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

NCT03838198 | Completed Results

• 2 other identifiers: HUM001291731K23MH113776-01
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide; Self Harm

Keywords

Adaptive Intervention; Sequential, Multiple Assignment, Randomized Trial (SMART); Adolescent; Motivational Interviewing; Suicide attempt; Safety planning; mobile technology

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (4)

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

OTHER

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); Behavioral: MI-Enhanced Text Boosters (2nd Component); Behavioral: MI-Enhanced Booster Call (3rd Component)

Safety plan + booster text messages (Group B)

OTHER

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); Behavioral: MI-Enhanced Text Boosters (2nd Component)

Safety plan + booster call (Group C)

OTHER

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); Behavioral: MI-Enhanced Booster Call (3rd Component)

Safety plan (Group D)

OTHER

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)

Interventions

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.

Safety plan (Group D); Safety plan + booster call (Group C); Safety plan + booster text messages (Group B); Safety plan + booster text messages + booster call (Group A)

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.

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

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.

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

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 33590475 DERIVED

MeSH Terms

Conditions

Suicide; Self-Injurious Behavior; Suicide, Attempted

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Ewa Czyz
• Organization: University of Michigan

ewac@umich.edu

734-764-9466

Study Officials

• Ewa Czyz

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 12, 2019
• Study Start: March 14, 2019
• Primary Completion: April 7, 2020
• Study Completion: April 7, 2020
• Last Updated: May 28, 2021
• Results First Posted: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)