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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This is a 3 year clincal 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	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	850 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 :	March 9, 2018
Estimated Primary Completion Date :	August 31, 2020
Estimated Study Completion Date :	August 31, 2020

Arms and Interventions

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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

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Primary Outcome Measures :

1. Dental caries [ Time Frame: Change from 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).
2. Self-efficacy to perform oral health behaviors (12 items) [ Time Frame: Change from 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 TM program.
3. Motivation to perform oral health behaviors (12 items) [ Time Frame: Change from 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 the TM program.
4. Outcome expectations regarding oral health behaviors [ Time Frame: 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 the TM program.
5. Number of goals set and completed during the OHT program [ Time Frame: End of treatment (4 months) ]
   OHT will set goals to brush (or supervise brushing) their children's teeth. Goals set and completed are automatically tracked in the TM 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. Both groups will be assessed each day for their adherence.

Secondary Outcome Measures :

1. Program Satisfaction [ Time Frame: 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). The MARS also measures 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.

Eligibility Criteria

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Ages Eligible for Study:	up to 7 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Belinda Borrelli, PhD	617-414-1116	belindab@bu.edu
Contact: Michelle Henshaw, DDS, MPH	617-638-5222	mhenshaw@bu.edu

Locations

United States, Massachusetts
Boston Medical Center	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Belinda Borrelli, PhD 617-414-1116 belindab@bu.edu

Sponsors and Collaborators

Boston University

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Principal Investigator:	Belinda Borrelli, PhD	Henry M. Goldman School of Dental Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Belinda Borrelli, Professor, Boston University
ClinicalTrials.gov Identifier:	NCT03294590 History of Changes
Other Study ID Numbers:	H36857; 4UH3DE025492-03 ( U.S. NIH Grant/Contract )
First Posted:	September 27, 2017
Last Update Posted:	March 14, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Belinda Borrelli, Boston University:

Child oral health behaviors; Text messages; Motivation; Self efficacy; Outcome Expectations; Bottle/sippy cup use	Sugar sweetened beverage consumption; Fluoride varnish; Healthy eating; Parent oral health behaviors; Parent oral health attitudes; Fluoride

Additional relevant MeSH terms:

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases	Fluorides; Cariostatic Agents; Protective Agents; Physiological Effects of Drugs