Clinical trial NCT06414993: Leveraging Parents and Peers to Increase Recovery Capital in Emerging Adults
Official title: Leveraging Parents and Peer Recovery Supports to Increase Recovery Capital in Emerging Adults With Polysubstance Use: Feasibility, Acceptability, and Scaling up of Launch
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polysubstance Drug Use (Indiscriminate Drug Use)
Keywords: Contingency management
Emerging adults
Polysubstance use
Peer recovery support services
Lead sponsor: Chestnut Health Systems
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-05-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Emerging adults (EAs; aged 18-26) are the highest-risk population for poly-substance use (misuse of more than one drug), compared to all other age groups and are the least-served population for substance use services. The overarching purpose of this pilot study is to assess whether an innovative services package, Launch, can reasonably work (is feasible) and whether providers and participants like it (acceptability). Launch works with both EAs and a supportive parent (or parental figure) and delivers peer recovery support services (PRSS) to EAs while helping parents use an effective, evidence-based program called contingency management, adapted for EAs, at home with their EA child. This study will also lay the groundwork for a future large-scale trial of Launch services.

Detailed description: The objective of the study is to investigate a scalable service that can be used in rural communities called Launch. Launch is an innovative adaptation of current evidence-based services for Emerging Adults (EAs), ages 18-26 years old with polysubstance use (poly-SU); with a particular emphasis on increasing their recovery capital. Recovery capital is the resources available to promote substance use recovery (e.g., vocational/educational skills, recovery-supportive community). Launch leverages (1) parents of EAs and (2) peer recovery support services (PRSS), while ensuring services are equitable and scalable by using digital technology and existing substance use services infrastructure. Participants will be 48 families that include an EA struggling with poly-SU and a parent or parental figure supportive of their EA child's recovery journey. Families will be randomized to one of three conditions detailed further in the attached materials that include either: (1) Virtual Parent Contingency Management for Emerging Adults (CM-EA) Coach for parents only, (2) In-Person PRSS for EAs only, or (3) a combination of Virtual Parent CM-EA Coach for parents and In-Person PRSS for EAs. Quantitative and qualitative measures will assess the feasibility and acceptability of Launch. Additionally, payors/providers of substance use services will be interviewed in this study with the aim of improving future uptake and implementation of the service should it be deemed effective.

The aims of the study are as follows:

1. Adapt and evaluate the Launch parent coach and PRSS training protocols/adherence tools.
2. Assess the feasibility and acceptability of (a) a virtual study protocol for recruiting, assessing, and retaining parents and EAs and (b) Launch components.
3. Determine from payors and providers the data needed for future funding and delivery of Launch, as well as develop a site recruitment pool for a rigorous R01 trial.

Eligibility criteria: This study has four different participants: (1) Emerging Adult (EA)/Parent Pairs, (2) Peer Workers, (3) Parent Coaches, and (4) Payors/Providers of Recovery Services.

1. Emerging Adult (EA)/Parent Pairs

   Inclusion Criteria:
   * EA (aged 18-26) who reports (1) misuse of opioids and/or stimulants and at least one other substance in the same week during the past 30 days, (2) at least one SU disorder reported by EA or parent as assessed via the DSM-V Checklist, and (3) has a supportive parent willing to be virtually coached to deliver CM-EA. Participating "parents" can include any supportive adult who is in a financially supportive caregiving role for the EA and has the desire and ability to implement the CM-EA program

   Exclusion Criteria:
   * Only EAs that present with unstable conditions requiring intensive treatment, such as hospital interventions, will be excluded from the sample. Examples of these conditions include participant reports of active suicidal or homicidal intentions or requests for medically supervised detox services.
2. Peer Workers

   Inclusion Criteria:
   * Certified peer worker (aged 18+) willing to be trained in vocational/educational skill building and participate in research protocols with study-enrolled emerging adult clients.

   Exclusion Criteria:
   * None
3. Parent Coaches

   Inclusion Criteria:
   * Individual (18+) with a background in clinical work willing to be trained in Contingency Management for Emerging Adults (CM-EA) and participate in research protocols with study-enrolled parent clients.

   Exclusion Criteria:
   * None
4. .Payors/Providers of Recovery Services

Inclusion Criteria:

* Individual (18+) who works at an administrative level at an organization that provides or pays for recovery services that would potentially fund or otherwise support the implementation of Launch services willing to be interviewed.

