Skills to Enhance Positivity in Suicidal Youth

Suicide, Attempted Clinical Trial

— STEP  

Official title:

Skills to Enhance Positivity in Adolescents at Risk for Suicide

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994873
• Other study ID #: 1023
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: September 1, 2026

Study information

• Verified date: May 2023
• Source: Brown University
• Contact: Anthony Spirito, PhD
• Phone: 4013692435
• Email: anthony_spirito[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital	Boston	Massachusetts
United States	Butler Hospital	Providence	Rhode Island
United States	Bradley Hospital	Riverside	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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