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Trial registered on ANZCTR


Registration number
ACTRN12619000969167p
Ethics application status
Submitted, not yet approved
Date submitted
4/06/2019
Date registered
9/07/2019
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
LEAP-CP: Learning through Everyday Activities with Parents for Indigenous Australian infants at high risk of cerebral palsy and neurodevelopmental disabilities
Scientific title
Peer delivered early intervention for infants at high risk of cerebral palsy and neurodevelopmental disabilities in Indigenous Australia
Secondary ID [1] 297339 0
Nil
Universal Trial Number (UTN)
Trial acronym
LEAP-CP-Indig
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 311454 0
Neurodevelopment disorder 313195 0
Condition category
Condition code
Neurological 310096 310096 0 0
Other neurological disorders
Musculoskeletal 311655 311655 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The LEAP-CP intervention is a multidisciplinary family-centred intervention delivered peer to peer in the home during 30 weekly 2-hour visits (over a 7-10 month period, allowing for missed visits due to illness and family/ ceremonies). During the visit, the Indigenous Allied Health Worker (peer trainer) will (1) gather feedback and troubleshoots the previous visit's activities, (2) deliver the therapeutic modules includes motivating infant-generated activities practiced to optimise learning; using principles of structure, repetition, and variation. Functional motor skills, such as reach/grasp and attaining anti-gravity postures. (3) deliver the educational module. The caregiver will be provided with written and pictographic information of the program specific to this study, to facilitate their use of the strategies each day during the upcoming week.
The education is discussion on topics based with question prompts for the community worker following 'the 5As' - ask (find out what the parent is currently doing through questions and observation), affirm (affirm their parenting strengths and wisdom), add (build on what they are doing), answers to problem (support the parent to problem silver barriers to implementing change) and action (support the parent to identify action for the coming week).

The Indigenous Allied Health Worker will receive a 3-day training package at the onset of the programme. This will include topics such as:
* Building rapport and positive therapeutic relationship with caregivers
* Exploring customs, beliefs and family culture
* Using everyday opportunities and routines to encourage infant development
* Observation skills and coaching
* Motor training and therapeutic principles
* Understanding typical development and development in children with cerebral palsy
* Ethics and research practices

Monitoring of the sessions will be conducted by the regional team leader, and they will collaborate with a centralised allied health coordinator on the program content on a monthly schedule utilising online telehealth facilities.
Intervention code [1] 313589 0
Rehabilitation
Intervention code [2] 314697 0
Treatment: Other
Comparator / control treatment
Care as usual consists of the routine primary and allied health programs provided in the community, in addition to specific post-natal health advice programs (eg first 1000 days programs). Care as usual will be documented on the health resource use form. If there are no routine post-natal programs delivered in the community, a basic health advice program will be delivered once per month (7 visits) by a community health worker, based on the World Health Organisation’s Integrated Management of Childhood Illness Key Family Practices. This includes counselling on breastfeeding and introduction of complementary nutrition, hygiene practices, vaccination counselling, and management of the sick child.
Control group
Active

Outcomes
Primary outcome [1] 318988 0
Peabody Developmental Motor Scales, 2nd Edition (PDMS-2)

The child’s motor outcomes will be assessed using the Peabody Developmental Motor Scales – 2nd edition (PDMS-2), a commonly used measure of motor skills in infants and children aged birth to 6 years. It has demonstrated validity and responsiveness in infants with CP.
Timepoint [1] 318988 0
Baseline, post intervention (7-10 months post intervention commencement), 3 years post intervention commencement(final outcome)
Primary outcome [2] 318989 0
Canadian Occupational Performance Measure (COPM)

COPM will be used to measure parent-perceived change in their child’s performance of the goal and their own satisfaction with progress.
Timepoint [2] 318989 0
Baseline, post intervention (7-10 months post intervention commencement)
Primary outcome [3] 318990 0
Depression, Anxiety and Stress Scale

