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Trial registered on ANZCTR


Registration number
ACTRN12611000965909
Ethics application status
Approved
Date submitted
29/08/2011
Date registered
8/09/2011
Date last updated
13/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of a parenting intervention for promoting positive home learning environments and learning outcomes for children in disadvantaged families: the Early Home Learning Study
Scientific title
Effectiveness of group-based and group plus home-based parenting interventions for promoting positive home learning environments and learning outcomes for children in disadvantaged families
Secondary ID [1] 259715 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
EHLS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
parenting confidence and self care 268348 0
early child development (emergent literacy) 268349 0
Condition category
Condition code
Mental Health 268477 268477 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention (smalltalk program) is based on an evidence based model which comprises of two child-focused domains (Quality Everyday Interactions and Stimulating Environment) and two parent-focused domains (Parent Self-Care and Parent Confidence). It also includes a fifth domain, Community Connectedness. The smalltalk program seeks to build on existing parenting strengths and target specific parenting skills known to promote child language and learning. It incorporates strategies that assist parents to adequately meet their own needs as a person and a parent.

The intervention is embedded in two existing service platforms – Maternal and Child Health (MCH) parent groups for children aged 6 to 12 months and Supported Playgroups (SPG) for children aged 1 to 3 years. The intervention is delivered across two levels of intensity – lower intensity: a supported playgroup or parenting group that includes smalltalk parenting strategies and higher intensity: a supported playgroup or parenting group that includes smalltalk parenting strategies plus individual coaching of families in their home.
In the SPG platform: the lower intensity program involves 1 x 2 hour group session per week over a period of 10 weeks; and the higher intensity program involves 1 x 2 hour group session per week over a period of 10 weeks, plus 1 x 1 1/2 hour home coaching visit fortnightly (total of 6 visits).
In the MCH platform: the lower intensity program involves 1 x 2 hour group session per week over a period of 6 weeks; and the higher intensity program involves 1 x 2 hour group session per week over a period of 6 weeks, plus 1 x 1 1/2 hour home coaching visit fortnightly (total of 6 visits).
Intervention code [1] 264141 0
Behaviour
Comparator / control treatment
The comparator group is a usual care or standard supported playgroup or parent group that does not include any smalltalk parenting content.
The groups run for 2 hours each week for a period of 10 weeks in the SPG platform and 6 weeks in the MCH platform.
Control group
Active

Outcomes
Primary outcome [1] 262248 0
Parent outcomes: Enhanced parent confidence and self-care (Self-efficacy; Kessler psychological screener; PANAS positive affect scale; SF-12; Coping), parent relational skills (Warmth and Hostile parenting; Infant Growth and Development Indices - IPCI) and teaching (Infant Growth and Development Indices - IPCI) skills.
These constructs will be measured through questionnaires (self report) and in-home observation.
Timepoint [1] 262248 0
The time points of data collection for all conditions (standard, lower intensity and higher intensity) are T1 = Baseline (before group commencement), T2 = Post (after the last group session) and T3 = Follow up (5 months after group).
Note. The SF-12 will only be administered at T1 and T3.
Primary outcome [2] 262249 0
Home learning environment outcomes: Improved parent activities with their child (Eg. Parent reads books to child), parent verbal responsivity (Eg. Parent plays rhyming games with child), home literacy environment (Eg. Literacy exposure). Decreased household chaos (Environmental chaos in the home scale).
These constructs will be measured through questionnaires (self report).
Timepoint [2] 262249 0
The time points of data collection for all conditions (standard, lower intensity and higher intensity) are T1 = Baseline (before group commencement), T2 = Post (after the last group session) and T3 = Follow up (5 months after group).
Secondary outcome [1] 273386 0
Child outcomes: Enhanced child language and emergent literacy. Expressive and receptive communication was assessed using the following: Ages and Stages Questionnaire: 3rd Ed. - Communication sub-scale; Communicative Development Index: SF; Infant Growth and Development Indices - ECI.
These constructs will be measured through questionnaires (parent self report) and in-home observation.
Timepoint [1] 273386 0
The time points of data collection for all conditions (standard, lower intensity and higher intensity) are T1 = Baseline (before group commencement), T2 = Post (after the last group session) and T3 = Follow up (5 months after group).
Secondary outcome [2] 279174 0
Child outcomes: Enhanced child socio-emotional wellbeing and general development. These outcomes were assessed using 4 behavioural difficulty items from the NEILS study; Ages and Stages Questionnaire: 3rd Ed. - Fine motor and Personal-social sub-scales; Infant Growth and Development Indices - IPCI).
These constructs will be measured through questionnaires (parent self report) and in-home observation.
Timepoint [2] 279174 0
The time points of data collection for all conditions (standard, lower intensity and higher intensity) are T1 = Baseline (before group commencement), T2 = Post (after the last group session) and T3 = Follow up (5 months after group).
Secondary outcome [3] 279186 0
Service outcomes: Enhanced capacity of existing child and family services. This was assessed though a number of items related to use of health and support services (Eg. MCH) and impact of service use on work and regular routine.
These constructs will be measured through questionnaires (parent self report).
Timepoint [3] 279186 0
The time points of data collection for all conditions (standard, lower intensity and higher intensity) are T1 = Baseline (before group commencement) and T3 = Follow up (5 months after group).

