Skills to Enhance Positivity in Suicidal Youth

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brown University
Study ID
NCT04994873
Status
Recruiting
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Conditions

  • Suicide, Attempted

Eligibility Criteria

Sex
ALL
Age
12 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • STEP — BEHAVIORAL
    Behavioral intervention to increase positive affect
  • Enhanced TAU — BEHAVIORAL
    Standard care plus a phone app with a personalized safety plan

Study Details

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.

Key Dates

Start date
Oct 4, 2021
Status verified
Jun 2025
Primary completion
Jul 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Suicidal events [ Time Frame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Children's HospitalBostonMassachusetts02115
Shirley Yen, PhD
[email protected]
401-378-7315
Butler HospitalProvidenceRhode Island02906
Anthony Spirito
[email protected]
4013692435
Bradley HospitalRiversideRhode Island02903
Anthony Spirito, PhD
[email protected]
4013692435
Jennifer C Wolff, PhD
[email protected]
540-921-7574

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Children's Hospital· Boston, MAButler Hospital· Providence, RIBradley Hospital· Riverside, RI

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