Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
216 participants
INTERVENTIONAL
2021-10-04
2026-09-01
Brief Summary
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Detailed Description
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Aim 1: Examine the effectiveness of STEP in reducing suicidal events (attempt or emergency intervention to intercede attempt), active SI (with intent or plan), and depression at 6-month f/u (primary) and suicidal events at 12-month follow-up (f/u). H1: It is hypothesized that those randomized to STEP, compared to ETAU, will have lower rates of suicide events (H1A), active SI (H1B), and depression (H1C) over the 6-month follow-up period; H1D: It is hypothesized that those randomized to STEP, compared to ETAU, will have lower rates of suicidal events at the 12-month, long term f/u.
Aim 2: Examine engagement of the hypothesized mechanisms at the 3- and 6-month f/u. It is hypothesized that those randomized to STEP, compared to ETAU, will have: H2A: higher attention to positive affect, assessed by implicit tasks; H2B: higher gratitude and satisfaction with life, assessed by self-report; H2C: lower negative affect, assessed by implicit tasks and self-report.
Aim 3: Examine whether hypothesized mechanisms mediate reduction of suicidal events and ideation. H3: Changes in attention to positive affect, gratitude, satisfaction with life, and negative affect at 3-month f/u will be related to improvements in suicidal ideation and suicidal events at the 6-month f/u.
Secondary Aim Examine elements supporting external validity. Acceptability, appropriateness, and feasibility of STEP to patients, parents, clinicians, and administrators will be assessed by: 1) a survey consisting of brief, standardized measures of these items, and 2) qualitative interviews to further explore these perceptions. These findings will be used to: 1) modify STEP to address potential barriers, and 2) develop implementation strategies designed to overcome these challenges, for testing in a future Hybrid Type III effectiveness-implementation trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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STEP: Positivity skill enhancement
This intervention includes the Enhanced TAU described below plus it entails 4 in-person sessions delivered during an inpatient psychiatric admission, followed by mood monitoring and skills messages delivered post-discharge via app, to promote the practice of increasing attention to positive affect and experiences as a means of reducing risk for suicidal behavior.
STEP
Behavioral intervention to increase positive affect
Enhanced TAU
his comparison intervention involves regular programming of the inpatient psychiatric unit, followed by safety plan and resources loaded onto an app that the participant has access to post-discharge.
Enhanced TAU
Standard care plus a phone app with a personalized safety plan
Interventions
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STEP
Behavioral intervention to increase positive affect
Enhanced TAU
Standard care plus a phone app with a personalized safety plan
Eligibility Criteria
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Inclusion Criteria
* hospitalized on an inpatient psychiatric unit due to suicide risk
* past month suicide attempts or suicidal ideation
* proficient in English (parent either English or Spanish
* access to a smart phone.
Ages 22 - 60 years
* work with adolescents hospitalized on an inpatient psychiatric unit due to suicide risk
* proficient in English or Spanish
Exclusion Criteria
* significant cognitive impairment or deficits
* ward of the State
* discharge to residential facility.
12 Years
60 Years
ALL
No
Sponsors
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Brown University
OTHER
Responsible Party
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Anthony Spirito
Professor
Locations
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Children's Hospital
Boston, Massachusetts, United States
Butler Hospital
Providence, Rhode Island, United States
Bradley Hospital
Riverside, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Yen S, Suazo N, Doerr J, Macrynikola N, Villarreal LS, Sodano S, O'Brien KHM, Wolff JC, Breault C, Gibb BE, Elwy R, Kahler CW, Ranney M, Jones R, Spirito A. Skills to Enhance Positivity in adolescents at risk for suicide: Protocol for a randomized controlled trial. PLoS One. 2023 Oct 20;18(10):e0287285. doi: 10.1371/journal.pone.0287285. eCollection 2023.
Other Identifiers
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1023
Identifier Type: -
Identifier Source: org_study_id
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