Prevention of OUD: The HOME Project (Housing Opportunities Motivation and Engagement)

  • STATUS
    Recruiting
  • End date
    Aug 8, 2024
  • participants needed
    240
  • sponsor
    Ohio State University
Updated on 8 April 2021

Summary

Homeless youth have a much higher rate of substance use than non-homeless peers with evidence suggesting that homeless youth have the highest rates of opioid use among youth subgroups in the country (Brands et al., 2005); heroin using homeless youth also appear to have the highest rates of IV drug use and HIV (Rhoades et al., 2014). Given the high rates of opioid use, exposure to violence, mental and physical health challenges, and high rates of mortality in homeless youth, it is surprising that no study to date utilizes a randomized controlled design to test prevention of opioid and other drug use among this vulnerable population. Resolution of youth homelessness through housing and prevention services, often referred to as "Housing First", as proposed in the current study, has great potential to reduce the likelihood for the development of an opioid use disorder as well as other problem behaviors associated with living on the streets. However, only 20-30% of homeless youth samples report ever having stayed at a crisis shelter, 9% report having ever accessed mental health services, and 15% report ever having received substance use treatment (Ray, 2006) indicating a need to reach and engage youth in services that are feasible and acceptable. This study will provide essential information for researchers and providers on the efficacy of housing + opioid and related risk prevention services in an RCT on opioid use, how moderators affect the response, and mechanisms underlying change.

Description

The overarching goal of this application is to evaluate a comprehensive intervention for the prevention of opioid use disorder and for increasing other resilient outcomes in this special population of high-risk young adults. Phase I of the study includes a nonrandomized pilot study with a sample of 21 youth to assess initial efficacy, feasibility of recruitment and acceptability of the housing + opioid and related risk prevention services. Upon meeting transition milestones, 240 youth will be randomized into housing + opioid and related risk prevention services versus opioid and related risk prevention services alone for Phase II. In this study, we seek to determine if adding housing to opioid and related risk prevention services yields a significant benefit above and beyond the benefit yielded by opioid and related risk prevention services alone. Phase II follow-up will be conducted at 3, 6, 9 and 12-months post-baseline to assess stability of effects. Sample inclusion criteria, recruitment and screening will be identical for both phases, as described below. The unique components of Phase I and Phase II are then described separately.

Sample Inclusion Criteria.

  1. We will include youth between the ages of 18 to 24 years. Our experience is that landlords will not accept leases signed by youth ages 16-17 years. "Homeless youth" commonly refers to those up to the age of 24 years (Robertson & Toro, 1999; USICH, 2010), thus, this age range generally reflects the age range of the homeless youth population served by providers across the country.
  2. Youth meets the criteria for homelessness as defined by the federal McKinney-Vento Act (2002) as "lacking a fixed, regular, stable, and adequate nighttime residence" and includes "living in a publicly or privately operated shelter designed to provide temporary living accommodations, or a public or private place not designed for, or ordinarily used as, regular sleeping accommodations for human beings."
  3. Youth fails to meet DSM 5 criteria for Opioid Use Disorder as assessed by the SCID (First et al., 2015).
  4. Those who receive a score over 10 on the Scale for Suicide Ideation - Worst Point (SSI-W) (Beck, Brown, & Steer, 1997), indicating moderate suicide risk, or report a past-year suicide attempt will be eligible for 10 sessions of Cognitive Therapy for Suicide Prevention (CTSP).

Participant recruitment and sample availability. Columbus is ranked the 16th largest city in the U.S. Many consider Columbus a "typical" American city because of the mix of races, range of incomes, urban, suburban, and nearby rural areas. Columbus has one drop-in center for homeless youth between the ages of 14-24 years (founded by MPI Slesnick). Last year (2018) approximately 1200 unduplicated homeless youth between the ages of 14-24 years were served at the drop-in center, with 70-95% of homeless youth reporting problem substance use, similar to national samples (e.g., Baer et al., 2003). The single adult shelters have a total of 457 beds for single men and 97 for single women on any given night. Service-connected youth will be recruited from the drop-in and adult shelters, non-service connected youth will be recruited through outreach to local soup kitchens, sandwich lines, the streets, parks and library. Given the high rates of homeless youth in Columbus, we do not anticipate any recruitment problems.

Screening and intake. Project staff will maintain offices within the drop-in center. Youth who are engaged on the streets will be transported to the drop-in center. An RA will engage and screen youth to determine basic eligibility for the study. After the brief screening and stated interest in the project, written consent will be obtained and the Structured Clinical Interview for DSM-5 Disorders (SCID) (First, Williams, Karg, & Spitzer, 2015) section on Opioid Use Disorder, will be administered to determine formal eligibility.

