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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23MH113776-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Safety plan (Group D) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MI-Enhanced Safety Plan at Hospitalization (1st Component) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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 | Following intervention and follow-up assessment, measured up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ewa Czyz | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33590475 | Derived | 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. |
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Of a larger number of hospital admissions records reviewed, 94 persons were deemed "eligible" and were approached. 82 consented to participate in the trial, of whom, two participants were consented but excluded prior to randomization because they were discharged early.
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| ID | Title | Description |
|---|---|---|
| FG000 | Safety Plan + Booster Text Messages + Booster Call | 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 in Period/Phase 2 a phone booster call. |
| FG001 | Safety Plan + Booster Text Messages | 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 without booster phone call. |
| FG002 | Safety Plan + Booster Call | 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. |
| FG003 | Safety Plan | 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 with neither follow-up text messages nor booster phone call. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Safety Plan (SP) vs. SP w/Texts |
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| Phase 2: Added Booster Call or Not |
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| 1 Month Follow up Period |
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| 3 Month Follow up Period |
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Phase 1 assigned all 80 participants to safety plan(SP) or SP+text. Phase 2 added booster calls vs. no calls to Phase 1 interventions. Each participant of the 80 is fully included in the two groups shown here. For race, some participants self-described in >1 category, not as "More than 1 race". Thus the totals of participants' self-descriptions for race in each column exceed the actual 40 people shown in other baseline measures.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 - Safety Plan | Participants who received 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | This is the actual number of participants assigned to this group |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Eligible youth whether consent was provided or not | Posted | Number | Percentage of eligible participants | At time of study enrollment, measured following study consent/assent |
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Data on suicide attempts was collected over a 3 month period.
Since all participants were hospitalized for suicide risk (ideation or attempts) to be eligible, those who were unreachable at follow-up weren't included in denominators of suicide attempt data, as they couldn't be presumed to have attempted suicide nor could they be presumed with certainty not to have attempted suicide. Thus it is most accurate to report only known data that is based on collected AEs. Non-serious Adverse Events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Plan + Booster Text Messages + Booster Call (Group A) | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide Attempt | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ewa Czyz | University of Michigan | 734-764-9466 | ewac@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2021 | Apr 5, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D013406 | Suicide, Attempted |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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).
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| 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. |
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| MI-Enhanced Text Boosters (2nd Component) | Behavioral | 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. |
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| MI-Enhanced Booster Call (3rd Component) | Behavioral | 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. |
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| COMPLETED |
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| NOT COMPLETED |
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| Adolescent Surveys Completed |
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| COMPLETED | Completed means parent survey completed |
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| NOT COMPLETED |
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| Adolescent Survey Completed |
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| COMPLETED | Completed means parent survey completed |
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| NOT COMPLETED |
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| Phase 1 - Safety Plan & Text Messages |
Participants who received the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | This is the actual number of participants assigned to this group | Count of Participants | Participants |
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| Race (NIH/OMB) | For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as "More than one race" . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants. | Count of Participants | Participants |
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| Count of participants with at least one suicide attempt during their lifetime | This is the actual number of participants assigned to this group | Count of Participants | Participants |
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| Last-month suicide attempt | This is the actual number of participants assigned to this group | Count of Participants | Participants |
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| Multiple attempt history | This is the actual number of participants assigned to this group | Count of Participants | Participants |
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| Lifetime nonsuicidal self-injury | This is the actual number of participants assigned to this group | Count of Participants | Participants |
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| Suicidal ideation mean | Suicidal Ideation (Columbia-Suicide Severity Rating Scale (C-SSRS)) is scored on a range from 0 (no suicidal ideation) to 5 (suicidal ideation with plan and intent). | This is the actual number of participants assigned to this group | Mean | Standard Deviation | units on a scale |
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| Common Diagnoses | This is the actual number of participants assigned to this group | Count of Participants | Participants |
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| Primary | 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 | No texts and boosters were planned for the associated data fields | Posted | Number | percent of participants | Following intervention, measured up to 1 month |
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| Primary | 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 | Intent to treat analysis includes all participants assigned | Posted | Number | percent of participants | Following intervention and follow-up assessment, measured up to 3 months |
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| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | Following intervention and follow-up assessment, measured up to 3 months |
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| 0 |
| 18 |
| 0 |
| 15 |
| 0 |
| 0 |
| EG001 | Safety Plan + Booster Text Messages (Group B) | 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. | 0 | 22 | 2 | 19 | 0 | 0 |
| EG002 | Safety Plan + Booster Call (Group C) | 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. | 0 | 18 | 3 | 14 | 0 | 0 |
| EG003 | Safety Plan (Group D) | 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. | 0 | 22 | 3 | 20 | 0 | 0 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Booster Texts |
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| Booster Call (Phase 2) |
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| Likelihood of recommending plan to a friend score |
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