Family Access to Dentist Study
FADS
Family Intervention With Caregivers of Children With Dental Needs
2 other identifiers
interventional
1,305
1 country
2
Brief Summary
The study is a multi-site, double blind, parallel arm, community-based randomized controlled trial (phase III RCT) to evaluate the effectiveness of new referral approaches to increase receipt of dental care among inner-city urban and rural elementary school children who were screened at school and have restorative treatment needs. The study has 5 arms: The experimental intervention is the use of a theoretically driven CSM referral letter alone, the letter plus a Dental Information Guide, a reduced CSM referral letter alone, or a reduced CSM referral letter plus a reduced Dental Information Guide. The control strategy is the use of a standard referral letter. All participating K-4 grade children will receive a screening at the beginning of the school year and at the study end point 7 months later to determine if the child received dental care. Due to lower than expected enrollment in both the Ohio and Washington sites, a second year of recruitment was added to include Bedford School District and East Cleveland School District (only KG and other grades if they did not enroll in the first year). The same study procedures, schedule and design was utilized for the second year of recruitment. The primary aim is to evaluate the effectiveness of experimental (new) versus standard referral approach given to parents/caregivers in increasing receipt of dental care among their children in grades K-4. The secondary aim is to assess changes in parent/caregiver illness representation/perception and behavioral intention between enrollment (beginning of school year) and follow-up (end of school year) to understand the underlying mechanisms of the new vs. standard referral approach that result in receipt of dental care. The hypothesis is that CSM-based interventions will increase receipt of dental care compared to the standard referral letter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2015
CompletedFirst Posted
Study publicly available on registry
March 20, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
June 16, 2022
CompletedJune 16, 2022
May 1, 2022
1.8 years
March 17, 2015
February 1, 2022
May 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Receipt of Dental Care-restoration or Extraction of at Least One Tooth at Final Exam
The primary outcome was receipt of dental care based on a change in the child's oral health status, as determined by clinical examinations between baseline screening (beginning of schoolyear) and follow-up at study exit (end of school year). A child was classified as having received dental care if she or he had any tooth at follow-up with an ICDAS sealant code (1 or 2),restoration code (3 to 8), or extraction code (X), previously identified at baseline via an active ICDAS lesion code ≥2.
Between baseline and follow-up (7 months after baseline)
Secondary Outcomes (2)
Change in Illness Perception Assessed by IPQ-RD
Between baseline and final follow-up
Number of Caregivers With Change in Behavioral Intention
Final follow-up (7 months)
Study Arms (5)
Standard letter
ACTIVE COMPARATORModified standard letter will be sent to caregivers.
Intervention letter
EXPERIMENTALThe CSM-based referral letter alone will be sent to caregivers
Reduced intervention letter
EXPERIMENTALThe reduced (removing text corresponding to "timeline") CSM-based referral letter alone will be sent to caregivers.
Intervention letter+DIG
EXPERIMENTALThe CSM-based referral letter with the dental information guide will be sent to caregivers.
Reduced intervention letter+reduced DIG
EXPERIMENTALThe reduced CSM-based referral letter with the reduced dental information guide will be sent to caregivers.
Interventions
Standard referral letter according to Ohio Department of Health Bureau guidelines. This letter is consistent with others used across the country.
Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control).
Reduced (removing text corresponding to "timeline") CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control).
Dental information guide (DIG) to reinforce/change illness perception, knowledge about dental caries, and resources to seek care. DIG is a brochure with illustrations which provides myths and facts about dental caries, hints for getting dental care, making appointments and Medicaid access, transportation and dentist availability resources.
Text and illustrations related to the "timeline" construct of the CSM have been removed in the reduced dental information guide.
Eligibility Criteria
You may qualify if:
- Provide signed and dated consent form (also assent form for children 7 and older)
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female child, grades K-4
- Child in good general health as evidenced by parent report (including children with special health care needs)
- Based on the beginning of the school year dental screening, caregivers will be randomized if their child has tooth with an International Caries Detection and Assessment System (ICDAS) active lesion score of ≥ 2
You may not qualify if:
- Illiterate
- Non-English speaking (in East Cleveland Public Schools)
- Under 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Case Western Reserve Universitylead
- University of Washingtoncollaborator
- National Institute of Dental and Craniofacial Research (NIDCR)collaborator
- Harvard Universitycollaborator
Study Sites (2)
Case Western Reserve University
Cleveland, Ohio, 44106, United States
University of Washington
Seattle, Washington, 98195-7475, United States
Related Publications (1)
Nelson S, Milgrom P, Albert JM, Selvaraj D, Cunha-Cruz J, Curtan S, Copeland T, Heima M, Rothen M, Beck G, Ferretti G, Riedy C. Randomized Trial Based on the Common-Sense Model of Self-regulation to Increase Child Dental Visits. JDR Clin Trans Res. 2019 Oct;4(4):323-332. doi: 10.1177/2380084419830662. Epub 2019 Feb 22.
PMID: 30931720DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
We were not able to recruit the full sample size of 660 parents/caregivers for 80% power, due to lower-than-expected school enrollment. Although examiners were trained and calibrated, it was difficult to detect tooth-colored fillings and sealants. So, our outcomes may have been underestimated in all arms. Since our outcomes were clinically determined, it is possible that parents may have taken their child to the dentist but did not complete all necessary treatments.
Results Point of Contact
- Title
- Dr. Suchitra Nelson
- Organization
- Case Western Reserve University
Study Officials
- PRINCIPAL INVESTIGATOR
Suchitra Nelson, PhD
Case Western Reserve University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 17, 2015
First Posted
March 20, 2015
Study Start
August 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
June 16, 2022
Results First Posted
June 16, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share