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NCT Number: NCT04994873

Skills to Enhance Positivity in Suicidal Youth

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.

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Key information

Conditions

Suicide, Attempted Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

STEP

Behavioral

Behavioral intervention to increase positive affect

Enhanced TAU

Behavioral

Standard care plus a phone app with a personalized safety plan

Primary outcomes

  1. Suicidal events

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

    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).

  2. Suicidal ideation

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

    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

  3. Proportion of Weeks with Suicidal ideation

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

    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.

  4. Depression

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

    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 outcomes

  1. Attention to positive affect

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

    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).

  2. Implicit positive and negative affect

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

    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).

  3. Explicit positive and negative affect

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

    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.

  4. Gratitude

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

    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.

  5. Satisfaction with life scale

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

    5 self-report questions about participant satisfaction with life with scores ranging from 7 to 35 with higher scores indicating higher satisfaction with life.

Study contacts

Contact information is provided by the study sponsor or research team.

Anthony Spirito, PhD

CONTACT

[email protected]

4013692435

Shirley Yen, PhD

CONTACT

[email protected]

4013787315

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Official study title

Skills to Enhance Positivity in Adolescents at Risk for Suicide

Acronym: STEP

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2021
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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