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Trial registered on ANZCTR


Registration number
ACTRN12616000653460
Ethics application status
Approved
Date submitted
14/04/2016
Date registered
19/05/2016
Date last updated
12/02/2019
Date data sharing statement initially provided
12/02/2019
Date results information initially provided
12/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
LEAP-CP: Learning through Everyday Activities with Parents for infants at high risk of Cerebral Palsy in a low-income country
Scientific title
Community-based parent delivered early detection and intervention program for infants at high risk of cerebral palsy in a low-resource setting: a randomised controlled trial
Secondary ID [1] 288977 0
nil
Universal Trial Number (UTN)
Trial acronym
LEAP-CP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 298370 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298474 298474 0 0
Other physical medicine / rehabilitation
Neurological 298688 298688 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The LEAP-CP intervention is a multidisciplinary family-centred intervention comprising of 2 parts; (1) delivered peer to peer in the home during 15 fortnightly 2-hour visits (over a 7-10 month period, allowing for missed visits due to illness and family/ religious events); (2) delivered by the caregiver to the infant daily (based on the games/ strategies delivered in the fortnightly peer to peer visit.

During the fortnightly visit, the Community Disability Worker (peer trainer) will (i) gather feedback and troubleshoots the previous fortnight’s activities, (ii) deliver the therapeutic modules, (iii) deliver the educational module. The caregiver will be provided with written and pictographic information of the three modules each fortnight to facilitate their use of the strategies each day during the upcoming fortnight.

Therapeutic Modules:
The therapeutic modules are first modeled with the infant by the CDW, and then the caregiver encouraged to engage with their infant, with CDW coaching. The therapeutic modules consist of:
1. Multidimensional activity based curriculum for infants aged 3-18 months, based on the Creative Curriculum Learning Games (Sparling & Lewis 2008) as a framework for structure and approach. Culturally modified activity cards are translated into Bengali, and include pictographic prompts for ‘how to make this game easier’ and ‘how to encourage practice in other situations’. The CDW will present four activity cards to the caregiver each fortnight from which the caregiver selects two to learn and deliver with their infant during the fortnight (total of 30 games for the program duration). The four options will be selected based on the infant’s age and developmental stage, with guidance from the Community Coordinator. The literature highlights the importance of collaborative selection of therapeutic activities. When delivering a game, the CDW ensures that the infant can complete at least part of the task actively, to ensure optimal motor learning.
2. Individualised goal-directed module: Specific goal-based strategies will be introduced using strategy sheets developed for the study by a multidisciplinary team of clinicians specialised in cerebral palsy (physiotherapy, occupational therapy, speech pathology, psychology and physician). Caregivers will be supported to choose a self-generated intervention goal in visit number 2, individualised to their infant. Each goal area includes red flags for referral for complex and high risk presentations. As a goal is achieved, caregivers will be encouraged to choose a new goal. If the infant remains on a goal without progress for greater than 4 visits (2 months), caregivers will be encouraged to choose a new goal.

Parent Educational Modules (one per fortnight):
Module 1. Building rapport and program overview (Novak 2006)
- Introduction of CDW, caregiver and infant
- Building rapport and general observation of preferred play activity
- What does the LEAP/ SC program cover (frequency of visits, content)

Module 2. Setting goals and problem solving approach (Novak 2006)
- Identify infant and family strengths/ abilities
- Discuss caregiver’s needs and priorities for their infant and family (development and care)
- Goal setting with the COPM
- Introduction of a problem solving approach and caregiver coaching

Module 3. Living a meaningful life (Whittingham 2013, 2014)
- Dealing with grief
- Finding hope to live a meaningful life
- Parent self-care

Module 4. Breastfeeding (WHO 1993)
- Importance of exclusive breastfeeding
- What is optimal breastfeeding
- Observation of a feed (with support strategies)

Module 5. Parent-infant bonding and interaction (Care for Child Development modules; Whittingham 2013, 2014)
- Increasing caregiver’s awareness of infant movements and behaviours (reading their cues)
- Building a warm connection between caregiver and infant
- Responding consistently and positively to the infant (praise and advise the caregiver on care practices)

