Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children (iSmile)
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|ClinicalTrials.gov Identifier: NCT03294590|
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : March 14, 2019
|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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||850 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Masking Description:||Outcome Assessors and Oral Health Examiners will be blind to treatment condition.|
|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|
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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294590
|Contact: Belinda Borrelli, PhDfirstname.lastname@example.org|
|Contact: Michelle Henshaw, DDS, MPHemail@example.com|
|United States, Massachusetts|
|Boston Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Belinda Borrelli, PhD 617-414-1116 firstname.lastname@example.org|
|Principal Investigator:||Belinda Borrelli, PhD||Henry M. Goldman School of Dental Medicine|