An interventional study of adaptive intervention in Suicidal and Self-injurious Behavior and Linkage to Care, sponsored by Rhode Island Hospital. Recruiting at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Health services research
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.
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.
303 studies on the registry are indexed under Self-Injurious Behavior; 105 are open to participants now.
This study's planned enrollment of 186 is above the median of 70 across 254 interventional studies indexed under Self-Injurious Behavior.
Browse Self-Injurious Behavior studies →Rhode Island Hospital is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Digitally delivered psychosocial
Behavioral: adaptive intervention
Digitally delivered psychosocial with text messages
Behavioral: adaptive intervention
Digitally delivered psychosocial with text messages and human family navigator
Behavioral: 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.
Intervention Feasibility
Recruitment rate (% of ppl who agree to be in the study), Study completion (% of ppl who complete entire study)
Time frame: 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.
Time frame: 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.
Time frame: 3-month and 6-month follow-up assessments
Started Mar 2025 (actual). Primary completion is estimated for Jan 2029, 46 months after the start.
Of 161 non-industry interventional studies with no phase under Self-Injurious Behavior, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 53. This study's planned 46 months is above that.
Counting every sponsor, half of 163 studies reached it within 28 months; a quarter within 15 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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