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

Primary Purpose

Suicide, Self Harm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MI-Enhanced Safety Plan at Hospitalization (1st Component)
MI-Enhanced Text Boosters (2nd Component)
MI-Enhanced Booster Call (3rd Component)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Adaptive Intervention, Sequential, Multiple Assignment, Randomized Trial (SMART), Adolescent, Motivational Interviewing, Suicide attempt, Safety planning, mobile technology

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Safety plan + booster text messages + booster call (Group A)

Safety plan + booster text messages (Group B)

Safety plan + booster call (Group C)

Safety plan (Group D)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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
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
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

Secondary Outcome Measures

Full Information

First Posted
February 6, 2019
Last Updated
May 6, 2021
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03838198
Brief Title
An Adaptive Intervention for Adolescents at Risk for Suicide: A Pilot SMART
Official Title
Developing an Adaptive Intervention for Suicidal Adolescents Following Inpatient Hospitalization: A Pilot SMART
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 14, 2019 (Actual)
Primary Completion Date
April 7, 2020 (Actual)
Study Completion Date
April 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Self Harm
Keywords
Adaptive Intervention, Sequential, Multiple Assignment, Randomized Trial (SMART), Adolescent, Motivational Interviewing, Suicide attempt, Safety planning, mobile technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safety plan + booster text messages + booster call (Group A)
Arm Type
Other
Arm Description
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.
Arm Title
Safety plan + booster text messages (Group B)
Arm Type
Other
Arm Description
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.
Arm Title
Safety plan + booster call (Group C)
Arm Type
Other
Arm Description
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.
Arm Title
Safety plan (Group D)
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MI-Enhanced Safety Plan at Hospitalization (1st Component)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MI-Enhanced Text Boosters (2nd Component)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MI-Enhanced Booster Call (3rd Component)
Intervention Description
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 Outcome Measure Information:
Title
Percentage of Eligible Participants Recruited to the Study
Description
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.
Time Frame
At time of study enrollment, measured following study consent/assent
Title
Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability
Description
Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability
Time Frame
Following intervention, measured up to 1 month
Title
Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability
Description
Percentage of participants who complete study assessments, including daily surveys, one month and three month follow ups are used to assess feasibility and acceptability
Time Frame
Following intervention and follow-up assessment, measured up to 3 months
Title
Satisfaction Ratings Will be Used to Assess Acceptability
Description
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
Time Frame
Following intervention and follow-up assessment, measured up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewa Czyz
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33590475
Citation
Czyz EK, King CA, Prouty D, Micol VJ, Walton M, Nahum-Shani I. Adaptive intervention for prevention of adolescent suicidal behavior after hospitalization: a pilot sequential multiple assignment randomized trial. J Child Psychol Psychiatry. 2021 Aug;62(8):1019-1031. doi: 10.1111/jcpp.13383. Epub 2021 Feb 15.
Results Reference
derived

Learn more about this trial

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

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