Skills to Enhance Positivity in Suicidal Youth (STEP)

Brown University

Status: Enrolling

Conditions: Suicide, Attempted

Treatments: Behavioral: Enhanced TAU; Behavioral: STEP

Study type: Interventional

Funder types: Other

Identifiers

NCT04994873

1023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 estimated patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups

STEP: Positivity skill enhancement

Experimental group

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.

Treatment:

Behavioral: STEP

Enhanced TAU

Active Comparator group

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.

Treatment:

Behavioral: Enhanced TAU