NCT06414993

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jun 2024Sep 2026

First Submitted

Initial submission to the registry

May 7, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

June 7, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

April 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

May 7, 2024

Last Update Submit

April 6, 2026

Conditions

Keywords

Contingency managementEmerging adultsPolysubstance usePeer recovery support services

Outcome Measures

Primary Outcomes (8)

  • Levels of Emerging Adult Perceptions of Acceptability of the Launch Intervention (measured at 6 months).

    Levels of acceptability of the Launch intervention, such as if participants like the intervention, as reported by emerging adults on the Acceptability of Intervention Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention acceptability.

    6 months

  • Levels of Parent Perceptions of Acceptability of the Launch Intervention (measured at 6 months).

    Levels of acceptability of the Launch intervention, such as if participants like the intervention, as reported by parents on the Acceptability of Intervention Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention acceptability.

    6 months

  • Levels of Emerging Adult Perceptions of Launch Intervention Appropriateness (measured 6 months).

    Levels of Launch intervention appropriateness, such as if the intervention is a good match, as reported by emerging adults on the Intervention Appropriateness Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention appropriateness.

    6 months

  • Levels of Parent Perceptions of Launch Intervention Appropriateness (measured 6 months).

    Levels of Launch intervention appropriateness, such as if the intervention is a good match, as reported by parents on the Intervention Appropriateness Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention appropriateness.

    6 months

  • Levels of Emerging Adult Perceptions of Feasibility of the Launch Intervention (measured at 6 months).

    Levels of Launch intervention feasibility, such as if the intervention is easy to use, as reported by emerging adults on the Feasibility of Intervention Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention feasibility.

    6 months

  • Levels of Parent Perceptions of Feasibility of the Launch Intervention (measured at 6 months).

    Levels of Launch intervention feasibility, such as if the intervention is easy to use, as reported by parents on the Feasibility of Intervention Measure. Scores range from 4-20. Higher scores indicate higher levels of intervention feasibility.

    6 months

  • Levels of Emerging Adult Client Satisfaction with Launch Services (measured at 6 months).

    Levels of satisfaction with the Launch services reported by emerging adult clients on the Client Satisfaction Questionnaire 8-item scale adapted to reflect receipt of Launch services.

    6 months

  • Levels of Parent Client Satisfaction with Launch Services (measured at 6 months).

    Levels of satisfaction with the Launch services reported by parent clients on the Client Satisfaction Questionnaire 8-item scale (CSQ-8) adapted to reflect receipt of Launch services.

    6 months

Secondary Outcomes (19)

  • Changes from baseline to 6 months post-baseline in Emerging Adult Substance Use Disorders (measured at 0 and 6 months).

    Baseline to 6 months

  • Changes from baseline to 6 months post-baseline in Emerging Adult Substance Use and Problems (measured at 0 and 6 months).

    Baseline to 6 months

  • Changes from baseline to 6 months post-baseline in Emerging Adult Polysubstance Use (measured at 0 and 6 months).

    Baseline to 6 months

  • Changes from baseline to 6 months post-baseline in Emerging Adult Quality of Life (measured at 0 and 6 months).

    Baseline to 6 months

  • Changes from baseline to 6 months post-baseline in Emerging Adult Service Utilization (measured at 0 and 6 months).

    Baseline to 6 months

  • +14 more secondary outcomes

Study Arms (3)

Contingency Management for Emerging Adults (CM-EA) Only

EXPERIMENTAL

The parents in this group will receive CM-EA delivered virtually by a parent coach approximately weekly (20-40 minute sessions) for 6 months.

Behavioral: Contingency Management for Emerging Adults (CM-EA)

Standard Peer Recovery Support Services (PRSS)+Vocational/Educational (V/E) Skill Building

EXPERIMENTAL

The EAs in this group will receive PRSS+Vocational/Educational (V/E) Skill Building delivered by peer workers in-person in the local community and/or virtually, for approximately weekly (1 hour sessions) for 6 months.

Behavioral: Standard Peer Recovery Support Services (PRSS) +Vocational/Educational (V/E) Skill Building services

CM-EA and PRSS+V/E

EXPERIMENTAL

Families receive both CM-EA and PRSS + V/E as described above.