Community Engagement. Too often, interventions do not reach those for whom the interventions were developed (Spoth & Greenberg, 2005). Implementation science promotes the integration of research in to practice and policy, with implementation science studies often focused on investigating the bottlenecks that impede the uptake and adoption of interventions. Several calls have sought to transform translational science so that research supported interventions can quickly reach the targeted populations in need (Fogarty International Center, 2013), with the Institute of Medicine (IOM) noting that "there is no time to lose" (IOM, 1999). The IOM has emphasized a greater focus on engaging community stakeholders from the earliest phases of research, as such continuous involvement improves dissemination and uptake (Spoth & Greenberg, 2005). Indeed, multiple guidelines and lessons learned from dissemination of evidence-based interventions have been published (e.g., Collins & Sapiano, 2016). Standards for dissemination include that the program has the ability to go to scale, has training and technical support available, and a statement of the causal mechanisms relating the intervention to the outcome (Flay et al., 2005). This study will provide a solid base for the next step in translating research to practice and policy. At the end of the study, the materials and knowledge will be in place to conduct an effectiveness or broad-based dissemination effort.

The Community Advisory Group, including homeless providers, homeless youth, landlords, substance use treatment experts and policy makers will meet throughout the project period, shaping study procedures, and easing transition of intervention to practice by the end of the study. Furthermore, Nationwide Children's Hospital (NCH) has led several large housing initiatives in the city, and MPI Kelleher's primary appointment is with NCH, where he works with the City, United Way and housing developers. Engagement will continue beyond the study period between researchers and community partners in order to support implementation of the prevention intervention. Also, at the end of the study period, a conference will be held at The Ohio State University to engage executive directors and their staff from drop-in centers from around the country, as well as other homeless youth researchers and providers.

Phase I (UG3) Using the same recruitment strategy, eligibility criteria and assessment package (including stress biomarkers) as Phase II, a non-randomized pilot of the housing + opioid and related risk prevention services intervention (N = 21) will be completed in year

  1. The sample size of 21 reflects three months of recruitment of seven youth/month. All youth will receive the 6-month housing + opioid and related prevention services intervention. Youth will be assessed at baseline, 3 and 6-months using the proposed assessment battery, and qualitative interviews. The primary purpose of this phase is to document feasibility of recruitment, acceptability of the intervention, and initial pre-post change on targeted outcome measures. However, other activities, including creating a base of landlords to provide rentals to youth and initiating the Community Advisory Group, will also be a focus. As the housing + prevention services and assessment battery are identical in Phase 1 and Phase II, they are described in detail following the description of Phase II. Those aspects unique to Phase I are discussed immediately below.

Phase I: Assessment of acceptability, feasibility and initial efficacy of the intervention. Several studies assess intervention acceptability, feasibility and initial efficacy using similar procedures to those described below (von Haastregt et al., 2007; Zlotnick et al., 2003). Acceptability of the intervention will be assessed by the retention of youths in the intervention, the total number of advocacy sessions attended, length of time remaining in project supported housing, and by the percentage of eligible youth who agree to participate in the study. In addition, the extent to which landlords consent to continuing participation in the second phase of the trial is essential. Assessment of feasibility includes documentation of 1) whether participants can be recruited, engaged, and maintained in the housing + opioid and related risk prevention services as proposed, data which can be obtained from RA screening forms and advocate records (meetings attended, maintenance of housing), and 2) whether the timeline proposed for housing youths (anticipated to average 4 weeks, and time to housing will be tracked) and other intervention procedures can be maintained as proposed. In order to estimate initial efficacy, we will assess youth at baseline, 3 and 6-months to determine change in identified targeted outcomes (e.g. opioid and other substance use, homelessness and related problems). In addition to the quantitative analysis, qualitative interviews with each youth will provide a fuller understanding of the youths' response to the intervention.

Phase I: Quantitative Analysis. Repeated measures ANOVA will be used to test the efficacy of the intervention (time effects). Three testing occasions (e.g., baseline, 3, and 6 months) will be the within-subject dependent variables. The primary outcome is opioid use, and secondary outcomes are listed below under "dependent variables." It is predicted that there will be a main effect of time; youth will show reductions in opioid use, and improved functioning in other domains at post-intervention (6-months).

