- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07383714
Incentivar Ações Parentais para a Prevenção do Suicídio Juvenil
Estimular a Ação Parental com um Ensaio Controlado Randomizado de Intervenção por Mensagem de Texto para a Prevenção do Suicídio
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Matthew Nguyen
- Número de telefone: 469-509-2493
- E-mail: matthew.nguyen@UTSouthwestern.edu
Estude backup de contato
- Nome: Amy Conger
- Número de telefone: 214-4562705
- E-mail: amy.conger@UTSouthwestern.edu
Locais de estudo
-
-
Texas
-
Dallas, Texas, Estados Unidos, 75287
- Recrutamento
- Children's Medical Center
-
Contato:
- Emine Rabia Ayvaci, MD
- Número de telefone: +16508040602
- E-mail: emine.ayvaci@utsouthwestern.edu
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Control Arm
Treatment as usual (ED-based lethal means counseling) |
|
|
Comparador Ativo: 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. |
|
Experimental: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Parent-reported adherence to lethal means restriction (LMR)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adolescent Perceived Access to Lethal Means
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Exploratory Outcome
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Emine Rabia Ayvaci, MD, University of Texas Southwestern Medical Center
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STU20252399
- GAA202508-0021 (Número de outro subsídio/financiamento: New and Emerging Children's Mental Health Researchers Initiative)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
No individual participant data is planned to be shared with other researchers.
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