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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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
- Conditions
- Suicide, Suicide, Attempted, Suicidal Ideation, Self Harm
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MI- Safety Plan; Behavioral: Texts messages; Behavioral: 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. Receives: Behavioral: MI- Safety Plan; Behavioral: 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. 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) | 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. Receives: Behavioral: MI- Safety Plan; Behavioral: Texts messages; Behavioral: Monitoring; Behavioral: 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. Receives: Behavioral: MI- Safety Plan; Behavioral: Monitoring; Behavioral: 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. 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.
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)
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
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.
- First posted16 Mar 2022
- Study start7 Nov 2022
- Primary completion22 Jan 2026
- Study completion6 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ewa Czyz, University of Michigan
- Investigators
- Ewa Czyz, Principal investigator, University of Michigan
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Intervention to Prevent Adolescent Suicidal Behavior Following Psychiatric Hospitalization
- ClinicalTrials.gov ID
- NCT05282225
- Acronym / sponsor ID
- HUM00204329
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Sequential, multiple assignment, randomized trial (SMART) design of an adjunctive, multi-component intervention.
| Arm | Type | Receives |
|---|---|---|
| MI-SP +supportive Texts + monitoring (Sequence A) | Experimental | Behavioral: MI- Safety Plan, Behavioral: Texts messages, Behavioral: MonitoringSequencing 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. |
| MI-SP + monitoring (Sequence D) | Experimental | Behavioral: MI- Safety Plan, Behavioral: MonitoringSequencing 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. |
| MI-SP + supportive Texts + monitoring + portal follow-up for non-responders (Sequence B). | Experimental | Behavioral: MI- Safety Plan, Behavioral: Texts messages, Behavioral: Monitoring, Behavioral: Portal follow-upSequencing 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. |
| MI-SP + supportive Texts + monitoring + booster call for non-responders (Sequence C) | Experimental | Behavioral: MI- Safety Plan, Behavioral: Texts messages, Behavioral: Monitoring, Behavioral: Booster callSequencing 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. |
| MI-SP + monitoring + portal follow-up for non-responders (Sequence E) | Experimental | Behavioral: MI- Safety Plan, Behavioral: Monitoring, Behavioral: Portal follow-upSequencing 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. |
| MI-SP + monitoring + booster call for non-responders (Sequence F) | Experimental | Behavioral: MI- Safety Plan, Behavioral: Monitoring, Behavioral: Booster callSequencing 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MI- Safety PlanThe 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 | Behavioural | 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 messagesFor 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. | Behavioural | 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) |
| MonitoringAdolescent 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. | Behavioural | 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) |
| Portal follow-upThis 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. | Behavioural | 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 callThe 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. | Behavioural | MI-SP + monitoring + booster call for non-responders (Sequence F), MI-SP + supportive Texts + monitoring + booster call for non-responders (Sequence C) |
Primary outcome
The Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: up to 3 months after discharge
This is a semi-structured interview and will be used to assess suicidal behavior (actual, interrupted, aborted suicide attempts).
2 secondary outcomes
C-SSRS will be used to assess the secondary outcome of time-to-suicidal behavior within 6 months of discharge
Time frame: up to 6 months
Suicidal Ideation Questionnaire-Junior (SIQ-JR)
Time frame: up to 6 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Czyz principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
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.