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Trial registered on ANZCTR


Registration number
ACTRN12619000488101
Ethics application status
Approved
Date submitted
1/03/2019
Date registered
25/03/2019
Date last updated
3/03/2020
Date data sharing statement initially provided
25/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Partnering with Parents: Building quality relationships that benefit children
Scientific title
Practice Quality Improvement Program - Early Childhood Education and Care (ECEC) Working with Parents: A Cluster Randomised Controlled Trial
Secondary ID [1] 297474 0
Nil known
Universal Trial Number (UTN)
U1111-1229-0197
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
educator confidence 311788 0
parent psychological distress 311789 0
Condition category
Condition code
Mental Health 310404 310404 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will implement the Partnering with Parents practice support system. The intervention embeds evidence-based approaches to working in partnership with parents in Early Childhood Education and Care (ECEC) services. The aim is to create an environment welcoming of and responsive to parents as well as strengthening educators’ skills and confidence to interact with parents in a way that is supportive of their parenting. There are three components:

• Making moments matter: Creating a positive relational environment every day for parents that parallels educator interactions with children and other staff. Strategies are Warm & Gentle, Tuning In, Following Their lead, Listening and Talking, and Teachable Moments. These strategies are used in typical day to day conversations educators have with parents.
• More than moments: Having constructive conversations with parents when needed. This would involve raising a concern with a parent or responding to a parent's concern.
• Working on concerns: This involves working collaboratively through a series of phases with a parent on an issue requiring more intensive, and possibly longer term, attention.

Implementation of Partnering with Parents involves e-learning, face-to-face training and post training support. Implementation commences with identified Practice Coaches completing a set of e-learning tasks that introduce the components of the system, provide simulated filmed examples of parent-educator interactions and test their knowledge with short quizzes. Practice Coaches are educational leaders, room leaders, and managers or identified staff who will provide specific coaching to all staff in the centre on conversations with parents.

Following this introductory training, project team members will conduct a half-day face-to-face training session with staff who have been nominated by their centres to be Practice Coaches. Shortly after face-to-face training, members of the project team will provide the first of three implementation support sessions by phone to Practice Coaches.

Practice Coaches will support educators to implement the Making moments matter strategies for 10 weeks. We call this day-by-day coaching. Practice Coaches will each receive two additional support phone calls from the Parenting Research Centre (PRC) in Weeks 4 and 7. Practice Coaches will attend training via webinar in Weeks 2, 3, and 5 in More than moments and Just-in-time coaching as well as Working on concerns. After Week 10, parents and educators will be sent the Post questionnaire which includes Process items to capture what elements of the system are being used.
Intervention code [1] 313799 0
Behaviour
Comparator / control treatment
ECEC long day care and kindergarten services will be recruited to implement Partnering with Parents, and each service will be considered a ‘cluster’ of participants. Services will be randomly allocated to either an intervention group or a wait list control group. The wait list control group receive the program after the intervention group has completed the intervention.
Control group
Active

Outcomes
Primary outcome [1] 319286 0
Educator confidence in working with parents as measured by study-specific questionnaire
Timepoint [1] 319286 0
Timepoint 1 = Before starting the intervention
Timepoint 2 = After completing the 10-week intervention
Timepoint 3 = Three months after completing the intervention
Primary outcome [2] 319287 0
Educator skills in working with parents as measured by study-specific questionnaire
Timepoint [2] 319287 0
Timepoint 1 = Before starting the intervention
Timepoint 2 = After completing the 10-week intervention
Timepoint 3 = Three months after completing the intervention
Secondary outcome [1] 367580 0
Parent inclusiveness at centre as measured by study-specific questionnaire
Timepoint [1] 367580 0
Timepoint 1 = Before starting the intervention
Timepoint 2 = After completing the 10-week intervention
Timepoint 3 = Three months after completing the intervention
Secondary outcome [2] 367581 0
Supportiveness of centre as measured by study-specific questionnaire
Timepoint [2] 367581 0
Timepoint 1 = Before starting the intervention
Timepoint 2 = After completing the 10-week intervention
Timepoint 3 = Three months after completing the intervention
Secondary outcome [3] 367582 0
Parenting involvement with their child's centre and learning as measured by study-specific questionnaire
Timepoint [3] 367582 0
Timepoint 1 = Before starting the intervention
Timepoint 2 = After completing the 10-week intervention
Timepoint 3 = Three months after completing the intervention
Secondary outcome [4] 368330 0
Staff satisfaction with using Partnering with Parents as assessed by study-specific questionnaire
Timepoint [4] 368330 0
Timepoint 2 = After completing the 10-week intervention
Timepoint 3 = Three months after completing the intervention
Secondary outcome [5] 368335 0
Parent satisfaction with discussing concerns with educators as assessed by study-specific questionnaire
Timepoint [5] 368335 0
Timepoint 1 = Before starting the intervention
Timepoint 2 = After completing the 10-week intervention
Timepoint 3 = Three months after completing the intervention
Secondary outcome [6] 368337 0
Parent psychological distress as measured by study-specific questionnaire
Timepoint [6] 368337 0
Timepoint 1 = Before starting the intervention
Timepoint 2 = After completing the 10-week intervention
Timepoint 3 = Three months after completing the intervention

