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Clinical Trials/NCT05282225
NCT05282225
Active, not recruiting
Not Applicable

Adaptive Intervention to Prevent Adolescent Suicidal Behavior Following Psychiatric Hospitalization

University of Michigan3 sites in 1 country300 target enrollmentNovember 7, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicide
Sponsor
University of Michigan
Enrollment
300
Locations
3
Primary Endpoint
The Columbia-Suicide Severity Rating Scale (C-SSRS)
Status
Active, not recruiting
Last Updated
5 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 7, 2022
End Date
June 30, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ewa Czyz

Assistant Professor, Department of Psychiatry, University of Michigan

University of Michigan

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.

Outcomes

Primary Outcomes

The Columbia-Suicide Severity Rating Scale (C-SSRS)

Time Frame: up to 3 months after discharge

This is a semi-structured interview and will be used to assess suicidal behavior (actual, interrupted, aborted suicide attempts).

Secondary Outcomes

  • C-SSRS will be used to assess the secondary outcome of time-to-suicidal behavior within 6 months of discharge(up to 6 months)
  • Suicidal Ideation Questionnaire-Junior (SIQ-JR)(up to 6 months after discharge)

Study Sites (3)

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