Eligibility
Key inclusion criteria
To be eligible to participate, parents/carers must meet the following essential criteria:
- At least one child in the age range of their assigned treatment group: MCH platform – 6 to 12 months at group commencement; or SPG platform - 1 year to 3 years at group commencement.
- Ability to speak and understand basic spoken English

In addition to the above criteria, parents/carers may also be eligible if they meet one of the following (optional) criteria:
- single parent families
- indigenous families
- health care card
- young parent families (<25 years of age)
- socially isolated
- very low income
- culturally and linguistically diverse backgrounds
- concern as indicated by PEDS
Minimum age
6 Months
Maximum age
36 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Families will not be eligible to participate if:
- The parent/carer does not speak English.
- The parent/carer those would benefit from other services (Eg. High level intervention from child protection or other)

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)
Recruitment
Regardless of whether they are eligible for the maternal and child health platform or the supported playgroup platform, participants will be identified via MCH services or community referrals in their local government area (LGA). A rolling recruitment strategy will be applied.
The MCH representative or community service organisation (CSO) will briefly introduce the study to the family. If willing, the MCH representative or CSO will obtain verbal consent from the family and pass their details onto the LGA’s Site Coordinator. The Site Coordinator will contact the family, explain the study in more detail, obtain verbal consent and mail out a Participant Information and Consent form. When the researcher visits the family’s home for the first home assessment, they will ask the family to provide their written consent.

Allocation concealment:
A computer program designed by Dr Ukoumunne from the MCRI will be used to ensure the appropriate randomisation occurs. This will be conducted independently by Dr Ukoummune (or staff member) for this process.
As the unit of randomisation is the locality, concealment occurs at the level of locality. Sites and localities will be randomised and informed of the outcome of the randomisation, after they have given full consent to participation in the trial. As individual participants are recruited to programs (conditions) offered by their nearest service, they will not be blinded to allocation at recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This study employs a stratified, blocked, cluster randomised design. Individual participants are clustered according to the geographical location of their nearest service (the locality identified for participation in the research), with localities randomised within strata to one of three intervention conditions (condition 1 = usual care group; condition 2 = group with smalltalk parenting strategies; condition 3 = group with smalltalk parenting strategies plus home coaching). Each locality will be assigned 1 program variant (condition), i.e. the locality is the unit of randomisation. Stratification is used to ensure that conditions are randomised in a blocked design, to provide at least one program for each condition within each site (LGA or combination of LGAs).
As there are three conditions, randomisation occurs in blocks of three localities, as follows:
1) Each site (LGA or combined LGA) will provide the study team with the finalised list of localities available to conduct programs. Localities in each site (LGA) will be stratified into blocks of three. Where the number of localities within a site is a not multiple of three (e.g. 4, 5, 7 or 8 localities), the first 3 (or 6) localities will be put in the within-site blocks. The remainder will be placed in a ‘pool’ to create cross-site blocks with the ‘left-over’ localities from other sites.
2) Within-in site blocks will be randomised in a balanced design: 1 locality in each block will be randomised to conditions 1, 2 and 3.
3) Localities in the cross-site pool will be allocated into blocks of three, with the ‘left-over’ localities from the same site, allocated to the same block (thereby ensuring that these localities by nature of their block allocation, will be randomised to different conditions). Localities in each cross-site block, will then be randomised in a balanced design to conditions 1, 2 and 3.
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3754 0
3020
Recruitment postcode(s) [2] 3755 0
3036
Recruitment postcode(s) [3] 3756 0
3042
Recruitment postcode(s) [4] 3757 0
3810
Recruitment postcode(s) [5] 3758 0
3250
Recruitment postcode(s) [6] 3759 0
3233
Recruitment postcode(s) [7] 3760 0
3260
Recruitment postcode(s) [8] 3761 0
3072
Recruitment postcode(s) [9] 3762 0
3070
Recruitment postcode(s) [10] 3763 0
3073
Recruitment postcode(s) [11] 3764 0
3199
Recruitment postcode(s) [12] 3765 0
3198
Recruitment postcode(s) [13] 3766 0
3910
Recruitment postcode(s) [14] 3767 0
3552
Recruitment postcode(s) [15] 3768 0
3523
Recruitment postcode(s) [16] 3769 0
3758
Recruitment postcode(s) [17] 3770 0
3175
Recruitment postcode(s) [18] 3771 0
3173
Recruitment postcode(s) [19] 3772 0
3171
Recruitment postcode(s) [20] 3773 0
3172
Recruitment postcode(s) [21] 3774 0
3174
Recruitment postcode(s) [22] 3775 0
3018
Recruitment postcode(s) [23] 3776 0
3016
Recruitment postcode(s) [24] 3777 0
3194
Recruitment postcode(s) [25] 3778 0
3192
Recruitment postcode(s) [26] 3779 0
3196
Recruitment postcode(s) [27] 3780 0
3152
Recruitment postcode(s) [28] 3781 0
3178
Recruitment postcode(s) [29] 3782 0
3337
Recruitment postcode(s) [30] 3783 0
3338
Recruitment postcode(s) [31] 3784 0
3023
Recruitment postcode(s) [32] 3785 0
3939
Recruitment postcode(s) [33] 3786 0
3931
Recruitment postcode(s) [34] 3787 0
3915
Recruitment postcode(s) [35] 3788 0
3912
Recruitment postcode(s) [36] 3789 0
3689
Recruitment postcode(s) [37] 3790 0
3690
Recruitment postcode(s) [38] 3791 0
3691
Recruitment postcode(s) [39] 3792 0
3030
Recruitment postcode(s) [40] 3793 0
3029
Recruitment postcode(s) [41] 3794 0
3140
Recruitment postcode(s) [42] 3795 0
3793
Recruitment postcode(s) [43] 3796 0
3158
Recruitment postcode(s) [44] 3797 0
3777
Recruitment postcode(s) [45] 3798 0
3797
Recruitment postcode(s) [46] 4473 0
3805
Recruitment postcode(s) [47] 4474 0
3632
Recruitment postcode(s) [48] 4475 0
3220

Funding & Sponsors
Funding source category [1] 264598 0
Government body
Name [1] 264598 0
Department of Education and Early Childhood Development
Country [1] 264598 0
Australia
Primary sponsor type
Other
Name
Parenting Research Centre
Address
5/232 Victoria Parade
East Melbourne, 3002
Victoria
Country
Australia
Secondary sponsor category [1] 263737 0
None
Name [1] 263737 0
Address [1] 263737 0
Country [1] 263737 0
Other collaborator category [1] 251846 0
Individual
Name [1] 251846 0
Associate Professor Jan Nicholson
Address [1] 251846 0
Murdoch Children's Research Institute
Royal Children's Hospital, Flemington Road
Parkville VIC 3052
Country [1] 251846 0
Australia
Other collaborator category [2] 251847 0
Individual
Name [2] 251847 0
Professor Donna Berthelsen
Address [2] 251847 0
Queensland University of Technology
B Block Level 4, Queensland University of Technology
412 Victoria Park Rd
Kelvin Grove QLD 4059
Country [2] 251847 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260595 0
Department of Health Human Research Ethics Committee
Ethics committee address [1] 260595 0
Ethics committee country [1] 260595 0
Australia
Date submitted for ethics approval [1] 260595 0
Approval date [1] 260595 0
11/08/2010
Ethics approval number [1] 260595 0
8/10/2011

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

Contacts
Principal investigator
Name 32296 0
Address 32296 0
Country 32296 0
Phone 32296 0
Fax 32296 0
Email 32296 0
Contact person for public queries
Name 15543 0
Dr Naomi Hackworth
Address 15543 0
Parenting Research Centre
5/232 Victoria Parade
East Melbourne, 3002
Victoria
Country 15543 0
Australia
Phone 15543 0
+61 3 8660 3581
Fax 15543 0
+61 3 8660 3599
Email 15543 0
[email protected]
Contact person for scientific queries
Name 6471 0
Dr Naomi Hackworth
Address 6471 0
Parenting Research Centre
5/232 Victoria Parade
East Melbourne, 3002
Victoria
Country 6471 0
Australia
Phone 6471 0
+61 3 8660 3581
Fax 6471 0
+61 3 8660 3599
Email 6471 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
EmbaseImpact of a Brief Group Intervention to Enhance Parenting and the Home Learning Environment for Children Aged 6-36 Months: a Cluster Randomised Controlled Trial.2017https://dx.doi.org/10.1007/s11121-017-0753-9
N.B. These documents automatically identified may not have been verified by the study sponsor.