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

NCT07092345 | Recruiting DMC

• 2 other identifiers: 2037770K23MH136332
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Intervention Feasibility

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

  3-month & 6-month follow-up assessments

• Child and Adolescent Service Assessment (CASA)

  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-month and 6-month follow-up assessments

• Intervention Acceptability

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

  3-month and 6-month follow-up assessments

Study Arms (3)

Psychosocial

EXPERIMENTAL

Digitally delivered psychosocial

Behavioral: adaptive intervention

Psychosocial with text messages

EXPERIMENTAL

Digitally delivered psychosocial with text messages

Behavioral: adaptive intervention

Psychosocial with text messages and family navigator

EXPERIMENTAL

Digitally delivered psychosocial with text messages and human family navigator

Behavioral: adaptive intervention

Interventions

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.

Psychosocial; Psychosocial with text messages; Psychosocial with text messages and family navigator

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (4)

• Cancilliere MK, Ramanathan A, Hoffman P, Jencks J, Spirito A, Donise K. Characteristics of a Pediatric Emergency Psychiatric Telephone Triage Service. Pediatr Emerg Care. 2022 Oct 1;38(10):494-501. doi: 10.1097/PEC.0000000000002831. Epub 2022 Aug 18.

  PMID: 35981327 BACKGROUND

• Spirito A, Simon V, Cancilliere MK, Stein R, Norcott C, Loranger K, Prinstein MJ. Outpatient psychotherapy practice with adolescents following psychiatric hospitalization for suicide ideation or a suicide attempt. Clin Child Psychol Psychiatry. 2011 Jan;16(1):53-64. doi: 10.1177/1359104509352893. Epub 2010 Apr 19.

  PMID: 20404070 BACKGROUND

• Cancilliere MK, Donise K. A Comparison of Acute Mental Health Presentations to Emergency Services Before and During the COVID-19 Pandemic. R I Med J (2013). 2022 May 2;105(4):9-15.

  PMID: 35476729 BACKGROUND

• Cancilliere MK, Guthrie KM, Donise K, Lin T, Orchowski L, Spirito A. Development of an Emergency Department Family Navigator and Text Message Intervention for Caregivers to Reduce Youth Risk of Suicide and Self-injurious Behavior. R I Med J (2013). 2024 Aug 1;107(8):28-38.

  PMID: 39058987 BACKGROUND

MeSH Terms

Conditions

Self-Injurious Behavior; Suicidal Ideation; Emergencies

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: July 29, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

US (1)