CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,305 enrolled
Drug / intervention
Standard letter +4 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02395120
NCT02395120N/ACompleted

Family Intervention With Caregivers of Children With Dental Needs

Case Western Reserve University·interventional·Posted Mar 20, 2015·Updated Jun 16, 2022

In Brief

A clinical study evaluating Standard letter, Intervention letter, and 3 other interventions for Dental Caries. Completed, enrolled 1,305 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 20, 2015
Enrollment StartAug 1, 2015
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.3 years ago

Interventions

Standard letterbehavioral

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

Intervention letterbehavioral

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 intervention letterbehavioral

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).

DIGbehavioral

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.

Reduced DIGbehavioral

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