Module 6. Encouraging your baby’s active and independent play (Law 2011)
- Importance of infant being active in task engagement.
- How to encourage active play: activity selection (just right challenge) and providing appropriate physical support and cues

Module 7. Introduction of complementary feeding (WHO 2004)
- Importance of complementary feeding
- Family beliefs and community practices
- Preparing safe and nutritious early foods
- Foods for energy and specific nutrients
- Observation of a snack (with support strategies)

Module 8. Infant health (WHO, 2014)
- Reflux: signs, basic management and when to seek help
- Epilepsy: signs and when to seek help
- Diarrhoeal disease: basic management and when to seek help
- Other common health concerns and health seeking behaviour

Module 9. Growth monitoring (WHO 2009)
- Growth measures
- 24 hour recall of dietary intake
- Counselling regarding recommended daily intake (food groups).

Module 10. Adding repetition and variability to your baby’s play (Fetters 2010)
- Building on parent observation skills
- Moving and sitting
- How to set up the infant’s environment to encourage repetition and variable practice
- How much variability is beneficial to learning, and how much is too much?

Module 11. Creating enriched environments to encourage independent play (Morgan 2013)
- How to create an enriched environment at home, using home-based objects and toys
- Choosing the right toy for the right skill
- Using hands for reaching
- Making home-made toys

Module 12. Responding to your baby’s cues and communication (Pepper & Weitzman 2004)
- Child lead interaction
- Observe, Wait, Listen
- Adding language to interaction
- Creating communication opportunities

Module 13. Finding joy in your baby (Whittingham 2013, 2014)
- Creating space for positive emotions with your baby: mindfulness
- Become an accepting space for your baby

Module 14. Sharing books with your baby (Pepper & Weitzman 2004)
- Why reading is important, even with babies
- How to read (with and without literacy)
- Making your own books
Module 15. Connecting with your community (Nakamanya 2015, Whittingham 2015)
- CDW discusses feasibility of facilitating a local parent support network with other mothers in the program.
- Maximising social support from family and friends
- Exploring connection to universal services in the community, such as playgroups.
- Access to health and therapy services.

Dose: The overall dose delivered directly to the infant will be 104.2 hours for the 15 fortnight intervention. The overall dose delivered to the caregiver will be 30 hours (2 hours per fortnight). The infant intervention dose is a combination of:
(1) the intervention delivered to the infant during the CDW visit with the caregiver and infant (1 hour per fortnight, to a total program dose of 15 hours. While the CDW visit is for 2 hours in duration, 1 hour will be parent education which is not included in the direct infant intervention dose);
(2) the intervention delivered daily by the caregiver (which is graded with infant age as follows). The caregiver delivered intervention will commence at 3-6 months C.A. at a dose of 20 minutes per day for 5 days per week (1.6 hours) up to 6 months C.A. (total dose 19.2 hours); then graduate to 30 minutes per day for 5 days per week (2.5 hours per week) from 6-9 months C.A. (total 30 hours); then 40 minutes per day for 5 days per week (3.3 hours per week) from 9-12 months C.A. (total 40 hours).

Service Delivery with Community Disability Workers (CDW)
A caregiver enrolled in the intervention will be trained as a Community Disability Worker (CDW) to deliver the intervention (peer to peer). One caregiver will be employed as a CDW for each community cluster (approximately six infants). They will receive a five day training package at the onset of the program (with the Chief Investigator, an Australian Post-doctoral fellow and speech pathologist). This will include topics such as:
- Building rapport and a 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 cerebral palsy.
- Ethics and research practices

CDWs will also receive training for 3 hours each fortnight with the Community Coordinator (Bangladesh trained therapist or allied health professional) to support them in the specific content of the program (therapeutic and educational modules). During this fortnightly session, they will also have opportunity for supervision, debriefing, and troubleshooting.

Concurrent therapies: Any concurrent therapies provided to the infants in either arm of the study will be recorded by the CDW on the HRU form during their fortnightly visit.

Adverse events: Any adverse events associated with the program will be screened at 6 and 12 months using open-ended questions by non-treating personnel.

