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Trial registered on ANZCTR


Registration number
ACTRN12617000770369
Ethics application status
Approved
Date submitted
17/05/2017
Date registered
25/05/2017
Date last updated
1/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Learn, Engage and Play (LEaP): The Development and Evaluation of a Therapeutic Playgroup for Children with Developmental Delay
Scientific title
Learn, Engage and Play (LEaP): The Development and Evaluation of a Therapeutic Playgroup for Children with Developmental Delay
Secondary ID [1] 291986 0
Nil
Universal Trial Number (UTN)
Trial acronym
LEaP
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Developmental Delay 303336 0
Communication delay 303337 0
Condition category
Condition code
Mental Health 302769 302769 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For children and families participating in the RCT they will be randomised into either the ‘Treatment as Usual’ group or the ‘Playgroup Intervention’ group.

Playgroup Intervention: Lean, Engage a Play (LEaP) Playgroup
The manualised playgroup intervention will be delivered in a group of 8 to 10 families with two allied health clinicians as facilitators. It will be run for 2 hourly sessions, once a week for 8 weeks at a community centre. The sessions will have a consistent routine including play-based indoor and outdoor activities, group music and singing, story time, snack time, free play and farewell activities. The playgroup intervention overarching frameworks are family centred practice, self-efficacy theory and peer support theory. Therapists will use a coaching based framework when facilitating the group and when working on strategies with families. Parents will be given information each week and expected to use strategies learnt in playgroup sessions at home between sessions. Strategies will aim to enhance parent-child interaction and children's communication. An example of strategies are; i) Be face to face and get down to your child’s level; ii) Pay attention to what your child is interested in and; iii) Show enjoyment and join in with what they are doing.

Parents will not be prevented from accessing other therapies as part of their ‘treatment as usual’. We will also seek to quantify all contact with health professionals by asking parents to complete a monthly diary. We will also qualify the nature of this contact by directly contacting the health professional(s) involved.
Intervention code [1] 298109 0
Treatment: Other
Comparator / control treatment
Treatment as Usual: The control group
Families in the “treatment as usual’ group will receive current treatment offered within the Child Development Service, this is the Western Australian's Health Department's early intervention service. This is likely to involve a ‘parent information workshop.’ This is a two hour workshop where the parent and/or the child attend to get information about their child’s developmental concerns. Depending on the nature of the workshop that the parent is offered this may be run by a speech pathologist, an occupational therapist, a physiotherapist, a social worker and/or clinical psychologist. Parents will not be prevented from accessing other therapies. Within the ‘Treatment as Usual’ group, we will quantify all contact with health professionals by asking parents to complete a monthly diary. We will also qualify the nature of this contact by directly contacting the health professional(s) involved. This has been previously used in RCT and effective incorporated in statistical analysis.
Control group
Active

Outcomes
Primary outcome [1] 302160 0
The primary outcome measure is the total score of the Parenting Stress Index Short Form (PSI-SF).
Timepoint [1] 302160 0
Participants will assessed at baseline and at two follow-up assessments, time-locked to the baseline assessment:
1. Follow-up assessment 1: immediate post-treatment (8 weeks post-baseline).
2. Follow-up assessment 2: 12 weeks following treatment completion (20 weeks post baseline),
Secondary outcome [1] 335011 0
The Secondary Outcomes are the total score of the Tool to Measures Parenting Self-Efficacy (TOPSE) (Kendall & Bloomfield, 2005).
Timepoint [1] 335011 0
Participants will assessed at baseline and at two follow-up assessments, time-locked to the baseline assessment:
1. Follow-up assessment 1: immediate post-treatment (8 weeks post-baseline).
2. Follow-up assessment 2: 12 weeks following treatment completion (20 weeks post baseline),
Secondary outcome [2] 335012 0
Canadian Occupational Performance Measure (COPM) (Law et al, 2005)
Timepoint [2] 335012 0
Participants will assessed at baseline and at two follow-up assessments, time-locked to the baseline assessment:
1. Follow-up assessment 1: immediate post-treatment (8 weeks post-baseline).
2. Follow-up assessment 2: 12 weeks following treatment completion (20 weeks post baseline),
Secondary outcome [3] 335029 0
Goal Attainment Scale
Timepoint [3] 335029 0
Participants will assessed at baseline and at two follow-up assessments, time-locked to the baseline assessment:
1. Follow-up assessment 1: immediate post-treatment (8 weeks post-baseline).
2. Follow-up assessment 2: 12 weeks following treatment completion (20 weeks post baseline),
Secondary outcome [4] 335030 0
Family Support Scale (Dunst, Jenkins, & Trivette, 1984)
Timepoint [4] 335030 0
Participants will assessed at baseline and at two follow-up assessments, time-locked to the baseline assessment:
1. Follow-up assessment 1: immediate post-treatment (8 weeks post-baseline).
2. Follow-up assessment 2: 12 weeks following treatment completion (20 weeks post baseline),
Secondary outcome [5] 335031 0
The Medical Outcome Study Short Form Health Survey (SF-12) (Medical Outcomes Trust, 2006)
Timepoint [5] 335031 0
Participants will assessed at baseline and at two follow-up assessments, time-locked to the baseline assessment:
1. Follow-up assessment 1: immediate post-treatment (8 weeks post-baseline).
2. Follow-up assessment 2: 12 weeks following treatment completion (20 weeks post baseline),
Secondary outcome [6] 335032 0
Test of Environmental Supportiveness (TOES) (Bundy, 1999)
Timepoint [6] 335032 0
Participants will assessed at baseline and at two follow-up assessments, time-locked to the baseline assessment:
1. Follow-up assessment 1: immediate post-treatment (8 weeks post-baseline).
2. Follow-up assessment 2: 12 weeks following treatment completion (20 weeks post baseline),
Secondary outcome [7] 335033 0
The Test of Playfulness (ToP) (Bundy, Nelson, Metzger, & Bingaman, 2001)
Timepoint [7] 335033 0
Participants will assessed at baseline and at two follow-up assessments, time-locked to the baseline assessment:
1. Follow-up assessment 1: immediate post-treatment (8 weeks post-baseline).
2. Follow-up assessment 2: 12 weeks following treatment completion (20 weeks post baseline),
Secondary outcome [8] 335034 0
MacArthur-Bates Communicative Development Inventory (Fenson et al., 1994)
Timepoint [8] 335034 0
Participants will assessed at baseline and at two follow-up assessments, time-locked to the baseline assessment:
1. Follow-up assessment 1: immediate post-treatment (8 weeks post-baseline).
2. Follow-up assessment 2: 12 weeks following treatment completion (20 weeks post baseline),

