT participants remained on BUP at the study's endpoint, indicating that mobile technology can help facilitate access to essential opioid use disorder treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile, Community-Based Buprenorphine Treatment for Veterans Experiencing Homelessness With Opioid Use Disorder: A Pilot, Feasibility Study. Iheanacho, T., Payne, K., Tsai, J.[2022]

The opioid crisis has significantly impacted pregnant women, with a fourfold increase in opioid use disorder (OUD) diagnoses over the past decade, highlighting the urgent need for targeted interventions.

The OPTI-Mom 2.0 study aims to evaluate a patient navigation (PN) intervention designed to improve care engagement and treatment retention for pregnant women with OUD, potentially reducing adverse outcomes for both mothers and their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot multisite study of patient navigation for pregnant women with opioid use disorder. Cochran, G., Smid, MC., Krans, EE., et al.[2021]

The study is testing a rapid access buprenorphine program in six Washington State communities, aiming to improve access for individuals with opioid use disorder (OUD) who face barriers to treatment, particularly those who are unhoused or using syringe services.

This Community-Based Medication-First model will evaluate effectiveness by comparing outcomes like arrests and health care utilization between participants in the program and a matched comparison group, providing insights into how to better serve those with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Community-Based Medication-First program for opioid use disorder: a hybrid implementation study protocol of a rapid access to buprenorphine program in Washington State. Banta-Green, CJ., Owens, MD., Williams, JR., et al.[2022]

A study involving 225 participants from medication-assisted treatment (MAT) programs in West Virginia highlighted that most individuals currently in MAT prefer personalized treatment plans and shared decision-making with their healthcare providers.

Participants expressed mixed opinions on policies regarding the duration of MAT, use of marijuana or anti-anxiety medications during treatment, and attendance in peer recovery groups, indicating the need for flexible and individualized approaches to support retention in MAT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Assisted Treatment Program Policies: Opinions of People in Treatment. Carter, M., Boyd, J., Bennett, T., et al.[2023]

Younger adolescents and young adults (ages 10-24) show shorter retention rates in medications for opioid use disorder (MOUD), indicating a need for targeted interventions to improve treatment adherence in this age group.

Factors such as concurrent substance use, family conflict, and the flexibility of MOUD dosage significantly influence retention rates, suggesting that personalized treatment approaches could enhance outcomes for younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to and Retention in Medications for Opioid Use Disorder Among Adolescents and Young Adults. Viera, A., Bromberg, DJ., Whittaker, S., et al.[2021]

A study involving 35 youth with opioid use disorders explored their preferences for outpatient treatment options, revealing that they value both intensive outpatient treatment (IOP) and community-based 12-step groups for different reasons.

Key themes identified included the importance of structured recovery support, mechanisms of accountability, and the significance of relationships, indicating that both treatment approaches offer unique benefits that may be complementary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-residential treatment outpatient care preferences: Perspectives of youth with opioid use disorder. Monico, LB., Ludwig, A., Lertch, E., et al.[2023]

Youth involved in the legal system (YILS) face significantly higher rates of opioid and substance use disorders, prompting the need for targeted prevention strategies, which are currently limited in research.

Four innovative studies are being conducted to prevent opioid initiation among YILS, including real-time feedback systems, direct access to shelters, and skills training for youth and caregivers, aiming to create effective interventions tailored to this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Opioid Use and Disorder Among Youth Involved in the Legal System: Innovation and Implementation of Four Studies Funded by the NIDA HEAL Initiative. Ahrens, K., Blackburn, N., Aalsma, M., et al.[2023]

A study involving 96 community-based treatment staff across five methadone maintenance clinics showed that a seven-session seminar on methadone medical maintenance (MMM) significantly improved staff perceptions of its benefits, including facilitating patient participation in rehabilitation activities and ensuring adequate counseling services for MMM patients.

After the seminar, one clinic adopted an adaptive stepped care model, and three out of five clinics began implementing MMM, indicating that educational interventions can effectively promote the adoption of evidence-based practices in opioid treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing methadone medical maintenance in community-based clinics: disseminating evidence-based treatment. King, VL., Burke, C., Stoller, KB., et al.[2013]

Citations

1. withpower.com withpower.com/trial/phase-mental-disorders-2-2024-faa63

Social Connections for Preventing Opioid Use Disorder in ... What data supports the effectiveness of the treatment Motivational Interviewing/Community Reinforcement Approach (MI/CRA) for preventing opioid use disorder ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10948604/

The effectiveness of the community reinforcement approach ... The Community Reinforcement Approach is an evidence-based treatment modality for alcohol and drug addiction treatment with proven efficacy ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9206860/

Comparing the Effectiveness of Three Substance Use ... Abstract. Objective: Many adolescents and young adults receiving substance use treatment have experienced or are at risk for homelessness.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0001691824004827

Effectiveness of the adolescent-community reinforcement ... The results revealed that A-CRA was associated with higher rates of abstinence, reduced frequency of cannabis use, decreased substance-related problems, and ...

5. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/bitstreams/add09f90-1677-4c84-bd01-f16436a32b5f/download

Prevention of Opioid Use and Disorder Among Youth Involved ... The objective of Housing, Opportunities, Motivation, and Engagement (HOME) is to determine whether a supportive housing intervention can prevent opioid ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06311838

Study Details | NCT06311838 | Building Social and ... This intervention combines all three interventional models: Motivational Interviewing/Community Reinforcement Approach along with Strengths-Based Outreach and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4437822/

A Comparison of Three Interventions for Homeless Youth ... The purpose of this study was to identify the most effective intervention for addressing substance use, as well as secondary outcomes including housing, mental ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547215000409

A Comparison of Three Interventions for Homeless Youth ... The current study offers findings from a comparative effectiveness trial of three empirically-supported interventions for homeless adolescents and young adults.

9. chapinhall.org chapinhall.org/wp-content/uploads/Chapin-Hall_VoYC_Evidence-Review_Individual-Counseling-and-Treatment.pdf

Evidence Summary Here, we summarize evaluations of Individual counseling and treatment interventions for youth experiencing homelessness. The evidence here includes only impact.