- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07383714
Nudging Foreldrehandlinger for Ungdomsselvmordsforebygging
Nudging Foreldrehandling Med En Randomisert Kontrollert Studie Av SMS-intervensjon For Selvmordsforebygging
The goal of the study is to determine effectiveness of a behaviorally informed text messaging intervention to help parents increase safety practices and reduce their teens' access to lethal means following a suicide-related emergency department visit.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study tests a text messaging program that helps parents keep their teens safe after a visit to the emergency department for suicidal thoughts or behavior. Adolescents face a higher risk of suicide after leaving the emergency department, and limiting access to lethal means such as firearms, medications, or other dangerous items can help prevent suicide. The investigators invite parents and their teens aged 12 to 17 who visit the emergency department at Children's Medical Center Dallas for suicide-related reasons to join the study. After enrolling, families will be randomly assigned to one of three groups. The first group receives usual care, which includes standard counseling about keeping teens safe in the emergency room and no study text messages. The second group receives direct text messages three times a week with reminders about safety reminders. The third group receives risk-framing text messages three times a week, which include safety reminders and information about suicide risk following an emergency room visit to motivate parents to take action. The study measures whether these text messages help parents follow safety recommendations at home. Parents and teens complete short surveys at the start of the study, six weeks later, and twelve weeks later. The study also tracks whether the teen returns to the emergency department or attempts suicide again. The study aims to determine if text messages can increase parental safety practices, reduce teens' access to lethal means, and prevent future suicide attempts. UT Southwestern Medical Center and Children's Health Dallas conduct the study. Messages are delivered through a secure, HIPAA-compliant virtual platform to ensure privacy.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Matthew Nguyen
- Telefonnummer: 469-509-2493
- E-post: matthew.nguyen@UTSouthwestern.edu
Studer Kontakt Backup
- Navn: Amy Conger
- Telefonnummer: 214-4562705
- E-post: amy.conger@UTSouthwestern.edu
Studiesteder
-
-
Texas
-
Dallas, Texas, Forente stater, 75287
- Rekruttering
- Children's Medical Center
-
Ta kontakt med:
- Emine Rabia Ayvaci, MD
- Telefonnummer: +16508040602
- E-post: emine.ayvaci@utsouthwestern.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Guardian must be able and willing to provide informed consent, and the participant must be able and willing to provide assent.
- Parent and adolescent willingness and ability to participate in study procedures and complete assessments at baseline, 6 weeks, and 12 weeks.
- Presentation to the ED for a suicide-related emergency, defined as suicidal ideation within the last 2 weeks or a suicide attempt within the past month.
- Adolescents aged 12-17 years during the consent.
- Access to a mobile phone with text messaging capability for the parent/legal guardian.
- Ability to communicate in English.
Exclusion Criteria:
- Absence of a legal guardian capable of providing consent.
- Parents/legal guardians without access to a mobile phone with texting capability.
- Inability to communicate in English.
- Adolescents in state custody or under legal restrictions that prevent study participation.
- Adolescents involved in the justice system in a manner that would interfere with study participation.
- Adolescents with autism spectrum disorder or intellectual development disorder needing substantial or very substantial support
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control Arm
Treatment as usual (ED-based lethal means counseling) |
|
|
Aktiv komparator: Direct Nudge
Thrice-weekly direct text messages encouraging Lethal Mean Restriction practices. |
The intervention consists of thrice-weekly, behaviorally informed text messages delivered to parents over six weeks period. |
|
Eksperimentell: Risk-Framing Nudge Arm
Thrice-weekly direct text messages encouraging Lethal Mean Restriction practices and suicide risk statistics to recalibrate parental risk perception |
Thrice-weekly messages incorporating safety precautions and evidence-based suicide risk statistics to recalibrate parental risk perception. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Parent-reported adherence to lethal means restriction (LMR)
Tidsramme: Baseline to 6 weeks
|
Change in parental adherence to lethal means restriction practices will be assessed using the Parent Adherence to Lethal Means Restriction (PA-LMR), a structured parent-report survey measuring adherence to multiple lethal means restriction behaviors. Items are rated on a Likert scale, with total scores ranging from 11 to 55; higher scores indicate greater adherence. |
Baseline to 6 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adolescent Perceived Access to Lethal Means
Tidsramme: Baseline to 6 weeks
|
Perceived Access to Lethal Means is a self-report measure assessing adolescents' perceptions of their access to potentially lethal methods. Items assess the perceived ease of access, with total scores ranging from 5 to 30; higher scores indicate greater perceived access to lethal means. |
Baseline to 6 weeks
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Exploratory Outcome
Tidsramme: Baseline to 12 weeks
|
Number of participants (adolescents) with a suicide-related Emergency Department revisit and/or suicide attempt within 12 weeks post-randomization |
Baseline to 12 weeks
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Emine Rabia Ayvaci, MD, University of Texas Southwestern Medical Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Barber CW, Miller MJ. Reducing a suicidal person's access to lethal means of suicide: a research agenda. Am J Prev Med. 2014 Sep;47(3 Suppl 2):S264-72. doi: 10.1016/j.amepre.2014.05.028.
- Tversky A, Kahneman D. The framing of decisions and the psychology of choice. Science. 1981 Jan 30;211(4481):453-8. doi: 10.1126/science.7455683.
- Bauer BW, Capron DW. How Behavioral Economics and Nudges Could Help Diminish Irrationality in Suicide-Related Decisions. Perspect Psychol Sci. 2020 Jan;15(1):44-61. doi: 10.1177/1745691619866463. Epub 2019 Nov 7.
- Marcus SC, Cullen SW, Xie M, Bridge JA, Caterino JM, Schmutte T, Olfson M. Evaluating the Effect of Routine Lethal Means Counseling in the Emergency Department on Suicide Mortality Among Mental Health Patients. AJPM Focus. 2025 Mar 19;4(4):100336. doi: 10.1016/j.focus.2025.100336. eCollection 2025 Aug.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STU20252399
- GAA202508-0021 (Annet stipend/finansieringsnummer: New and Emerging Children's Mental Health Researchers Initiative)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
No individual participant data is planned to be shared with other researchers.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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