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Набор скоро начнётся NCT06616090

Nurse Implemented Infant-Mother Attachment Security Program

Без фазы С лечением Nurse's Role Infant Development Maternal Behavior

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: Nurse Implemented Infant-Mother Attachment Security Program.
Кому может быть актуально
Состояния в реестре: Nurse's Role, Infant Development, Maternal Behavior. Базовые параметры: Без ограничений · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Investigating the Effectiveness of Nurse Implemented Attachment-Based Maternal Sensitivity Program in Primary Family Health Care Services

Обзор

This study focuses on adapting and evaluating an attachment-based intervention program implemented by nurses in Family Health Centers (FHCs) in Turkey. The program aims to enhance parental sensitivity and infant-mother attachment security. Evidence suggests that such programs, developed in Western countries, effectively improve parenting behaviors and attachment quality. Despite the positive effects of similar programs in Turkey, their integration into primary healthcare for wider public benefit remains unexplored. The project will develop an intervention protocol based on effective methods from previous attachment-based programs into routine childcare visits at FHCs. A randomized controlled trial involving 120 mothers with 9- to 12-month-old babies in Istanbul will be recruited. FHCs will be randomly assigned to intervention and control groups, with 60 mother-infant dyads in each condition. Nurses will deliver the program during childcare visits at 9, 12, 15, and 18 months. Intervention FHCs will also use reminders like posters and short films in the waiting rooms to reinforce the concepts. Effectiveness will be evaluated through pretest, posttest, and follow-up home visits using observational and self-report measures on attachment security, maternal sensitivity, as well as maternal psychological characteristics, along with infant socioemotional measures. Upon completion of the project, control FHC nurses will receive training to deliver a condensed version of the program.

Подробное описание

This study aims to adapt and evaluate the effectiveness of an attachment-based, protective-preventive intervention program implemented by nurses in Family Health Centers (FHC) that routinely follow up infants' health. Attachment-based parenting intervention programs have been developed and implemented in Western countries given that parental sensitivity and secure attachment relationship in the early years are critical precursors of psychological resilience. These evidence-based programs have been widely shown to reinforce responsive parenting behaviors and improve attachment quality. A few attachment-based programs have been adopted in Turkey with documented positive effects. However, adaptations of such programs within the primary healthcare services that actively reach families have yet to be conducted to evaluate their potential widespread use for public benefit. In this proposed project, effective application methods of attachment-based programs identified in previous studies, will be integrated to the current well-child care visits in FHCs. It is expected that this program will positively affect maternal sensitivity, caregiving competence, positive discipline methods, mother-child attachment security, and reduce child problem behaviors (e.g., internalizing and externalizing problems). It is also expected that the program effectiveness will be more robust among mothers from socioeconomically disadvantaged families, those with initially low levels of sensitivity, and anxious attachment pattern. To test these expectations with a randomized controlled trial, 120 mothers with 9-month-old babies from FHCs in Istanbul will participate. Selected FHCs will be randomly assigned to intervention and control conditions. Mother-infant dyads will be divided into intervention (N = 60) and control (N = 60) groups. Following a comprehensive training, nurses will apply five modules with sensitivity and positive discipline themes, including a booster module, to the mother-infant dyads during well-child care visits at the 9th, 12th, 13th, 14th and 15th months following the pretest measurements. The application will draw on nurses' positive feedback to mothers utilizing short video recordings and in-the-moment mother-baby interactions consistent with each module theme. Additionaly, mothers will be exposed to the reminders (e.g., pictures, posters, short film screenings) reflecting maternal sensitivity and secure attachment in the waiting rooms of the intervention FHCs. The proposed project will be carried out by experts from psychology with research and experience in attachment-based intervention in collaboration with the experts working in family medicine, nursing, and primary healthcare. To examine program effectiveness, pretest, posttest, and follow-up measurements will occur at pre-defined times through home visits to mothers. Data on mother and infant demographics and psychological characteristics will be collected using multimethod measurement in line with the program goals. Thus, maternal sensitivity level will be assessed using the Ainsworth Sensitivity Scale and Maternal Sensitivity Q-Sort, and the mother-infant attachment quality will be assessed using the short form of the Attachment Q-Sort. Besides observation, mother-reported sensitivity and attitudes towards discipline, caregiving competence, mental processes underlying child's emotions and behaviors, and psychological characteristics (e.g., adult attachment pattern, depressive symptoms) will be evaluated with widely used measurement tools. Finally, infant development and temperament will be assessed via mother report. Following the intervention program, training will also be given to nurses in the control FHCs, who will deliver a condensed maternal sensitivity program to control mothers. The program will be disseminated to relevant experts and institutions, including the priority stakeholders in the family primary healthcare system. If the program's effectiveness is demonstrated, special efforts will be made to scale-up the program. Given that attachment-based early intervention programs positively affect child development throughout life, improve the family environment and social relations and reduce public expenditure on health problems in the long run, the proposed program is expected to create a similar impact in Turkey and lead to positive psychosocial change.

Вмешательства

  • Поведенческое Nurse Implemented Infant-Mother Attachment Security Program
    The intervention will draw on video-feedback of mother-infant interactions during the well-child visit. Nurses will videotape the dyad during routine visit in the Family Health Center and show short clips to mothers during the session in order to provide mother positive feedback on their sensitive caregiving. Additionaly, intervention mothers will be exposed to the reminders (e.g., pictures, posters, short film screenings) reflecting maternal sensitivity and secure attachment in the waiting room

Первичные конечные точки

  • Maternal sensitivity 1 [Срок оценки: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old]
  • Maternal sensitivity 2 [Срок оценки: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old]
  • Attachment Security [Срок оценки: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old]
  • Maternal Sensitive Discipline [Срок оценки: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old]
  • Infant Socio-Emotional Development [Срок оценки: Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old]
Вторичные конечные точки (6)
  • Maternal Reflective Functioning [Срок оценки: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old]
  • Maternal Attachment Representation [Срок оценки: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old]
  • Maternal Efficacy in Parenting [Срок оценки: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old]
  • Maternal depression [Срок оценки: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old]
  • General Parenting Practices [Срок оценки: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old]
  • Marital Conflict [Срок оценки: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old]

Критерии участия

Критерии включения

  • mothers with 9- to 12-month infants
  • having a normally developing infant.

Критерии исключения

  • mothers with infants who have a chronic pediatric health problem
  • mother with infants whose developmental problems are detected during routine evaluations
  • mothers with temporary protection status (i.e., immigrants) due to potential communication problems
  • if the mother is not the primary caregiver

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
Простое слепое
Основная цель
Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр
  • Sabanci University — Istanbul

Идентификаторы

NCT: NCT06616090 · 123K416

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