Behavioral: Contingency Management for Emerging Adults (CM-EA)Behavioral: Standard Peer Recovery Support Services (PRSS) +Vocational/Educational (V/E) Skill Building services

Interventions

Standard PRSS begin by identifying clients' needs in key domains (e.g., transportation, employment). After needs are identified, a peer worker addresses needs through informational resources and community referrals and engages clients in positive recreational activities offering advice, hope and empowerment to encourage steps toward a reduction in substance use and eventual abstinence. When desired, peer workers also link clients to a broader recovery peer community. In addition, the peer worker will dedicate time to increasing recovery capital via improving skills related to V/E advancement using a workbook, Targeting Employment for Emerging Adults: A Toolkit for Mental Health Providers, for which peer workers will be trained.

CM-EA and PRSS+V/EStandard Peer Recovery Support Services (PRSS)+Vocational/Educational (V/E) Skill Building

After CM-EA is introduced, a contingency contract is developed between a parent and emerging adult (EA) that provides EAs with rewards for negative drug screens and completion of developmentally appropriate goals to build recovery capital, along with disincentives for positive screens or engaging in inappropriate behaviors. Concurrently, parents are taught to conduct random urine drug screens. Additionally, parents are trained to complete functional analyses in collaboration with their EA to identify the EA's triggers for poly-substance use and negative behaviors. Individualized triggers are targeted via self-management planning and drug refusal skills training. At the end of CM-EA, plans are made with the family for sustaining abstinence and improvements in other behaviors.

CM-EA and PRSS+V/EContingency Management for Emerging Adults (CM-EA) Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 year, (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

You may not qualify if:

  • 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.
  • Peer Workers
  • 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.
  • None
  • Parent Coaches
  • 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.
  • None
  • Payors/Providers of Recovery Services
  • 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.
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Rising Sun Recovery

Hiram, Georgia, 30141, United States

Location

A New Horizon

Bloomington, Illinois, 61701, United States

Location

Chestnut Health Systems

Granite City, Illinois, 62040, United States

Location

Take Action Today

West Frankfort, Illinois, 62896, United States

Location

Wabash Valley Recovery Center

Terre Haute, Indiana, 47807, United States

Location

Chestnut Health Systems

Hillsboro, Missouri, 63050, United States

Location

Chestnut Health Systems

Eugene, Oregon, 97401, United States

Location

WeCare Hawkins

Rogersville, Tennessee, 37857, United States

Location

Related Publications (1)

  • Drazdowski TK, Castedo de Martell S, Sheidow AJ, Chapman JE, McCart MR. Leveraging Parents and Peer Recovery Supports to Increase Recovery Capital in Emerging Adults With Polysubstance Use: Protocol for a Feasibility, Acceptability, and Appropriateness Study of Launch. JMIR Res Protoc. 2024 Jul 22;13:e60671. doi: 10.2196/60671.

Study Officials

  • Tess K Drazdowski, PhD

    Chestnut Health Systems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 16, 2024

Study Start

June 7, 2024

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Attendance data, client satisfaction data, and EA outcomes data will be shared. Participants will be assigned a unique identifier to allow linking across data files. These data will be stored in an electronic file format (e.g., csv), accessible to standard analytic software (e.g., Excel, SAS) and will undergo formatting and quality assurances prior to sharing. Data dictionaries and codebooks, detailing variable-level information also will be shared. The PI agrees to deposit and maintain the data, and any secondary analysis of data prior to depositing data into the NAHDAP or similar repository. The PI understands that NAHDAP and similar repositories have data access policies and procedures consistent with NIH and the Helping End Addiction Long-term (HEAL) Initiative data sharing policies. HEAL data stewards will ensure that data are available to the HEAL Ecosystem after deposit.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be shared upon acceptance of the data for publication or within six months after the completion of the 6-month follow-up assessments, whichever is earlier.
Access Criteria
Information on where the data will be available and how to access the data will be included in any publications and presentations that the study team authors using these data. The repositories (e.g., NAHDAP), HEAL Data Ecosystem, and funding sources will be acknowledged in any publications and presentations. Repositories such as the NAHDAP have policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.

Locations