Phase I: Qualitative Analysis. In order to increase our understanding of youths' response to the intervention such as experiences associated with differing levels of housing success and satisfaction with services, each youth at 6 months post-baseline will be interviewed regarding their experiences in the study. Supplementing the quantitative findings, interviews can provide better understanding of factors that promote engagement and success among youth as well as factors that prevented youth from successfully maintaining their housing. Additionally, qualitative data can help explain any unexpected findings, and provide a greater richness when reporting and interpreting the quantitative outcomes. Dr. Brittany Brakenhoff conducted a mixed methods study (funded by NIDA, R36DA041530) in which youth were interviewed regarding their perceptions of barriers to safe sex. She is an expert in qualitative methods and will lead the qualitative data collection. The qualitative portion will follow a phenomenological approach, which provides a framework for collecting and analyzing qualitative data as a way to better understand how youth experienced the intervention providing insight into youths' perceptions of whether they benefited from the intervention in a way that was meaningful to them (Creswell, 2012). Youth will be asked about their overall experience in the research study as well as their perception of how the intervention impacted their life. Youth will be asked to discuss aspects of the intervention they benefited from, aspects they did not find helpful, and how to make the intervention more helpful. All interviews will be independently coded by three members of the research team and discrepancies in coding will be discussed until an agreement is reached. NVivo 11 (QSR international) will be used to assist with coding. Member checking will provide additional verification of the results, a subsample of 5 youth who participated in the non-randomized pilot will be asked to review and provide feedback on the initial qualitative findings. While quantitative data can show whether participants changed their behavior, qualitative data can determine if those changes actually resulted in perceived meaningful improvements in the participants' lives.

Phase II (UH3) In Phase II, 240 homeless youths between the ages of 18 to 24 years recruited from the streets and drop-in center will be randomly assigned to 1) 6-months of housing + opioid and related risk prevention services (n = 120), or to 2) opioid and related risk prevention services alone (n = 120). In addition, sll youth will be screened using the Scale for Suicide Ideation - Worst Point (SSI-W). Those who receive a score over 10, indicating moderate suicide risk, or report a past-year suicide attempt will be eligible for 10 sessions of Cognitive Therapy for Suicide Prevention (CTSP). We expect that approximately N =100 youth will meet the criteria for receiving CTSP, and that these youth should be nearly equally distributed in the housing + risk prevention services condition (N = 50) and risk prevention services alone (N = 50). We considered a design that included an assessment only condition, but given the level of risk and need of this population, we rejected this option. Using an intent to treat design, follow-up assessments will be completed at 3, 6, 9 and 12 months post-baseline. Standard methods of cost analysis will be used to estimate the cost of each intervention condition. We have consistently obtained adequate follow-up rates with homeless samples in our prior research (between 83-100% follow-up rates at 9 months for homeless mothers, and 75% at 12 months for non-housed homeless youth samples). In our efforts to maintain acceptable follow-up rates, we will obtain extensive locator information at the baseline assessment in which participants designate hang-out spots and agencies they frequent in Columbus, as well as collaterals. Collaterals may include friends, family members, probation/parole officers or social workers who would likely know where the participant would be if project staff lost touch with them. At each follow-up appointment, the research assistant (RA) will update locator information. We have also found that homeless youth who feel connected to our program and its advocates/RAs stay in contact. Upon completion of the baseline assessment interview, youths will be randomly assigned to the intervention conditions using a computerized urn randomization program. Four advocates will provide services so that advocate effects can be examined (Baldwin et al., 2011), and each advocate will provide all opioid and related risk prevention services to the youth on their caseload. Advocates will be crossed by condition to "equate" conditions on advocate characteristics. This approach is preferred over nesting as advocates in both conditions are trained in the same procedures which include SBOA, MI, and HIV risk and suicide prevention (CTSP). Nesting would likely be considered the better choice if treatment philosophies differed among the intervention conditions. RA's will be blind to condition at all assessment timepoints.

Project Intervention: Housing + Prevention Services versus Prevention Services alone Housing + Opioid and Related Risk Prevention Services integrates independent housing, Strengths-Based Outreach and Advocacy (SBOA), HIV prevention and MI (Miller & Rollnick, 2012) and Cognitive Therapy for Suicide Prevention (CTSP). In the housing + opioid and related risk prevention services condition, youth will be housed in an apartment of their choosing and receive six months of utility and rental assistance of up to $600 per month. The independent housing is not contingent on the youth's substance use or attendance in prevention services. SBOA, MI, HIV risk and suicide prevention occur simultaneously in this approach. Addressing basic needs but not opioid and other drug use, through MI and service linkage, may lead to difficulty in maintaining basic needs and vice versa. During the intervention, advocates assist youth in accessing community supports so that if more assistance is needed at the end of the intervention period, youth will have been linked to those additional supports. Findings from the pilot study with non-service connected youth indicated that up to 26 advocacy sessions should be offered. Each component of the intervention is described below.

