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

Not Applicable

Completed

Conditions: Caries, Dental
Health Behavior

Interventions: Other: OHT Parent targeted text messages
Other: CWT Parent targeted text messages

Registration Number: NCT03294590

Lead Sponsor: Boston University

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 754

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral health text messages (OHT)	OHT Parent targeted text messages	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.
Child wellness text messages (CWT)	CWT Parent targeted text messages	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.

Primary Outcome Measures

Name	Time	Method
Dental Caries Increment	24-month time point (oral assessment)	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).
Parent/Caregiver Confidence to Brush	4-month time point (survey)	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)
Parent/Caregiver Motivation to Perform Oral Health Behaviors	4-month time point (survey)	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)
Parent/Caregiver Outcome Expectations for Oral Health Behaviors	4-month time point (survey)	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).
Self-efficacy to Perform Oral Health Behaviors	4-month time point (survey)	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).
Dental Caries Increment (Surface Level)	24-month time point (oral assessment)	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).

Secondary Outcome Measures

Name	Time	Method
Child Preventive Dental Visits	4-month, 12-month, and 24-month time points (survey)	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.
Child Diet - Beverage Intake	4-month, 12-month, and 24-month time points (survey)	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).
Satisfaction With Text Message Program Features	4-month time point (survey)	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).
Perceived Impact of OHT Program on Parental Awareness	24-month (survey)	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.
Child Tooth Brushing	4-month, 12-month, and 24-month time points (survey)	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).
Diffusion of Text Messages (Satisfaction)	4-month time point (survey)	One item adapted from the Mobile App Rating Scale (MARS) asks parent/caregiver participants whether they showed (or forwarded) text messages to anyone else
Fluoridated Toothpaste Use	4-month, 12-month, and 24-month time points (survey)	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.
Text Message Program Length Satisfaction	4-month time point (survey)	One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants satisfaction with the duration of the text message program.
Child Diet - Food Frequency	4-month, 12-month, and 24-month time points (survey)	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).
Child Oral Health-related Quality of Life	4-month, 12-month, and 24-month time points (survey)	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).
Parent/Caregiver Tooth Brushing	4-month, 12-month, and 24-month time points (survey)	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).
Parents' Perceived Impact of iSmile	4-month time point (survey)	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).
Parents/Caregivers Toothbrushing (Clinical Guidelines)	4-month, 12-month, and 24-month time points (survey)	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.
Child Toothbrushing (Clinical Guidelines)	4-month, 12-month, and 24-month time points (survey)	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.
Text Message Program Quality	4-month time point (survey)	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).
Text Message Program Star Rating	4-month time point (survey)	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.