An Adaptive Intervention for Adolescents at Risk for Suicide: A Pilot SMART

Suicide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03838198
• Other study ID #: HUM00129173
• Secondary ID: 1K23MH113776-01
• Status: Completed
• Phase: N/A
• Start date: March 14, 2019
• Est. completion date: April 7, 2020

Study information

• Verified date: May 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Self Harm
• Suicide

Intervention

Behavioral:
• MI-Enhanced Safety Plan at Hospitalization (1st Component)
The MI-enhanced safety plan intervention component is delivered during hospitalization and includes an individual and family meetings. The goal of the individual meeting with the adolescent is to develop an individualized safety plan for use during a suicidal crisis. This "best practices" approach of safety planning is augmented with Motivational Interviewing (MI) as a core strategy to explicitly elicit adolescents' motivation and commitment to behavior change (i.e. use safety plan; adaptive coping), address barriers or ambivalence, and strengthen self-efficacy. The focus of the family meeting, which is similarly guided by MI, is to prepare parents/guardians, with input from the adolescent, for how they may support the adolescent in implementing the individualized safety plan after discharge and on strengthening parents' commitment and self-efficacy.
• MI-Enhanced Text Boosters (2nd Component)
For participants randomized to receive text boosters, booster text messages will be sent daily for 4 weeks. The messages will be tailored to encourage use of individualized coping strategies identified as part of safety planning at hospitalization and will include additional adaptive coping tools and resources. The text message content and tone will be consistent with principles of MI.
• MI-Enhanced Booster Call (3rd Component)
The focus of the post-discharge booster phone call with adolescent and with parent, each conducted separately, will be to to further adjust the safety plan to better meet post-discharge needs, to further enhance adolescents' motivation and commitment to use coping strategies, and to further support adolescents' and parents' self-efficacy to manage suicidal crises.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

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