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

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ClinicalTrials.gov Identifier: NCT03838198
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Ewa Czyz, 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.

Condition or disease Intervention/treatment Phase
Suicide Self Harm Behavioral: MI-Enhanced Safety Plan at Hospitalization (1st Component) Behavioral: MI-Enhanced Text Boosters (2nd Component) Behavioral: MI-Enhanced Booster Call (3rd Component) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This Sequential, Multiple Assignment, Randomized Trial (SMART) pilot of a Motivational Interview (MI)-enhanced safety planning intervention is designed to inform the development of a technology-augmented adaptive intervention for youth at risk for suicide. The MI-SafeCope intervention includes three components: (1) MI-enhanced safety plan delivered during hospitalization (encompassing individual and family meetings); (2) post-discharge booster call; and (3) post-discharge daily text message boosters. In this SMART pilot, adolescents will be randomized to either MI-enhanced safety plan alone or in combination with text boosters for two weeks after discharge (Phase 1 intervention). At the end of week 2, adolescents will be re-randomized to two additional weeks of either: continuation of Phase 1 intervention or continuation of Phase 1 intervention with the addition of post-discharge booster call. Thus, participants will receive one of four treatment sequences (Groups A-D).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Developing an Adaptive Intervention for Suicidal Adolescents Following Inpatient Hospitalization: A Pilot SMART
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Safety plan + booster text messages + booster call (Group A)
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.
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.

Behavioral: 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.

Behavioral: 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.

Safety plan + booster text messages (Group B)
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.
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.

Behavioral: 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.

Safety plan + booster call (Group C)
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.
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.

Behavioral: 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.

Safety plan (Group D)
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.
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.




Primary Outcome Measures :
  1. Percentage of eligible participants recruited will be used to asses feasibility and acceptability [ Time Frame: At time of study enrollment, measured following study consent/assent ]
  2. Percentage of randomized participants and who complete intervention components will be used to assess feasibility and acceptability [ Time Frame: Following intervention, measured up to 1 months ]
  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 ]
  4. Satisfaction ratings will be used to assess acceptability [ Time Frame: Following intervention and follow-up assessment, measured up to 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838198


Contacts
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Contact: Ewa Czyz 734-764-9466 ewac@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ewa Czyz    734-647-6727    ewac@umich.edu   
Sponsors and Collaborators
University of Michigan
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Ewa Czyz University of Michigan

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Responsible Party: Ewa Czyz, Research Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03838198     History of Changes
Other Study ID Numbers: HUM00129173
1K23MH113776-01 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ewa Czyz, University of Michigan:
Adaptive Intervention
Sequential, Multiple Assignment, Randomized Trial (SMART)
Adolescent
Motivational Interviewing
Suicide attempt
Safety planning
mobile technology
Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms