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

Health Behavior Clinical Trial

— iSmile  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294590
• Other study ID #: H-36857
• Secondary ID: 4UH3DE025492-03
• Status: Completed
• Phase: N/A
• Start date: March 9, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: October 2023
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 754
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Months to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries
• Health Behavior

Intervention

Other:
• OHT Parent targeted text messages
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 messages
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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Type of Beverage Consumed Between Meals	Parent/caregiver participants are asked to indicate what beverage their child consumes most often between meals.	4-month, 12-month, and 24-month time points (survey)
Other	Challenge Week During the OHT Text Message Program	We assessed the number of parent/caregiver participants in the OHT arm who agreed to do the challenge (setting the goal of brushing their child's teeth every day, twice per day) that occurred within the 4-month text message program.	4-month time point
Other	Dental Caries (Per Subject)	Number of primary teeth with new dental caries per child	24-Month (oral health assessment)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)