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NCT Number: NCT07092345

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

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.

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Key information

Conditions

Suicidal and Self-Injurious Behavior Behavior Behavioral Symptoms Disease Attributes Emergencies Linkage to Care Pathologic Processes Pathological Conditions, Signs and Symptoms Self-Injurious Behavior Suicidal Ideation Suicide

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location status: Recruiting

Location contact

Mary Kathryn Cancilliere, PhD

CONTACT

[email protected]

401-444-7443

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Intervention Feasibility

    Time frame: 3-month & 6-month follow-up assessments

    Recruitment rate (% of ppl who agree to be in the study), Study completion (% of ppl who complete entire study)

  2. Child and Adolescent Service Assessment (CASA)

    Time frame: 3-month and 6-month follow-up assessments

    Youth 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.

  3. Intervention Acceptability

    Time frame: 3-month and 6-month follow-up assessments

    Client Satisfaction Questionnaire. An 8-item questionnaire that provides (positive & negative) feedback from user opinion. Higher scores = greater satisfaction with intervention.

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: ED_SMART

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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