An Adaptive Intervention to Increase Engagement to Community-Based Care After an ED Admission
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorRhode Island Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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,
Trial design
Design model
Factorial
Treatments tested in this trial
adaptive intervention
BehavioralWe 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.
Treatment groups
186 Participants
are divided into 3 treatment groupsGroup A: PsychosocialExperimental treatment 1 intervention
Group B: Psychosocial with text messagesExperimental treatment 1 intervention
Group C: Psychosocial with text messages and family navigatorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 assessments2
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 assessments3
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 assessmentsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rhode Island Hospital
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov