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Trial registered on ANZCTR


Registration number
ACTRN12622000656730
Ethics application status
Approved
Date submitted
14/04/2022
Date registered
4/05/2022
Date last updated
9/05/2024
Date data sharing statement initially provided
4/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An effectiveness-implementation trial of the Parenting+ program for new parents
Scientific title
An effectiveness-implementation trial of the Parenting+ program for new parents: Examining the impact on health literacy, health and service use
Secondary ID [1] 306835 0
NHMRC grant identification number APP2002381
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
New parenthood 325921 0
Health Literacy Skills 325922 0
Health education 325923 0
Condition category
Condition code
Public Health 323234 323234 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parenting+ is an innovative health literacy intervention for new parents that is built on a model of health literacy skill development shown to increase health literacy in disadvantaged and culturally-diverse adults in Australia. Parenting+ is a free 4-6 week health literacy program that embeds functional health literacy skills into parenting topics of interest, identified from our previous work, in four core content areas:
Topic 1: Child development
Topic 2: Healthy eating and physical activity
Topic 3: Adjusting for parenthood
Topic 4: First aid, medicine and immunization

To develop transferable health literacy skills, three core skill sets are included across all topics: 1) skills to access and critically appraise health information; 2) skills for shared decision making and 3) skills for implementing health behaviours.

The Parenting+ program will be delivered face-to-face or online in small groups of approximately 6-8 participants by trained facilitators (e.g. Child and Family Health Nurses; bilingual community educators) in community settings (for example, in a community health centre). The Parenting+ program will be delivered as 4 x 2-hour parenting skill development sessions over a 4-6 week period depending upon participant availability. Sessions will include presentations on parenting skills, short video demonstrations, interactive exercises, group discussions, and question-answer.

Parenting+ facilitator training: All Parenting+ facilitators will attend a half-day training session led by the University of Sydney. Training will address adult education theory and practice; behaviour change techniques and health literacy skill development. Training will be conducted at in-person workshops of up to 12 facilitators at least two weeks prior to the first participant enrollment at the site. The training will include the Parenting+ module presentation slides, short videos, and interactive question-answer session. The adherence to the training will be monitored by a session attendance checklist.

Assessment of adherence/fidelity: Facilitators' actions and content covered in each session will be recorded in itemised checklists and logs. Investigators will conduct structured observation of Parenting+ program for content analysis.
Intervention code [1] 323299 0
Prevention
Intervention code [2] 323300 0
Lifestyle
Intervention code [3] 323301 0
Behaviour
Comparator / control treatment
Control groups will attend standard parenting programs (e.g. as organised by Local Health Districts). Community health nurses or equivalent will deliver the standard parenting program face-to-face or online over 4-6 weeks in general. The content, frequency, and duration of the standard parenting program provided at each site will vary depending on local priorities and the structure of the program. Investigators will monitor and document the content and structure provided at the standard parenting program throughout the trial by observation and detailed field notes and will compare the key differences between the standard parenting programs and the Parenting+ intervention.
Control group
Active

Outcomes
Primary outcome [1] 330986 0
Parental health literacy skills (specific): We have purpose-designed a 13-item performance-based functional health literacy skills measure (the Parenting Plus Skills Index, PPSI) using a three-phase validation study with a modified Delphi method and multidimensional Item Response Theory modelling in two independent samples (n=1007) (Ayre et al., 2020) (https://pubmed.ncbi.nlm.nih.gov/31982204/)
Timepoint [1] 330986 0
Pre-intervention(baseline) and immediate (end of last session of the parenting program), 6 months, 12 months post-intervention
Secondary outcome [1] 408356 0
Health literacy: The validated Health Literacy Questionnaire (HLQ) (Osbourne et al., 2013) which comprises 9 independent sub scales will be used to assess different aspects of health literacy.
Timepoint [1] 408356 0
Pre-intervention(baseline) and immediate (end of last session of the parenting program), 6 months, 12 months post-intervention
Secondary outcome [2] 408357 0
Parent’s Health-related quality of life will be assessed by The Medical Outcomes Study 12-Item Short Form Version 2 (SF-12v2; Optum, Eden Prairie, MN).
Timepoint [2] 408357 0
6 and 12 months post-intervention
Secondary outcome [3] 408358 0
Primary caregiver’s competence and attachment anxieties will be assessed by a 15-item sub-scale from the validated Postpartum Specific Anxiety Scale (PSAS). This scale asks about the parent’s confidence in their role as the primary caregiver, their relationship with their infant, and their ability to look after their child. The scale Correlates with related measures of general anxiety e.g. STAI and Edinburgh Postnatal Depression Scale.
Timepoint [3] 408358 0
6 and 12 months post-intervention.
Secondary outcome [4] 408359 0
Paediatric quality of life (parent completed) will be assessed by the 36-item (ages 1-12 months) PedsQL™ Infant Scales. It is a generic and widely used health-related quality of life (HRQOL) instrument for infants (completed by parents), covering the domains of Physical Functioning, Physical Symptoms, Emotional Functioning, Social Functioning and Cognitive Functioning.
Timepoint [4] 408359 0
6 and 12 months post-intervention
Secondary outcome [5] 408360 0
Optimal engagement is a composite score combining breastfeeding, infant feeding, immunisation and attendance at scheduled health checks. Individual variables that will be measured to construct the composite score are as follows:
-Self-reported exclusive breastfeeding rates at 6 months and any breastfeeding
-Self-reported infant feeding practices (infant age at introduction of solids, frequency of fruit juice consumption).
-Adherence to scheduled health checks (e.g. immunisation and birth weight checks by self-report at 6, 12 months, immunisation verified against the register at 12 months)
-Adherence to scheduled health checks (e.g. immunisation and birth weight checks by self-report at 6, 12 months, immunisation verified against the register at 12 months)
Timepoint [5] 408360 0
Pre-intervention(baseline), 6 and 12 months post-intervention
Secondary outcome [6] 408361 0
Parent/caregiver’ awareness and use of health information sources (e.g. Healthdirect’s Pregnancy, Birth and Baby; Get Healthy NSW; MotherSafe; NPS Medicines Line; Save the Date to Vaccinate App) via self-report. Participants seeking information via Healthdirect website will be recorded by Healthdirect by asking if the parent is part of the Parenting+ program, linking the participant and their child’s first name initials and date of birth.
Timepoint [6] 408361 0
Immediate (end of last session of the parenting program), 6 months, 12 months post-intervention
Secondary outcome [7] 408362 0
Health service use: Parents will be asked to self-report the number of times they have visited the a) hospital emergency department and b) Early Childhood Centre for their child after they participated in the parenting group.
GP and specialist visits and medicines use provided through Medicare Benefits Scheme (MBS) and Pharmaceutical Benefits Scheme (PBS) claims data over 12 months post-intervention. Child immunisation information will be obtained from Australian Immunisation Register (AIR) data. Number of emergency department (ED) visits (infants) will be assessed using the ED Data Collection (EDDC) Registry over 12 months post-intervention, with a focus on the % of non-urgent (ATS-5) or semi-urgent (ATS-4) presentations.
Timepoint [7] 408362 0
Immediate (end of last session of the parenting program), 6 months, 12 months post-intervention
Secondary outcome [8] 408363 0
The cost-effectiveness of Parenting+ (versus usual care) will be determined from a health funder perspective. Healthcare utilisation will be determined using linked Medicare, Pharmaceutical Benefits Schedule and emergency department (ED) visit data and self-reported data. Parental quality of life will be determined using the SF-12v2 and an incremental cost effectiveness ratio will be expressed as incremental cost (AUD) per quality adjusted life year (QALY) gained.
Timepoint [8] 408363 0
12 months post intervention

Eligibility
Key inclusion criteria
Parent with a child between 4-26 weeks at time of recruitment.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents with a child aged >26 weeks.
Parents do not provide consent to participate

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)
Randomisation of the clusters (parenting group) will be done by a statistician from the University of Sydney who is not involved in study implementation using a computer-assisted block randomisation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done at the group/cluster level. A statistician from the University of Sydney will generate the permuted blocks randomisation of bock sizes of 2-6 clusters using computer software. The block randomization will ensure 1:1 intervention and control cluster ratio at each site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will randomise 88 clusters (parenting groups) in intervention and control arms (44 clusters in each arm). Each cluster will comprise on average 7 participants. To detect a 0.3 standard deviations difference in parental health literacy skills index between Parenting+ and standard parenting programs with 90% power at a 5% significance level and adjusting for an intra-class correlation coefficient of 0.025 the minimum required sample size is 273 participants in each arm. Allowing for a ~10% loss to follow-up, 616 participants (308 in each arm) will be enrolled in the study.

All analyses will be done by intention-to-treat comparing the intervention and standard parenting group arms (using individual-level data). Mixed-effects regression models adjusting for clustering at the parenting group level will be used for analyses, with intervention included as a fixed effect and controlling for potential confounders. Linear mixed models will be used for continuous dependent variables; logistic mixed models will be used for categorical outcomes.

The cost-effectiveness of Parenting+ intervention (versus usual care) will be analysed from a health funder perspective. An incremental cost-effectiveness ratio will be expressed as incremental cost per quality-adjusted life year (QALY) gained.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
30/03/2023
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
29/05/2026
Actual
Sample size
Target
616
Accrual to date
345
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37271 0
2144 - Auburn
Recruitment postcode(s) [2] 37272 0
2767 - Doonside
Recruitment postcode(s) [3] 37273 0
2770 - Mount Druitt
Recruitment postcode(s) [4] 37274 0
2150 - Parramatta
Recruitment postcode(s) [5] 37275 0
2160 - Merrylands
Recruitment postcode(s) [6] 37277 0
2015 - Alexandria
Recruitment postcode(s) [7] 37278 0
2041 - Balmain
Recruitment postcode(s) [8] 37279 0
2192 - Belmore
Recruitment postcode(s) [9] 37280 0
2194 - Campsie
Recruitment postcode(s) [10] 37281 0
2046 - Chiswick
Recruitment postcode(s) [11] 37282 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [12] 37283 0
2132 - Croydon
Recruitment postcode(s) [13] 37284 0
2206 - Earlwood
Recruitment postcode(s) [14] 37285 0
2046 - Five Dock
Recruitment postcode(s) [15] 37286 0
2037 - Forest Lodge
Recruitment postcode(s) [16] 37287 0
2037 - Glebe
Recruitment postcode(s) [17] 37288 0
2140 - Homebush
Recruitment postcode(s) [18] 37289 0
2195 - Lakemba
Recruitment postcode(s) [19] 37290 0
2040 - Leichhardt
Recruitment postcode(s) [20] 37291 0
2204 - Marrickville
Recruitment postcode(s) [21] 37292 0
2196 - Punchbowl
Recruitment postcode(s) [22] 37293 0
2565 - Ingleburn
Recruitment postcode(s) [23] 37294 0
2567 - Narellan
Recruitment postcode(s) [24] 40224 0
2200 - Bankstown
Recruitment postcode(s) [25] 40225 0
2017 - Zetland
Recruitment postcode(s) [26] 40226 0
2576 - Bowral
Recruitment postcode(s) [27] 40227 0
2171 - Hoxton Park

Funding & Sponsors
Funding source category [1] 311164 0
Government body
Name [1] 311164 0
Australian National Health and Medical Research Council (NHMRC)
Country [1] 311164 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Room 128B Edward Ford Building A27,
The University of Sydney,
NSW 2006
Country
Australia
Secondary sponsor category [1] 312520 0
Government body
Name [1] 312520 0
Western Sydney Local Health District
Address [1] 312520 0
WSLHD Child and Family Health Nursing
Integrated Community Health
Auburn Community Health Centre
Norval Street Auburn
NSW 2142
Country [1] 312520 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310694 0
Western Sydney Local Health District HREC
Ethics committee address [1] 310694 0
Ethics committee country [1] 310694 0
Australia
Date submitted for ethics approval [1] 310694 0
13/05/2019
Approval date [1] 310694 0
02/01/2020
Ethics approval number [1] 310694 0
2019/ETH00672

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

Contacts
Principal investigator
Name 118538 0
Prof Kirsten McCaffery
Address 118538 0
Sydney School of Public Health,
Room 128B Edward Ford Building A27,
The University of Sydney, NSW 2006
Country 118538 0
Australia
Phone 118538 0
+61 2 9351 7220
Fax 118538 0
Email 118538 0
kirsten.mccaffery@sydney.edu.au
Contact person for public queries
Name 118539 0
Danielle Marie Muscat
Address 118539 0
Sydney School of Public Health,
127 Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 118539 0
Australia
Phone 118539 0
+61 2 9351 7819
Fax 118539 0
Email 118539 0
danielle.muscat@sydney.edu.au
Contact person for scientific queries
Name 118540 0
Danielle Marie Muscat
Address 118540 0
Sydney School of Public Health,
127 Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 118540 0
Australia
Phone 118540 0
+61 2 9351 7819
Fax 118540 0
Email 118540 0
danielle.muscat@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
We will share self-reported de-identified individual participant data from baseline (participant characteristics) and follow-up visits (outcomes) that are included in published results.
When will data be available (start and end dates)?
The data will be made available after six months following the publication of the main results and will be available for 5 years after publication.
Available to whom?
Researchers will be able to request access the participant’s self-reported data collected during the trial upon submitting a methodologically sound proposal to the principal investigator and considered on a case-by-case basis.
Available for what types of analyses?
Data will be available for analysis to achieve the aims in the approved proposal.
How or where can data be obtained?
Data can be accessed on a reasonable request with a methodologically sound proposal subject to approvals by Principal Investigator (kirsten.mccaffery@sydney.edu.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15713Ethical approval  danielle.muscat@sydney.edu.au 383870-(Uploaded-11-04-2022-11-01-41)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.