Suicide, AttemptedSTEPNCT04994873
Skills to Enhance Positivity in Suicidal Youth
A study testing STEP and Enhanced TAU in people with Suicide, Attempted, run by Brown University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- STEP and Enhanced TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Oct 2021to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- Ages 22 - 60 years
- work with adolescents hospitalized on an inpatient psychiatric unit due to suicide risk
- proficient in English or Spanish
Who cannot join
- active psychotic disorder
- significant cognitive impairment or deficits
- ward of the State
- discharge to residential facility.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospital
Boston, Massachusetts, 02115
Butler Hospital
Providence, Rhode Island, 02906
Bradley Hospital
Riverside, Rhode Island, 02903
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide, Attempted
- Being tested
- STEP, Enhanced TAU
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEPBehavioural
Behavioral intervention to increase positive affect
Enhanced TAUBehavioural
Standard care plus a phone app with a personalized safety plan
| Study group | Role | What they receive |
|---|---|---|
| STEP: Positivity skill enhancement | Experimental | 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. Receives: Behavioral: STEP |
| Enhanced TAU | Active comparator | 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. Receives: Behavioral: Enhanced TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start4 Oct 2021
- Primary completion1 Jul 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 condition randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Spirito, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994873
- Sponsor's protocol ID
- 1023
- Acronym
- STEP
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2021
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will release demographics, primary and secondary data thru the NDA
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.
PubMed 37862324
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skills to Enhance Positivity in Adolescents at Risk for Suicide
- ClinicalTrials.gov ID
- NCT04994873
- Acronym / sponsor ID
- STEP / 1023
- Conditions
- Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 condition randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| STEP: Positivity skill enhancement | Experimental | Behavioral: STEPThis 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. |
| Enhanced TAU | Active comparator | Behavioral: Enhanced TAUhis 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. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- active psychotic disorder
- significant cognitive impairment or deficits
- ward of the State
- discharge to residential facility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEPBehavioral intervention to increase positive affect | Behavioural | STEP: Positivity skill enhancement |
| Enhanced TAUStandard care plus a phone app with a personalized safety plan | Behavioural | Enhanced TAU |
Primary outcome
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).
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
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.
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.
5 secondary outcomes
Attention to positive affect
Time frame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Implicit positive and negative affect
Time frame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Explicit positive and negative affect
Time frame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Gratitude
Time frame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Satisfaction with life scale
Time frame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 37862324Yen 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.
- Individual participant dataSharing planned: Yes. We will release demographics, primary and secondary data thru the NDA
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEP and Enhanced TAU in people with Suicide, Attempted, run by Brown University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal events (time frame: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04994873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.