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

Sponsor

Boston University (Other)

Overall Status

Completed

CT.gov ID

NCT03294590

Collaborator

National Institute of Dental and Craniofacial Research (NIDCR) (NIH)

754

Enrollment

Location

Arms

47.7

Actual Duration (Months)

15.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 3 year clinical study, 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 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.

Condition or Disease	Intervention/Treatment	Phase
Caries, Dental Health Behavior	Other: OHT Parent targeted text messages Other: CWT Parent targeted text messages	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

754 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Masking Description:

Outcome Assessors and Oral Health Examiners will be blind to treatment condition.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 9, 2018

Actual Primary Completion Date :

Feb 28, 2022

Actual Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oral health text messages (OHT) 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 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.
Active Comparator: Child wellness text messages (CWT) 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 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.

Arm

Intervention/Treatment

Experimental: Oral health text messages (OHT)

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

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.

Active Comparator: Child wellness text messages (CWT)

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

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.

Outcome Measures

Primary Outcome Measures

Change in Dental caries [baseline to 24 months]
Tooth surface level data in children, collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of caries incidence rates (development of a new cavitated lesion or filled surface in a previously sound tooth surface or tooth surface without a cavitated lesion).
Change in Self-efficacy to perform oral health behaviors (12 items) [baseline to end of treatment (4 months)]
The overall self-efficacy score represents how sure participants are that they can engage in recommended behavior to take care of their children's teeth. The overall self-efficacy score is the mean response. The 12 items are scored on a 1-7 scale, 1 = not sure at all to 7 = extremely sure. Higher scores are favorable. A one-item measure of this construct will be assessed during the text messaging.
Change in Parent/caregiver confidence (9 items) [baseline to end of treatment (4 months)]
A 9-item self-efficacy scale will also be used to assess parent/caregiver confidence in their ability to brush their child's teeth under different situations. The scale's score range 1 - 4, and higher scores indicate greater confidence. A one-item measure of this construct will be assessed during the text messaging.
Change in Motivation to perform oral health behaviors (12 items) [baseline to end of treatment (4 months)]
The overall motivation score represents how much participants want to engage in recommended behavior to take care of their children's teeth. The overall motivation score is the mean response. The 12 items are scored on a 1-7 scale, 1 = do not want to at all to 7 = very much want to. Higher scores are favorable. A one-item measure of this construct will be assessed during text messaging.
Outcome expectations regarding oral health behaviors [Change from baseline to end of treatment (4 months)]
This measure assesses the degree to which 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). A one-item measure of this construct will be assessed during text messaging.
Number of goals set and completed during the OHT program [End of treatment (4 months)]
Toothbrushing goals will be set, completed and automatically tracked in the text message platform system. Whether or not participants 'opt in' to participating in 'challenge weeks' will also be assessed. For OHT, this will entail setting a goal of brushing every day, twice per day. Adherence will be assessed on a daily basis.

Secondary Outcome Measures

Program Satisfaction [End of treatment (4 months)]
The Mobile App Rating Scale (MARS) was adapted to oral health and modified to measure satisfaction with the text messaging program (e.g., would you recommend this program; '1'= not at all to '5' definitely); showing the TMs to others (yes/no); perceived helpfulness of TMs to family/friends; how much longer they want to receive the program; and satisfaction with each of the proposed program components (e.g., setting goals, choosing topics) and structure (e.g, time of day TMs received, frequency). Higher scores are favorable.
Parents' attitudes toward their child's oral health [End of treatment (4 months)]
The MARS will also be used to measure the perceived impact of the intervention on parents' attitudes towards their child's oral health measured with six items on a scale of 1 (strongly disagree) to 5 (strongly agree; e.g., iSMILE has improved my attitude toward my child's oral health) Perceived impact on oral health practices are measured with six items on a scale of 1 'not at all' to 10 'very much.' Higher scores are favorable.
Change in Child dental visits [Baseline to 24 months]
Survey items derived from the Basic Research Factors Questionnaire (BRFQ) will be adapted to measure the number of times the child has visited the dentist, and the reasons for the dental visits at all questionnaire assessment time points (including during text messaging).
Change in Tooth monitoring [Baseline to 24 months]
Survey items derived from the Basic Research Factors Questionnaire (BRFQ) will be adapted to measure the frequency with which parents or caregivers check their child's teeth for early sign of cavities. Tooth monitoring will be assessed at all questionnaire assessment time points.
Change in Fluoridated toothpaste [Baseline to 24 months]
An item derived from the Basic Research Factors Questionnaire (BRFQ) will assess whether parents or caregivers use toothpaste containing fluoride when brushing their child's teeth.
Change in Bottle or sippy cup [Baseline to 24 months]
Survey items derived from the Basic Research Factors Questionnaire (BRFQ) will be adapted to assess child's use of the bottle or sippy cup, and content of the bottle or sippy cup at all questionnaire assessment time points (including during text messaging).
Change in Oral health knowledge [Baseline to 24 months]
Survey items derived from the Basic Research Factors Questionnaire (BRFQ) will be used to assess parent/caregiver knowledge of child oral health hygiene routines and feeding practices. A total knowledge score is computed which represents percent oral health knowledge items correctly answered by parent/caregiver (higher scores indicates greater knowledge).
Change in Attitudes toward oral health [Baseline, 24 months]
Survey items derived from the Basic Research Factors Questionnaire (BRFQ) will be adapted to measure parent/caregiver's attitudes towards their child oral health at all questionnaire assessment time points.
Child diet - food frequency [baseline, 2 months, 4 months, 12 months, 24 months]
A food frequency questionnaire (FFQ) will be administered to assess the child's diet. Food/beverages items in the FFQ are categorized into groups according to the degree to which they promote dental caries. A weighted estimated cariogenicity score is then computed (higher scores indicates greater consumption of food/beverage that promotes dental caries)
Child diet - beverage [baseline, 2 months, 4 months, 12 months, 24 months]
The beverage questionnaire for preschoolers (BEVQ-PS) will be administered to assess the child's beverage diet. For each beverage item, the frequency and the amount of consumption are computed as average fluid ounces per day and average calories per fluid ounces per day. A composite score is calculated for total daily beverage calories (higher scores indicate greater calories intake from all beverages) and total daily sugar sweetened beverages calories (higher scores indicate greater calories intake from sugar sweetened beverages).
Child tooth brushing [baseline, 2 months, 4 months, 12 months, 24 months]
Using the week prior to each assessment point as the time frame, we will assess the number of days and the number of times the child's teeth were brushed in that week. During text messaging, child brushing will also be measured via text message assessments.
Oral health behaviors - parent/caregiver [baseline, 2 months, 4 months, 12 months, 24 months]
Using the week prior to each assessment point as the time frame, the number of days and the number of times parent/caregiver's brushed their own teeth that week will be assessed.
Child oral health-related quality of life [baseline, 2 months, 4 months, 12 months, 24 months]
The Early Childhood Oral Health Impact Scale (ECOHIS) will be administered at baseline, 4, 12, and 24 months to measure parent/caregiver perceptions of their child's oral health. Lower scores indicate better oral health-related quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Months to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.