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

Not Applicable

Completed

• Conditions: Suicide; Self Harm
• Interventions: Behavioral: MI-Enhanced Safety Plan at Hospitalization (1st Component); Behavioral: MI-Enhanced Text Boosters (2nd Component); Behavioral: MI-Enhanced Booster Call (3rd Component)

• Registration Number: NCT03838198
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-12
• Study Start: 2019-03-14
• Primary Completion: 2020-04-07
• Study Completion: 2020-04-07
• Results First Submitted: 2021-04-07
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-06
• Last Update Submitted: 2021-05-06
• Results First Posted: 2021-05-28
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Suicide attempt (previous month), and/or
• Suicidal ideation (previous week)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Safety plan + booster text messages + booster call (Group A)	MI-Enhanced Safety Plan at Hospitalization (1st Component)	Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call.
Safety plan + booster text messages + booster call (Group A)	MI-Enhanced Booster Call (3rd Component)	Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call.
Safety plan + booster text messages (Group B)	MI-Enhanced Safety Plan at Hospitalization (1st Component)	Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.
Safety plan + booster text messages + booster call (Group A)	MI-Enhanced Text Boosters (2nd Component)	Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call.
Safety plan + booster text messages (Group B)	MI-Enhanced Text Boosters (2nd Component)	Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.
Safety plan + booster call (Group C)	MI-Enhanced Booster Call (3rd Component)	Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.
Safety plan (Group D)	MI-Enhanced Safety Plan at Hospitalization (1st Component)	Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization.
Safety plan + booster call (Group C)	MI-Enhanced Safety Plan at Hospitalization (1st Component)	Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.

Primary Outcome Measures

Name	Time	Method
Satisfaction Ratings Will be Used to Assess Acceptability	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	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	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	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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States