- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06349915
A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents (SWEEP)
April 1, 2024 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, NY.
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 app will be used to evaluate whether a curriculum of these narratives provides anti-suicidal benefits to at-risk adolescents.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 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.
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.
The 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, the primary outcome of the study, five times per day.
This app will also collect secondary and additional outcomes.
The investigator team will evaluate whether participants experience reductions in the intensity of suicidal thoughts over the course of the 14-day trial.
Study Type
Interventional
Enrollment (Estimated)
46
Phase
- 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
- Name: Peter J Franz, Ph.D.
- Phone Number: 6077278620
- Email: peter.franz@einsteinmed.edu
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
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 |
Intervention / Treatment |
---|---|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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
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.
Investigators
- 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.
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)
September 1, 2024
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
April 1, 2024
First Submitted That Met QC Criteria
April 1, 2024
First Posted (Actual)
April 5, 2024
Study Record Updates
Last Update Posted (Actual)
April 5, 2024
Last Update Submitted That Met QC Criteria
April 1, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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