NCT01123330

Brief Summary

The Detroit Dental Health Project (DDHP)aims to promote oral health and reduce disparities within the community of low-income African-American children (0-5 years) and their main caregivers (14+ years), living in the City of Detroit. The driving theme of the Project is to identify determinants and design interventions to answer the following question: why do some low-income African-American children and their main caregivers have better oral health than others who live in the same community? The Project has 3 support cores, 4 research core projects and 1 pilot study. The Project has selected a multistage random sample of African-American families living in the poorest 39 Census Tracts in the City of Detroit. A total of 1,022 families were recruited and interviewed at a community center in Detroit during the year 2 (2002). We have collected data about the social characteristics of parents, families, and neighborhoods that are associated with disparities in oral health; lead levels in saliva and blood of the caregivers; and dietary intake. All these families will be recalled in the year 4 (2004) and year 6 (2006) for longitudinal data collection. We are currently developing a tailored multi-media educational intervention (Project #3), based on data collected in the first phase (2002). The educational intervention will be administered using a randomized controlled design in year 4 (2004). Additionally, the Project is evaluating the impact on access to dental care of a state-funded experiment on utilization where Medicaid children are managed like privately insured patients (Project #4).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,042

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
Last Updated

May 14, 2010

Status Verified

May 1, 2010

Enrollment Period

6 years

First QC Date

May 12, 2010

Last Update Submit

May 12, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Carious lesions

    The carious process was measured using the International Caries Detection and Assessment System (ICDAS). The codes range from measurement of the first visible carious change in enamel (Code 1) to extensive cavitation (Code 6). Both primary carious lesions and lesions adjacent to restorations and sealants (CARS) were recorded,.

    Measures at baseline (2002-03); wave 2 (2004-05); wave 3 (2007)

Study Arms (2)

Motivational Interviewing plus DVD

EXPERIMENTAL

Caregivers watched a 15-minute educational video designed for the project emphasizing the importance of good oral health in children, and how the caregiver can keep children free from tooth decay. The MI interviewer engaged the parent in a discussion of their thoughts and concerns regarding their child's oral health and what changes they wished to make regarding monitoring their child's oral health. Feedback from the child's dental exam was also reviewed. MI+DVD caregivers received a brochure displaying a photo of their child and for those who chose to set specific goals for their child's oral health, those goals were listed on the brochure. Caregivers choosing not to set specific goals were offered a list of 10 project recommendations regarding dietary intake, oral hygiene, and dental check-ups. The session ended with a dialogue regarding possible barriers to implementing the personal plan and how the caregiver planned to overcome those barriers.

Behavioral: Motivational Interviewing

DVD only

ACTIVE COMPARATOR

Caregivers watched the same educational video. At the end of the video, caregivers were given a glossy-printed brochure displaying the project developed recommendations as well as the child's photograph. The brochure was not re-mailed, as it was for the MI+DVD group and caregivers in this condition did not receive any feedback from the dental examination regarding their child's oral health status.

Behavioral: Motivational Interviewing

Interventions

DVD onlyMotivational Interviewing plus DVD

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • African-American
  • years of age
  • below 250% of poverty

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (25)

  • Delva J, Tellez M, Finlayson TL, Gretebeck KA, Siefert K, Williams DR, Ismail AI. Cigarette smoking among low-income African Americans: a serious public health problem. Am J Prev Med. 2005 Oct;29(3):218-20. doi: 10.1016/j.amepre.2005.05.004.

  • Delva J, Tellez M, Finlayson TL, Gretebeck KA, Siefert K, Williams DR, Ismail AI. Correlates of cigarette smoking among low-income African American women. Ethn Dis. 2006 Spring;16(2):527-33.

  • Finlayson TL, Siefert K, Ismail AI, Delva J, Sohn W. Reliability and validity of brief measures of oral health-related knowledge, fatalism, and self-efficacy in mothers of African American children. Pediatr Dent. 2005 Sep-Oct;27(5):422-8.

  • Finlayson TL, Siefert K, Ismail AI, Sohn W. Psychosocial factors and early childhood caries among low-income African-American children in Detroit. Community Dent Oral Epidemiol. 2007 Dec;35(6):439-48. doi: 10.1111/j.1600-0528.2006.00352.x.

  • Finlayson TL, Siefert K, Ismail AI, Sohn W. Maternal self-efficacy and 1-5-year-old children's brushing habits. Community Dent Oral Epidemiol. 2007 Aug;35(4):272-81. doi: 10.1111/j.1600-0528.2007.00313.x.

  • Reisine S, Ajrouch KJ, Sohn W, Lim S, Ismail A. Characteristics of African-American male caregivers in a study of oral health in Detroit--a brief communication. J Public Health Dent. 2009 Summer;69(3):197-200. doi: 10.1111/j.1752-7325.2008.00115.x.

  • Sanders AE, Lim S, Sohn W. Resilience to urban poverty: theoretical and empirical considerations for population health. Am J Public Health. 2008 Jun;98(6):1101-6. doi: 10.2105/AJPH.2007.119495. Epub 2008 Apr 29.

