Clinical trial NCT05282225: Adaptive Intervention for Adolescents Following Inpatient Psychiatric Care
Official title: Adaptive Intervention to Prevent Adolescent Suicidal Behavior Following Psychiatric Hospitalization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Suicide, Attempted
Suicidal Ideation
Self Harm
Keywords: Adaptive Intervention
Technology-based interventions
In-patient
Sequential, Multiple Assignment, Randomized Trial (SMART)
Adolescent
Safety planning
Mobile technology
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-03-16
Enrollment: 300
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: Sequential, multiple assignment, randomized trial (SMART) design of an adjunctive, multi-component intervention.
Primary purpose: TREATMENT

Brief summary: This study is being completed to examine different combinations of technology-augmented strategies to identify an effective Adaptive intervention (AI) addressing post-discharge suicide risk with high implementation potential.

Detailed description: The proposed study is a sequential multiple assignment randomized trial (SMART) to identify an effective adaptive intervention (AI) for adolescents at elevated suicide risk transitioning from acute psychiatric care. Participants will be initially randomized to Motivational Interview (MI)-enhanced safety planning (MI-SP) or to MI-SP with supportive text messages delivered for four weeks after discharge (Texts) (Phase 1 intervention). Adolescents who are classified as Phase 1 non-responders at the end of the first or at the end of the second week post-discharge, based on their responses to daily surveys , will be re-randomized to either added booster call or portal follow-up (Phase 2 intervention). Those classified as Phase 1 responders at the end of the second week post discharge will continue with the initially assigned intervention options. Thus, participants will receive one of six treatment sequences resulting from the different intervention components or their combinations. These six treatment sequences, in turn, will form four AIs.

The study team anticipates that AIs that begin with MI-SP plus text-based support will have:

* lower odds of suicidal behavior 3 months post discharge
* longer time to suicidal behavior over the 6 month follow-up
* less severe suicidal ideation over the 6-month follow-up

Additionally, the study team anticipates that the AI that begins with MI-SP + Texts followed by portal follow-up for non-responders will lead to:

* lowest odds of suicidal behavior within 3 months
* longest time to suicidal behavior over the 6 month follow up
* least severe ideation over the 6-month follow-up

Eligibility criteria: Inclusion Criteria:

* A suicide attempt in the last month or (2) past-week suicidal ideation (based on the Columbia-Suicide Severity Rating Scale (C-SSRS). In the absence of C-SSRS ratings in the chart, attending physician indication in the chart of the presence of suicidal ideation within the last week or the presence of a suicide attempt in the last month will be used.

Exclusion Criteria:

* Adolescent presenting with severe cognitive impairment or with altered mental status (acute psychosis or acute manic state)
* Transfer to medical unit or residential placement
* No availability of a legal guardian
* Adolescent not owning a cell phone.

Primary outcomes:
measure: The Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: up to 3 months after discharge
Secondary outcomes:
measure: C-SSRS will be used to assess the secondary outcome of time-to-suicidal behavior within 6 months of discharge
timeFrame: up to 6 months
measure: Suicidal Ideation Questionnaire-Junior (SIQ-JR)
timeFrame: up to 6 months after discharge
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan's (Child and Adolescent Psychiatric Inpatient Program)
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System (Kingwood Hospital)
state: Michigan
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: University of Michigan
name: Ewa Czyz
role: PRINCIPAL_INVESTIGATOR
References: