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An Adaptive Intervention for Adolescents at Risk for Suicide: A Pilot SMART
NA trial testing MI-Enhanced Safety Plan at Hospitalization (1st Component) in Suicide in 82 participants. Completed in 7 April 2020.
| Lead sponsor | University of Michigan |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 82 |
| Start date | 14 March 2019 |
| Primary completion | 7 April 2020 |
| Estimated completion | 7 April 2020 |
| Sites | 1 location across United States |
University of Michigan
Adults 13 to 17, any sex, with Suicide or Self Harm. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| All Eligible Youth | 87.2 |
Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability
| Group | Value | 95% CI |
|---|---|---|
| Safety Plan + Booster Text Messages + Booster Call (Group A) | 100 | |
| Safety Plan + Booster Text Messages (Group B) | 100 | |
| Safety Plan + Booster Call (Group C) | 100 | |
| Safety Plan (Group D) | 100 |
| Group | Value | 95% CI |
|---|---|---|
| Safety Plan + Booster Text Messages + Booster Call (Group A) | 100 | |
| Safety Plan + Booster Text Messages (Group B) | 100 |
| Group | Value | 95% CI |
|---|---|---|
| Safety Plan + Booster Text Messages + Booster Call (Group A) | 88.9 | |
| Safety Plan + Booster Call (Group C) | 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
| Group | Value | 95% CI |
|---|---|---|
| Safety Plan + Booster Text Messages + Booster Call (Group A) | 100 | |
| Safety Plan + Booster Text Messages (Group B) | 100 | |
| Safety Plan + Booster Call (Group C) | 94.4 | |
| Safety Plan (Group D) | 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
| Group | Value | 95% CI |
|---|---|---|
| Safety Plan + Booster Text Messages + Booster Call (Group A) | 3.59 | ± 0.51 |
| Safety Plan + Booster Text Messages (Group B) | 3.55 | ± 0.51 |
| Safety Plan + Booster Call (Group C) | 3.31 | ± 0.79 |
| Safety Plan (Group D) | 3.55 | ± 0.6 |
| Group | Value | 95% CI |
|---|---|---|
| Safety Plan + Booster Text Messages + Booster Call (Group A) | 3.82 | ± 0.39 |
| Safety Plan + Booster Text Messages (Group B) | 3.77 | ± 0.43 |
| Safety Plan + Booster Call (Group C) | 3.38 | ± 0.81 |
| Safety Plan (Group D) | 3.64 | ± 0.49 |
Time frame: Data on suicide attempts was collected over a 3 month period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Safety Plan + Booster Text… | Safety Plan + Booster Text… | Safety Plan + Booster Call… | Safety Plan (Group D) |
|---|---|---|---|---|---|
| Suicide Attempt | Psychiatric disorders | — | — | — | — |
Most-reported serious reactions: Suicide Attempt.
Data from ClinicalTrials.gov NCT03838198 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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