Skills to Enhance Positivity in Suicidal Youth

NCT04994873 | Recruiting DMC

• 1 other identifier: 1023
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (4)

• Suicidal events

  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).

  baseline; change from baseline at 3 months, 6 months, and 12 months follow-up

• Suicidal ideation

  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

  baseline; change from baseline at 3 months, 6 months, and 12 months follow-up

• Proportion of Weeks with Suicidal ideation

  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.

  baseline; change from baseline at 3 months, 6 months, and 12 months follow-up

• Depression

  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.

  baseline; change from baseline at 3 months, 6 months, and 12 months follow-up

Secondary Outcomes (5)

• Attention to positive affect

  baseline; change from baseline at 3 months, 6 months, and 12 months follow-up

• Implicit positive and negative affect

  baseline; change from baseline at 3 months, 6 months, and 12 months follow-up

• Explicit positive and negative affect

  baseline; change from baseline at 3 months, 6 months, and 12 months follow-up

• Gratitude

  baseline; change from baseline at 3 months, 6 months, and 12 months follow-up

• Satisfaction with life scale

  baseline; change from baseline at 3 months, 6 months, and 12 months follow-up

Study Arms (2)

STEP: Positivity skill enhancement

EXPERIMENTAL

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.

Behavioral: STEP

Enhanced TAU

ACTIVE COMPARATOR

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.

Behavioral: Enhanced TAU

Interventions

STEP BEHAVIORAL

Behavioral intervention to increase positive affect

STEP: Positivity skill enhancement

Enhanced TAU BEHAVIORAL

Standard care plus a phone app with a personalized safety plan

Enhanced TAU

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Ages 22 - 60 years
• work with adolescents hospitalized on an inpatient psychiatric unit due to suicide risk
• proficient in English or Spanish

You may not qualify if:

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

Sponsors & Collaborators

• Brown University: lead

Study Sites (3)

Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Butler Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

Bradley Hospital

Riverside, Rhode Island, 02903, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 37862324 DERIVED

MeSH Terms

Conditions

Suicide, Attempted

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Anthony Spirito, PhD

CONTACT

4013692435; anthony_spirito@brown.edu

Shirley Yen, PhD

CONTACT

4013787315; shirley_yen@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The baseline assessment will occur prior to randomization and follow-up assessors will be blind to participant condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2 condition randomized clinical trial

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: August 6, 2021
• Study Start: October 4, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Final data set available within one year of completion
• Access Criteria: University-based researchers

Locations

US (3)