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Идёт набор NCT07092345

An Adaptive Intervention to Increase Engagement to Community-Based Care After an ED Admission

Без фазы С лечением Suicidal and Self-injurious Behavior Linkage to Care

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: adaptive intervention.
Кому может быть актуально
Состояния в реестре: Suicidal and Self-injurious Behavior, Linkage to Care. Базовые параметры: 8 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

An Adaptive Intervention to Increase Engagement to Community-based Care After an ED Admission: For Youth at Risk for Suicide and Self-injurious Behavior

Обзор

The goal of this study is to develop a feasible brief, family-based adaptive intervention, via SMART design, for youth with suicidal and non-suicidal self-injurious behavior (SSIB) to increase community-based mental health (MH) care attendance and reduce SSIB risk post emergency department (ED) admission. The intervention will focus to increase understanding on youth MH literacy, MH communication, and MH engagement. Integrating an adaptive intervention via a SMART design in the ED could address subsequent barriers to youth obtaining appropriate level of community-based MH care and therefore reduce ED readmissions.

Подробное описание

This adaptive intervention allows for two stages of randomization to address treatment non-response. First, youth and caregivers (dyads) will be randomized to receive 1st-stage interventions in the ED, either the digital psychosocial-only condition or the psychosocial with digital health communication via text messages condition. If after two weeks, youth are identified as non-response, then dyads will be re-randomized to 2nd-stage intervention(s) that will include the use of a family navigation model.

Вмешательства

  • Поведенческое adaptive intervention
    We will utilize an adaptive interventions via Sequential Multiple Assignment Randomized Trial (SMART) design provide a tailored, stepped-care approach for the type, intensity, and dose of treatment, thus, providing the most intensive care to only those who need it, particularly treatment non-response. First, youth and caregivers (dyads) will be randomized to receive 1st-stage interventions in the ED, either the digital psychosocial-only (PS) condition or the psychosocial with digital health comm

Первичные конечные точки

  • Intervention Feasibility [Срок оценки: 3-month & 6-month follow-up assessments]
  • Child and Adolescent Service Assessment (CASA) [Срок оценки: 3-month and 6-month follow-up assessments]
  • Intervention Acceptability [Срок оценки: 3-month and 6-month follow-up assessments]

Критерии участия

Критерии включения

  • Youth 8 to 17 years
  • Youth presenting to the ED with suicide and self-injurious behavior
  • Youth living at home with at least one legal guardian/caregiver

Критерии исключения

  • Youth presenting to the ED with psychosis, sexual assault, child abuse
  • Youth in police custody,
  • Youth with an active investigation with the department of child and youth services (DCYF)
  • Youth unable to assent due to severity of illness or developmental disabilities,
  • Youth who cannot communicate in English or Spanish,
  • Youth without a caregiver/legal guardian who can provide consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Hasbro Children's Hospital — Providence

Публикации

  • Cancilliere MK, Ramanathan A, Hoffman P, Jencks J, Spirito A, Donise K. Characteristics of a Pediatric Emergency Psychiatric Telephone Triage Service. Pediatr Emerg Care. 2022 Oct 1;38(10):494-501. doi: 10.1097/PEC.0000000000002831. Epub 2022 Aug 18. PMID 35981327
  • Spirito A, Simon V, Cancilliere MK, Stein R, Norcott C, Loranger K, Prinstein MJ. Outpatient psychotherapy practice with adolescents following psychiatric hospitalization for suicide ideation or a suicide attempt. Clin Child Psychol Psychiatry. 2011 Jan;16(1):53-64. doi: 10.1177/1359104509352893. Epub 2010 Apr 19. PMID 20404070
  • Cancilliere MK, Donise K. A Comparison of Acute Mental Health Presentations to Emergency Services Before and During the COVID-19 Pandemic. R I Med J (2013). 2022 May 2;105(4):9-15. PMID 35476729
  • Cancilliere MK, Guthrie KM, Donise K, Lin T, Orchowski L, Spirito A. Development of an Emergency Department Family Navigator and Text Message Intervention for Caregivers to Reduce Youth Risk of Suicide and Self-injurious Behavior. R I Med J (2013). 2024 Aug 1;107(8):28-38. PMID 39058987

Идентификаторы

NCT: NCT07092345 · 2037770 · K23MH136332

Первоисточники (государственные реестры)

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