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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Women; Caries of Infancy
• Intervention / Treatment: Behavioral: Anticipatory Guidance Using Motivational Interviewing; Behavioral: Conventional Ministry of Health Anticipatory Guidance

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ABDUL MALIK NOR AIDA, DOCTOR OF DENTAL SURGERY; Phone Number: +60139127520; Email: aidafgg05@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Anticipatory Guidance through Motivational Interviewing	Behavioral: Anticipatory Guidance Using Motivational Interviewing; A collaborative, patient-centered communication approach that helps strengthen patients' motivation to change health behaviors
Experimental: Control group; Conventional Ministry of Health anticipatory guidance	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ECC of infants	Incidence of early childhood caries on infants (using charts from Evans et al., 2017)	6 months
Dental caries risk status of infants	Dental caries risk status of infants (using Caries Risk Assessment from Evans et al., 2017)	6 months

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Estimated): April 12, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: USM/JEPeM/KK/25080733

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No