Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000532909
Ethics application status
Approved
Date submitted
28/04/2011
Date registered
23/05/2011
Date last updated
9/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Teeth Tales: An exploratory trial implementing a community based child oral health promotion intervention for Australian families from refugee and migrant backgrounds
Scientific title
A longitudinal community-based exploratory trial implementing an intervention for migrant and refugee background families with children (aged 1-4years); to improve community oral health knowledge and practices and the cultural appropriateness and accessibility of services, compared to matched comparison groups. Measurements include child oral health outcomes, parental knowledge, attitudes and behaviours and staff reported organisational cultural competency, as well as trial costs and processes.
Secondary ID [1] 260070 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral health 265745 0
Condition category
Condition code
Oral and Gastrointestinal 265888 265888 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The community program will consist of informal group sessions led by the peer educator to discuss the key oral health themes of eat well, drink well, clean well, as well as access to and use of local oral health services. Additionally the program will act to promote and provide links to local community groups and services. The participants will be able to discuss the relationship between traditional and cultural practices with the key oral health themes. They will be given an opportunity to apply and practice the learnings. The sessions will run for approximately two hours a week for three weeks and will be held at culturally appropriate sites. All participants will be given a family oral health resource pack that will consist of information resources addressing the key oral health messages, details about local services, toothpaste and toothbrushes for the family, and topic relevant stickers and colouring sheets for the children. The final week will consist of a group visit to the local community health service to provide participants with an introduction to the dental and family support services available at the local community health service and through local government. Some changes to the duration and timing of sessions may be made to accommodate the availability and learning styles of the participants. The program will also include follow up reinforcement of key oral health messages. In addition, relevant local community health and government services will be supported through a review of organisational cultural competency and development and implementation of action plans to address any identified areas requiring improvement.
Intervention code [1] 264489 0
Early detection / Screening
Intervention code [2] 264490 0
Prevention
Intervention code [3] 264491 0
Behaviour
Comparator / control treatment
Active, no treatment group
Control group
Active

Outcomes
Primary outcome [1] 266649 0
Assess the impact of the intervention on child toothbrushing using parent questionnaire and child dental examination - proxy measures of debris index and modified gingival index.
Timepoint [1] 266649 0
At baseline and at 18 months follow up
Primary outcome [2] 290432 0
Assess the impact of the intervention on parent knowledge of child oral hygiene needs by parent questionnaire.
Timepoint [2] 290432 0
At baseline and at 18 months follow up
Secondary outcome [1] 276140 0
Measure change in child oral health over time for target cultural groups by child dental examination (ICDAS and Care index) and parent questionnaire
Timepoint [1] 276140 0
At baseline and 18months follow up
Secondary outcome [2] 276141 0
Measure change in child and parent oral health related behaviours over time for target cultural groups by parent questionnaire
Timepoint [2] 276141 0
At baseline and at 18 months follow up
Secondary outcome [3] 276142 0
Measure change in parent/care-giver oral health related knowledge, confidence and attitudes over time for target cultural groups by parent questionnaire
Timepoint [3] 276142 0
At baseline and at 18 months follow up
Secondary outcome [4] 276143 0
Assess change in cultural competency of local health and dental services over time by staff survey and document review
Timepoint [4] 276143 0
At baseline and at 18 months follow up
Secondary outcome [5] 304507 0
Assess access to dental and other services over time for target cultural groups by parent questionnaire and organisational service use reports
Timepoint [5] 304507 0
At baseline and at 18 months follow up
Secondary outcome [6] 304508 0
Determine the costs of the intervention by staff and organisational records
Timepoint [6] 304508 0
Measures collected 6monthly and assessed at endpoint
Secondary outcome [7] 304509 0
Identify facilitators and barriers to implementing both components of the intervention by project documentation, formal reflexive practice discussions and observation activities, and focus group discussions with cultural partner organisations
Timepoint [7] 304509 0
Project documentation and reflexive practice discussions collected on a fortnightly basis for the duration of the trial. Focus group discussions held at end of intervention.
Secondary outcome [8] 304510 0
Assess intervention, fidelity, dose and reach by project documentation, focus groups and interviews, and researcher observations.
Timepoint [8] 304510 0
Project documentation collected continuously. Focus groups conducted at end of intervention. Interviews conducted mid-CORe intervention. Researcher observations conducted weekly throughout intervention.

Eligibility
Key inclusion criteria
Families living within the Melbourne metropolitan area that have children aged between 1-4 years at baseline, and identify with one of the targeted cultural groups, will be eligible to participate.
Participating parents living in areas local to Merri Community Health Services, Moreland will be eligible to be allocated to intervention.
Minimum age
1 Years
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Families not living within the Melbourne metropolitan area, and/or who do not have children aged between 1-4 years at baseline, and/or do not identify with one of the targeted cultural groups, will not be eligible to participate.
Participating parents not living in areas local to Merri Community Health Services, Moreland will not be eligible to be allocated to intervention.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
14/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3954 0
3058
Recruitment postcode(s) [2] 3955 0
3121
Recruitment postcode(s) [3] 3956 0
3056
Recruitment postcode(s) [4] 3957 0
3057
Recruitment postcode(s) [5] 3958 0
3055
Recruitment postcode(s) [6] 3959 0
3060
Recruitment postcode(s) [7] 3960 0
3046
Recruitment postcode(s) [8] 7328 0
3043 - Gowanbrae
Recruitment postcode(s) [9] 7329 0
3043 - Tullamarine
Recruitment postcode(s) [10] 7330 0
3044 - Pascoe Vale
Recruitment postcode(s) [11] 7331 0
3044 - Pascoe Vale South
Recruitment postcode(s) [12] 7332 0
3068 - Fitzroy North