Eligibility
Key inclusion criteria
• Parents and staff who volunteer to provide information
• Parents with at least one child enrolled in a participating centre either part-time or full-time
• ECEC staff and parents able to read English to answer questionnaires
• ECEC staff with access to email and internet
• Parents with capacity (computer or phone) to access questionnaires online.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• ECEC staff and parents not able to read English to answer questionnaires
• ECEC staff without access to email and internet
• Parents without capacity (computer or phone) to access questionnaires online.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur on the basis of centres (clusters) not individual staff or parent participants. Centres are likely to vary in size (i.e. number of families and staff) and it is possible that centre size could have an impact on outcomes (e.g., if larger centre have more resources to support staff to attend professional training and apply new learning). To control for possible influence of centres’ size differences, we will use a stratified randomisation process that has the best chance of the intervention and control groups having centres of similar sizes. Stratified randomisation is a two-stage procedure.

First, we will match every centre with another of a similar size – resulting in matched pairs. Centres will be rank ordered by team size, then paired based on size (i.e., largest team with next largest team and so on). To begin the second stage of randomisation we will use the online randomisation software www.random.org to create a random order of numbers from one to six. Then, moving down the matched pairs list, the first random number will be allocated to the first member of the first pair. This will continue until the first member of every pair has a random number. A centre with number one, two or three will be allocated to the intervention group. Their pair will be allocated to the control group. A centre with number four, five and six will be allocated to the control group. Their pair will be allocated to the intervention group. This process will ensure that each centre has a 50% chance of being allocated to the intervention group.

Random number generation and assignment to pairs will be performed by a Research Assistant at the Parenting Research Centre who will be unaware of the names or locations of the centres. The Project Manager will allocate an alphabetical letter to each centre before the Research Assistant begins randomisation.

Given the way we will be providing training, it is not possible to conceal membership of the experimental or control conditions from researchers involved in the training of participants once the trial commences.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Wait list control group receive the intervention after the intervention group has completed participation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimates were calculated using the results of measures from our field test conducted as a part of Phase 2. Our field test incorporated collection of data from both educators and parents, and included measures of parent-educator relationships, educator skill and confidence in communicating with parents, parent confidence, and parent satisfaction with their centre’s communication. Variability in responses across these measures ranged from low to moderate. We chose to estimate the required sample size for the cRCT using a measure of parent satisfaction with communication. This measure was chosen as it demonstrated moderate response variability in the field test, and therefore is likely to result in significant pre- to post-changes with intervention (i.e., less chance of a ceiling effect). Therefore, using the measure of parent satisfaction with communication with their child’s ECEC centre we identified that a total of 140 parents over 7 clusters (centres) will be sufficient to detect a 1 standard deviation (SD) improvement in parent-rated satisfaction with communications with their educator. This assumes a 2-sided p<.05 and effect size of .5 with power of 80% to randomise into intervention vs control.
We will attempt to recruit 14 centres to account for the possibility of attrition and thus increase the chance of obtaining the required number of participants.

Three types of participants are proposed for this trial:
1. ECEC staff: Practice Coaches
Approximately 105 ECEC room leaders, educational leaders and managers from participating centres who will be nominated by centres to take on the role of Practice Coach. Each Practice Coach will receive online and face-to-face training from the PRC team to facilitate delivery of the Partnering with Parents practice support system at their centres.
2. ECEC staff: Educators
Approximately 446 educators who are employed by the participating centres and who will implement practice support strategies, coached by and with assistance from Practice Coaches at their centre.
3. Parents
Approximately 2376 parents who have a child enrolled at the participating centres. This is based on approximations of the number of parents who will have a child enrolled at the participating centres. Note that a response rate of 14% will be required to meet sufficient power for this trial. Whilst this appears a very easily attainable response rate, our experience from the field test was that a response rate of only 14% should be expected.