The Depression, Anxiety, Stress Scale – Short Form (DASS) is a 21 item self-report questionnaire reflecting the frequency or severity of the caregiver’s experiences with depression, anxiety and stress over the past week. It has high internal consistency (a=0.83, 0.78 and 0.87 for depression, anxiety and stress respectively (Norton, 2007). High convergent validity has been established between the DASS and other measures of similar constructs: DASS depression scale and the Beck Depression Inventory (r= 76), DASS anxiety scale and the Beck Anxiety Scale (r= .74) and DASS stress scale and the Positive and Negative Affect Schedule (r= .74).
Timepoint [3] 318990 0
Baseline, post intervention (7-10 months post intervention commencement), 3 years post intervention commencement (final outcome)
Secondary outcome [1] 366655 0
Bayley Scales of Infant Development III (BSID-III)

The child’s cognitive and communication outcomes will be assessed using the BSID-III, the gold standard norm-referenced assessment of infant development (0-3 y).
Timepoint [1] 366655 0
Baseline, post intervention (7-10 months post intervention commencement)
Secondary outcome [2] 366656 0
Pediatric Evaluation of Disability Inventory -- Computer Adaptive Test (PEDI-CAT)

The child’s functional outcomes in self-care, mobility and social function will be assessed using parent-report on the PEDI-CAT. The PEDI-CAT has been Rasch-analysed in children with disabilities and typical development. Raw scores will be converted to standardised scores (0-100).
Timepoint [2] 366656 0
Baseline, post intervention (7-10 months post intervention commencement)
Secondary outcome [3] 366657 0
Nutritional status (length/ height, weight, mid upper arm circumference)

Nutritional status will be determined using length/ height and weight which will be converted to z scores using the World Health Organization age and gender referenced data.
Weight will be measured using scales, length, and arm circumferences will be measured using tape measure.
Timepoint [3] 366657 0
Baseline, post intervention (7-10 months post intervention commencement)
Secondary outcome [4] 366658 0
Near Vision Detection Scale

Near Detection Scale (NDS) is a 10-point vision assessment of visual fixation on graded standardised lures viewed at near distance (30cm), ranging from no light perception (0) to 1.2cm ‘lure’ (yellow candy presented on a dark green/ black cloth).
Timepoint [4] 366658 0
Baseline, post intervention (7-10 months post intervention commencement)
Secondary outcome [5] 366659 0
Emotional Availability Scale (EAS)

The Emotional Availability Scale (EAS)26 27 is a 20-minute observation of the parent-infant relationship. The parent-infant observation will be a naturalistic observation of a parent-infant interaction in the family’s own home. The IAHW will assist parents to record the interaction, using a recording device of their own or supported by the community worker. The EAS measures the quality of the relationship itself across six scales: parental sensitivity, parental structuring, parental non-intrusiveness, parental non-hostility, child responsiveness and child involvement. The scale has high inter-rater reliability for parental responsiveness (.96), involving (.87), sensitivity (.93) and structuring.
Timepoint [5] 366659 0
Baseline, post intervention (7-10 months post intervention commencement)
Secondary outcome [6] 366660 0
Infant Toddler Social Emotional Assessment (ITSEA)

The ITSEA is a 92-item parent-report checklist of the child’s adaptive behaviours (e.g. attention, ability to sleep). The ITSEA has been shown to be responsive to improvements from home-based parent-infant intervention. It has strong test-retest reliability (a=.75-.91) and concurrent/discriminant validity.
Timepoint [6] 366660 0
Baseline, post intervention (7-10 months post intervention commencement)
Secondary outcome [7] 366661 0
Infant Toddler Quality of Life Questionnaire (IT-QOL)

The ITQOL was developed for use in infants and toddlers 2 months - 5 years. The ITQOL short form measures quality of life across physical, mental and social well-being. The test has 47 items in the short-form and is completed by parent-report. For each of the 47 concepts, item responses are scored, summed, and transformed to a scale from 0 (worst health) to 100 (best health).
Timepoint [7] 366661 0
Baseline, post intervention (7-10 months post intervention commencement)
Secondary outcome [8] 367775 0
Home Observation for Measurement of the Environment (HOME) Inventory: Infant and Toddler Version

Home Observation for Measurement of the Environment (HOME) Inventory: Infant and Toddler Version is a measure of the quality and quantity of parent and home stimulation, covering six domains of parent responsiveness, acceptance, and involvement; and the home physical environment including availability of learning materials, and variety of stimulation.
Timepoint [8] 367775 0
Baseline, post intervention (7-10 months post intervention commencement)

Eligibility
Key inclusion criteria
Infants aged 3 months to 2 years, residing in a study geographical area, with one or both parents identifying as Aboriginal or Torres Strait Islander will be recruited to this study.