Fidelity: Intervention dose will be measured by (1) token counting; (2) videoed activities; (3) CDW feedback. Two fortnights per caregiver will be randomly selected to estimate the frequency the caregiver applies the intervention strategies. Caregivers are asked to put a token in the jar for every 10 minute interaction with their infant, to estimate the total fortnightly interaction time. Caregivers with literacy will complete a paper version. In addition, 10 minutes of interaction will be videoed by the CDW to quantify the use of the previous fortnight’s strategies by the caregiver. The CDW will also record feedback from the caregiver, including successes and challenges to implementation. Frequency and duration of access to local therapy services will be recorded fortnightly on the Health Resource Use Form, and included in the analysis.
Intervention code [1] 294472 0
Rehabilitation
Comparator / control treatment
The control group will receive 15 fortnightly visits from a different CDW, delivering ‘standard care’ based on the World Health Organisation ‘Integrated Management of Childhood Illness: Key Family Practices'. This includes counselling on breastfeeding and introduction of complementary nutrition, hygiene practices, immunisation counselling, and management of the sick child.
Control group
Active

Outcomes
Primary outcome [1] 297976 0
Infant functional abilities: change in normative scores on the mobility domain of the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT). This measure was the primary outcome a priori (ie before any recruitment commenced), however the mobility domain was selected as the primary outcome domain.
Timepoint [1] 297976 0
Baseline, and post-intervention (18 months CA)
Primary outcome [2] 297977 0
Caregiver mental health: change in scores on the Depression, Anxiety, Stress Scale – Short Form (DASS)
Timepoint [2] 297977 0
Baseline, and post-intervention (infant aged 18 months CA)
Secondary outcome [1] 322807 0
Infant cognitive development: Bayley Scales of Infant Development III (BSID-III)
Timepoint [1] 322807 0
Baseline, and post-intervention (18 months CA)
Secondary outcome [2] 322808 0
Infant nutritional status: Weight, to the nearest 100g (converted into Z scores based on WHO guidelines)
Timepoint [2] 322808 0
Baseline, fortnight 8 of intervention, and post-intervention (18 months CA)
Secondary outcome [3] 322809 0
Health resource use, recorded on Health Resource Use Form (Boyd 2013)
Timepoint [3] 322809 0
Baseline, and post-intervention (18 months CA)
Secondary outcome [4] 323371 0
Infant motor skills: Peabody Developmental Motor Scales - Second edition (PDMS-2)
Timepoint [4] 323371 0
Baseline, and post-intervention (18 months CA)
Secondary outcome [5] 323372 0
Infant nutritional status: Height/ length to nearest completed millimetre (converted into Z scores according to WHO guidelines)
Timepoint [5] 323372 0
Baseline, fortnight 8 of intervention, and post-intervention (18 months CA)
Secondary outcome [6] 323373 0
Infant nutritional status: Body Mass Index Z score (WHO guidelines)
Timepoint [6] 323373 0
Baseline, fortnight 8 of intervention, and post-intervention (18 months CA)
Secondary outcome [7] 323374 0
Infant nutritional status: Head circumference, to nearest completed millimetre
Timepoint [7] 323374 0
Baseline, fortnight 8 of intervention, and post-intervention (18 months CA)
Secondary outcome [8] 323375 0
Infant nutritional status: Mean upper arm circumference, to nearest completed millimetre
Timepoint [8] 323375 0
Baseline, fortnight 8 of intervention, and post-intervention (18 months CA)
Secondary outcome [9] 323376 0
Infant neurological status: Hammersmith Infant Neurological Examination (HINE)
Timepoint [9] 323376 0
Baseline (if not completed as part of eligibility assessment), and post-intervention (18 months CA)
Secondary outcome [10] 323377 0
Quality and extent of stimulation in the home: HOME Inventory
Timepoint [10] 323377 0
Baseline, and post-intervention (18 months CA)
Secondary outcome [11] 344245 0
Near Vision Detection Scale
Timepoint [11] 344245 0
Baseline, post intervention (18 months CA)
Secondary outcome [12] 344246 0
Canadian Occupational Performance Measure (COPM)
Timepoint [12] 344246 0
Baseline (T0), Post intervention (T1), Final outcome at 18 months (T2)

