The Effectiveness of Motivational Interviewing in Preventing Early Childhood Caries Among Mothers of Infants in Terengganu.

Официальное название

The Effectiveness of Motivational Interviewing in Preventing Early Childhood Caries: A Cluster Randomised Controlled Trial Among Mothers of Infants in Terengganu.

Обзор

This study will be conducted in Ministry of Health (MOH) Maternal and Child Health Clinics (MCHCs) and MOH dental clinics in Setiu and Hulu Terengganu, selected for their similar sociodemographic characteristics. A two-arm, parallel cluster-randomized controlled trial (1:1 allocation) will be implemented, where the study group receives Anticipatory Guidance (AG) through Motivational Interviewing (MI), and the control group receives conventional MOH AG. Mothers aged ≥18 years who can understand Bahasa Malaysia and their healthy 6-month-old infants (full-term, without congenital conditions) are eligible. Mothers with postpartum depression and infants requiring special oral healthcare are excluded. A total of 228 mother-infant pairs will be recruited using multistage sampling. Three MCHCs from Setiu and three randomly selected MCHCs from Hulu Terengganu will participate. Systematic sampling will be applied within each clinic. Data collection occurs at infant ages 6, 9, and 12 months during routine immunization visits. At each visit, infants undergo oral examination using ICDAS and a caries risk assessment. Mothers complete age-specific validated questionnaires on knowledge and practices. The study group receives two MI sessions (at 6 and 9 months) with follow-up phone calls, while the control group receives routine AG by MOH staff. The MI protocol will be developed based on established MI frameworks and be validated through expert review, will be pretested among mothers and dental officers/therapists in MOH MCHC and MOH dental clinic in Besut district. While fidelity assessment of MI sessions conducted will be done using MITI 4.2.1 guidelines. All MI sessions will be delivered by the trained principal investigator. Approximately 8 minutes are required for infant oral examination, 7 minutes for questionnaire completion, and 30 minutes for MI. Data will be analysed using descriptive statistics, paired t-tests, independent t-tests, McNemar's test, and Chi-Square test with significance set at p \< 0.05. Ethical approval was obtained from Jawatankuasa Etika Penyelidikan Manusia USM (JEPeM)/ Human Research Ethics Committee USM (HREC) and Medical Research and Ethics Committee (MREC) MOH. Participation is voluntary, with confidentiality ensured. No major risks are expected.

Вмешательства

• Поведенческое Anticipatory Guidance Using Motivational Interviewing
  A collaborative, patient-centered communication approach that helps strengthen patients' motivation to change health behaviors
• Поведенческое Conventional Ministry of Health Anticipatory Guidance
  A process of providing practical developmentally appropriate health information about their children to parents so that they know what to expect during the child's current and approaching stage of development.

Первичные конечные точки

• Mothers' knowledge regarding infant oral health care [Срок оценки: 6 months]
• Mother's practice regarding infant oral health care [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Incidence of ECC of infants [Срок оценки: 6 months]
• Dental caries risk status of infants [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Mothers:

• Malaysian citizens
• Can read and understand Bahasa Malaysia
• Aged 18 years old and above
• Infants:

• Aged 6 months old (with or without erupted teeth)
• Born full-term (≥37 weeks of gestation)
• Without diagnosed congenital anomalies or syndromes

Критерии исключения

• Mothers

o Mothers experiencing postpartum depression or other significant postnatal issues

• Infants

• Diagnosed with special needs, chronic diseases, or developmental defects
• Infants who are at risk for oral health problems due to pre-existing medical conditions
• Infants requiring specialized oral healthcare, such as those with cleft lip and palate, enamel hypoplasia

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07538219 · USM/JEPeM/KK/25080733

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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