Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000970943
Ethics application status
Approved
Date submitted
9/09/2011
Date registered
9/09/2011
Date last updated
9/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Building the capacity of family day care educators to promote childrens social and emotional wellbeing: An exploratory cluster randomised controlled trial.
Scientific title
Trialling the use of the Thrive Program to increase family day care educators knowledge about children's social and emotional wellbeing.
Secondary ID [1] 262800 0
Nil
Universal Trial Number (UTN)
U1111-1123-5633
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children's social and emotional wellbeing 270507 0
Condition category
Condition code
Mental Health 270667 270667 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 270668 270668 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Family day care educators and the coordinating staff (the latter refered to as field workers) will both receive the Thrive
program. The Thrive program includes 3 workshops for field workers and family day care educators (2 hours each; delivered over a one month period), monthly activity exchanges with other educators (1-2 hours) and focused discussion on social and emotional wellbeing during field worker monthy visits (1 hour). The intervention group will also receive resources associated with the workshops on promoting childrens social and emotional wellbeing. The intervention will be delivered over a 12 month period.
Intervention code [1] 269144 0
Other interventions
Comparator / control treatment
The intervention group will receive the Thrive Program over a 12-month period, during which time the control group will continue to deliver care as per standard practice (ie continue to provide regulated care for children and to attend professional development as per requirements). The intervention program will be delivered to the intervention group and then to the control group after a delay of 15 months from start of the intervention in the active group.
Control group
Active

Outcomes
Primary outcome [1] 269388 0
The primary outcome is family day care educators' knowledge about children's social and emotional wellbeing. In the absence of any existing relevant items, new items have had to be developed to measure this construct, including general questions of "How would you rate your knowledge about children's social and emotional wellbeing", and "How would you rate your knowledge of who to contact if you are worried about the social and emotional wellbeing of a child in your care?" (Scale 0-10 with 0= almost no knowledge, 10=very knowledgeable). More specific questions about risk and protective factors of mental health are asked in open-ended format and are specific to child age (under 5 years, primary school age).
Timepoint [1] 269388 0
A baseline survey assessing knowledge about childrens social and emotional wellbeing will be conducted with all consenting educators and field workers (n=~70). The survey will also be administered at one-month, six-months and 12-months post-intervention commencement.
Secondary outcome [1] 287527 0
Secondary outcomes include educator confidence and skills in promoting children's social and emotional wellbeing. In the absence of pre-existing and relevant survey items on confidence in promoting children's social and emotional wellbeing, new items have been developed to measure this construct. Confidence is measured by four self-report questions "Overall how confident are you in your ability to promote children's social and emotional wellbeing?", "How confident are you in your ability to identify children's social and emotional problems?", "How confident are you in talking with parents about promoting their children's social and emotional wellbeing?" and "How confident are you in talking with parents about potential problems with their children's social and emotional wellbeing?" (Scale 0-10 with 0= not confident, 10= very confident).
Timepoint [1] 287527 0
A baseline survey will be conducted with all consenting educators and field workers (n=~70). The survey will also be administered at one-months, six-months and 12-months post-intervention commencement.
Secondary outcome [2] 287528 0
Skills in promoting children's social and emotional wellbeing are measured in the survey by asking about the participant's daily activities (using items from the Longitudinal Study of Australian Children) and by asking for a description of their FDC practice: "Please tell us about the ways you promote the social and emotional wellbeing of children in your care?"

Skills in promoting social and emotional wellbeing are also assessed by objectively measuring quality of care. Quality of the FDC environment will be assessed through observations carried out at baseline and one month, six month and 12-months post-intervention by a trained researcher using the Family Child Care Environment Rating Scale Revised Edition (FCCERS-R) and the Caregiver Interaction Scale (CIS). The FCCERS-R has 38 items in 7 subscales. Four subscales (24 items) will be used in this study specific to mental health: personal care routines; listening and talking; activities; and interactions. Each item is scored from 1 (inadequate) to 7 (excellent). The FCCERS-R has high inter-observer reliability (0.83-0.90) and moderate to high internal consistency for the subscales (0.70-0.93).