Infants must be assessed as ‘high risk of CP/ NDD’ or have a confirmed diagnosis of CP (confirmed by paediatrician). Infants are determined to be high risk of CP/ NDD if assessed as:
(i) ‘Abnormal’ neuroimaging results associated with a motor disability including an abnormality in one or more of the following structures: sensorimotor cortex, basal ganglia, posterior limb of the internal capsule.
(ii) ‘Absent fidgety’ on General Movements for infants aged 12-17 weeks;
(iii) ‘Abnormal’ (score<56 at 3m, <59 at 6m, <73 at 9-24m) on the Hammersmith Infant Neurological Examination (90% predictive of CP) if aged >18 weeks.
(iv) The Rapid Neurodevelopmental Assessment will also be conducted to use in concurrent and predictive validity data for other disabilities.
Minimum age
3 Months
Maximum age
24 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with complex medical conditions requiring acute medical care will be excluded

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)
Group allocation will be assigned following baseline assessment by an independent researcher, as generated from a central database (RedCAP) using a concealed random number sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation based on computer generated sequences.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
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
Between group differences for the primary outcome measure (PDMS-2 raw score; continuous data) will be compared using linear regression analyses. The between-group differences at baseline for key characteristics (age, gender, epilepsy, GMFCS, motor type, preterm status) will be calculated, and if any characteristics differs at p<0.01 it will be included as a covariable in all regression models. The sample will be stratified by age (<12 months/ >12 months) and neurological severity (HINE<40). Secondary analyses will consider gains on function (PEDI-CAT) or cognitive outcomes (BSID-III), and caregiver outcomes, and analysed similiarly. Analyses will be conducted on an intention to treat basis. No imputation of missing data will occur. Statistical significance will be set at p<0.05. A/Prof Mark Chatfield (Biostatistics) will provide expert advice on the analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13810 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 13811 0
Cairns Base Hospital - Cairns
Recruitment hospital [3] 13812 0
The Townsville Hospital - Douglas
Recruitment hospital [4] 13813 0
Rockhampton Base Hospital - Rockhampton
Recruitment hospital [5] 13814 0
Mount Isa Base Hospital - Mount Isa
Recruitment postcode(s) [1] 26563 0
4101 - South Brisbane
Recruitment postcode(s) [2] 26564 0
4870 - Cairns
Recruitment postcode(s) [3] 26565 0
4814 - Douglas
Recruitment postcode(s) [4] 26566 0
4700 - Rockhampton
Recruitment postcode(s) [5] 26567 0
4825 - Mount Isa

Funding & Sponsors
Funding source category [1] 301902 0
Charities/Societies/Foundations
Name [1] 301902 0
Children's Hospital Foundation
Address [1] 301902 0
PO Box 9009
Wooloongabba QLD 4102
Country [1] 301902 0
Australia
Funding source category [2] 301910 0
Charities/Societies/Foundations
Name [2] 301910 0
Cerebral Palsy Alliance
Address [2] 301910 0
187 Allambie Road,
Allambie Heights NSW 2100
Country [2] 301910 0
Australia
Funding source category [3] 301911 0
Government body
Name [3] 301911 0
National Health and Medical Research Council
Address [3] 301911 0
16 Marcus Clarke Street,
Canberra City, ACT 2600
Country [3] 301911 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 301664 0
None
Name [1] 301664 0
None
Address [1] 301664 0
NA
Country [1] 301664 0
Other collaborator category [1] 280532 0
Other
Name [1] 280532 0
Apunipima Cape York Health Council
Address [1] 280532 0
186 Mccoombe St,
Bungalow QLD 4870
Country [1] 280532 0
Australia
Other collaborator category [2] 280533 0
Hospital
Name [2] 280533 0
Cairns and Hinterland Hospital and Health Services
Address [2] 280533 0
165 The Esplanade,
Cairns Qld 4870
Country [2] 280533 0
Australia
Other collaborator category [3] 280534 0
Hospital
Name [3] 280534 0
Townsville Hospital and Health Service
Address [3] 280534 0
100 Angus Smith Dr,
Douglas QLD 4814
Country [3] 280534 0
Australia
Other collaborator category [4] 280535 0
Hospital
Name [4] 280535 0
Rockhampton Base Hospital
Address [4] 280535 0
Canning St,
Rockhampton City QLD 4700
Country [4] 280535 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302592 0
Far North Queensland Human Research Ethics Committee
Ethics committee address [1] 302592 0
Level 7, William McCormack Place 2,
5B Sheridan Street
Cairns QLD 4870
Ethics committee country [1] 302592 0
Australia
Date submitted for ethics approval [1] 302592 0
26/06/2019
Approval date [1] 302592 0
Ethics approval number [1] 302592 0

