An Adaptive Intervention to Increase Engagement to Community-Based Care After an ED Admission
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: adaptive intervention.
- Who it may be relevant to
- Registry conditions: Suicidal and Self-injurious Behavior, Linkage to Care. Basic parameters: 8 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Detailed description
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.
Interventions
- 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 comm
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Hasbro Children's Hospital — Providence
Publications
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07092345 · 2037770 · K23MH136332