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

Lifespan

Status: Enrolling

Conditions: Linkage to Care; Suicidal and Self-injurious Behavior

Treatments: Behavioral: adaptive intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07092345

K23MH136332 (U.S. NIH Grant/Contract)

2037770

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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186 participants in 3 patient groups

Psychosocial

Experimental group

Description:

Digitally delivered psychosocial

Treatment:

Behavioral: adaptive intervention

Psychosocial with text messages

Experimental group

Description:

Digitally delivered psychosocial with text messages

Treatment:

Behavioral: adaptive intervention

Psychosocial with text messages and family navigator

Experimental group

Description:

Digitally delivered psychosocial with text messages and human family navigator

Treatment:

Behavioral: adaptive intervention