Summary
Brief summary
Cerebral palsy (CP) is the most common childhood physical disability, and among the most costly health conditions in Australia. Consistent with the prevailing trend for poorer health outcomes for Indigenous Australians, significantly more children from Indigenous communities have CP, usually with poorer functional skills. The current state of evidence allows reliable prediction of infants at risk of CP from 13 weeks, however children in remote Indigenous communities typically don’t seek diagnosis until far later, and also face significant barriers to accessing support and intervention. This means we are missing a significant window of opportunity for treatment when infants’ neuroplasticity is optimal.

This study aims to determine the effectiveness of an early intervention program for Indigenous infants at high risk of CP. This is a randomised single blind controlled trial of 86 high risk infants (inclusion criteria: absent fidgety General Movements at 12-18 weeks, or abnormal score on the Hammersmith Infant Neurological Evaluation at 18 weeks-2 years). Infants are randomised into a community-based parent-delivered 'best practice' intervention (30 weeks of enriched environment (based on the Learning Games curriculum, demonstrated effective in over 16 RCTs); goal-directed training; and parent education, including nutrition, parenting and health) versus standard care (based on the Integrated Management of Childhood Illness). The intervention will be conducted through an Indigenous Allied Health Worker model, based on the highly effective lay health worker model, to ensure long-term sustainability. Primary functional outcomes will be measured post intervention and at 3 years using the Peabody Developmental Motor Scales. It is hypothesised that children receiving the intervention will have improved motor and cognitive outcomes, and caregivers to have improved mental health. This program presents a feasible, transposable and scalable model which, if shown to be effective, has the potential to reduce the burden of disability in remote Indigenous communities of Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90750 0
Dr Katherine Benfer
Address 90750 0
Centre for Child Health Research
62 Graham St
South Brisbane QLD 4101
Country 90750 0
Australia
Phone 90750 0
+61 7 30697372
Fax 90750 0
Email 90750 0
k.benfer@uq.edu.au
Contact person for public queries
Name 90751 0
Dr Katherine Benfer
Address 90751 0
Centre for Child Health Research
62 Graham St
South Brisbane QLD 4101
Country 90751 0
Australia
Phone 90751 0
+61 7 30697372
Fax 90751 0
Email 90751 0
k.benfer@uq.edu.au
Contact person for scientific queries
Name 90752 0
Dr Katherine Benfer
Address 90752 0
Centre for Child Health Research
62 Graham St
South Brisbane QLD 4101
Country 90752 0
Australia
Phone 90752 0
+61 7 30697372
Fax 90752 0
Email 90752 0
k.benfer@uq.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?
De-identified individual data that underlie the results reported in published articles.
When will data be available (start and end dates)?
Data available from 6-36 months following article publication.
Available to whom?
These data will be made available for researchers with a methodologically sound proposal.
Available for what types of analyses?
Individual participant data meta-analysis.
How or where can data be obtained?
The proposal should be emailed to the corresponding author for consideration.
Roslyn Boyd (r.boyd@uq.edu.au), Iona Novak (INovak@cerebralpalsy.org.au), Cathy Morgan (cmorgan@cerebralpalsy.org.au), Koa Whittingham (koawhittingham@uq.edu.au)
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 2149 0
Study protocol
Citation [1] 2149 0
Link [1] 2149 0
Email [1] 2149 0
Other [1] 2149 0
Summary results
No Results