An interventional study of MI-Enhanced Safety Plan at Hospitalization (1st Component) and MI-Enhanced Text Boosters (2nd Component) in Suicide and Self Harm, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-05-28.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
701 studies on the registry are indexed under Suicide; 183 are open to participants now.
This study's enrollment of 82 is below the median of 104 across 560 interventional studies indexed under Suicide.
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Exclusion Criteria:
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.
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 B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.
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 C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.
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 D: Participants will receive the in-person MI-enhanced safety plan during hospitalization.
Behavioral: 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.
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.
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.
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Following intervention and follow-up assessment, measured up to 3 months
| Milestone | Safety Plan + Booster Text Messages + Booster Call | Safety Plan + Booster Text Messages | Safety Plan + Booster Call | Safety Plan |
|---|---|---|---|---|
| Started | 0 | 40 | 0 | 40 |
| Completed | 0 | 40 | 0 | 40 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Safety Plan + Booster Text Messages + Booster Call | Safety Plan + Booster Text Messages | Safety Plan + Booster Call | Safety Plan |
|---|---|---|---|---|
| Started | 18 | 22 | 18 | 22 |
| Completed | 18 | 0 | 17 | 0 |
| Not completed | 0 | 22 | 1 | 22 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 |
| Withdrew: In this smart trial design, this group was randomized to "no booster call. | 0 | 22 | 0 | 22 |
| Milestone | Safety Plan + Booster Text Messages + Booster Call | Safety Plan + Booster Text Messages | Safety Plan + Booster Call | Safety Plan |
|---|---|---|---|---|
| Started | 18 | 22 | 17 | 22 |
| Adolescent surveys completed | 16 | 22 | 16 | 22 |
| Completed | 16 | 22 | 16 | 21 |
| Not completed | 2 | 0 | 1 | 1 |
| Milestone | Safety Plan + Booster Text Messages + Booster Call | Safety Plan + Booster Text Messages | Safety Plan + Booster Call | Safety Plan |
|---|---|---|---|---|
| Started | 18 | 22 | 17 | 22 |
| Adolescent survey completed | 16 | 21 | 15 | 21 |
| Completed | 15 | 19 | 14 | 18 |
| Not completed | 3 | 3 | 3 | 4 |
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 eligible participants | All Eligible Youth |
|---|---|
| Percentage of Eligible Participants Recruited to the Study | 87.2 |
Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability
| percent of participants | Safety Plan + Booster Text Messages + Booster Call (Group A) | Safety Plan + Booster Text Messages (Group B) | Safety Plan + Booster Call (Group C) | Safety Plan (Group D) |
|---|---|---|---|---|
| Safety Plan (Phase 1) | 100 | 100 | 100 | 100 |
| Booster Texts | 100 | 100 | — | — |
| Booster Call (Phase 2) | 88.9 | — | 88.9 | — |
Percentage of participants who complete study assessments, including daily surveys, one month and three month follow ups are used to assess feasibility and acceptability
| percent of participants | Safety Plan + Booster Text Messages + Booster Call (Group A) | Safety Plan + Booster Text Messages (Group B) | Safety Plan + Booster Call (Group C) | Safety Plan (Group D) |
|---|---|---|---|---|
| Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability | 100 | 100 | 94.4 | 100 |
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
| units on a scale | Safety Plan + Booster Text Messages + Booster Call (Group A) | Safety Plan + Booster Text Messages (Group B) | Safety Plan + Booster Call (Group C) | Safety Plan (Group D) |
|---|---|---|---|---|
| Satisfaction score | 3.59 ± 0.51 | 3.55 ± 0.51 | 3.31 ± 0.79 | 3.55 ± 0.6 |
| Likelihood of recommending plan to a friend score | 3.82 ± 0.39 | 3.77 ± 0.43 | 3.38 ± 0.81 | 3.64 ± 0.49 |
Collected over Data on suicide attempts was collected over a 3 month period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety Plan + Booster Text Messages + Booster Call (Group A) | 0/18 (0%) | 0/15 (0%) | — |
| Safety Plan + Booster Text Messages (Group B) | 0/22 (0%) | 2/19 (10.5%) | — |
| Safety Plan + Booster Call (Group C) | 0/18 (0%) | 3/14 (21.4%) | — |
| Safety Plan (Group D) | 0/22 (0%) | 3/20 (15%) | — |
| Event | Safety Plan + Booster Text Messages + Booster Call (Group A) | Safety Plan + Booster Text Messages (Group B) | Safety Plan + Booster Call (Group C) | Safety Plan (Group D) |
|---|---|---|---|---|
| Suicide AttemptPsychiatric disorders | 0/15 | 2/19 | 3/14 | 3/20 |
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.
| Age, Continuous(years) | Phase 1 - Safety Plan | Phase 1 - Safety Plan & Text Messages | Total |
|---|---|---|---|
| Mean | 15.08 ± 1.4 | 15.25 ± 1.32 | 15.16 ± 1.35 |
| Sex: Female, Male(Participants) | Phase 1 - Safety Plan | Phase 1 - Safety Plan & Text Messages | Total |
|---|---|---|---|
| Female | 27 | 27 | 54 |
| Male | 13 | 13 | 26 |
| Race (NIH/OMB)(Participants) | Phase 1 - Safety Plan | Phase 1 - Safety Plan & Text Messages | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 1 | 4 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 3 | 2 | 5 |
| White | 32 | 35 | 67 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Count of participants with at least one suicide attempt during their lifetime(Participants) | Phase 1 - Safety Plan | Phase 1 - Safety Plan & Text Messages | Total |
|---|---|---|---|
| Count of participants | 21 | 19 | 40 |
| Last-month suicide attempt(Participants) | Phase 1 - Safety Plan | Phase 1 - Safety Plan & Text Messages | Total |
|---|---|---|---|
| Count of participants | 18 | 12 | 30 |
| Multiple attempt history(Participants) | Phase 1 - Safety Plan | Phase 1 - Safety Plan & Text Messages | Total |
|---|---|---|---|
| Count of participants | 14 | 14 | 28 |
| Lifetime nonsuicidal self-injury(Participants) | Phase 1 - Safety Plan | Phase 1 - Safety Plan & Text Messages | Total |
|---|---|---|---|
| Count of participants | 31 | 31 | 62 |
| Suicidal ideation mean(units on a scale) | Phase 1 - Safety Plan | Phase 1 - Safety Plan & Text Messages | Total |
|---|---|---|---|
| Mean | 3.90 ± .90 | 3.93 ± 0.92 | 3.91 ± 0.90 |
1 further baseline measures are reported on the registry.
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