Recruiting

Observational Study

Sponsor:

Brown University

Code:

NCT04994873

Conditions

Suicide, Attempted

Eligibility Criteria

Sex: All

Age: 12 - 60

Healthy Volunteers: Not accepted

Interventions

STEP

Enhanced TAU

Study Details

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

Study ID

NCT04994873

Start date

Oct 4, 2021

Status verified date

Jun, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria: Patients

  • Ages 12- 60 years
  • 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.

Inclusion Criteria: Stakeholders

Ages 22 - 60 years

  • work with adolescents hospitalized on an inpatient psychiatric unit due to suicide risk
  • proficient in English or Spanish

Exclusion Criteria:

  • active psychotic disorder
  • significant cognitive impairment or deficits
  • ward of the State
  • discharge to residential facility.

Study Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

STEP

Behavioral intervention to increase positive affect

Enhanced TAU

Standard care plus a phone app with a personalized safety plan

Primary outcome measure

  • Suicidal events [ Time Frame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up ]
  • Suicidal ideation [ Time Frame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up ]
  • Proportion of Weeks with Suicidal ideation [ Time Frame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up ]
  • Depression [ Time Frame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up ]

Central Contacts and Locations

Central contacts

Anthony Spirito, PhD

4013692435anthony_spirito@brown.edu

Shirley Yen, PhD

4013787315shirley_yen@brown.edu

Locations

Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Shirley Yen, PhD

401-378-7315shirley_yen@brown.edu

Butler Hospital

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

Anthony Spirito

4013692435anthony_spirito@brown.edu

Bradley Hospital

Recruiting

Riverside, Rhode Island, United States, 02903

Contacts

Anthony Spirito, PhD

4013692435anthony_spirito@brown.edu

Jennifer C Wolff, PhD

540-921-7574jennifer_wolff@brown.edu

More Information

Sponsor

Brown University

Last update posted

Oct 15, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brown University on 2025-10-15.