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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07092345
Acronym
ED_SMART
Enrollment
186
Registered
2025-07-29
Start date
2025-03-17
Completion date
2029-03-01
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Linkage to Care, Suicidal and Self-injurious Behavior

Keywords

suicidality, self-injurious behavior, adaptive intervention, emergency department, caregivers, youth

Brief 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.

Interventions

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.

Sponsors

Rhode Island Hospital
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Adaptive intervention via Sequential Multiple Assignment Randomized Trial (SMART) design

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Youth 8 to 17 years * Youth presenting to the ED with suicide and self-injurious behavior * Youth living at home with at least one legal guardian/caregiver

Exclusion criteria

* Youth presenting to the ED with psychosis, sexual assault, child abuse * Youth in police custody, * Youth with an active investigation with the department of child and youth services (DCYF) * Youth unable to assent due to severity of illness or developmental disabilities, * Youth who cannot communicate in English or Spanish, * Youth without a caregiver/legal guardian who can provide consent

Design outcomes

Primary

MeasureTime frameDescription
Intervention Feasibility3-month & 6-month follow-up assessmentsRecruitment rate (% of ppl who agree to be in the study), Study completion (% of ppl who complete entire study)
Child and Adolescent Service Assessment (CASA)3-month and 6-month follow-up assessmentsYouth Attendance to Community-based Mental Health Care. CASA question and caregiver report of youth attendance in behavioral health care/community-based mental health services (yes or no) after discharge from emergency department admission.
Intervention Acceptability3-month and 6-month follow-up assessmentsClient Satisfaction Questionnaire. An 8-item questionnaire that provides (positive \& negative) feedback from user opinion. Higher scores = greater satisfaction with intervention.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026