ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 51 for:    tooth decay | NIH

Family Access to Dentist Study (FADS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02395120
Recruitment Status : Active, not recruiting
First Posted : March 20, 2015
Last Update Posted : November 7, 2017
Sponsor:
Collaborators:
University of Washington
National Institute of Dental and Craniofacial Research (NIDCR)
Harvard University
Information provided by (Responsible Party):
Suchitra Nelson, Case Western Reserve University

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.


Condition or disease Intervention/treatment Phase
Dental Caries Behavioral: Standard letter Behavioral: Intervention letter Behavioral: Reduced intervention letter Behavioral: DIG Behavioral: Reduced DIG Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 611 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Family Intervention With Caregivers of Children With Dental Needs
Study Start Date : August 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard letter
Modified standard letter will be sent to caregivers.
Behavioral: Standard letter
Standard referral letter according to Ohio Department of Health Bureau guidelines. This letter is consistent with others used across the country.

Experimental: Intervention letter
The CSM-based referral letter alone will be sent to caregivers
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).

Experimental: Reduced intervention letter
The reduced (removing text corresponding to "timeline") CSM-based referral letter alone will be sent to caregivers.
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).

Experimental: Intervention letter+DIG
The CSM-based referral letter with the dental information guide will be sent to caregivers.
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: 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.

Experimental: Reduced intervention letter+reduced DIG
The reduced CSM-based referral letter with the reduced dental information guide will be sent to caregivers.
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: Reduced DIG
Text and illustrations related to the "timeline" construct of the CSM have been removed in the reduced dental information guide.




Primary Outcome Measures :
  1. Receipt of Dental Care - restoration or extraction of at least one tooth previously identified with an active ICDAS ≥2 at baseline [ Time Frame: Between baseline and follow-up (7 months after baseline) ]
    Defined as restoration or extraction of at least one tooth previously identified with an active ICDAS ≥2 at baseline


Secondary Outcome Measures :
  1. Change in Illness Perception assessed by IPQ-RD [ Time Frame: Between baseline, two week and final follow-up (7 months) ]
    Change in the overall Illness Perception Questionnaire-Revised fore Dental (IPQ-RD), cognitive (identity, consequences, timeline, cause, cure/controllability) representation sub-scale scores

  2. Change in Behavioral Intention [ Time Frame: Between baseline, two week and final follow-up (7 months) ]
    Behavioral intention is measured by the summative score of 2 items ("I want to take my child to the dentist", and "I plan to take my child to the dentist") on a 5 point scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT02395120


Locations
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Washington
University of Washington
Seattle, Washington, United States, 98195-7475
Sponsors and Collaborators
Case Western Reserve University
University of Washington
National Institute of Dental and Craniofacial Research (NIDCR)
Harvard University
Investigators
Principal Investigator: Suchitra Nelson, PhD Case Western Reserve University

Responsible Party: Suchitra Nelson, Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT02395120     History of Changes
Other Study ID Numbers: 1-14-15
U01DE024167-01 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Suchitra Nelson, Case Western Reserve University:
Dental Care
Caregiver Illness Perception
Common Sense Model of Self-Regulation
Dental Access
Referral letter
Dental Caries

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases