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Psychoeducation for Suicidal Youth (STEP Trial)

N/A
Recruiting
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged 12-60 years hospitalized on an inpatient psychiatric unit due to suicide risk
Patients with past month suicide attempts or suicidal ideation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
Awards & highlights

STEP Trial Summary

This trial will test the effectiveness of STEP, a psychoeducation program, in reducing suicidal events and ideation in 216 adolescents. Participants will be randomized to either STEP or ETAU, with STEP involving 4 in-person sessions focused on topics like positive and negative affect, mindfulness meditation, gratitude, and savoring.

Who is the study for?
This trial is for adolescents and adults aged 12-60 who are hospitalized for suicide risk, have had recent suicidal thoughts or attempts, and can use a smartphone. They must understand English or Spanish. Stakeholders working with these individuals can also participate.Check my eligibility
What is being tested?
The study compares STEP—a program with in-person sessions on positive thinking skills and mood monitoring—to Enhanced TAU (usual care plus safety app reminders). Participants will be randomly assigned to one of the two groups to assess effectiveness.See study design
What are the potential side effects?
Since this trial involves psychological interventions rather than medications, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing sensitive topics during sessions.

STEP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 60 years old and hospitalized for suicide risk.
Select...
I have had thoughts of suicide or attempted suicide in the past month.

STEP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; change from baseline at 3 months, 6 months, and 12 months follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; change from baseline at 3 months, 6 months, and 12 months follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Depression
Proportion of Weeks with Suicidal ideation
Suicidal events
+1 more
Secondary outcome measures
Attention to positive affect
Explicit positive and negative affect
Gratitude
+2 more

STEP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: STEP: Positivity skill enhancementExperimental Treatment1 Intervention
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.
Group II: Enhanced TAUActive Control1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
STEP
2014
Completed Phase 3
~80

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
456 Previous Clinical Trials
558,138 Total Patients Enrolled

Media Library

STEP Clinical Trial Eligibility Overview. Trial Name: NCT04994873 — N/A
Suicide Attempt Research Study Groups: STEP: Positivity skill enhancement, Enhanced TAU
Suicide Attempt Clinical Trial 2023: STEP Highlights & Side Effects. Trial Name: NCT04994873 — N/A
STEP 2023 Treatment Timeline for Medical Study. Trial Name: NCT04994873 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aim of this medical experiment?

"The core objective of this medical trial that will span baseline, 3 months, 6 months and 12 month follow-up is to assess suicidal events. Secondary outcomes include the Satisfaction with life scale (5 self-report questions from 7 to 35 points), Explicit positive and negative affect (20 items in two subscales from 0 to 30) as well as Attention to positive affect through eye tracking during a dot probe task assessing emotional/neutral words."

Answered by AI

Is enrollment currently open for this research study?

"Affirmative. Data published on clinicaltrials.gov illustrates that the medical trial, initially posted on October 4th 2021, is currently looking for enrollees. This study requires 216 participants to be recruited from 3 separate research sites."

Answered by AI

Do you accept participants aged 75 and over for this medical trial?

"The lower limit of the age qualification for this clinical trial is 12 years old while the upper boundary rests at 60."

Answered by AI

How many participants is this research endeavor seeking to include?

"Affirmative. Data hosted on clinicaltrials.gov affirms that this research trial, which was first published on October 4th 2021, is actively recruiting participants. Approximately 216 patients need to be recruited from 3 distinct medical facilities."

Answered by AI

Who is eligible to take part in this experiment?

"Qualified applicants must have attempted suicide in the past and be aged between 12 to 60 years old. This trial will include 216 participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Skills to Enhance Positivity in Suicidal Youth
Anthony Spirito 2021. "Skills to Enhance Positivity in Suicidal Youth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04994873.
~75 spots leftby Sep 2025
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