Montefiore Health System
The Bronx, New York, 10467, United States
Location status: Recruiting
NCT Number: NCT06349915
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.
Interested in participating?
Request Info14 year–18 year
All sexes
Interventional
Not applicable
The Bronx, New York, 10467, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Albert Einstein College of Medicine
Other
Acronym: SWEEP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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