Strengths-Based Outreach and Advocacy (SBOA). Those individuals experiencing homelessness with access to a social service worker, or who utilize community services, are more likely to exit homelessness (Dworsky & Piliavin, 2000; Raleigh-DuRoff, 2004; Zlotnick et al., 2003). In general, the range and severity of adverse outcomes increases over time; the longer a young person experiences homelessness, the more likely they are to experience opioid and other substance use, victimization and mortality, and the harder it becomes to exit street life (Ferguson et al., 2011; Milburn et al., 2006; Scutella et al., 2013), highlighting the importance of engaging disconnected youth to services. SBOA focuses on identifying and engaging youth from the streets and drop-ins/shelters etc. and assisting these youth to meet their basic needs (i.e., referrals to food pantries), obtain government entitlements (i.e., SSDI/SSI, cash assistance, food stamps), and connect to other needed supports (education, job training). The advocates provide referrals and/or transport youth to appointments as needed. The initial meeting provides an opportunity to gather information. The advocate will review each of six general areas with the youth to gather a history and picture of the current situation: (1) housing needs; (2) health care; (3) food; (4) legal issues, (5) employment and (6) education. The advocate will assist youth assigned to the opioid and related risk prevention services only comparison condition to obtain housing within the community, as is usually provided with SBOA, but unlike the youth in the housing intervention, they are not provided housing by the project. Once this review is complete, an initial intervention plan is developed with specific goals and objectives. Advocates are available 24 hours for crises.

HIV prevention. Some have argued that HIV prevention should be offered to all individuals seeking therapy for drug problems (Roehrich et al., 1994). Every youth will receive the 2-session intervention which uses cognitive-behavioral techniques with a focus on skills building/behaviors (role plays with condom application, cleaning needles, communication/negotiation and problem solving), used in prior projects with homeless youth with success reducing risk behaviors (e.g., Carmona et al., 2014; Slesnick & Kang, 2008). Successful practice of skills is expected to increase confidence and self-efficacy which is expected to increase the youth's use of skills including condom use and negotiation in other micro-system interactions. The first session is devoted to AIDS education, assessment of risk, risk reduction and skills practice. Session 2 focuses on sexual assertiveness and practicing negotiation. Role plays are incorporated to allow the youth to practice social competency skills relevant to their life situations.

Motivational Interviewing (MI). Typically offered as a brief intervention of 1-2 sessions, Motivational Interviewing (MI, Miller & Rollnick, 2012) has a strong record of efficacy in the prevention and treatment of alcohol and other drug use disorders (Copeland et al., 2015; Miller & Rollnick, 2012). MI assumes that the responsibility and capability for change lie within the client and needs to be evoked (rather than created or installed). Baer, Peterson and Wells (2004) provide some rationale for utilizing brief feedback and motivational intervention with street living youth - the intervention is less costly and demands much less of a hard-to-reach population than more intensive interventions. Utilizing a sample of runaway adolescents recruited from a runaway shelter, Slesnick et al. (2013) found that substance use reductions were significant for those assigned to MI even to two years post-treatment. The advocate will administer MI. Four principles guide the practice of MI: express accurate empathy, develop discrepancy, roll with resistance and support self-efficacy. The Project Match manual was adapted for homeless/runaway youth in prior trials in consultation with William R. Miller and Bo Miller (NIAAA grant no. R01AA12173 and NIDA grant R29DA11590). Adaptation of the manual included attention to the unique life situation of homeless youth in understanding motivations and challenges to recovery while homeless. Session 1 begins with a period of open-ended MI, to establish therapeutic rapport and elicit client change talk. In session 2 the advocate continues to focus on enhancing intrinsic motivation for change, developing discrepancy, transitioning as appropriate into the negotiation of a change plan and evoking commitment to the plan.

Cognitive Therapy for Suicide Prevention (CTSP). The Cognitive Therapy Intervention for Suicide Attempters, developed by Aaron Beck, Gregory Brown and Amy Wenzel (Wenzel, Brown, & Beck, 2009) has shown promising results for both adults (Brown et al., 2005) and youth (Brent et al., 1993; Stanley et al., 2009). This approach is innovative in that suicidal behavior is the primary target for treatment, rather than being secondary to an underlying psychological disorder, which has been the standard in the field (Wenzel et al., 2009). As a short term treatment (10 sessions), the intervention is particularly feasible for youth who have high rates of treatment refusal and drop-out. CTSP is based upon the theoretical assumption that the manner by which people think and interpret their life events determines their emotional and behavioral responses to those events. Hence, maladaptive cognitions associated with suicidal ideation are the primary focus of the treatment. Given that the intervention protocol was developed based on empirical studies designed to identify cognitive processes relevant to suicidal acts, targeted vulnerability factors include hopelessness, social isolation, poor problem solving, and impaired impulse control. The treatment is designed as a 10 session protocol including weekly or bi-weekly meetings.

