Skills to Enhance Positivity in Suicidal Youth (STEP)

Skills to Enhance Positivity in Adolescents at Risk for Suicide

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.

Study Overview

• Status: Recruiting
• Conditions: Suicide, Attempted
• Intervention / Treatment: Behavioral: STEP; Behavioral: Enhanced TAU

Detailed Description

216 participants and their families (across two sites) will be randomized to either STEP or ETAU (as described in the research strategy). Aims and hypotheses are below:

Aim 1: Examine the effectiveness of STEP in reducing suicidal events (attempt or emergency intervention to intercede attempt), active SI (with intent or plan), and depression at 6-month f/u (primary) and suicidal events at 12-month follow-up (f/u). H1: It is hypothesized that those randomized to STEP, compared to ETAU, will have lower rates of suicide events (H1A), active SI (H1B), and depression (H1C) over the 6-month follow-up period; H1D: It is hypothesized that those randomized to STEP, compared to ETAU, will have lower rates of suicidal events at the 12-month, long term f/u.

Aim 2: Examine engagement of the hypothesized mechanisms at the 3- and 6-month f/u. It is hypothesized that those randomized to STEP, compared to ETAU, will have: H2A: higher attention to positive affect, assessed by implicit tasks; H2B: higher gratitude and satisfaction with life, assessed by self-report; H2C: lower negative affect, assessed by implicit tasks and self-report.

Aim 3: Examine whether hypothesized mechanisms mediate reduction of suicidal events and ideation. H3: Changes in attention to positive affect, gratitude, satisfaction with life, and negative affect at 3-month f/u will be related to improvements in suicidal ideation and suicidal events at the 6-month f/u.

Secondary Aim Examine elements supporting external validity. Acceptability, appropriateness, and feasibility of STEP to patients, parents, clinicians, and administrators will be assessed by: 1) a survey consisting of brief, standardized measures of these items, and 2) qualitative interviews to further explore these perceptions. These findings will be used to: 1) modify STEP to address potential barriers, and 2) develop implementation strategies designed to overcome these challenges, for testing in a future Hybrid Type III effectiveness-implementation trial.

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anthony Spirito, PhD; Phone Number: 4013692435; Email: anthony_spirito@brown.edu
• Study Contact Backup: Name: Shirley Yen, PhD; Phone Number: 4013787315; Email: shirley_yen@brown.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Children's Hospital
      • Contact: Shirley Yen, PhD; Phone Number: 401-378-7315; Email: shirley_yen@brown.edu
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Recruiting
      • Butler Hospital
      • Contact: Anthony Spirito; Phone Number: 4013692435; Email: anthony_spirito@brown.edu
    • Riverside, Rhode Island, United States, 02903
      • Recruiting
      • Bradley Hospital
      • Contact: Anthony Spirito, PhD; Phone Number: 4013692435; Email: anthony_spirito@brown.edu
      • Contact: Jennifer C Wolff, PhD; Phone Number: 540-921-7574; Email: jennifer_wolff@brown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: STEP; Behavioral intervention to increase positive affect
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.	Behavioral: Enhanced TAU; Standard care plus a phone app with a personalized safety plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention to positive affect	Using eye tracking we will measure fixation and overall gaze duration during a dot probe task using emotional and neutral words to determine whether there is a change in attention to positive affect (participant only).	baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Implicit positive and negative affect	Implicit positive affect will be assessed using the Implicit Positive and Negative Affect Test (IPANAT), which is an indirect assessment of automatic activation of affective representations that utilizes artificial words paired with positive and negative words (participant only).	baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Explicit positive and negative affect	Explicit positive affect will be assessed using the Modified Differential Emotions Scale (mDES) which is a 20 item short term self-report of positive and negative emotions administered to the participant only. There are 10 items in the positive affect and 10 items in the negative affect subscales with scores ranging from 0 to 30 for each subscale with higher scores reflecting higher affect.	baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Gratitude	Gratitude will be assessed with the 6 item Gratitude Scale, administered to the participant only. Scores range from 6 to 42 with higher scores indicating greater gratitude.	baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Satisfaction with life scale	5 self-report questions about participant satisfaction with life with scores ranging from 7 to 35 with higher scores indicating higher satisfaction with life.	baseline; change from baseline at 3 months, 6 months, and 12 months follow-up

Collaborators and Investigators

• Sponsor: Brown University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: July 25, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Behavior; Suicide, Attempted
• Other Study ID Numbers: 1023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will release demographics, primary and secondary data thru the NDA
• IPD Sharing Time Frame: Final data set available within one year of completion
• IPD Sharing Access Criteria: University-based researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No