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Studies

Interventional Completed

NCT04994873 on ClinicalTrials.gov

Skills to Enhance Positivity in Suicidal Youth

Official title: Skills to Enhance Positivity in Adolescents at Risk for Suicide

  • Sponsor: Brown University
  • Enrollment: 200 (Actual)
  • Study start: 2021-10-04 (Actual)
  • Primary completion: 2026-07-01 (Actual)
  • Study completion: 2026-09-01 (Actual)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: 2 condition randomized clinical trial
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Suicide, Attempted

Intervention / Treatment

  • Behavioral: STEP
  • Behavioral: Enhanced TAU

Primary Outcome Measures

  • Suicidal events (baseline; change from baseline at 3 months, 6 months, and 12 months follow-up)
    Composite variable of either a suicide attempt or emergency intervention to intercede when suicidal behavior may be imminent; Will be obtained from clinical interviews (C-SSRS; CASA) with the participant and parent(s).
  • Suicidal ideation (baseline; change from baseline at 3 months, 6 months, and 12 months follow-up)
    Suicide Ideation (SI) will be operationalized as proportion of participants with active SI as assessed by the Columbia Suicide Severity Rating Scale interview: 5 items on suicidal ideation rated yes or no
  • Proportion of Weeks with Suicidal ideation (baseline; change from baseline at 3 months, 6 months, and 12 months follow-up)
    The proportion of weeks during follow-up with active suicidal ideation as assessed by the Adolescent version of the Longitudinal Interview for Follow-Up Events (A-LIFE) scale (interview based assessment), with the participant.
  • Depression (baseline; change from baseline at 3 months, 6 months, and 12 months follow-up)
    Depressive symptom severity will be assessed using the Beck Depression Inventory II (BDI-II). The BDI-II will be administered to the adolescent participant and their parent (reporting on the adolescent participant) with scores ranging from 0 to 63 with higher scores reflecting greater depression.

Countries

United States

Locations and Investigators

  • Children's Hospital, Boston, United States
  • Butler Hospital, Providence, United States
  • Bradley Hospital, Riverside, United States