Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST).

Study Overview
=================
Brief Summary
-----------------
In the current study, MOST approach is proposed, to engineer an oral health behavior modification intervention, to increase the engagement of mothers in brushing their pre-school children's teeth.

Detailed Description
-----------------
The first phase of this study will be the preparation phase. This will comprise the development of a conceptual framework and conducting a feasibility pilot study consisting of three intervention components: Motivational interviewing (MI), Oral health promotion messages (OHPm), and Storytelling (ST). The second phase of the study is the optimization phase which constitutes a factorial trial of the three selected intervention components (MI, OHPm and ST). Each component will be set at two levels: yes (the intervention is applied) vs no (the intervention is not applied).

Official Title
-----------------
Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST) on Oral Hygiene Habits of Pre-school Children in Egypt.

Conditions
-----------------
Dental Caries in Children, Early Childhood Caries

Intervention / Treatment
-----------------
* Behavioral: Oral Health Behavioral Interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for mother's of children enrolled in study: Has children between 2 and <5 years of age Has children with high plaque index scores (PlI≥2 or visible plaque accumulation on maxillary anterior teeth). Literate and owns a mobile phone with already set-up or possibility to set-up Whats-App messenger application. Willing to participate in the study and receive periodic OHPm and ST videos. Exclusion Criteria: Mothers of children who are not willing to cooperate and show a definite negative behavior (Rating 1 Frankel's classification). Mothers of children who are physically disabled or medically compromised. Mothers of children in need of emergency dental treatments.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: A factorial trial following the Multiphase optimization Strategy (MOST)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition 1<br>Participants will receive the constant component only. | Behavioral: Oral Health Behavioral Interventions<br>* The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.<br>|
| Experimental: Condition 2<br>Participants will receive the constant component and storytelling videos . | Behavioral: Oral Health Behavioral Interventions<br>* The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.<br>|
| Experimental: Condition 3<br>Participants will receive the constant component and oral health promotion messages. | Behavioral: Oral Health Behavioral Interventions<br>* The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.<br>|
| Experimental: Condition 4<br>Participants will receive the constant component and a motivational interview session. | Behavioral: Oral Health Behavioral Interventions<br>* The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.<br>|
| Experimental: Condition 5<br>Participants will receive the constant component, oral health promotion messages and storytelling videos. | Behavioral: Oral Health Behavioral Interventions<br>* The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.<br>|
| Experimental: Condition 6<br>Participants will receive the constant component, oral health promotion messages, storytelling videos, and a motivational interview session. | Behavioral: Oral Health Behavioral Interventions<br>* The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.<br>|
| Experimental: Condition 7<br>Participants will receive the constant component, oral health promotion messages and a motivational interview session. | Behavioral: Oral Health Behavioral Interventions<br>* The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.<br>|
| Experimental: Condition 8<br>Participants will receive the constant component, storytelling videos, and a motivational interview session. | Behavioral: Oral Health Behavioral Interventions<br>* The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the plaque index scores of participating children | Measured by the Plaque index (PII) of Silness and Loe | at baseline, 3 and 6 months | 
| Change in children's frequency of toothbrushing and use of fluoridated toothpaste | Using the World Health Organization (WHO) questionnaire | at baseline, 3 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MOST, behavioural intervention, early childhood caries