Clinical trial NCT03838198: An Adaptive Intervention for Adolescents at Risk for Suicide: A Pilot SMART
Official title: Developing an Adaptive Intervention for Suicidal Adolescents Following Inpatient Hospitalization: A Pilot SMART
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Self Harm
Keywords: Adaptive Intervention
Sequential, Multiple Assignment, Randomized Trial (SMART)
Adolescent
Motivational Interviewing
Suicide attempt
Safety planning
mobile technology
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-02-12
Enrollment: 82
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This Sequential, Multiple Assignment, Randomized Trial (SMART) pilot of a Motivational Interview (MI)-enhanced safety planning intervention is designed to inform the development of a technology-augmented adaptive intervention for youth at risk for suicide. The MI-SafeCope intervention includes three components: (1) MI-enhanced safety plan delivered during hospitalization (encompassing individual and family meetings); (2) post-discharge booster call; and (3) post-discharge daily text message boosters. In this SMART pilot, adolescents will be randomized to either MI-enhanced safety plan alone or in combination with text boosters for two weeks after discharge (Phase 1 intervention). At the end of week 2, adolescents will be re-randomized to two additional weeks of either: continuation of Phase 1 intervention or continuation of Phase 1 intervention with the addition of post-discharge booster call. Thus, participants will receive one of four treatment sequences (Groups A-D).
Primary purpose: TREATMENT

Brief summary: To inform the development of a technology-augmented adaptive intervention for adolescents at risk for suicide, the goal of this study is to conduct a Sequential, Multiple Assignment, Randomized Trial (SMART) pilot of a Motivational Interview (MI)-enhanced safety planning intervention (MI-SafeCope). Findings from this study will provide the groundwork for the construction of a technology-augmented adaptive intervention that could lead to a reduction in suicidal behaviors and related events during the high-risk post-discharge period-an important suicide prevention target.


Eligibility criteria: Inclusion Criteria:

* Suicide attempt (previous month), and/or
* Suicidal ideation (previous week)

Exclusion Criteria:

* Severe cognitive impairment or altered mental status (psychosis, manic state)
* Transfer to medical unit or residential placement
* No availability of a legal guardian
* No cell phone with text messaging capability

Primary outcomes:
measure: Percentage of Eligible Participants Recruited to the Study
timeFrame: At time of study enrollment, measured following study consent/assent
measure: Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability
timeFrame: Following intervention, measured up to 1 month
measure: Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability
timeFrame: Following intervention and follow-up assessment, measured up to 3 months
measure: Satisfaction Ratings Will be Used to Assess Acceptability
timeFrame: Following intervention and follow-up assessment, measured up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ewa Czyz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Czyz EK, King CA, Prouty D, Micol VJ, Walton M, Nahum-Shani I. Adaptive intervention for prevention of adolescent suicidal behavior after hospitalization: a pilot sequential multiple assignment randomized trial. J Child Psychol Psychiatry. 2021 Aug;62(8):1019-1031. doi: 10.1111/jcpp.13383. Epub 2021 Feb 15.