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SuicideNCT05282225

Adaptive Intervention for Adolescents Following Inpatient Psychiatric Care

A study testing MI- Safety Plan, Texts messages and Monitoring in people with Suicide and Suicide, Attempted, run by University of Michigan at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Suicide, Suicide, Attempted, Suicidal Ideation
What is being tested?
MI- Safety Plan, Texts messages and Monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
3 sitesUnited States
Study dates
7 Nov 2022to 6 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • University of Michigan's (Child and Adolescent Psychiatric Inpatient Program)

    Ann Arbor, Michigan, 48109

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Henry Ford Health System (Kingwood Hospital)

    Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: Adaptive Intervention to Prevent Adolescent Suicidal Behavior Following Psychiatric Hospitalization

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
Being tested
MI- Safety Plan, Texts messages, Monitoring, Portal follow-up, Booster call
Keywords
Adaptive Intervention, Technology-based interventions, In-patient, Sequential, Multiple Assignment, Randomized Trial (SMART), Adolescent, Safety planning, Mobile technology
Medical subject headings
Suicide, Suicide, Attempted, Suicidal Ideation, Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MI- Safety PlanBehavioural

    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

  • Texts messagesBehavioural

    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.

  • MonitoringBehavioural

    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.

  • Portal follow-upBehavioural

    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.

  • Booster callBehavioural

    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.

Study groups in NCT05282225
Study groupRoleWhat they receive
MI-SP +supportive Texts + monitoring (Sequence A)ExperimentalSequencing 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.
Receives: Behavioral: MI- Safety Plan; Behavioral: Texts messages; Behavioral: Monitoring
MI-SP + monitoring (Sequence D)ExperimentalSequencing 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.
Receives: Behavioral: MI- Safety Plan; Behavioral: Monitoring
MI-SP + supportive Texts + monitoring + portal follow-up for non-responders (Sequence B).ExperimentalSequencing 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.
Receives: Behavioral: MI- Safety Plan; Behavioral: Texts messages; Behavioral: Monitoring; Behavioral: Portal follow-up
MI-SP + supportive Texts + monitoring + booster call for non-responders (Sequence C)ExperimentalSequencing 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.
Receives: Behavioral: MI- Safety Plan; Behavioral: Texts messages; Behavioral: Monitoring; Behavioral: Booster call
MI-SP + monitoring + portal follow-up for non-responders (Sequence E)ExperimentalSequencing 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.
Receives: Behavioral: MI- Safety Plan; Behavioral: Monitoring; Behavioral: Portal follow-up
MI-SP + monitoring + booster call for non-responders (Sequence F)ExperimentalSequencing 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.
Receives: Behavioral: MI- Safety Plan; Behavioral: Monitoring; Behavioral: Booster call

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: up to 3 months after discharge

Secondary outcomes (2)
  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).

    Measured: 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).

    Measured: up to 6 months after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2022
  2. Study start7 Nov 2022
  3. Primary completion22 Jan 2026
  4. Study completion6 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Sequential, multiple assignment, randomized trial (SMART) design of an adjunctive, multi-component intervention.
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05282225
Sponsor's protocol ID
HUM00204329
Other IDs
1R01MH126871
Status last verified
Jul 2026
First submitted
7 Mar 2022
Last updated
16 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MI- Safety Plan, Texts messages and Monitoring in people with Suicide and Suicide, Attempted, run by University of Michigan at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Columbia-Suicide Severity Rating Scale (C-SSRS) (time frame: up to 3 months after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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