CClinicalTrials.gg
CompletedNCT05282225Updated Jul 16, 2026

Adaptive Intervention for Adolescents Following Inpatient Psychiatric Care

An interventional study of MI- Safety Plan and Texts messages in Suicide, Suicide, Attempted and Suicidal Ideation, sponsored by University of Michigan. Completed at 3 sites in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by University of Michigan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
13 Years to 17 Years
Sex
All
01

Study 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.

Read the detailed description

The proposed study is a sequential multiple assignment randomized trial (SMART) to identify an effective adaptive intervention (AI) for adolescents at elevated suicide risk transitioning from acute psychiatric care. Participants will be initially randomized to Motivational Interview (MI)-enhanced safety planning (MI-SP) or to MI-SP with supportive text messages delivered for four weeks after discharge (Texts) (Phase 1 intervention). Adolescents who are classified as Phase 1 non-responders at the end of the first or at the end of the second week post-discharge, based on their responses to daily surveys , will be re-randomized to either added booster call or portal follow-up (Phase 2 intervention). Those classified as Phase 1 responders at the end of the second week post discharge will continue with the initially assigned intervention options. Thus, participants will receive one of six treatment sequences resulting from the different intervention components or their combinations. These six treatment sequences, in turn, will form four AIs.

The study team anticipates that AIs that begin with MI-SP plus text-based support will have:

  • lower odds of suicidal behavior 3 months post discharge
  • longer time to suicidal behavior over the 6 month follow-up
  • less severe suicidal ideation over the 6-month follow-up

Additionally, the study team anticipates that the AI that begins with MI-SP + Texts followed by portal follow-up for non-responders will lead to:

  • lowest odds of suicidal behavior within 3 months
  • longest time to suicidal behavior over the 6 month follow up
  • least severe ideation over the 6-month follow-up
02

Conditions studied

  • Suicide
  • Suicide, Attempted
  • Suicidal Ideation
  • Self Harm

Keywords

  • Adaptive Intervention
  • Technology-based interventions
  • In-patient
  • Sequential, Multiple Assignment, Randomized Trial (SMART)
  • Adolescent
  • Safety planning
  • Mobile technology
03

In context

Suicide

701 studies on the registry are indexed under Suicide; 183 are open to participants now.

This study's enrollment of 300 is above the median of 104 across 560 interventional studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

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

    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 Plan · Behavioral: Texts messages · Behavioral: Monitoring

  • Experimental
    MI-SP + monitoring (Sequence D)

    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 Plan · Behavioral: Monitoring

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

    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 Plan · Behavioral: Texts messages · Behavioral: Monitoring · Behavioral: Portal follow-up

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

    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 Plan · Behavioral: Texts messages · Behavioral: Monitoring · Behavioral: Booster call

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

    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 Plan · Behavioral: Monitoring · Behavioral: Portal follow-up

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

    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 Plan · Behavioral: Monitoring · Behavioral: Booster call

Interventions

  • BehavioralMI- Safety Plan

    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

  • BehavioralTexts messages

    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.

  • BehavioralMonitoring

    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.

  • BehavioralPortal follow-up

    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.

  • BehavioralBooster call

    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.

06

What researchers measure

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).

    Time frame: up to 3 months after discharge

Secondary outcomes

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

    The Columbia-Suicide Severity Rating Scale (C-SSRS), a semi-structured interview, will be used to assess suicidal behavior (actual, interrupted, aborted suicide attempts).

    Time frame: up to 6 months

  2. Suicidal Ideation Questionnaire-Junior (SIQ-JR)

    Suicide ideation will be measured using the Suicidal Ideation Questionnaire (SIQ-JR), a 15-item measure of adolescents' distress and suicidal intent. Scale scores range from 0 to 90, with higher scores meaning a worse outcome (i.e., greater suicide ideation).

    Time frame: up to 6 months after discharge

07

Study locations

3 sites
  • University of Michigan's (Child and Adolescent Psychiatric Inpatient Program)
    Ann Arbor, Michigan 48109, United States
  • Henry Ford Health System (Kingwood Hospital)
    Detroit, Michigan 48202, United States
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05282225
Lead sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Ewa Czyz (Assistant Professor, Department of Psychiatry, University of Michigan, University of Michigan) — Principal investigator
First posted
Mar 16, 2022
Start date
Nov 7, 2022
Primary completion
Jan 22, 2026
Completion
Apr 6, 2026
Last update
Jul 16, 2026

Study contacts

Ewa Czyz
principal investigator · University of Michigan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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