  • Siefert K, Finlayson TL, Williams DR, Delva J, Ismail AI. Modifiable risk and protective factors for depressive symptoms in low-income African American mothers. Am J Orthopsychiatry. 2007 Jan;77(1):113-23. doi: 10.1037/0002-9432.77.1.113.

  • Burt BA, Kolker JL, Sandretto AM, Yuan Y, Sohn W, Ismail AI. Dietary patterns related to caries in a low-income adult population. Caries Res. 2006;40(6):473-80. doi: 10.1159/000095645.

  • Kolker JL, Yuan Y, Burt BA, Sandretto AM, Sohn W, Lang SW, Ismail AI. Dental caries and dietary patterns in low-income African American children. Pediatr Dent. 2007 Nov-Dec;29(6):457-64.

  • Lim S, Sohn W, Burt BA, Sandretto AM, Kolker JL, Marshall TA, Ismail AI. Cariogenicity of soft drinks, milk and fruit juice in low-income african-american children: a longitudinal study. J Am Dent Assoc. 2008 Jul;139(7):959-67; quiz 995. doi: 10.14219/jada.archive.2008.0283.

  • Lim S, Zoellner JM, Lee JM, Burt BA, Sandretto AM, Sohn W, Ismail AI, Lepkowski JM. Obesity and sugar-sweetened beverages in African-American preschool children: a longitudinal study. Obesity (Silver Spring). 2009 Jun;17(6):1262-8. doi: 10.1038/oby.2008.656. Epub 2009 Feb 5.

  • Nriagu J, Burt B, Linder A, Ismail A, Sohn W. Lead levels in blood and saliva in a low-income population of Detroit, Michigan. Int J Hyg Environ Health. 2006 Mar;209(2):109-21. doi: 10.1016/j.ijheh.2005.11.005. Epub 2006 Jan 27.

  • Ismail AI, Sohn W, Lim S, Willem JM. Predictors of dental caries progression in primary teeth. J Dent Res. 2009 Mar;88(3):270-5. doi: 10.1177/0022034508331011.

  • Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.

  • Ismail AI, Sohn W, Tellez M, Willem JM, Betz J, Lepkowski J. Risk indicators for dental caries using the International Caries Detection and Assessment System (ICDAS). Community Dent Oral Epidemiol. 2008 Feb;36(1):55-68. doi: 10.1111/j.1600-0528.2006.00369.x.

  • Ismail AI, Lim S, Sohn W, Willem JM. Determinants of early childhood caries in low-income African American young children. Pediatr Dent. 2008 Jul-Aug;30(4):289-96.

  • Li Y, Ismail AI, Ge Y, Tellez M, Sohn W. Similarity of bacterial populations in saliva from African-American mother-child dyads. J Clin Microbiol. 2007 Sep;45(9):3082-5. doi: 10.1128/JCM.00771-07. Epub 2007 Jul 18.

  • Reisine S, Tellez M, Willem J, Sohn W, Ismail A. Relationship between caregiver's and child's caries prevalence among disadvantaged African Americans. Community Dent Oral Epidemiol. 2008 Jun;36(3):191-200. doi: 10.1111/j.1600-0528.2007.00392.x.

  • Sohn W, Ismail A, Amaya A, Lepkowski J. Determinants of dental care visits among low-income African-American children. J Am Dent Assoc. 2007 Mar;138(3):309-18; quiz 395-396, 398. doi: 10.14219/jada.archive.2007.0163.

  • Sohn W, Taichman LS, Ismail AI, Reisine S. Caregiver's perception of child's oral health status among low-income African Americans. Pediatr Dent. 2008 Nov-Dec;30(6):480-7.

  • Tellez M, Sohn W, Burt BA, Ismail AI. Assessment of the relationship between neighborhood characteristics and dental caries severity among low-income African-Americans: a multilevel approach. J Public Health Dent. 2006 Winter;66(1):30-6. doi: 10.1111/j.1752-7325.2006.tb02548.x.

  • Ajrouch KJ, Reisine S, Lim S, Sohn W, Ismail A. Situational stressors among African-American women living in low-income urban areas: the role of social support. Women Health. 2010 Mar;50(2):159-75. doi: 10.1080/03630241003705045.

  • Taichman LS, Sohn W, Lim S, Eklund S, Ismail A. Assessing patterns of restorative and preventive care among children enrolled in Medicaid, by type of dental care provider. J Am Dent Assoc. 2009 Jul;140(7):886-94. doi: 10.14219/jada.archive.2009.0282.

  • Ismail AI, Ondersma S, Jedele JM, Little RJ, Lepkowski JM. Evaluation of a brief tailored motivational intervention to prevent early childhood caries. Community Dent Oral Epidemiol. 2011 Oct;39(5):433-48. doi: 10.1111/j.1600-0528.2011.00613.x. Epub 2011 Mar 29.

MeSH Terms

Conditions

Dental Caries

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2010

First Posted

May 14, 2010

Study Start

October 1, 2001

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 14, 2010

Record last verified: 2010-05

Locations