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

Boston University754 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

754

Conditions

Caries, Dental Health Behavior

Interventions

OHT Parent targeted text messagesOTHER

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.

CWT Parent targeted text messagesOTHER

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.

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 7 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Caregiver and child must meet all of the following: 1. 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 2. The child must receive medical care at one of the participating pediatric clinics. 3. Speak, understand, and read either English or Spanish 4. 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 1. 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. 2. Children who cannot complete the baseline oral health exam.

Locations (1)

Boston Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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).

Time frame: 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)

Time frame: 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)

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 24-month time point (oral assessment)

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 4-month, 12-month, and 24-month time points (survey)

Data from ClinicalTrials.gov

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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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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).

Time frame: 4-month time point (survey)