We anticipate educators' and parents' responses to questionnaires will provide rich information to assist us to determine whether Partnering with Parents is effective in increasing educators’ confidence and skills in partnering with parents. We propose a number of ways to examine the process and outcome data.
We will measure the impact of the practice support system by way of staff and parent outcomes.

Analysis of the questionnaire results will be descriptive initially, for example, means and frequencies of response categories selected. Where normative data are available, for example, the Parenting Today in Victoria survey results and the Me as a Parent Scale, we will compare the trial findings with the population norms for parents of children of similar ages.

To estimate intervention effectiveness, statistical comparisons using analyses of variance/co-variance, regression and multilevel modelling procedures will be undertaken.
1. Pre-post (Time 1 – Time 2) and follow-up (Time 3) responses of participants in the intervention condition.
2. Time 1 – Time 2 responses of participants in the intervention and wait list conditions. (NB for the control group, Time 2 measurement will be undertaken before they commence Partnering with Parents). This second analysis is the main test of the strength of the intervention. We expect there will be greater change from Time 1 to Time 2 for the intervention group than for the control group.

We will examine responses of the control group before and after the intervention they receive. This is of interest but is not normally required (or reported) for the experimental design we have chosen. Using statistical modelling we will examine the extent to which outcomes are moderated or mediated by process and demographic factors.

We will analyse training feedback questionnaires descriptively to see the extent to which Practice Coaches felt adequately prepared to deliver the system in their centres. It would be of interest to examine the extent to which preparedness is related to outcomes. There is potential to include perceived adequacy of preparation as a mediating factor in the outcome analyses by using this measure in prediction models.

As an indication of family-centredness, we will look at items both educators and parents completed, to compare their perceptions (e.g. whether they both agree the centre is a welcoming environment for parents).

All qualitative data will be summarised and examined for themes. Thematic analysis is a multi-stage process involving familiarisation with the data, coding (identifying important features relevant to the research questions), searching for and reviewing themes, and defining and naming them. The approach will be deductive – that is, coding and theme development directed by existing concepts or ideas. Thematic analysis will be undertaken by a researcher who has not been involved in collecting the qualitative information.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2019
Actual
1/04/2019
Date of last participant enrolment
Anticipated
Actual
16/04/2019
Date of last data collection
Anticipated
Actual
8/12/2019
Sample size
Target
2927
Accrual to date
Final
420
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302043 0
Government body
Name [1] 302043 0
Department of Health and Human Services
Country [1] 302043 0
Australia
Primary sponsor type
Other
Name
Parenting Research Centre
Address
5/232 Victoria Parade, East Melbourne, VIC 3002
Country
Australia
Secondary sponsor category [1] 301954 0
None
Name [1] 301954 0
Address [1] 301954 0
Country [1] 301954 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302726 0
Parenting Research Centre Human Research Ethics Committee
Ethics committee address [1] 302726 0
Ethics committee country [1] 302726 0
Australia
Date submitted for ethics approval [1] 302726 0
01/02/2019
Approval date [1] 302726 0
08/02/2019
Ethics approval number [1] 302726 0
App48

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

Contacts
Principal investigator
Name 91174 0
Ms Olivia Clayton
Address 91174 0
Parenting Research Centre
Level 5, 232 Victoria Parade
East Melbourne VIC 3002
Country 91174 0
Australia
Phone 91174 0
+61 3 8660 3500
Fax 91174 0
Email 91174 0
oclayton@parentingrc.org.au
Contact person for public queries
Name 91175 0
Olivia Clayton
Address 91175 0
Parenting Research Centre
Level 5, 232 Victoria Parade
East Melbourne VIC 3002
Country 91175 0
Australia
Phone 91175 0
+61 3 8660 3500
Fax 91175 0
Email 91175 0
oclayton@parentingrc.org.au
Contact person for scientific queries
Name 91176 0
Olivia Clayton
Address 91176 0
Added Parenting Research Centre
Level 5, 232 Victoria Parade
East Melbourne VIC 3002
Country 91176 0
Australia
Phone 91176 0
+61 3 8660 3500
Fax 91176 0
Email 91176 0
oclayton@parentingrc.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will be gaining consent to share only aggregated data collected from participants


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
EmbaseBuilding the skills and confidence of early childhood educators to work with parents: study protocol for the Partnering with Parents cluster randomised controlled trial.2019https://dx.doi.org/10.1186/s12874-019-0846-1
N.B. These documents automatically identified may not have been verified by the study sponsor.