- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07383714
Inciter les actions parentales pour la prévention du suicide chez les jeunes
Inciter l'action parentale avec un essai contrôlé randomisé d'intervention par messages texte pour la prévention du suicide
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Matthew Nguyen
- Numéro de téléphone: 469-509-2493
- E-mail: matthew.nguyen@UTSouthwestern.edu
Sauvegarde des contacts de l'étude
- Nom: Amy Conger
- Numéro de téléphone: 214-4562705
- E-mail: amy.conger@UTSouthwestern.edu
Lieux d'étude
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Texas
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Dallas, Texas, États-Unis, 75287
- Recrutement
- Children's Medical Center
-
Contact:
- Emine Rabia Ayvaci, MD
- Numéro de téléphone: +16508040602
- E-mail: emine.ayvaci@utsouthwestern.edu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Control Arm
Treatment as usual (ED-based lethal means counseling) |
|
|
Comparateur actif: 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. |
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Parent-reported adherence to lethal means restriction (LMR)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adolescent Perceived Access to Lethal Means
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Exploratory Outcome
Délai: 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
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Emine Rabia Ayvaci, MD, University of Texas Southwestern Medical Center
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STU20252399
- GAA202508-0021 (Autre subvention/numéro de financement: New and Emerging Children's Mental Health Researchers Initiative)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
No individual participant data is planned to be shared with other researchers.
Informations sur les médicaments et les dispositifs, documents d'étude
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