Goal Attainment-Based Parent Education for ECC Prevention (GAT-ECC)

March 9, 2026 updated by: Serpil Boran, Karadeniz Technical University

Assessing the Effectiveness of Parent Education on the Prevention of Early Childhood Caries Based on Goal Attainment Theory

Preventing early childhood caries (ECC) requires improving parental knowledge and behavior, as parents play a critical role in establishing oral and dental health practices during early childhood. This study aimed to evaluate the effectiveness of a parent-focused educational intervention, delivered within the nursing discipline and grounded in King's Theory of Goal Attainment, in preventing ECC. A pretest-posttest randomized controlled experimental design was employed. The study was conducted with 100 parents of children aged 0-3 years who presented for treatment at the Department of Pediatric Dentistry. Parents in the intervention group received ECC-prevention education supported by booklets, brochures, and videos.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Early childhood caries (ECC) is a common dental health problem affecting children under the age of three, which can lead to pain, infection, and long-term oral health issues. Parental knowledge and behaviors play a critical role in the prevention of ECC, as early habits significantly influence children's oral health outcomes. This study aims to evaluate the effectiveness of structured parent education in improving parental knowledge and oral hygiene practices, and in reducing ECC incidence in young children.

This randomized controlled trial will include two groups: an experimental group receiving structured oral health education and a control group receiving standard care. A total of 100 parents with children aged 0-3 years who meet the inclusion criteria will be recruited at the Rize University Faculty of Dentistry, Department of Pedodontics. Participants will be randomly assigned to either group using a simple randomization method via an online randomization tool.

Eligible participants include parents of healthy children without chronic diseases, special care needs, or mental/communication disorders. Participants must be able to read, write, and speak Turkish. Parents who do not meet these criteria will be excluded.

The intervention consists of educational sessions on oral hygiene practices, diet, fluoride use, and early detection of dental caries. Parents in the control group will receive routine information and standard dental care without structured education. Primary outcomes include changes in parental knowledge scores and ECC incidence in children. Secondary outcomes include improvements in oral hygiene behaviors and adherence to preventive practices.

Data will be collected through questionnaires, clinical examinations, and follow-up visits. Statistical analyses will compare outcomes between the experimental and control groups to determine the effectiveness of the parent education program.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Centre
      • Rize, Centre, Turkey (Türkiye), 53020
        • Karadeniz Technical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Parents of children aged 0-3 years
  • Ability to read, write, and speak Turkish
  • Willingness to participate and provide written informed consent

Exclusion Criteria:

  • Parents of children with chronic diseases
  • Parents of children with special care needs
  • Parents unwilling to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Participants in this group receive structured parent education sessions, including oral hygiene training, diet counseling, and guidance on early childhood caries prevention.
Behavioral: Structured Parent Education
Participants in the experimental group receive structured parent education sessions covering oral hygiene practices, diet counseling, fluoride use, and strategies for early childhood caries prevention. Sessions include interactive discussions, demonstrations, and take-home educational materials.
Other Names:
  • Parent Education Program
  • Oral Health Training for Parents
No Intervention: Control group
Participants in this group receive standard care, including routine oral health information provided during regular clinic visits, without structured educational sessions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parental Knowledge Score
Time Frame: Baseline, 3 months

The Early Childhood Caries Prevention Knowledge and Behavior Questionnaire was used to assess parents' knowledge and practices regarding the prevention of early childhood caries (ECC). The questionnaire was developed by the research team based on a review of the relevant literature and King's purposive data collection approach. It consists of 26 items evaluating parental knowledge and behaviors related to oral hygiene practices, dietary habits, fluoride use, dental visit timing, and risk factors for ECC.

Each correct response receives 1 point, and incorrect or "do not know" responses receive 0 points. The total score ranges from 0 to 26. Higher scores indicate greater parental knowledge and more appropriate oral health behaviors related to the prevention of early childhood caries.

The reliability of the questionnaire was assessed using Cronbach's alpha, which was found to be 0.727, indicating acceptable internal consistency.
Baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Serpil Boran, MSc, Karadeniz Technical University, Graduate School of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TDK-2025-16367 (Other Grant/Funding Number: KTU Scientific Research Projects Coordination Office)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participant data collected in this study will be made available for research purposes. Qualified researchers may request access, which will be provided through a secure data sharing process. The data will be accessible for up to 5 years after publication of the main study results, subject to ethical approval and data use agreements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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