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Идёт набор NCT06289101

text4FATHER R21: Social Media - Efficacy Trial

Без фазы С лечением Fathers Mobile Health Nuclear Family

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: text4FATHER.
Кому может быть актуально
Состояния в реестре: Fathers, Mobile Health, Nuclear Family. Базовые параметры: от 18 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
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Официальное название

Adapting text4FATHER to Directly Link to First-time Expectant Fathers Using Social Media to Improve Infant and Family Health

Обзор

This project will be the first to examine the efficacy of a text messaging intervention designed to recruit first-time fathers-to-be using social media across the U.S. to become involved during pregnancy through two months of postnatal age to support infant, mother, and father well-being.

Подробное описание

Father engagement in the prenatal and infant periods is associated with improved infant outcomes (e.g., physical, social and emotional health and development), and mother and father well-being. However, this key window of opportunity has been insufficiently leveraged to promote father engagement, especially, first-time fathers-to-be.

text4FATHER, a multi-modal text messaging program, is designed to increase first-time fathers' knowledge, self-efficacy, and behavioral engagement. text4FATHER sends texts twice-weekly to fathers with threaded content to support infant, partner, and father well-being including resource weblinks to support behavior change from mid-pregnancy through 2 months postnatally. Text content was developed using formative research and feedback from the target population, consensus building with experts, and an evidence-based review.

Вмешательства

  • Поведенческое text4FATHER
    Receipt of twice-weekly texts that include resource links and instructions to support behavior change (e.g., videos, infographics) and start mid-pregnancy and continuing through 2 months of age.

Первичные конечные точки

  • Change in Self-efficacy as assessed by the Parenting Sense of Competence Scale (PSOC) [Срок оценки: Baseline and 7 months]
  • Karitane Parenting Confidence Scale (KPCS) [Срок оценки: Baseline and 7 months]
  • Father Engagement Scale (FES) [Срок оценки: Baseline and 7 months]

Критерии участия

Критерии включения

  • Aged ≥18 years
  • Live in the U.S.
  • Speak English
  • Mother gestational age at enrollment less than 25 weeks
  • First-time father-to-be
  • Willing/able to receive texts.

Критерии исключения

  • Individuals who are minors
  • Do not speak English
  • Unable to provide informed consent
  • Not a first-time father
  • Not willing/unable to receive texts
  • In the past 12 months, any safety concern reported between father-to-be and the mother-to-be, including report of any physical, emotional, sexual harm, threatening behaviors, police involvement, restraining or protective order

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Johns Hopkins University — Baltimore

Публикации

  • Marcell AV, Johnson SB, Nelson T, Labrique AB, Eck KV, Skelton S, Aqil A, Gibson D. Protocol for the Feasibility, Acceptability, and Preliminary Efficacy Trial of text4FATHER for Improving Underserved Fathers' Involvement in Infant Care. J Health Care Poor Underserved. 2021;32(3):1110-1135. doi: 10.1353/hpu.2021.0117. PMID 34421016
  • Allport BS, Johnson S, Aqil A, Labrique AB, Nelson T, Kc A, Carabas Y, Marcell AV. Promoting Father Involvement for Child and Family Health. Acad Pediatr. 2018 Sep-Oct;18(7):746-753. doi: 10.1016/j.acap.2018.03.011. Epub 2018 Apr 10. PMID 29653255
  • Allport-Altillo BS, Aqil AR, Nelson T, Johnson SB, Labrique AB, Carabas Y, Marcell AV. Parents' Perspectives on Supporting Father Involvement in African American Families During Pregnancy and Early Infancy. J Natl Med Assoc. 2020 Aug;112(4):344-361. doi: 10.1016/j.jnma.2020.04.002. Epub 2020 May 11. PMID 32409095
  • Aqil A, Allport BS, Johnson SB, Nelson T, Labrique AB, Marcell AV. Content to share with expectant fathers: Views of professionals focused on father involvement. Midwifery. 2019 Mar;70:119-126. doi: 10.1016/j.midw.2018.12.018. Epub 2018 Dec 24. PMID 30611921

Идентификаторы

NCT: NCT06289101 · IRB00422008 · R21HD112617

Первоисточники (государственные реестры)

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