Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001448730
Ethics application status
Approved
Date submitted
18/10/2022
Date registered
14/11/2022
Date last updated
16/12/2022
Date data sharing statement initially provided
14/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Happy Parenting Project: Respectful Approach Classes for Early Parenting
Scientific title
Investigating the Efficacy of Respectful Approach Classes for Strengthening the Parent-Child Relationship in Early Parenting
Secondary ID [1] 307572 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 327112 0
Parent-child relationship difficulties 327113 0
Unhealthy meal environment 327114 0
Poor parenting confidence 328168 0
Condition category
Condition code
Mental Health 324259 324259 0 0
Other mental health disorders
Diet and Nutrition 325021 325021 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVENTION
In-person intervention (Arm 1)
Families will be asked to attend two sets of Respectful Approach parenting classes, held in a group setting (approximately 8-10 children with their primary carers/parents). The Respectful Approach is a preventative initiative, based on principles of the ‘Pikler Approach®’ originally developed by Hungarian paediatrician Dr Emmi Pikler and later established in the USA by infant specialist Magda Gerber.

Each set of classes will run once per week for eight weeks (for a total of 16 classes over the two sessions). Families will attend the first set of classes when their child is around four months of age and the second set of classes when their child is around twelve months of age. For the in-person classes, children will attend with their parents to provide ‘live’ opportunities for sensitive observation and interactions. Session attendance will be taken and parents in the intervention will be encouraged to complete and reflect on weekly challenges . These will be used to assess adherence to the Respectful Approach principles. Families will also be invited to engage in a private, researcher-supervised Facebook group for on-going peer support.

Online intervention (Arm 2)
Families will attend the classes covering the same content as the in-person group but over web video conference. For the online classes, families will be invited to submit a video of their child for discussion. All assessments will be the same as the in-person intervention.

THE CLASSES
The parent-child classes will be facilitated by qualified educators experienced in running classes and parent education, and also have completed additional specialist training in the Respectful Approach (RIE® Foundations: Theory and Observation). Each class will run for around 1 hour. Classes cover a different topic each week based on Respectful Approach principles of mutual trust, sensitive observation, quality caregiving (with a focus on mealtimes), a prepared environment, time for uninterrupted play and consistency. Participants will receive weekly handouts including educational information around the topic for discussion for that week. These handouts have been specifically designed for this study.

INTERVENTION LOCATION
- Arm 1: in-person sessions will be provided for free at an appropriate venue within the
Perth Metropolitan region (e.g., community centre)
- Arm 2: online classes will be held via video conferencing software (e.g., Microsoft Teams or Zoom)
Intervention code [1] 324076 0
Prevention
Intervention code [2] 324077 0
Behaviour
Intervention code [3] 324662 0
Lifestyle
Comparator / control treatment
The control group will consist of parents/carers attending facilitated outdoor play group classes without any education. Classes will occur at similar time periods to the intervention groups, which will enable us to determine whether any beneficial effects observed from baseline measures are due to the social/group aspects or the Respectful Approach program itself. The outdoor play group will provide some activity stations appropriate to the age of the child, involving items such as blocks, books, sticks, large rocks etc.
Control group
Active

Outcomes
Primary outcome [1] 332258 0
Parent-child relationship as assessed by reflective functioning scores on The 5 Minute Speech Sample
Timepoint [1] 332258 0
Parent-infant classes:
Baseline, 8-9 weeks post baseline

Parent-toddler classes:
Baseline, 8-9 weeks post baseline
Primary outcome [2] 332259 0
Parent stress as assessed by the Parental Stress Scale
Timepoint [2] 332259 0
Parent-infant classes:
Baseline, 8-9 weeks post baseline

Parent-toddler classes:
Baseline, 8-9 weeks post baseline
Primary outcome [3] 332367 0
Parent and child stress as assessed by salivary cortisol levels
Timepoint [3] 332367 0
Parent-infant classes:
Baseline, 8-9 weeks post baseline

Parent-toddler classes:
Baseline, 8-9 weeks post baseline
Secondary outcome [1] 412748 0
Child dietary intake as assessed through interview by a dietitian (approx 20 minute one-on-one interview with parent)
Timepoint [1] 412748 0
Parent-infant classes:
Baseline, 8-9 weeks post baseline

Parent-toddler classes:
Baseline, 8-9 weeks post baseline
Secondary outcome [2] 413205 0
Mealtime environment and behaviour as assessed by The Feeding Practices and Structure Questionnaire
Timepoint [2] 413205 0
Parent-infant classes:
Baseline, 8-9 weeks post baseline

Parent-toddler classes:
Baseline, 8-9 weeks post baseline
Secondary outcome [3] 413207 0
Child development (as assessed by the Ages and Stages questionnaire)
Timepoint [3] 413207 0
Pre and post overall intervention (at ages ~4 months and ~14 months).
We will also use this assessment at a later follow up when the child is approx 3 years and 5 years of age (collected through standard ORIGINS follow ups) and potentially for other participants not through ORIGINS (funding dependent).
Secondary outcome [4] 415690 0
Parenting confidence as assessed by scores on the Parent Sense of Competence Scale
Timepoint [4] 415690 0
Parent-infant classes:
Baseline, 8-9 weeks post baseline

