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Completed

NCT Number: NCT03838198

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

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.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Self Harm Self-Injurious Behavior Suicide, Attempted

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MI-Enhanced Safety Plan at Hospitalization (1st Component)

Behavioral

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)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 12, 2019
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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