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 — BEHAVIORAL
    We 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: Psychosocial
    Digitally delivered psychosocial
  • Experimental: Psychosocial with text messages
    Digitally delivered psychosocial with text messages
  • Experimental: Psychosocial with text messages and family navigator
    Digitally 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)

FacilityCityStateZIPSite coordinators
Hasbro Children's HospitalProvidenceRhode Island02903
Mary Kathryn Cancilliere, PhD
401-444-7443

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