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

NCT07538219 | Not Yet Recruiting DMC

• 1 other identifier: USM/JEPeM/KK/25080733
• Study Type: interventional
• Target: 228
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy Women; Caries of Infancy

Outcome Measures

Primary Outcomes (2)

• Mothers' knowledge regarding infant oral health care

  Questionnaire from Mukhtar et al., 2023

  6 months

• Mother's practice regarding infant oral health care

  Questionnaire from Mukhtar et al., 2023

  6 months

Secondary Outcomes (2)

• Incidence of ECC of infants

  6 months

• Dental caries risk status of infants

  6 months

Study Arms (2)

Study group

EXPERIMENTAL

Anticipatory Guidance through Motivational Interviewing

Behavioral: Anticipatory Guidance Using Motivational Interviewing

Control group

EXPERIMENTAL

Conventional Ministry of Health anticipatory guidance

Behavioral: Conventional Ministry of Health Anticipatory Guidance

Interventions

Conventional Ministry of Health Anticipatory Guidance BEHAVIORAL

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.

Control group

Anticipatory Guidance Using Motivational Interviewing BEHAVIORAL

A collaborative, patient-centered communication approach that helps strengthen patients' motivation to change health behaviors

Study group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Mothers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Central Study Contacts

ABDUL MALIK NOR AIDA, DOCTOR OF DENTAL SURGERY

CONTACT

+60139127520; aidafgg05@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 20, 2026
• Study Start: April 12, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04