Feasibility and Pilot Testing of a Team-Based Psychosocial Intervention for Young Adults Transitioning from Homelessness to Housing

Introduction: Pilot testing is a critical step to ensure an adapted intervention is feasible and acceptable for delivery in a new context. In recognition of this important stage of intervention development, the National Institutes of Health established the R34 mechanism which funds initial development of a clinical trial including finalization of the protocol, and the collection of pilot and feasibility data (https://grants.nih.gov/funding/activity-codes/r34). The aim of this presentation is to provide an example of the design and feasibility outcomes (e.g., recruitment, retention) that were examined in an R34 study funded by the National Institute of Mental Health. The focus of the study was to test an adaptation of Critical Time Intervention specific to youth and young adults transitioning from homelessness into supported housing.

Methods: The adapted intervention, Charge Up!, is a team-based, phased intervention that lasted 6 months. The feasibility trial occurred in a transitional housing to rapid rehousing context at two sites. We conducted a staged, feasibility pilot: 1) open trial (N=8), 2) randomized pilot trial (RCT, n=52). We conducted qualitative interviews with key stakeholders following the open trial and conducted structured interviews at baseline, 3 months, 6 months, and 12 months. During the RCT, we tracked feasibility of recruitment and randomization, intervention delivery, and retention.

Results: During the open trial, we established the appropriate housing setting for the intervention and finalized the intervention structure and core elements. Acceptability and feasibility data confirmed that participants appreciated the overall approach of the intervention and staff found the added support to be beneficial to their work, supporting moving forward with the next phase of the pilot trial. Outcome evaluation measures were streamlined to reduce participant burden and a strategy for randomization in the next phase was finalized. For the subsequent trial, the target pace of recruitment was largely as expected with 52 participants recruited and randomized over 13 months, though pace of recruitment varied widely depending on housing capacity. Retention was initially challenging but the team employed multiple strategies such as providing calendars, weekly check in calls, and weekly meetings focused on tracking participants which increased retention. Intervention fidelity was examined by tracking the number of sessions with each of the study team members participants received in conjunction with key milestone meetings. Study measures were examined for validity by comparing scores with qualitative case data.

Discussion/Implications: Findings from the feasibility and pilot phases of the trial have laid the foundation for a more rigorous test of the intervention in a larger trial. Based on pilot data, the team is able to more accurately estimate the yield and timeline for recruitment procedures and has developed robust procedures for enhancing retention. The key components for operationalizing fidelity of the adapted intervention have also been finalized which will contribute to a subsequent trial with stronger internal validity. Finally, most project measures showed validity for the study population and strengthened confidence in the measurement strategy for a full trial.