Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children

Study Overview
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Brief Summary
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This is a randomized clinical trial to test the efficacy of a parent-targeted text message-based intervention program on caries incidence and oral health behaviors (child and parent). Parents (n= 850) across all pediatric clinic sites (Boston Medical Center and Community Health Centers (CHCs); DotHouse CHC, South End Community Health Center, and Codman Square CHC) will be randomized to receive either text messages (TMs) regarding oral health or TMs regarding child wellness. The study will enroll English and Spanish speaking parents and their youngest child who is < 7 years old, has at least one tooth showing, and attends the targeted pediatric clinic to receive primary care (n= 1700). Parents will complete self-report surveys at baseline, and 2, 4, 12, and 24-months after baseline; receive and respond to TM assessments during the 4-month intervention; and will also receive TMs during a 'booster' period of one month, which will occur 12-months post baseline. Parent's children will be assessed for caries by a clinical oral examination performed by licensed Clinical Examiners at baseline, 12-and-24-months post-baseline.

Official Title
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Randomized Controlled Trial of Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children

Conditions
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Caries, Dental, Health Behavior

Intervention / Treatment
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* Other: OHT Parent targeted text messages
* Other: CWT Parent targeted text messages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caregiver and child must meet all of the following: Caregiver must be a parent or legal guardian of a child less than 7 years old, and the child must have their first tooth showing The child must receive medical care at one of the participating pediatric clinics. Speak, understand, and read either English or Spanish Have a mobile phone. Exclusion Criteria: If the caregiver or child meets any of the following criteria, the dyad will be excluded from participation in this study Children with severe congenital tooth malformations: At screening the caregiver will be asked if their child has known systemic diseases associated with abnormal tooth development or abnormal oral health status such as cleft lip or palate, amelogenesis imperfecta, or dentinogenesis imperfecta. Children who cannot complete the baseline oral health exam.

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral health text messages (OHT)<br>Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics. | Other: OHT Parent targeted text messages<br>* For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.<br>|
| Active Comparator: Child wellness text messages (CWT)<br>Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics. | Other: CWT Parent targeted text messages<br>* For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Caries Increment | Surface level caries data in children was collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface). | 24-month time point (oral assessment) | 
| Parent/Caregiver Confidence to Brush | 9-item self-efficacy measure to assess parent/caregiver participant confidence in their ability to brush their child's teeth under different situations. (Finlayson measure; range 1 - 4; higher scores mean better outcome) | 4-month time point (survey) | 
| Parent/Caregiver Motivation to Perform Oral Health Behaviors | A oral health motivation measure to assess parent/caregiver participants motivation to engage in recommended child oral health behaviors (score range 1 - 7; higher scores mean better outcome) | 4-month time point (survey) | 
| Parent/Caregiver Outcome Expectations for Oral Health Behaviors | An outcome expectancies measure to assess the degree to which parent/caregiver participants perceive that performing the oral health behaviors (e.g., brushing) will lead to the desired outcome (e.g., reduced dental caries) in their children (Stewart et al., 1997; range 1 - 4; higher scores mean better outcome). | 4-month time point (survey) | 
| Self-efficacy to Perform Oral Health Behaviors | The overall self-efficacy score represents how sure parent/caregiver participants are that they can engage in recommended behavior to take care of their children's teeth. (Based on Albino et al 2017; range 1 - 7; higher scores mean better outcome). | 4-month time point (survey) | 
| Dental Caries Increment (Surface Level) | Caries data in children participants collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of a surface of tooth-level caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface). | 24-month time point (oral assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Text Message Program Length Satisfaction | One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants satisfaction with the duration of the text message program. | 4-month time point (survey) | 
| Parents' Perceived Impact of iSmile | Three items adapted from the MARS to measure the perceived impact of the OHT text message program on parent/caregiver participants' attitudes towards their child's oral health (range 1 - 7; higher scores mean a better outcome). | 4-month time point (survey) | 
| Child Preventive Dental Visits | One item adapted from the Basic Research Factors Questionnaire (BRFQ) to assess the number of parent/caregiver participants who indicated that their child had a preventive dental visit. | 4-month, 12-month, and 24-month time points (survey) | 
| Fluoridated Toothpaste Use | One item derived from the Basic Research Factors Questionnaire (BRFQ) to measure whether parent/caregiver participants use toothpaste containing fluoride when brushing their child's teeth. | 4-month, 12-month, and 24-month time points (survey) | 
| Perceived Impact of OHT Program on Parental Awareness | One item adapted from the Basic Research Factors Questionnaire (BRFQ) to measure parent/caregiver participants' (in the OHT arm) awareness of their child oral health. | 24-month (survey) | 
| Child Diet - Food Frequency | Parent/caregiver participants completed a food frequency questionnaire (FFQ) to assess their child's diet. Food/beverages items in the FFQ are categorized into groups according to the degree to which they promote dental caries, and a weighted estimated cariogenicity score (ECS) is computed (minimum and maximum scores range 0 - 3.80; higher scores mean a worse outcome). | 4-month, 12-month, and 24-month time points (survey) | 
| Child Diet - Beverage Intake | Parent/caregiver participants completed the beverage questionnaire for preschoolers (BEVQ-PS) to assess their child's beverage intake. For each beverage item, the frequency and the amount of consumption are computed as average fluid ounces per day, and a composite score is computed for sugar sweetened beverages (including 100% fruit juice) consumption and then categorized into higher consumption (vs lower). | 4-month, 12-month, and 24-month time points (survey) | 
| Child Tooth Brushing | An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week (range: 0 - 21; higher scores mean a better outcome). | 4-month, 12-month, and 24-month time points (survey) | 
| Parent/Caregiver Tooth Brushing | An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week (range: 0 - 21; higher scores mean a better outcome). | 4-month, 12-month, and 24-month time points (survey) | 
| Child Oral Health-related Quality of Life | The Early Childhood Oral Health Impact Scale (ECOHIS) to measure parent/caregiver participants' perceptions of their child's oral health (range 0 - 16; higher scores mean a worse outcome). | 4-month, 12-month, and 24-month time points (survey) | 
| Satisfaction With Text Message Program Features | One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants' overall level of satisfaction with the text message program features (range 1 - 7; higher scores mean a better outcome). | 4-month time point (survey) | 
| Child Toothbrushing (Clinical Guidelines) | An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week recoded into child met clinical guidelines for brushing (brushing at least two times per day, seven days of the week) vs not. | 4-month, 12-month, and 24-month time points (survey) | 
| Parents/Caregivers Toothbrushing (Clinical Guidelines) | An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week recoded into parent/caregiver participants met clinical guidelines for brushing (brushed at least two times per day, seven days of the week) vs not. | 4-month, 12-month, and 24-month time points (survey) | 
| Diffusion of Text Messages (Satisfaction) | One item adapted from the Mobile App Rating Scale (MARS) asks parent/caregiver participants whether they showed (or forwarded) text messages to anyone else | 4-month time point (survey) | 
| Text Message Program Star Rating | One item adapted from the Mobile App Rating Scale (MARS) asks participants to give a star rating of the text message program. The star rating score range 1 star to 5 stars; a higher number of stars mean a better outcome. | 4-month time point (survey) | 
| Text Message Program Quality | Parent/caregiver participants responded to an investigator developed survey to measure several aspects of text messages quality (range 1 - 7; higher scores mean a better outcome). | 4-month time point (survey) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child oral health behaviors, Text messages, Motivation, Self efficacy, Outcome Expectations, Sugar sweetened beverage consumption, Fluoride varnish, Healthy eating, Parent oral health behaviors, Parent oral health attitudes, Fluoride, early childhood caries