Funding & Sponsors
Funding source category [1] 264963 0
Government body
Name [1] 264963 0
Australian Research Council (linkage funding)
Country [1] 264963 0
Australia
Funding source category [2] 264964 0
Government body
Name [2] 264964 0
Merri Community Health Service
Country [2] 264964 0
Australia
Funding source category [3] 264965 0
Government body
Name [3] 264965 0
Dental Health Service Victoria
Country [3] 264965 0
Australia
Funding source category [4] 264966 0
Government body
Name [4] 264966 0
Moreland City Council
Country [4] 264966 0
Australia
Primary sponsor type
University
Name
The McCaughey Centre, The University of Melbourne
Address
Level 5, 207 Bouverie Street, Carlton, VIC 3010
Country
Australia
Secondary sponsor category [1] 264059 0
Other
Name [1] 264059 0
Merri Community Health Services, Health Promotion and Research Unit
Address [1] 264059 0
11 Glenlyon Road, Brunswick, VIC 3056
Country [1] 264059 0
Australia
Other collaborator category [1] 251971 0
Charities/Societies/Foundations
Name [1] 251971 0
Arabic Welfare
Address [1] 251971 0
Level 1, 233 Sydney Road, Brunswick, VIC 3056
Country [1] 251971 0
Australia
Other collaborator category [2] 251972 0
Charities/Societies/Foundations
Name [2] 251972 0
Pakistan Australia Association Melbourne (PAAM)
Address [2] 251972 0
PO BOX 2080, Meadow Heights, VIC 3048
Country [2] 251972 0
Australia
Other collaborator category [3] 251973 0
Charities/Societies/Foundations
Name [3] 251973 0
Victorian Arabic Social Services
Address [3] 251973 0
178 Dallas Drive, Broadmeadows, VIC, 3047
Country [3] 251973 0
Australia
Other collaborator category [4] 251974 0
Government body
Name [4] 251974 0
Dental Health Service Victoria
Address [4] 251974 0
720 Swanston Street, Carlton VIC 3053
Country [4] 251974 0
Australia
Other collaborator category [5] 251975 0
Government body
Name [5] 251975 0
Moreland City Council
Address [5] 251975 0
90 Bell Street, Coburg, VIC, 3058
Country [5] 251975 0
Australia
Other collaborator category [6] 251976 0
Other Collaborative groups
Name [6] 251976 0
The Centre for Culture, Ethnicity and Health
Address [6] 251976 0
81-85 Barry Street, Carlton, VIC, 3053
Country [6] 251976 0
Australia
Other collaborator category [7] 251977 0
Other
Name [7] 251977 0
North Richmond Community Health
Address [7] 251977 0
23 Lennox Street, Richmond, VIC 3121
Country [7] 251977 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266928 0
The University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 266928 0
Ethics committee country [1] 266928 0
Australia
Date submitted for ethics approval [1] 266928 0
29/04/2010
Approval date [1] 266928 0
19/07/2010
Ethics approval number [1] 266928 0
1033207
Ethics committee name [2] 266929 0
Department of Education and Early Childhood Development Research Committee
Ethics committee address [2] 266929 0
Ethics committee country [2] 266929 0
Australia
Date submitted for ethics approval [2] 266929 0
26/10/2010
Approval date [2] 266929 0
13/12/2010
Ethics approval number [2] 266929 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32542 0
Dr Lisa Gibbs
Address 32542 0
McCaughey VicHealth Centre for Community Wellbeing
University of Melbourne
Level 5, 207 Bouverie Street
Carlton 3053
Victoria, Australia
Country 32542 0
Australia
Phone 32542 0
+61 3 8344 0920
Fax 32542 0
Email 32542 0
[email protected]
Contact person for public queries
Name 15789 0
Lisa Gibbs
Address 15789 0
Level 5, 207 Bouverie Street, Carlton, VIC 3010, Australia
Country 15789 0
Australia
Phone 15789 0
+61 3 8344 0920
Fax 15789 0
+61 3 9348 2832
Email 15789 0
[email protected]
Contact person for scientific queries
Name 6717 0
Lisa Gibbs
Address 6717 0
Level 5, 207 Bouverie Street, Carlton, VIC 3010, Australia
Country 6717 0
Australia
Phone 6717 0
+61 3 8344 0920
Fax 6717 0
+61 3 9348 2832
Email 6717 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIAn exploratory trial implementing a community-based child oral health promotion intervention for Australian families from refugee and migrant backgrounds: a protocol paper for Teeth Tales2014https://doi.org/10.1136/bmjopen-2013-004260
EmbaseTeeth Tales: A community-based child oral health promotion trial with migrant families in Australia.2015https://dx.doi.org/10.1136/bmjopen-2014-007321
N.B. These documents automatically identified may not have been verified by the study sponsor.