Parent-toddler classes:
Baseline, 8-9 weeks post baseline
Secondary outcome [5] 415691 0
Child dietary intake as assessed by Australian Eating Survey
Timepoint [5] 415691 0
Child at approx 3 years and 5 years of age (through ORIGINS follow ups)
Secondary outcome [6] 415692 0
Child screen time as assessed by ORIGINS questionnaire
Timepoint [6] 415692 0
Child at approx 3 years and 5 years of age (through ORIGINS follow ups)
Secondary outcome [7] 415693 0
Child behaviour, social, and emotional development (as assessed by Connors Early Childhood questionnaire and Strengths and Difficulties Questionnaire)



Timepoint [7] 415693 0
Child at approx 3 years and 5 years of age (through ORIGINS follow ups)
Secondary outcome [8] 415694 0
Child growth trajectories and body composition (for ORIGINS participants, as assessed with height and weight measured using digital scales and a stadiometer, and fat and fat free mass measured using the BodPod; as recorded by trained research assistants)
Timepoint [8] 415694 0
Child at approx 3 years and 5 years of age (through ORIGINS follow ups)
Secondary outcome [9] 416741 0
Child growth trajectories, as assessed at scheduled child health nurse visits
Timepoint [9] 416741 0
Birth, 8 weeks, 4 months, 12 months, 2 years

Eligibility
Key inclusion criteria
- Parents/carers with children aged around 4 months of age
- Good understanding of spoken and written English
- Access to the internet and device to engage in online content
- Willing and able to attend at least six out of eight sessions per year for two years, in person or online, with child (no other siblings to attend the education class – parents who care for other children need to be able to arrange alterative care, or we will investigate options for onsite care)
- For participants enrolled in the larger ORIGINS Project: likely to be still participating in the ORIGINS Project until at least the 3-year follow up
Minimum age
3 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents under 18 years of age

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified permuted block allocation. Stratified by socioeconomic status (either high or low).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE

A-priori sample size requirement was calculated using G*Power. Based on results from our pilot study, for a mixed-model repeated-measures design with three groups (two intervention groups, one control) and three time points, the minimum required sample size to detect, at least, a small-to-medium Group × Time interaction effect (Cohen’s f = 0.175) at 90% power and 1 % level of significance (to account for multiple parent- and child-related outcomes including confidence and stress) is 117 (39 per group). However, a common problem that arises in early parenting longitudinal studies is the high rates of attrition, with
Bigelow (2018) reporting high rates of attrition over a 12-month period, mostly due to parents returning to the workforce. Therefore, assuming a 20% attrition rate, the adjusted required sample size is 141 (47 per group). As we would also like to access ORIGINS data to assess outcomes at 3 and 5 years, we have added an additional 30 ORIGINS participants to account for longitudinal drop out/loss to follow up to this time point (total n = 171, 57 per group).

DATA ANALYSIS
Quantitative data from self-report questionnaires, observations and voice recordings will be analysed using SPSS Statistics Version 24.0 (IBM Corp, 2016). A linear mixed model will be used to determine any statistically significant variations between the intervention and control groups across all measures over the intervention periods, to ascertain the effect of a ‘Respectful Approach’ intervention. Confounding factors will be evaluated and included as covariates in the linear mixed model. Some potential confounding factors include age, education level, first time parent, single parent (or marital status), history of depression. Results will be deemed significant if p<0.05. As recommended, we will report results from fully adjusted as well as crude analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/01/2023
Actual
Date of last participant enrolment
Anticipated
31/10/2023
Actual
Date of last data collection
Anticipated
31/05/2029
Actual
Sample size
Target
171
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 311844 0
Government body
Name [1] 311844 0
East Metropolitan Health Service
Country [1] 311844 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 313321 0
None
Name [1] 313321 0
Address [1] 313321 0
Country [1] 313321 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311287 0
Ramsay Health Care (RHC) WA|SA HREC
Ethics committee address [1] 311287 0
Ethics committee country [1] 311287 0
Australia
Date submitted for ethics approval [1] 311287 0
01/04/2022
Approval date [1] 311287 0
12/04/2022
Ethics approval number [1] 311287 0
2205W
Ethics committee name [2] 311807 0
CAHS HREC
Ethics committee address [2] 311807 0
Ethics committee country [2] 311807 0
Australia
Date submitted for ethics approval [2] 311807 0
Approval date [2] 311807 0
Ethics approval number [2] 311807 0

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

Contacts
Principal investigator
Name 120578 0
A/Prof Therese O'Sullivan
Address 120578 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 120578 0
Australia
Phone 120578 0
+61863043529
Fax 120578 0
Email 120578 0
[email protected]
Contact person for public queries
Name 120579 0
Therese O'Sullivan
Address 120579 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 120579 0
Australia
Phone 120579 0
+61863043529
Fax 120579 0
Email 120579 0
[email protected]
Contact person for scientific queries
Name 120580 0
Therese O'Sullivan
Address 120580 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 120580 0
Australia
Phone 120580 0
+61863043529
Fax 120580 0
Email 120580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Requests for deidentified data will be considered by the research team
When will data be available (start and end dates)?
From 2030, no end date scheduled at this stage
Available to whom?
Requests for deidentified data will be considered by the research team
Available for what types of analyses?
Requests for deidentified data will be considered by the research team
How or where can data be obtained?
Please contact the PI for data requests (email [email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17575Study protocol    Please contact the PI for supporting documents (em... [More Details]



Results publications and other study-related documents

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