Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04994873
Study type Interventional
Source Brown University
Contact Anthony Spirito, PhD
Phone 4013692435
Email anthony_spirito@brown.edu
Status Recruiting
Phase N/A
Start date October 4, 2021
Completion date September 1, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT03185026 - Psychoeducation for Suicidal Behavior N/A
Recruiting NCT05609487 - Evaluation of the Safety Plan to Prevent Suicidal Reiteration N/A
Recruiting NCT06322199 - Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 3
Completed NCT03134885 - Evaluation of a Regional Post-discharge Monitoring System for Suicide Attempters
Completed NCT01535482 - Cognitive Therapy for Suicidal Older Men N/A
Completed NCT01118208 - Blister Packaging Medication to Increase Treatment Adherence and Clinical Response N/A
Completed NCT01360736 - A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL) N/A
Completed NCT05580757 - Pharmacists as Gate Keepers in Suicide Prevention: Needs of Pharmacists
Not yet recruiting NCT05427734 - Treating Drivers of Suicide Using Jaspr Health N/A
Recruiting NCT06406972 - Brief Admission by Self-referral for Individuals With Self-harm: Effects on Compulsory Care
Recruiting NCT05537376 - A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness N/A
Completed NCT03227991 - Safety Planning Intervention to Reduce Short Term Risk N/A
Recruiting NCT04962373 - Brief Admission for Adolescents Who Self-harm
Completed NCT02985047 - Brief Admission Skane: Replacing General Admission for Individuals With Self-harm and Acute Risk of Suicide N/A
Enrolling by invitation NCT06060535 - Implementation of Suicide Risk Models in Health Systems N/A
Recruiting NCT04592809 - Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents Phase 3
Completed NCT01176929 - Randomized Controlled and Prospective Trial of a Cohort of People Who Made a Suicide Attempt N/A
Completed NCT00558805 - Family Intervention for Suicidal Youth: Emergency Care Phase 2
Recruiting NCT05390918 - Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior N/A
Recruiting NCT04746261 - A Randomized Clinical Study of "Attempted Suicide Short Intervention Program" in Swedish Healthcare - ASSIP N/A