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Clinical Trials/NCT03838198
NCT03838198CompletedNot Applicable

Developing an Adaptive Intervention for Suicidal Adolescents Following Inpatient Hospitalization: A Pilot SMART

University of Michigan2 sites in 1 country82 target enrollmentStarted: March 14, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
82
Locations
2
Primary Endpoint
Satisfaction Ratings Will be Used to Assess Acceptability

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
13 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Satisfaction Ratings Will be Used to Assess Acceptability

Time Frame: Following intervention and follow-up assessment, measured up to 3 months

Satisfaction was scored by responses to two questions: How satisfied were you? on a 4 point scale, where 1 means very dissatisfied and 4 means very satisfied and how likely would you be to recommend this program to a friend in similar circumstances, on the same point scale, where 1 means definitely not and 4 means definitely yes

Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability

Time Frame: Following intervention and follow-up assessment, measured up to 3 months

Percentage of participants who complete study assessments, including daily surveys, one month and three month follow ups are used to assess feasibility and acceptability

Percentage of Eligible Participants Recruited to the Study

Time Frame: At time of study enrollment, measured following study consent/assent

Eligible participants were candidates for participation based on medical record review who were approached for consent/assent. The percentage of eligible participants who consented to the study is presented below.

Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability

Time Frame: Following intervention, measured up to 1 month

Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ewa Czyz

Assistant Professor

University of Michigan

Study Sites (2)

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