Clinical trial NCT06349915: A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents
Official title: A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicide
Keywords: digital intervention
community participation
ecological momentary assessment
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention
name: Yeshiva University
name: Ilumivu
First posted: 2024-04-05
Enrollment: 46
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The first 6 participants will serve as a brief pilot to validate outcomes and the acceptability of the intervention. The study team may make slight changes to the intervention (e.g., time of day the suicide recovery narratives are administered, or which narratives are presented) before recruiting the remaining 40 participants.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Suicidal Thoughts
timeFrame: 5 times per day during 14-day trial
Secondary outcomes:
measure: Suicidal Urge Resistance
timeFrame: 5 times per day during 14-day trial
measure: Social Connectedness
timeFrame: 5 times per day during 14-day trial
measure: Optimism
timeFrame: 5 times per day during 14-day trial
measure: Social Support
timeFrame: 5 times per day during 14-day trial
measure: Intervention Acceptability
timeFrame: Study conclusion (at the end of the 14-day trial)
Other outcomes:
measure: Emotions
timeFrame: 5 times per day during 14-day trial
measure: Treatment Readiness
timeFrame: Baseline (prior to starting the 14-day trail) and study conclusion (at the end of the 14-day trial)
Locations:
city: Bronx
country: United States
facility: Montefiore Health System
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Peter J Franz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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