Exclusion Criteria:

* None

Primary outcomes:
measure: Levels of Emerging Adult Perceptions of Acceptability of the Launch Intervention (measured at 6 months).
timeFrame: 6 months
measure: Levels of Parent Perceptions of Acceptability of the Launch Intervention (measured at 6 months).
timeFrame: 6 months
measure: Levels of Emerging Adult Perceptions of Launch Intervention Appropriateness (measured 6 months).
timeFrame: 6 months
measure: Levels of Parent Perceptions of Launch Intervention Appropriateness (measured 6 months).
timeFrame: 6 months
measure: Levels of Emerging Adult Perceptions of Feasibility of the Launch Intervention (measured at 6 months).
timeFrame: 6 months
measure: Levels of Parent Perceptions of Feasibility of the Launch Intervention (measured at 6 months).
timeFrame: 6 months
measure: Levels of Emerging Adult Client Satisfaction with Launch Services (measured at 6 months).
timeFrame: 6 months
measure: Levels of Parent Client Satisfaction with Launch Services (measured at 6 months).
timeFrame: 6 months
Secondary outcomes:
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Substance Use Disorders (measured at 0 and 6 months).
timeFrame: Baseline to 6 months
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Substance Use and Problems (measured at 0 and 6 months).
timeFrame: Baseline to 6 months
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Polysubstance Use (measured at 0 and 6 months).
timeFrame: Baseline to 6 months
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Quality of Life (measured at 0 and 6 months).
timeFrame: Baseline to 6 months
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Service Utilization (measured at 0 and 6 months).
timeFrame: Baseline to 6 months
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Abstinence Self Efficacy (measured at 0 and 6 months).
timeFrame: Baseline to 6 months
measure: Changes from baseline to 6 months post-baseline in Emerging Adult Recovery Capital (measured at 0 and 6 months).
timeFrame: Baseline to 6 months
measure: Changes from baseline to 6 months post-baseline in Recovery Capital (measured at 0 and 6 months).
timeFrame: Baseline to 6 months
measure: Levels of Emerging Adult Client Quality of Relationship with Peer Worker (measured at 6 months).
timeFrame: 6 months
measure: Levels of Emerging Adult Client Quality of Relationship with Parent (measured at 0 and 6 months).
timeFrame: Baseline to 6 months
measure: Levels of Emerging Adult Session Attendance with Peer Worker (measured weekly from baseline to 6 months).
timeFrame: Duration of services until 6 months after baseline
measure: Levels of Parent Session Attendance with CM-EA Parent Coach (measured weekly from baseline to 6 months).
timeFrame: Duration of services until 6 months after baseline
measure: Attitudes at 6 months post-baseline in Emerging Adult Attitudes Toward the Services Provided, Research Protocol, and Parent/Emerging Adult Relationship (measured at 6 months).
timeFrame: 6 months
measure: Attitudes at 6 months post-baseline in Parent Attitudes Toward the Services Provided, Research Protocol, and Parent/Emerging Adult Relationship (measured at 6 months).
timeFrame: 6 months
measure: Attitudes at end of services in Peer Worker Attitudes Toward the Services Provided, Impacts on Emerging Adult Clients, and Services Improvement (measured at 6 months).
timeFrame: From date of consent until the date of two months past last client session completed, assessed up to 2 years
measure: Attitudes at end of services in Parent Coach Attitudes Toward the Services Provided, Impacts on Parent Clients, and Services Improvement (measured at 6 months).
timeFrame: From date of consent until the date of two months past last client session completed, assessed up to 2 years
measure: Changes from baseline to end fo services in Peer Worker Services and Vocational/Educational Activity Completion (measured monthly throughout services duration).
timeFrame: Duration of services, after each session with an emerging adult until 6 months after baseline
measure: Changes from baseline to end fo services in Parent Contingency Management for Emerging Adults (CM-EA) Adherence (measured monthly throughout services duration).
timeFrame: Duration of services, after each session with a parent until 6 months after baseline
measure: Descriptions of Economic-Related Information for Future Large-Scale Study from Payors/Providers of Recovery Services (measured once at any point during the study period).
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Chestnut Health Systems
state: Oregon
Study officials:
affiliation: Chestnut Health Systems
name: Tess K Drazdowski, PhD
role: PRINCIPAL_INVESTIGATOR
References: