NCT07092345

An Adaptive Intervention to Increase Engagement to Community-Based Care After an ED Admission

An Adaptive Intervention to Increase Engagement to Community-based Care After an ED Admission: For Youth at Risk for Suicide and Self-injurious Behavior

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Rhode Island Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This adaptive intervention allows for two stages of randomization to address treatment non-response. First, youth and caregivers (dyads) will be randomized to receive 1st-stage interventions in the ED, either the digital psychosocial-only condition or the psychosocial with digital health communication via text messages condition. If after two weeks, youth are identified as non-response, then dyads will be re-randomized to 2nd-stage intervention(s) that will include the use of a family navigation model.

Conditions

• Suicidal and Self-injurious Behavior
• Linkage to Care

Interventions

Type	Name	Description
BEHAVIORAL	adaptive intervention	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.

Timeline

• Start date: 2025-03-17
• Primary completion: 2029-01-01
• Completion: 2029-03-01
• First posted: 2025-07-29
• Last updated: 2025-07-29

Locations

1 site across 1 country: United States