The CIS has 26 items divided into four subscales that measure sensitivity, harshness, detachment and permissiveness of caregivers in the childhood care/education environment. Items are scored from 1 (not at all true) to 4 (very much true). It has a moderate to high inter-observer reliability (0.75-0.97) and high internal subscale consistency (0.81-0.91). In this study, we expect to see improvements in the four subscales of the FCCERS-R and in the CIS, reductions in harshness and detachment and improvements in the sensitivity subscales. The total time commitment for the observation is ~ two hours.
Timepoint [2] 287528 0
A baseline survey will be conducted with all consenting educators and field workers (n=~70). The survey will also be administered at one-months, six-months and 12-months post-intervention commencement. All educators will also have an in-home quality-of-care assessment at baseline, one month, six month and 12-months post-intervention commencement.
Secondary outcome [3] 287721 0
Organisational mental health promotion will be assessed using a mental health promotion audit. This audit, which assesses organisational structure, workforce development, resource allocation and leadership will be completed by the scheme manager. The interview is expected to take around 30-45 minutes. Example items include How is promoting childrens social and emotional wellbeing incorporated in to your fieldwork and management roles? Have fieldworkers, educators undertaken any professional development specific to promoting childrens social and emotional wellbeing? How available and easy to access is information about promoting childrens social and emotional wellbeing?"
Timepoint [3] 287721 0
The audit will be completed at baseline, and 6 month and 12 month post-intervention commencement.

Eligibility
Key inclusion criteria
All family day care educators and field workers within the scheme are eligible to receive the intervention program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The clusters for randomisation will be the fieldworkers (n=5) who each supervise 10-15 educators. Randomisation will be conducted in accordance with ICH Guideline E9 by CI Mackinnon, who is independent of the administration of the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The intervention group will receive the intervention over a 12-month period, whilst during which time the control group will continue standard practice. The intervention program will be delivered to the intervention group and then to the control group after a time delay of 15 months. We will also be assessing implementation factors, examining equity, recording all costs and resources, and following indicators of sustainability of the program.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269622 0
Government body
Name [1] 269622 0
Australian Research Council Linkage Project
Country [1] 269622 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Carlton, Melbourne
Victoria 3010
Country
Australia
Secondary sponsor category [1] 266654 0
None
Name [1] 266654 0
Address [1] 266654 0
Country [1] 266654 0
Other collaborator category [1] 252181 0
Government body
Name [1] 252181 0
Victorian Health Promotion Foundation
Address [1] 252181 0
Ground Floor, 15-31 Pelham St
Carlton South
Victoria, 3053
Country [1] 252181 0
Australia
Other collaborator category [2] 252182 0
Charities/Societies/Foundations
Name [2] 252182 0
Windermere Family Services
Address [2] 252182 0
48 Webb St
Narre Warren
Victoria, 3805
Country [2] 252182 0
Australia
Other collaborator category [3] 252183 0
Other Collaborative groups
Name [3] 252183 0
Family Day Care Australia
Address [3] 252183 0
PO Box 571
Gosford,
New South Wales, 2250
Country [3] 252183 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269571 0
University of Melbourne
Ethics committee address [1] 269571 0
Human Research Ethics
The University of Melbourne
Melbourne Research
The Univerity of Melbourne
Level 5, Alan Gilbert Building
VIC 3010
Ethics committee country [1] 269571 0
Australia
Date submitted for ethics approval [1] 269571 0
Approval date [1] 269571 0
Ethics approval number [1] 269571 0
1136446

Summary
Brief summary
Childhood mental health problems are highly prevalent, experienced by one in five children living in low socioeconomic families. Although childcare settings, including family day care are ideal to promote children’s social and emotional wellbeing at a population level in a sustainable way, family day care educators receive limited training in promoting children’s mental health. This study is an exploratory wait-list control cluster randomised controlled trial to test the appropriateness, acceptability, cost, and effectiveness of “Thrive,” an intervention program to build the capacity of Family Day Care educators to promote children’s social and emotional wellbeing. Thrive aims to increase educators’ knowledge, confidence and skills in promoting children’s social and emotional wellbeing.

A capacity building intervention in child mental health promotion for Family Day Care is an essential contribution to research, policy and practice. This initiative is the first internationally, and essential in building an evidence base of interventions in this extremely policy-timely setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32990 0
Address 32990 0
Country 32990 0
Phone 32990 0
Fax 32990 0
Email 32990 0
Contact person for public queries
Name 16237 0
Dr Elise Davis
Address 16237 0
The McCaughey Centre
Melbourne School of Population Health
The University of Melbourne
Level 5, 207 Bouverie St
Carlton, Victoria 3010
Country 16237 0
Australia
Phone 16237 0
+61 3 83440921
Fax 16237 0
+61393482832
Email 16237 0
eda@unimelb.edu.au
Contact person for scientific queries
Name 7165 0
Dr Elise Davis
Address 7165 0
The McCaughey Centre
Melbourne School of Population Health
The University of Melbourne
Level 5, 207 Bouverie St
Carlton, Victoria 3010
Country 7165 0
Australia
Phone 7165 0
+61 3 83440921
Fax 7165 0
+61393482832
Email 7165 0
eda@unimelb.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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