Recruiting

Adaptive Intervention

Sponsor:

Rhode Island Hospital

Code:

NCT07092345

Conditions

Suicidal and Self-injurious Behavior

Linkage to Care

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

adaptive intervention

Study Details

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.

Conditions

Suicidal and Self-injurious Behavior

Linkage to Care

Study ID

NCT07092345

Start date

Mar 17, 2025

Status verified date

Aug, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

186 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

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.

Primary outcome measure

  • Intervention Feasibility [ Time Frame: 3-month & 6-month follow-up assessments ]
  • Child and Adolescent Service Assessment (CASA) [ Time Frame: 3-month and 6-month follow-up assessments ]
  • Intervention Acceptability [ Time Frame: 3-month and 6-month follow-up assessments ]

Central Contacts and Locations

Locations

Hasbro Children's Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Mary Kathryn Cancilliere, PhD

401-444-7443marykathryn.cancilliere@brownhealth.org

More Information

Sponsor

Rhode Island Hospital

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2026-08-14.