NCT05282225

Brief Summary

This study is being completed to examine different combinations of technology-augmented strategies to identify an effective Adaptive intervention (AI) addressing post-discharge suicide risk with high implementation potential.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Nov 2022Jun 2026

First Submitted

Initial submission to the registry

March 7, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

November 7, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

3.6 years

First QC Date

March 7, 2022

Last Update Submit

November 21, 2025

Conditions

Keywords

Adaptive InterventionTechnology-based interventionsIn-patientSequential, Multiple Assignment, Randomized Trial (SMART)AdolescentSafety planningMobile technology

Outcome Measures

Primary Outcomes (1)

  • The Columbia-Suicide Severity Rating Scale (C-SSRS)

    This is a semi-structured interview and will be used to assess suicidal behavior (actual, interrupted, aborted suicide attempts).

    up to 3 months after discharge

Secondary Outcomes (2)

  • C-SSRS will be used to assess the secondary outcome of time-to-suicidal behavior within 6 months of discharge

    up to 6 months

  • Suicidal Ideation Questionnaire-Junior (SIQ-JR)

    up to 6 months after discharge

Study Arms (6)

MI-SP +supportive Texts + monitoring (Sequence A)

EXPERIMENTAL

Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group A: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of supportive Texts and monitoring post discharge.

Behavioral: MI- Safety PlanBehavioral: Texts messagesBehavioral: Monitoring

MI-SP + monitoring (Sequence D)

EXPERIMENTAL

Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group D: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of monitoring post discharge.

Behavioral: MI- Safety PlanBehavioral: Monitoring

MI-SP + supportive Texts + monitoring + portal follow-up for non-responders (Sequence B).

EXPERIMENTAL

Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group B: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of supportive Texts and monitoring post discharge in addition to the portal follow-up for non-responders.

Behavioral: MI- Safety PlanBehavioral: Texts messagesBehavioral: MonitoringBehavioral: Portal follow-up

MI-SP + supportive Texts + monitoring + booster call for non-responders (Sequence C)

EXPERIMENTAL

Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group C: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of supportive Texts and monitoring post discharge in addition to the booster call for non-responders.

Behavioral: MI- Safety PlanBehavioral: Texts messagesBehavioral: MonitoringBehavioral: Booster call

MI-SP + monitoring + portal follow-up for non-responders (Sequence E)

EXPERIMENTAL

Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group E: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of monitoring post discharge in addition to the portal follow-up for non-responders.

Behavioral: MI- Safety PlanBehavioral: MonitoringBehavioral: Portal follow-up

MI-SP + monitoring + booster call for non-responders (Sequence F)

EXPERIMENTAL

Sequencing of intervention components (Phase 1 and Phase 2) resulting in Sequence or Group F: Participants will receive the in-person MI-enhanced safety plan (MI-SP) during hospitalization followed by 4 weeks of monitoring post discharge in addition to the booster call for non-responders.

Behavioral: MI- Safety PlanBehavioral: MonitoringBehavioral: Booster call

Interventions

MI- Safety PlanBEHAVIORAL

The MI-enhanced safety plan (MI-SP) 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-SP + monitoring (Sequence D)MI-SP + monitoring + booster call for non-responders (Sequence F)MI-SP + monitoring + portal follow-up for non-responders (Sequence E)MI-SP + supportive Texts + monitoring + booster call for non-responders (Sequence C)MI-SP + supportive Texts + monitoring + portal follow-up for non-responders (Sequence B).MI-SP +supportive Texts + monitoring (Sequence A)
Texts messagesBEHAVIORAL

For participants randomized to receive supportive text messages (Texts), 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-SP + supportive Texts + monitoring + booster call for non-responders (Sequence C)MI-SP + supportive Texts + monitoring + portal follow-up for non-responders (Sequence B).MI-SP +supportive Texts + monitoring (Sequence A)
MonitoringBEHAVIORAL

Adolescent participants will complete daily surveys for 4 weeks (including assessment of suicidal ideation, behavior, and other relevant risk and protective factors) and these will be monitored daily to identify presence of heightened suicidal ideation and presence of suicidal behavior. In addition, daily surveys will be used to determine if adolescents are sufficient responders to Phase 1 intervention.

MI-SP + monitoring (Sequence D)MI-SP + monitoring + booster call for non-responders (Sequence F)MI-SP + monitoring + portal follow-up for non-responders (Sequence E)MI-SP + supportive Texts + monitoring + booster call for non-responders (Sequence C)MI-SP + supportive Texts + monitoring + portal follow-up for non-responders (Sequence B).MI-SP +supportive Texts + monitoring (Sequence A)

This will be part of Phase 2. The portal follow-up will similarly address content offered in the booster call. For the adolescent, the focus will be on revisiting and adjusting the safety plan, addressing barriers to safety plan adherence, as well as enhancing motivation and self-efficacy to use healthy coping. For the parent, portal communication will focus on revisiting safety recommendations provided as part of MI-SP, addressing barriers in implementing safety recommendations and in supporting the adolescent's safety plan use, as well as enhancing parents' motivation and self-efficacy in these areas. The portal will enable additional asynchronous contacts up to 3 weeks to provide added support and problem solving, based on identified barriers and concerns, to promote post-discharge behavior change. Counselors will initiate approximately 6 contacts with adolescents and, separately, with parents over 3 weeks as soon as non-response is detected.

MI-SP + monitoring + portal follow-up for non-responders (Sequence E)MI-SP + supportive Texts + monitoring + portal follow-up for non-responders (Sequence B).
Booster callBEHAVIORAL

The focus of the post-discharge booster phone call with adolescent and with parent, each conducted separately, is 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.

MI-SP + monitoring + booster call for non-responders (Sequence F)MI-SP + supportive Texts + monitoring + booster call for non-responders (Sequence C)

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • A suicide attempt in the last month or (2) past-week suicidal ideation (based on the Columbia-Suicide Severity Rating Scale (C-SSRS). In the absence of C-SSRS ratings in the chart, attending physician indication in the chart of the presence of suicidal ideation within the last week or the presence of a suicide attempt in the last month will be used.

You may not qualify if:

  • Adolescent presenting with severe cognitive impairment or with altered mental status (acute psychosis or acute manic state)
  • Transfer to medical unit or residential placement
  • No availability of a legal guardian
  • Adolescent not owning a cell phone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Michigan's (Child and Adolescent Psychiatric Inpatient Program)

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System (Kingwood Hospital)

Detroit, Michigan, 48202, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

SuicideSuicide, AttemptedSuicidal IdeationSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Ewa Czyz

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Sequential, multiple assignment, randomized trial (SMART) design of an adjunctive, multi-component intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Psychiatry, University of Michigan

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 16, 2022

Study Start

November 7, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations