Family Access to Dentist Study

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.

Conditions

• Dental Caries

Interventions

BEHAVIORAL

Standard letter

Standard referral letter according to Ohio Department of Health Bureau guidelines. This letter is consistent with others used across the country.

BEHAVIORAL

Intervention letter

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).

BEHAVIORAL

Reduced intervention letter

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).

BEHAVIORAL

DIG

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.

BEHAVIORAL

Reduced DIG

Text and illustrations related to the "timeline" construct of the CSM have been removed in the reduced dental information guide.

Sponsors & Collaborators

• University of Washington

  collaborator OTHER

• National Institute of Dental and Craniofacial Research (NIDCR)

  collaborator NIH

• Harvard University

  collaborator OTHER

• Case Western Reserve University

  lead OTHER

Principal Investigators

• Suchitra Nelson, PhD · Case Western Reserve University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

10 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2017-05-31

Completion

2017-05-31

Countries

• United States

Study Locations