SuicideNCT03838198
An Adaptive Intervention for Adolescents at Risk for Suicide: A Pilot SMART
A study testing MI-Enhanced Safety Plan at Hospitalization (1st Component), MI-Enhanced Text Boosters (2nd Component) and MI-Enhanced Booster Call (3rd Component) in people with Suicide and Self Harm, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 17 years
- What is being tested?
- MI-Enhanced Safety Plan at Hospitalization (1st Component), MI-Enhanced Text Boosters (2nd Component) and MI-Enhanced Booster Call (3rd Component)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2019to 7 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Suicide attempt (previous month), and/or
- Suicidal ideation (previous week)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing an Adaptive Intervention for Suicidal Adolescents Following Inpatient Hospitalization: A Pilot SMART
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.
- Being tested
- MI-Enhanced Safety Plan at Hospitalization (1st Component), MI-Enhanced Text Boosters (2nd Component), MI-Enhanced Booster Call (3rd Component)
- Keywords
- Adaptive Intervention, Sequential, Multiple Assignment, Randomized Trial (SMART), Adolescent, Motivational Interviewing, Suicide attempt, Safety planning, mobile technology
- Medical subject headings
- Suicide, Self-Injurious Behavior, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI-Enhanced Safety Plan at Hospitalization (1st Component)Behavioural
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.
MI-Enhanced Text Boosters (2nd Component)Behavioural
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.
MI-Enhanced Booster Call (3rd Component)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: MI-Enhanced Safety Plan at Hospitalization (1st Component) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Following intervention and follow-up assessment, measured up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start14 Mar 2019
- Primary completion7 Apr 2020
- Study completion7 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 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).
- Masking
- None (open label)
- Enrolment
- 82 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
- NCT03838198
- Sponsor's protocol ID
- HUM00129173
- Other IDs
- 1K23MH113776-01
- Status last verified
- May 2021
- First submitted
- 6 Feb 2019
- Last updated
- 28 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33590475
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Adaptive Intervention for Suicidal Adolescents Following Inpatient Hospitalization: A Pilot SMART
- ClinicalTrials.gov ID
- NCT03838198
- Acronym / sponsor ID
- HUM00129173
- Keywords
- Adaptive Intervention, Sequential, Multiple Assignment, Randomized Trial (SMART), Adolescent, Motivational Interviewing, Suicide attempt, Safety planning, mobile technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 7 Apr 2020 (actual)
- Study completion
- 7 Apr 2020 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Posted 28 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Safety plan + booster text messages + booster call (Group A) | Other | Behavioral: MI-Enhanced Safety Plan at Hospitalization (1st Component), Behavioral: MI-Enhanced Text Boosters (2nd Component), Behavioral: MI-Enhanced Booster Call (3rd Component)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. |
| Safety plan + booster text messages (Group B) | Other | Behavioral: MI-Enhanced Safety Plan at Hospitalization (1st Component), Behavioral: MI-Enhanced Text Boosters (2nd Component)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. |
| Safety plan + booster call (Group C) | Other | Behavioral: MI-Enhanced Safety Plan at Hospitalization (1st Component), Behavioral: MI-Enhanced Booster Call (3rd Component)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. |
| Safety plan (Group D) | Other | Behavioral: MI-Enhanced Safety Plan at Hospitalization (1st Component)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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Suicide attempt (previous month), and/or
- Suicidal ideation (previous week)
Key exclusion criteria (4 listed)
- 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
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-Enhanced Safety Plan at Hospitalization (1st Component)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. | Behavioural | 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)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. | Behavioural | Safety plan + booster text messages (Group B), Safety plan + booster text messages + booster call (Group A) |
| MI-Enhanced Booster Call (3rd Component)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. | Behavioural | Safety plan + booster call (Group C), Safety plan + booster text messages + booster call (Group A) |
Primary outcome
Percentage of Eligible Participants Recruited to the Study
Time frame: At time of study enrollment, measured following study consent/assent
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.
Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability
Time frame: Following intervention, measured up to 1 month
Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability
Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability
Time frame: Following intervention and follow-up assessment, measured up to 3 months
Percentage of participants who complete study assessments, including daily surveys, one month and three month follow ups are used to assess feasibility and acceptability
Satisfaction Ratings Will be Used to Assess Acceptability
Time frame: Following intervention and follow-up assessment, measured up to 3 months
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33590475Czyz 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.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI-Enhanced Safety Plan at Hospitalization (1st Component), MI-Enhanced Text Boosters (2nd Component) and MI-Enhanced Booster Call (3rd Component) in people with Suicide and Self Harm, run by University of Michigan at 1 site 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 2 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 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 28 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Eligible Participants Recruited to the Study (time frame: At time of study enrollment, measured following study consent/assent). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03838198, which also lists 1 linked publication.
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 28 May 2021.