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Идёт набор NCT05834907

Hands and Hearts Together

Без фазы С лечением Parent-Child Relations Development, Infant Parenting Development, Child

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: Circle of Security Parenting, Little Talks.
Кому может быть актуально
Состояния в реестре: Parent-Child Relations, Development, Infant, Parenting, Development, Child. Базовые параметры: от 8 мес. · 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

Prevention of Attachment Insecurity, Physiological Dysregulation, and Child Behavior Problems

Обзор

Growing evidence demonstrates that secure attachment in childhood predicts children's healthy social, biological, and behavioral functioning, whereas insecure attachment predicts behavior problems and physiological dysregulation; thus, efforts to foster secure attachment are crucial for promoting the healthy development of children and families. This proposal describes a randomized controlled trial (RCT) of an innovative intervention program that can be widely implemented designed to foster children's secure attachment, promote healthy physiological regulation, and reduce the risk for behavior problems: The Circle of Security ® Parenting (COS-P) intervention. To this end, investigators will conduct an RCT with 249 parent-child dyads enrolled or are eligible but not yet enrolled in two diverse Early Head Start (EHS) programs.

Вмешательства

  • Поведенческое Circle of Security Parenting
    COS-P is an attachment-based, home visiting intervention intended to supporting parents in serving as "a secure base" from which their children can explore the world, and to which their children can return in times of distress (Bowlby, 1988). Such secure base parenting increases the likelihood of children's secure attachment. COS-P also targets parental responses to children's expression of their needs (e.g., crying), and is designed to help parents understand the ways in which their own (parent
  • Поведенческое Little Talks
    Little Talks is an early literacy home visiting intervention developed for low-income, racial and ethnic minority infants and toddlers, and has been tested in Early Head Start contexts (Manz et al., 2016; Manz et al. 2017). Little Talks uses book sharing to promote early literacy and has been adapted in both English and Spanish. The intervention utilizes modular treatments during home visits, teaching parents how to facilitate language interactions with their children through book sharing. Age a

Первичные конечные точки

  • Strange Situation Procedure (SSP) #1 [Срок оценки: Baseline]
  • Strange Situation Procedure (SSP) #2 [Срок оценки: Immediately post-intervention]
  • Strange Situation Procedure (SSP) #3 [Срок оценки: 6-month follow up]
  • Macarthur Preschool Strange Situation (PACS) #1 [Срок оценки: Baseline]
  • Macarthur Preschool Strange Situation (PACS) #2 [Срок оценки: Immediately post-intervention]
  • Macarthur Preschool Strange Situation (PACS) #3 [Срок оценки: 6-month follow up]
  • Cortisol Stress Reactivity and Recovery #1 [Срок оценки: Baseline]
  • Cortisol Stress Reactivity and Recovery #2 [Срок оценки: Immediately post-intervention]
  • Cortisol Stress Reactivity and Recovery #3 [Срок оценки: 6-month follow up]
  • Child Behavior Checklist (CBCL) #1 [Срок оценки: Baseline]
Вторичные конечные точки (12)
  • Financial Stress Questionnaire #1 [Срок оценки: Baseline]
  • Financial Stress Questionnaire #2 [Срок оценки: Immediately post-intervention]
  • Financial Stress Questionnaire #3 [Срок оценки: 6-month follow-up]
  • O'Leary-Porter Overt Hostility Scale #1 [Срок оценки: Baseline]
  • O'Leary-Porter Overt Hostility Scale #2 [Срок оценки: Immediately post-intervention]
  • O'Leary-Porter Overt Hostility Scale #3 [Срок оценки: 6-month follow-up]
  • Adverse Childhood Experiences Questionnaire (ACE-Q) [Срок оценки: Baseline]
  • Role Overload #1 [Срок оценки: Baseline]
  • Role Overload #2 [Срок оценки: Immediately post-intervention]
  • Role Overload #3 [Срок оценки: 6-month follow-up]
  • My Exposure to Violence [Срок оценки: Baseline]
  • Experiences in Close Relationships Scale (ECR) #1 [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Parents whose children (age 8 to 36 months) are enrolled or are eligible to be enrolled in Harrisburg PA and Lehigh Valley PA Early Head Start programs

Критерии исключения

  • Parents who are not sufficiently fluent in the language in which COS-P intervention will be conducted (Spanish or English)

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
Двойное слепое
Основная цель
Профилактика

Центры проведения

США · 2 центра
  • University of Maryland, College Park — College Park
  • Lehigh University — Bethlehem

Публикации

  • Achenbach, T. M., & Rescorla, L. A. (2000). Manual for the ASEBA Preschool Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.
  • Ainsworth, M., Blehar, M., Waters, E., & Wall, S. (1978). Patterns of attachment. Erlbaum.
  • Bayley, N. 1969. Bayley scales of infant development. New York: Psychological Corp.
  • Bernard K, Dozier M. Examining infants' cortisol responses to laboratory tasks among children varying in attachment disorganization: stress reactivity or return to baseline? Dev Psychol. 2010 Nov;46(6):1771-8. doi: 10.1037/a0020660. PMID 20873923
  • Bowlby, J. (1988). A secure base. Basic Books.
  • Brennan, K. A., Clark, C. L., & Shaver, P. R. (1998). Self-report measurement of adult attachment: An integrative overview. In J. A. Simpson, W. S. Rholes, J. A. Simpson, W. S. Rholes (Eds.), Attachment theory and close relationships (pp. 46-76). Guilford.
  • Carroll KM, Nich C, Sifry RL, Nuro KF, Frankforter TL, Ball SA, Fenton L, Rounsaville BJ. A general system for evaluating therapist adherence and competence in psychotherapy research in the addictions. Drug Alcohol Depend. 2000 Jan 1;57(3):225-38. doi: 10.1016/s0376-8716(99)00049-6. PMID 10661673
  • Carter, A. S., & Briggs-Gowan, M. J. (2000). The Infant-Toddler Social and Emotional Assessment (ITSEA). Unpublished Manual. University of Massachusetts Boston Department of Psychology, Boston, MA. Yale University, New Haven, CT. Available by request at alice.carter@umb.edu.

Идентификаторы

NCT: NCT05834907 · 1857396-18 · 1R01HD105676-01A1

Первоисточники (государственные реестры)

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