Eligibility
Key inclusion criteria
Participants will be eligible if they meet the following inclusion criteria.
i) Children aged 18 months to 42 months referred and accepted to the Child Development Service between February 2017 to December 2017
ii) Children with 2 or more domains as measured by the Ages and Stages Questionnaire (ASQ-3) as being ‘at risk.’
Minimum age
18 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the study if they meet the following criteria:
i) Established disability diagnosis such as Autism Spectrum Disorder or Cerebral Palsy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of participants will be concealed from the primary investigators and completed by someone at another site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated by simple randomisation using a randomisation table created by computer software.
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
We seek to recruit 140 children between the ages of 18 months to 42 months of age, who will be randomised to two groups (n=70). The estimated sample size was based on the use of the Parent Stress Index (PSI) as this is the primary outcome measure of this study. This was modelled on a study examining stress of parents with a preterm infant using this measure. That study required 60 children for both the experimental and control groups to detect a clinically significant change in the PSI score (0.48SD) with 80% power and using a=0.05. With little information concerning this quantity, but no reason to expect that it would be a significant issue, the study will aim to recruit 70 children for each group, to allow for potential loss to follow up.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/06/2017
Actual
Date of last participant enrolment
Anticipated
8/12/2017
Actual
Date of last data collection
Anticipated
6/04/2018
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 16058 0
6000 - Perth
Recruitment postcode(s) [2] 16286 0
6000 - Perth Gpo

Funding & Sponsors
Funding source category [1] 296497 0
University
Name [1] 296497 0
Graduate Research School, Office of Research and Development, Curtin University
Country [1] 296497 0
Australia
Primary sponsor type
Government body
Name
Child Development Service, Western Australia
Address
Child and Adolescent Community Health
Level 8 Eastpoint Plaza, 233 Adelaide Terrace Perth WA 6000
Country
Australia
Secondary sponsor category [1] 295457 0
Charities/Societies/Foundations
Name [1] 295457 0
Perth Children’s Hospital Foundation
Address [1] 295457 0
Perth Children’s Hospital Foundation
Level 1, 68 Hay Street, Subiaco WA 6008
Country [1] 295457 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297722 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 297722 0
Ethics committee country [1] 297722 0
Australia
Date submitted for ethics approval [1] 297722 0
07/11/2016
Approval date [1] 297722 0
20/01/2017
Ethics approval number [1] 297722 0
2015181EP
Ethics committee name [2] 297723 0
Curtin Univeristy Ethics Committee
Ethics committee address [2] 297723 0
Ethics committee country [2] 297723 0
Australia
Date submitted for ethics approval [2] 297723 0
20/02/2017
Approval date [2] 297723 0
21/02/2017
Ethics approval number [2] 297723 0
HR228/2015

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

Contacts
Principal investigator
Name 74934 0
Prof Catherine Elliott
Address 74934 0
Paediatric Rehabilitation, Princess Margaret Hospital
Level 5, Hay St Building
Princess Margaret Hospital
Roberts Road, Subiaco, WA 6008
Western Australia
Country 74934 0
Australia
Phone 74934 0
+61 8 9380 2109
Fax 74934 0
Email 74934 0
Catherine.Elliott@health.wa.gov.au
Contact person for public queries
Name 74935 0
Sonya Girdler
Address 74935 0
School of Occupational Therapy and Social Work
Faculty of Health Sciences, Student Services Office
Curtin University
Building 407.210
Kent Street, Bentley WA, 6102
Country 74935 0
Australia
Phone 74935 0
+61 8 9266 3630
Fax 74935 0
Email 74935 0
sonya.girdler@curtin.edu.au
Contact person for scientific queries
Name 74936 0
Sonya Girdler
Address 74936 0
School of Occupational Therapy and Social Work
Faculty of Health Sciences, Student Services Office
Curtin University
Building 407.210
Kent Street Bentley WA 6102
Country 74936 0
Australia
Phone 74936 0
+61 8 9266 3630
Fax 74936 0
Email 74936 0
sonya.girdler@curtin.edu.au

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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4055Plain language summaryNo A total of 71 children ages between 18 and 36 mont... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomised Controlled Trial of a Therapeutic Playgroup for Children with Developmental Delays.2021https://dx.doi.org/10.1007/s10803-020-04580-7
N.B. These documents automatically identified may not have been verified by the study sponsor.