A crisis plan is developed in the first session and is expanded as therapy progresses. It includes emergency contact numbers as well as positive coping behaviors, such as walking or taking a hot bath that the client can perform alone. Consistent with the Interpersonal Theory of Suicide (Joiner, 2002) and Rudd's theory (2004, 2006), the experience of prior suicidal behaviors is considered associated with increased risk for future suicide attempts. Therefore, assessment of recent suicidal thoughts and behaviors is conducted every session. Clients in need of additional mental health treatment or services are referred to those respective agencies. The treatment process is highly structured and consists of three phases. During the initial phase of treatment (sessions 1-4) clients are educated about the cognitive model and a cognitive case-conceptualization is developed to guide the intervention based on client's individual risk-factors and experiences. Specifically, automatic thoughts, core beliefs, and key life events associated with suicidal behaviors and thoughts are identified. The middle phase of treatment (sessions 4-7) focuses on both cognitive restructuring and behavior change through a variety of cognitive techniques designed to address suicide-specific risk factors. For example, therapists teach clients positive behaviors, such as distraction, relaxation, and intense physical sensations. These techniques can be used to cope with a suicidal crisis and may mitigate the effect of the acquired ability to enact lethal injury. Another form of coping is through a personal support system. Thus, therapists help clients develop/strengthen their social network, which may include other homeless youth, intimate partners, pro-social adults and drop-in center staff. Therapists can also work with the client to create a hope kit, which includes reasons to live such as memories, letters, pictures or other reminders of positive relationships with others. Although relationships with parents are problematic, some youth maintain positive relationships with extended family members or siblings, mentors or friends. Creating a hope kit and accessing support systems can create a sense of connection and belongingness. The objective of the later sessions (8-10) is to prevent relapses through practicing the newly-acquired skills through a guided imagery process. Youth may receive up to 9 maintenance sessions within 6 months post-baseline.

Housing. Those randomized to receive housing + opioid and related risk prevention services will receive each prevention component above, plus 6-months of housing. The Housing First Model was developed by Pathways to Housing to provide immediate access to independent apartments and supportive services for the most vulnerable homeless people with severe mental illness and substance use disorders, without any prerequisites for sobriety or participation in psychiatric treatment (Tsemberis et al., 2004; Tsemberis & Asmussen, 1999). It is based on the beliefs that housing is a fundamental human right, recovery from mental illness is possible, and that consumers can make competent choices (Tsemberis et al., 2004). The central tenet of Housing First is that consumers have choice/control over "where they live, how they live, who they allow to live with them, who enters the home, to abstain from substance use or not, to comply with treatment demands or not, and the support that they receive" (Greenwood et al., 2005, p. 225). These Housing First principles underlie various housing approaches (HUD, 2014). The advocate will work with the youth to identify appropriate housing among the available choices, and will initiate the procedure for payment from Nationwide Children's Hospital directly to the landlord once housing is identified. The project will cover damage deposit, application fees (including FABCO report, credit report), and will automatically pay the landlords the rental checks at the beginning of each month. As in the prior Stage 1 and 2 studies, Nationwide Children's Hospital will not sign leases on behalf of the youth, and so the youth will sign the lease. The amount budgeted in this application for rent includes that needed for both rent and utilities. Considerations. While we may not be able to prevent contamination of sharing housing across groups, we propose some strategies to reduce its impact should it occur. At each follow-up, youth will be asked to note if they know other youth in the research project, and to identify those youths' names. We can then link intervention condition with the youth to provide some estimate of contamination. We will fully describe any probable contamination from both a research and clinical perspective.

Details
Condition Substance Use
Treatment SBOA + Housing, SBOA Only, Risk Prevention Services + Housing, Risk Prevention Services Only
Clinical Study IdentifierNCT04135703
SponsorOhio State University
Last Modified on8 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

ages of 18 to 24 years
meets McKinney-Vento definition of homeless
fails to meet DSM 5 criteria for Opioid Use Disorder as assessed by the SCID

Exclusion Criteria

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