Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Psychotic Disorders
  • Substance Use
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The model is a cluster randomized controlled trial with randomization at the team level.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 15 years and 32 years
Gender
Both males and females

Description

The pilot study examines the feasibility of a cluster randomized controlled trial to measure the effectiveness of Invest in My Recovery Bank (IMRB) compared to usual care (UC). IMRB is a peer-led, manualized intervention to support youth and young adults receiving treatment for early psychosis with ...

The pilot study examines the feasibility of a cluster randomized controlled trial to measure the effectiveness of Invest in My Recovery Bank (IMRB) compared to usual care (UC). IMRB is a peer-led, manualized intervention to support youth and young adults receiving treatment for early psychosis with reducing or stopping problematic substance use. Peer providers, who represent clusters of service participants, will participate in a multi-day IMRB training. Training will include exploring the theoretical basis for the intervention approach and logic model, impact of service participant and peer provider on intervention design, the intervention strategies, and opportunities to build skill in each intervention component (e.g., role play with feedback). Peer providers will also receive twice monthly supervision to support intervention fidelity and resolve questions. The proposed pilot study aims to: (a) determine if peer providers can implement IMRB with adequate fidelity; (b) determine if youth and young adults engage in the intervention with peer providers and find it acceptable; (c) estimate the rates of drop-out for each of the two study arms; (d) estimate both between-participant (within-provider team) and between-team variability (e.g., standard deviation, interquartile range) on key outcome measures for a future comparative cluster randomized trial of the intervention; and (e) identify any changes needed to the intervention approach, manual, or training materials. Nineteen teams across 16 sites will be randomly assigned to IMRB or UC, ensuring that the three sites with more than one team have at least one team randomized to each arm. All youth meeting eligibility criteria will be enrolled in the study and will receive either IMRB or UC, based on the assignment status of their provider team. Intervention integrity will be measured through a peer-completed fidelity checklist. Participant outcomes will be measured through existing data collection at each participating organization. All participant outcome and service data is reported through the EPINET-TX platform, which allows for measurement-based care at participating sites and research using de-identified data.

Tracking Information

NCT #
NCT04517279
Collaborators
  • Southern Methodist University
  • Thresholds Inc.
Investigators
Not Provided