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Skills to Enhance Positivity in Suicidal Youth (STEP)

Primary Purpose

Suicide, Attempted

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STEP
Enhanced TAU
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's HospitalRecruiting
  • Butler HospitalRecruiting
  • Bradley HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

STEP: Positivity skill enhancement

Enhanced TAU

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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
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.
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.

Secondary Outcome Measures

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).
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).
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.
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.
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.

Full Information

First Posted
July 25, 2021
Last Updated
May 1, 2023
Sponsor
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT04994873
Brief Title
Skills to Enhance Positivity in Suicidal Youth
Acronym
STEP
Official Title
Skills to Enhance Positivity in Adolescents at Risk for Suicide
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 condition randomized clinical trial
Masking
Outcomes Assessor
Masking Description
The baseline assessment will occur prior to randomization and follow-up assessors will be blind to participant condition
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STEP: Positivity skill enhancement
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced TAU
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
STEP
Intervention Description
Behavioral intervention to increase positive affect
Intervention Type
Behavioral
Intervention Name(s)
Enhanced TAU
Intervention Description
Standard care plus a phone app with a personalized safety plan
Primary Outcome Measure Information:
Title
Suicidal events
Description
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).
Time Frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Title
Suicidal ideation
Description
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
Time Frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Title
Proportion of Weeks with Suicidal ideation
Description
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.
Time Frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Title
Depression
Description
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.
Time Frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Secondary Outcome Measure Information:
Title
Attention to positive affect
Description
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).
Time Frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Title
Implicit positive and negative affect
Description
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).
Time Frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Title
Explicit positive and negative affect
Description
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.
Time Frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Title
Gratitude
Description
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.
Time Frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Title
Satisfaction with life scale
Description
5 self-report questions about participant satisfaction with life with scores ranging from 7 to 35 with higher scores indicating higher satisfaction with life.
Time Frame
baseline; change from baseline at 3 months, 6 months, and 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Spirito, PhD
Phone
4013692435
Email
anthony_spirito@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shirley Yen, PhD
Phone
4013787315
Email
shirley_yen@brown.edu
Facility Information:
Facility Name
Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirley Yen, PhD
Phone
401-378-7315
Email
shirley_yen@brown.edu
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Spirito
Phone
401-369-2435
Email
anthony_spirito@brown.edu
Facility Name
Bradley Hospital
City
Riverside
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Spirito, PhD
Phone
401-369-2435
Email
anthony_spirito@brown.edu
First Name & Middle Initial & Last Name & Degree
Jennifer C Wolff, PhD
Phone
540-921-7574
Email
jennifer_wolff@brown.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Skills to Enhance Positivity in Suicidal Youth

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