An Adaptive Intervention to Increase Engagement to Community-Based Care After an ED Admission
Part of paid clinical trials in Providence, Rhode Island.
- Sponsor
- Rhode Island Hospital
- Study ID
- NCT07092345
- Status
- Recruiting
Conditions
- Linkage to Care
- Suicidal and Self-injurious Behavior
Eligibility Criteria
- Sex
- ALL
- Age
- 8 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- adaptive intervention — BEHAVIORALWe will utilize an adaptive interventions via Sequential Multiple Assignment Randomized Trial (SMART) design provide a tailored, stepped-care approach for the type, intensity, and dose of treatment, thus, providing the most intensive care to only those who need it, particularly treatment non-response. First, youth and caregivers (dyads) will be randomized to receive 1st-stage interventions in the ED, either the digital psychosocial-only (PS) condition or the psychosocial with digital health communication (PS+text) condition. If identified as non-response at 2-weeks, then dyads will be re-randomized to 2nd-stage intervention(s). Specifically, the PS condition non-responders will be re-randomized to the PS+text condition or the PS+text+FN condition. The 1st-stage PS+text condition non-responders will receive the PS+text+FN condition only.
Study Details
The goal of this study is to develop a feasible brief, family-based adaptive intervention, via SMART design, for youth with suicidal and non-suicidal self-injurious behavior (SSIB) to increase community-based mental health (MH) care attendance and reduce SSIB risk post emergency department (ED) admission. The intervention will focus to increase understanding on youth MH literacy, MH communication, and MH engagement. Integrating an adaptive intervention via a SMART design in the ED could address subsequent barriers to youth obtaining appropriate level of community-based MH care and therefore reduce ED readmissions.
Key Dates
- Start date
- Mar 17, 2025
- Status verified
- Jul 2025
- Primary completion
- Jan 31, 2029
- Completion
- Mar 31, 2029
Study Design
- Enrollment
- 186 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: PsychosocialDigitally delivered psychosocial
- Experimental: Psychosocial with text messagesDigitally delivered psychosocial with text messages
- Experimental: Psychosocial with text messages and family navigatorDigitally delivered psychosocial with text messages and human family navigator
Primary Outcome Measure
Intervention Feasibility [ Time Frame: 3-month & 6-month follow-up assessments ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Hasbro Children's Hospital | Providence | Rhode Island | 02903 |
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