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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06349915
Other study ID # 2023-15217
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date April 2026

Study information

Verified date April 2024
Source Albert Einstein College of Medicine
Contact Peter J Franz, Ph.D.
Phone 6077278620
Email peter.franz@einsteinmed.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 46
Est. completion date April 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender All
Age group 14 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Albert Einstein College of Medicine American Foundation for Suicide Prevention, Yeshiva University

References & Publications (1)

Franz PJ, Mou D, Kessler DT, Stubbing J, Jaroszewski AC, Ray S, Cao-Silveira VB, Bachman S, Schuster S, Graupensperger D, Alpert JE, Porath M, Nock MK. Digital bibliotherapy as a scalable intervention for suicidal thoughts: A randomized controlled trial. J Consult Clin Psychol. 2022 Aug;90(8):626-637. doi: 10.1037/ccp0000752. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Emotions 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
Other Treatment Readiness 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)
Primary Suicidal Thoughts 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 Suicidal Urge Resistance 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
Secondary Social Connectedness 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
Secondary Optimism 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
Secondary Social Support 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
Secondary Intervention Acceptability 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)
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