Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04135703 |
| Other study ID # |
2019B0287 |
| Secondary ID |
326920 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2019 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Ohio State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 report suicide ideation on the Scale for Suicide Ideation - Worst Point
(SSI-W) (Beck, Brown, & Steer, 1997) will also receive suicide prevention.
Participant recruitment and sample availability. 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.
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.
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. 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.
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.
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, all youth will be screened using the Scale
for Suicide Ideation - Worst Point (SSI-W). We expect that approximately N =100 youth will
report suicidal ideation and those youth will also receive the suicide prevention
intervention.
Using an intent to treat design, follow-up assessments will be completed at 3, 6, 9 and 12
months post-baseline. 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. 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). Each component of the intervention is described below.
Strengths-Based Outreach and Advocacy (SBOA). 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. 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).
Motivational Interviewing (MI). 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.
Housing. Those randomized to receive housing + opioid and related risk prevention services
will receive each prevention component above, plus 6-months of housing. The advocate will
work with the youth to identify appropriate housing among the available choices. 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.
