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Skills to Enhance Positivity in Suicidal Youth

Study acronym: STEP
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 5 more changesShow less
    • Enrollment target: estimated 216 to confirmed 200
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Site details revised at 3 of 3 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date: Sep 1, 2025 to Jul 1, 2026v12
  3. Primary completion date: Mar 1, 2028 to Sep 1, 2025
    • Study completion date: Mar 1, 2028 to Sep 1, 2026
    • Start date: Dec 1, 2022 to Oct 4, 2021
    v11
  4. Primary completion date: Jul 1, 2026 to Mar 1, 2028
    • Start date: Oct 4, 2021 to Dec 1, 2022
    • Study completion date: Dec 31, 2026 to Mar 1, 2028
    v10
  5. Primary completion date: Sep 1, 2025 to Jul 1, 2026
    • Study completion date: Sep 1, 2026 to Dec 31, 2026
    • Site contacts updated at 2 of 3 sites
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. 2 versions Re-verified since May 1, 2023, no change to tracked fieldsv7-v8
  2. Primary completion date: Jul 19, 2025 to Sep 1, 2025
    • Study completion date: Jul 19, 2026 to Sep 1, 2026
    • Start date: Oct 8, 2021 to Oct 4, 2021
    • Eligibility criteria expanded, about 1 word
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of May 1, 2022 to Oct 8, 2021
    • Eligibility criteria expanded, about 27 words
    v4
  5. Start date: Dec 1, 2021 to May 1, 2022v3
  6. Secondary endpoints: details revised at 5 of 5 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Hybrid Type I Effectiveness-Implementation design. Specifically, this study proposes to test the effectiveness of STEP in reducing suicidal events and ideation in 216 adolescents, admitted to inpatient psychiatric care due to suicide risk. Participants will be randomized to either STEP or ETAU. STEP involves 4 in-person sessions (3 individual, 1 family) focused on psychoeducation regarding positive and negative affect, mindfulness meditation, gratitude, and savoring. Mood monitoring prompts and skill reminders will be sent daily for the first month post-discharge and three times a week for the following two months. The ETAU condition will receive reminders to log into a safety resource app, matched in frequency to the STEP group. Effectiveness aspects of the design include using clinical staff as interventionists and having very few exclusion criteria.
Trial Details
NCT Number NCT04994873
Lead Sponsor Brown University
Conditions
(from sponsor)		 Suicide, Attempted
Related terms Suicide, Attempted
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov