A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents (SWEEP)

July 29, 2026 updated by: Albert Einstein College of Medicine
Suicide risk has increased among youth in underserved communities, where access to mental healthcare is limited. To address this need, the investigator team plans to evaluate the preliminary efficacy of a brief, low-cost, culturally responsive digital intervention for ethnically diverse youth at risk for suicide in The Bronx, New York. In collaboration with community stakeholders, suicide recovery narratives, featuring adolescents' experiences related to recovery from suicidal thoughts will be developed. A smartphone ecological momentary assessment (EMA) app will be used to evaluate whether a curriculum of these narratives provides anti-suicidal benefits to at-risk adolescents.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single-arm investigation of a novel suicide prevention intervention, called "Supporting Wellbeing with Everyday Experiences of Peers" (SWEEP). In a preliminary phase (Phase 1) of the study, suicide recovery narratives: short first-person stories about lived experience with and recovery from Bronx Adolescents will be collected. The investigator team will then evaluate evaluate the anti-suicidal benefits of this intervention in a single-arm trial. In a subsequent phase (Phase 2), adolescent participants (n=46) will be provided with the SWEEP intervention, which involves reading or listening to one suicide recovery narrative each day during the 14-day trial. Six of the 46 participants will be adolescents, with recent suicidal thoughts or depression, who are currently receiving mental healthcare in Montefiore's Outpatient Psychiatry Department, rather than those on the waitlist to receive these services. All six participants will then complete a post-intervention qualitative interview to inform potential changes to intervention procedures. During this second phase, suicide recovery narratives will be provided, in audio and text formats, via a smartphone app. That same smartphone app will also collect real-time (ecological momentary) assessments of suicidal thoughts, as well as secondary and additional outcomes, five times per day. The investigator team will evaluate whether participants experience reductions in the intensity of suicidal thoughts over the course of the 14-day trial. During Phase 3, participants will be recruited to a control condition (n=15) and a treatment condition (n=30). Those in the Phase 3 treatment condition will receive the same intervention (1 SWEEP narrative per day for 14 days + 3x/day EMA) as those in Phase 2. Those in the Control condition will receive 3x/day EMA only.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • past-month history of suicidal thoughts
  • past-month history of Major depressive disorder
  • possession of apple or android smartphone with data plan

Exclusion Criteria:

  • inability to read/write in English
  • Active mania
  • Active psychosis
  • Autism spectrum disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
This is a single-arm study. All participants will be allocated to the intervention arm, in which they will receive the digital narrative therapy.
Behavioral: Supporting Wellbeing with Everyday Experiences of Peers (SWEEP)
Each day during a 14-day trial period, participants will receive one narrative featuring lived experience with and recovery from suicidal thoughts and behaviors. These narratives will be presented in audio and text format via a smartphone app. Participants will also complete self-report surveys assessing study outcomes using the same smartphone app five times per day.
Other Names:
  • SWEEP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Suicidal Thoughts
Time Frame: 5 times per day during 14-day trial
Participants will self-report their current subjective intensity of suicidal thoughts using an 11-point Likert-type scale, with higher scores indicating more intense suicidal thoughts.
5 times per day during 14-day trial

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Suicidal Urge Resistance
Time Frame: 5 times per day during 14-day trial
Participants will self-report the strength of their current ability to resist suicidal urges using an 11-point Likert-type scale, with higher scores indicating greater ability to resist suicidal urges.
5 times per day during 14-day trial
Social Connectedness
Time Frame: 5 times per day during 14-day trial
Participants will self-report their current feelings of being connected to other people using an 11-point Likert-type scale, with higher scores indicating feeling more being connected to other people.
5 times per day during 14-day trial
Optimism
Time Frame: 5 times per day during 14-day trial
Participants will self-report their current of feelings of optimism about the future using an 11-point Likert-type scale, with higher scores indicating greater optimism.
5 times per day during 14-day trial
Social Support
Time Frame: 5 times per day during 14-day trial
Participants will self-report their current perception of the availability of emotional support from others using an 11-point Likert-type scale, with higher scores indicating the perception greater availability of emotional support from others.
5 times per day during 14-day trial
Intervention Acceptability
Time Frame: Study conclusion (at the end of the 14-day trial)
Participants will self-report their current perception of acceptability of the SWEEP intervention across three items. Participants will rate the usefulness of receiving the narratives using a 7-point Likert-type scale, with higher scores indicating that the narratives were more useful. Participants will rate the difficulty of reading or listening to the narratives each day using a 7-point Likert-type scale, with higher scores indicating that the narratives were more difficult to read or listen to. This item will be reverse coded. Participants will rate how willing they are to recommend the narratives to their peers using a 7-point Likert-type scale, with higher scores indicating greater willingness to recommend the narratives. Each of these items will be evaluated in isolation, as well as in aggregate using both summation and an arithmetic mean score.
Study conclusion (at the end of the 14-day trial)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Emotions
Time Frame: 5 times per day during 14-day trial
Participants will self-report the current intensity of 10 emotions: excited, guilty, scared, proud, irritated, ashamed, inspired, nervous, determined, angry. Each emotion will be rated on an 11-point Likert-type scale with higher scores indicating more intense emotion. Each of these items will be evaluated in isolation, as well as in aggregate using arithmetic mean. For aggregating an overall emotion score, the positive emotions excited, proud, inspired, and determined will be reverse-scored to provide an aggregate rating of negative emotion.
5 times per day during 14-day trial
Treatment Readiness
Time Frame: Baseline (prior to starting the 14-day trail) and study conclusion (at the end of the 14-day trial)
Participants will self-report their current readiness for mental health treatment across 4 items. Participants will rate their motivation for beginning regular mental health services using a 7-point Likert-type scale, with higher scores indicating greater readiness to begin regular services. Participants will rate their anxiety about discussing personal difficulties with a mental health professional using a 7-point Likert-type scale, with higher scores indicating greater anxiety. This item will be reverse coded. Participants will rate how confident they feel that regular mental health services will be helpful using a 7-point Likert-type scale, with higher scores indicating greater confidence. Participants will rate how necessary they feel that regular mental health services are for them using a 7-point Likert-type scale, with higher scores indicating greater feelings of necessity. Each item will be evaluated in isolation and in aggregate using both summation and arithmetic mean score.
Baseline (prior to starting the 14-day trail) and study conclusion (at the end of the 14-day trial)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Albert Einstein College of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Foundation for Suicide Prevention
Yeshiva University
Ilumivu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter J Franz, Ph.D., Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-15217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The research team will consider requests to share specific data with qualified research teams upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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