Eligibility
Key inclusion criteria
Infants must live in one of the study geographical areas, be aged 12-40 weeks C.A. and be diagnosed with cerebral palsy (CP) or assessed to be at high risk of cerebral palsy. Eligibility assessments will be videoed by the community coordinator and scored by certified General Movements (GMs) assessors. Infants will be determined at risk if:
- Aged 12-17 weeks corrected age (CA) with absent fidgety movements on the GMs assessment (98% predictive of CP). GMs is a feasible assessment in this context as it can be videoed by the community coordinator and scored by a general movements certified rater.
- Aged 18-40 weeks CA and score as ‘abnormal’ on the Hammersmith Infant Neurological Examination (90% predictive of CP)
Minimum age
12 Weeks
Maximum age
40 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Revised exclusion criteria:
(i) Infants diagnosed with neurodegenerative conditions
(ii) Infants with known or suspected congenital or chromosomal abnormalities which are likely to affect their neurodevelopmental outcome
(iii) Infants that are considered medically fragile

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)
The clinician completing the eligibility assessment will be unaware of the group allocation. Eligibility assessments will be completed by Associate Investigators, and eligible infant codes sent to the CIA off-site who will hold the allocation schedule (based on a random computer generated 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 receiving the treatment/s
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
Sample size:
The primary hypothesis is that the community-based intervention will improve children’s normative standard scores on the mobility domain of the PEDI-CAT at 18 months by 0.5SD compared to standard care. A sample size of 64 children per group will be required to detect this change (alpha=0.05, beta=0.8). Assuming 10% attrition during the year, this would equate to 71 children per group (total recruitment n=142).
Analysis:
Descriptive statistics (frequencies, means and 95% confidence intervals) will be used to describe each of the samples (at baseline and post-intervention). Intention to treat analysis will be used to compare outcomes post-intervention, using the mobility domain of the PEDI-CAT as the primary outcome measure. Between-group differences on the mobility domain of the PEDI-CAT normative standard score (continuous data) will be compared using multivariate linear regression, adjusting for differences between sample characteristics (eg. age, gender, epilepsy, GMFCS, motor type, preterm status, socioeconomic status). Secondary analyses will consider gains on motor or cognitive outcomes (PDMS-2, BSID-III), caregiver outcomes and health economics. All analyses will be conducted using STATA 13, with significance set at p<0.05.

Recruitment
Recruitment status
Active, not 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 outside Australia
Country [1] 8763 0
India
State/province [1] 8763 0
West Bengal

