Family Intervention With Caregivers of Children With Dental Needs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,305
- Locations
- 4
- Primary Endpoint
- Number of Participants With Receipt of Dental Care-restoration or Extraction of at Least One Tooth at Final Exam
Study Overview
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.
Detailed Description
Purpose:
The purpose of this study is 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 primary outcome is the assessment of dental care receipt through dental exams. The secondary outcomes are change in caregiver illness perception, measured through the IPQ-RD, and behavioral intention measured through items in the caregiver questionnaire.
Study Design:
The study will utilize a multi-site, double-blind, parallel arm, community-based randomized trial design. The experimental intervention will be based upon the Common Sense Model of Self-Regulation (CSM) to address parent/caregiver illness perception and navigation of resources to increase receipt of dental care during a 7-month follow-up period for children with restorative dental needs. In this five arm study the new CSM theory-driven referral letter alone, the new CSM referral letter and Dental Information Guide (DIG), the new CSM theory-driven reduced referral letter alone, and the new CSM theory-driven reduced referral letter and reduced Dental Information Guide (DIG) will each be compared to a standard referral letter to increase receipt of dental care among inner-city urban African American, and rural Hispanic and White elementary school children.
Participants:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •(parents/caregivers and their children)
- •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
Exclusion Criteria
- •(parents/caregivers)
- •Illiterate
- •Non-English speaking (in East Cleveland Public Schools)
- •Under 18 years of age
Outcomes
Primary Outcomes
Number of Participants With Receipt of Dental Care-restoration or Extraction of at Least One Tooth at Final Exam
Time Frame: Between baseline and follow-up (7 months after baseline)
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.
Secondary Outcomes
- 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))
Investigators
Suchitra Nelson
Professor
Case Western Reserve University
