Suicide Clinical Trial
Official title:
Developing an Adaptive Intervention for Suicidal Adolescents Following Inpatient Hospitalization: A Pilot SMART
Verified date | May 2021 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | April 7, 2020 |
Est. primary completion date | April 7, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Eligible Participants Recruited to the Study | 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. |
At time of study enrollment, measured following study consent/assent | |
Primary | Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability | Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability | Following intervention, measured up to 1 month | |
Primary | Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability | Percentage of participants who complete study assessments, including daily surveys, one month and three month follow ups are used to assess feasibility and acceptability | Following intervention and follow-up assessment, measured up to 3 months | |
Primary | Satisfaction Ratings Will be Used to Assess Acceptability | 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 | Following intervention and follow-up assessment, measured up to 3 months |
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