Funding & Sponsors
Funding source category [1] 293344 0
Government body
Name [1] 293344 0
Queen Elizabeth II Diamond Jubilee Scholarship, Endeavour, Australian Government (directly administered scholarship)
Address [1] 293344 0
Department of Education and Training
International Group
International Mobility Branch
Endeavour Scholarships and Fellowships
GPO Box 9880
CANBERRA ACT 2601
AUSTRALIA
Country [1] 293344 0
Australia
Funding source category [2] 296018 0
Charities/Societies/Foundations
Name [2] 296018 0
Cerebral Palsy Alliance Research Foundation
Address [2] 296018 0
187 Allambie Rd, Allambie Heights, NSW 2100
PO Box 6427, Frenchs Forest, NSW 2086
Country [2] 296018 0
Australia
Primary sponsor type
University
Name
Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland
Address
Centre for Child Health Research
Level 6, 62 Graham St
South Brisbane Qld 4101
Country
Australia
Secondary sponsor category [1] 292163 0
Hospital
Name [1] 292163 0
Apollo Gleneagles Hosptial, Kolkata
Address [1] 292163 0
58, Canal Circular Rd
Kadapara, Kolkata, West Bengal 700054
India
Country [1] 292163 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294812 0
Children’s Health Services Human Research Ethics Committee
Ethics committee address [1] 294812 0
Children’s Health Queensland
Level 7, Centre for Children’s Health Research
62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 294812 0
Australia
Date submitted for ethics approval [1] 294812 0
06/06/2016
Approval date [1] 294812 0
05/07/2016
Ethics approval number [1] 294812 0
HREC/16/QRCH/214
Ethics committee name [2] 294813 0
The University of Queensland Human Ethics
Ethics committee address [2] 294813 0
Ethics committee country [2] 294813 0
Australia
Date submitted for ethics approval [2] 294813 0
01/07/2016
Approval date [2] 294813 0
15/08/2016
Ethics approval number [2] 294813 0
2016001073
Ethics committee name [3] 294814 0
Bangladesh Medical Research Council
Ethics committee address [3] 294814 0
BMRC Bhaban,
Mohakhali, Dhaka-1212
Ethics committee country [3] 294814 0
Bangladesh
Date submitted for ethics approval [3] 294814 0
06/06/2016
Approval date [3] 294814 0
04/10/2016
Ethics approval number [3] 294814 0
BMRC/NREC/2016-2019/1564
Ethics committee name [4] 294815 0
Apollo Gleneagles Hospital Human Research Ethics
Ethics committee address [4] 294815 0
58, Canal Circular Rd
Kadapara, Kolkata, West Bengal 700054
India
Ethics committee country [4] 294815 0
India
Date submitted for ethics approval [4] 294815 0
23/11/2016
Approval date [4] 294815 0
03/12/2016
Ethics approval number [4] 294815 0
IEC/2016/12/35
Ethics committee name [5] 299875 0
Dr BC Roy Postgraduate Institute of Pediatric Sciences, Institutional Ethics Committee
Ethics committee address [5] 299875 0
111, Narkeldanga Main Rd
Kolkata 700054
Ethics committee country [5] 299875 0
India
Date submitted for ethics approval [5] 299875 0
06/01/2017
Approval date [5] 299875 0
07/01/2017
Ethics approval number [5] 299875 0
BCH/ME/PR/54

Summary
Brief summary
One in seven people globally has a disability, forming the world’s largest and most disadvantaged minority. Cerebral palsy (CP) is the most common cause of childhood disability, with 80% of the estimated global burden in low and middle income countries (LMIC). The current state of evidence allows reliable prediction of infants at risk of CP from 13 weeks, however children in LMIC typically do not receive their diagnosis until 5 years. 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 detection and intervention program for infants at high risk of CP in a low income country. This is a cluster-randomised double blind controlled trial of 142 high risk infants living in South Asia (inclusion criteria: absent fidgety General Movements at 12-17 weeks, or abnormal score on the Hammersmith Infant Neurological Evaluation at 18-26 weeks). Infants are randomised into a community-based parent-delivered 'best practice' intervention (15 fortnights of enriched environment (based on the Learning Games curriculum, demonstrated effective in over 16 RCTs); goal-directed motor 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 a train the trainer model, based on the highly effective lay health worker model, to ensure long-term sustainability. Primary functional outcomes will be measured at 18 months using the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test. 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 LMICs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65106 0
Dr Katherine Benfer
Address 65106 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
The University of Queensland
Centre for Child Health Research
Level 6, 62 Graham St
South Brisbane, QLD 4101
Country 65106 0
Australia
Phone 65106 0
+91 9051997889
Fax 65106 0
Email 65106 0
k.benfer@uq.edu.au
Contact person for public queries
Name 65107 0
Dr Katherine Benfer
Address 65107 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
The University of Queensland
Centre for Child Health Research
Level 6, 62 Graham St
South Brisbane, QLD 4101
Country 65107 0
Australia
Phone 65107 0
+91 9051997889
Fax 65107 0
Email 65107 0
k.benfer@uq.edu.au
Contact person for scientific queries
Name 65108 0
Dr Katherine Benfer
Address 65108 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
The University of Queensland
Centre for Child Health Research
Level 6, 62 Graham St
South Brisbane, QLD 4101
Country 65108 0
Australia
Phone 65108 0
+91 9051997889
Fax 65108 0
Email 65108 0
k.benfer@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary