Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000959370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
2/07/2026
Date registered
Help: Date registered
4/08/2026
Date last updated
Help: Date last updated
4/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
4/08/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Community-based early detection and parent delivered early intervention for infants at high risk of Cerebral Palsy: Learning through Everyday Activities with Parents (LEAP-CP).
Scientific title
Community-based early detection and parent delivered early intervention for infants at high risk of Cerebral Palsy: Learning through Everyday Activities with Parents (LEAP-CP). A Hybrid Type II Effectiveness Implementation trial of infant outcomes and program appropriateness.
Additional trial identifiers [1] 317470 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
LEAP-CP
Related trial records
This trial is related to Trial ACTRN12610000653460. The LEAP-CP International lead was the Chief investigator on the related trial, Dr Katherine Benfer. She is also a lead investigator on this trial. The initial trial was conducted in India. This trial will be conducted in Bangladesh. The Bangladesh trial has a new protocol, as adjustments have been made to the initial trial in India. Trial ACTRN 126190000969167 is also related, sharing the same Chief Investigator. That trial is in Australia.

Health condition
Health condition(s) studied:
Cerebral Palsy 342172 0
Condition category
Condition code
Neurological 338298 338298 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 338299 338299 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The LEAP-CP intervention has two Steps. Step 1: Community Based early detection of infants 'at risk of cerebral palsy' is a multidomain, parent delivered early intervention program 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 Health Worker (CHW/peer trainer) will (i) gather feedback and troubleshoot 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 program specific to this study to facilitate their use of the strategies each day during the upcoming fortnight.

Therapeutic Modules:
The therapeutic modules are first modelled with the infant by the CHW, and then the caregiver encouraged to engage with their infant, with CHW 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 CHW 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 CHW 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.
3. Parent Educational Modules: Parent education focuses on building caregiver understanding and capacity around (i) how babies learn (ii) responsive caregiving and self-care (iii) feeding, nutrition and health.

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 CHW visit with the caregiver and infant (1 hour per fortnight, to a total program dose of 15 hours. While the CHW 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 Corrected Age (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 Health Workers (CHW)
A community member will be trained as a Community Health Worker (CHW) to deliver the intervention (peer to peer). One community member will be employed as a CHW for each community cluster (approximately six-eight infants). They will receive a ten day training package at the onset of the program (with the Chief Investigator, an Australian PhD candidate and Physiotherapist and the Clinical Coordinator, a Bengali Physiotherapist). 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

CHWs will also receive training for 3 hours each fortnight with the Community Coordinator (Bangladesh trained 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 CHW on the Health Resource Utilisation form during their fortnightly visit.

Fidelity: Intervention dose will be routinely measured by (1) Caregiver recordings on a calendar (2) videoed activities by the CHW to quantify the use of the previous fortnight’s strategies by the caregiver (3) CHW feedback including successes and challenges to implementation. In addition, Specific Fidelity Checklists will be used at 3-6 months and 18-21 months of the trial commencement. Frequency and duration of access to local therapy services will be recorded fortnightly on the Health Resource Use Form (HRU) and included in the analysis.

Adaptations. The presence and type of adaptations will be intentionally evaluated at several points throughout the trial. For Step 1: Early detection: Between 3-6 months of the trial commencement. Step 2: Early Intervention: Between 3-6 months of the trial commencement and again between 18-21 months of the trial commencement using specific adaptation checklists based on the FRAME (Stirman et al 2019). Adaptations may be co-designed with caregivers, CHW's and Clinical coordinators such as scripts used to introduce the project to Families/caregivers. Adaptations may also be made in response to CHW training outcomes, such as the addition of further visual information to support and consolidate understanding of checklists which are used to identify potential participants.
Intervention code [1] 334269 0
Rehabilitation
Description of the comparator or control
The control group will receive 15 fortnightly visits from a different CHW, 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, the importance of play, hygiene practices, immunisation counselling, and management of the sick child. The anticipated duration of the visit will be one hour, delivered peer to peer in the home during 15 fortnightly visits (over a 7-10 month period, allowing for missed visits due to illness and family/ religious events). The caregiver will be offered written and pictographic information of the education which was presented at each visit.
The CHW's delivering this intervention will receive a five day training package at the onset of the program (with the Chief Investigator, an Australian PhD candidate and Physiotherapist and the Clinical Coordinator, a Bengali Physiotherapist) and a fortnightly mentoring session throughout the whole trial.
This will include topics such as:
- Building rapport and a positive therapeutic relationship with caregivers
- Exploring strategies to share information effectively with caregivers
- Understanding typical development and development in cerebral palsy.
- Ethics and research practices.
Fidelity: CHW feedback including successes and challenges to implementation. In addition, Specific Fidelity Checklists will be used at 3-6 months and 18-21 months of the trial commencement. Frequency and duration of access to local therapy services will be recorded fortnightly on the Health Resource Use Form (HRU) and included in the analysis.
Control group
Active

Outcomes
Primary outcome [1] 346014 0
Infant Motor skill development
Timepoint [1] 346014 0
Baseline, Post intervention (after completion of the 15 fortnightly sessions) and 2 years corrected age (CA)
Primary outcome [2] 346016 0
The appropriateness of novice Community Health Workers (CHW's) to deliver the LEAP-CP program- a composite outcome.
Timepoint [2] 346016 0
Training records will be completed throughout the initial CHW training and continued throughout the entire project which includes the fortnightly coaching sessions with the Clinical coordinator. Fidelity videos will be taken three months after commencement of service delivery to each participant and again as service delivery is completed for every child participant. The face to face interviews will be conducted after initial training, mid point of the child participant recruitment and at the conclusion of the project. Service delivery records to determine infant age at commencement and completion of intervention will be completed at child participant commencement and child participant completion.
Secondary outcome [1] 464221 0
Overall infant development (motor, cognition, communication and language and social-emotional development), as a composite development score
Timepoint [1] 464221 0
Baseline, Post intervention (after completion of the 15 fortnightly sessions) and 2 years corrected age (CA)
Secondary outcome [2] 464223 0
Caregiver perceived change in their child's performance of the goal and their own satisfaction with progress
Timepoint [2] 464223 0
Baseline, Post intervention (after completion of the 15 fortnightly sessions) and 2 years corrected age (CA)
Secondary outcome [3] 464227 0
Anthropometry will be used as a measure of infant nutritional status (height/length) to nearest completed millimetre (converted into z-scores according to WHO guidelines).
Timepoint [3] 464227 0
Baseline, Fortnight 4 and 11 of intervention and 2 years corrected age (CA)
Secondary outcome [4] 464228 0
Neurological status and Severity.
Timepoint [4] 464228 0
Baseline and 2 years corrected age (CA)
Secondary outcome [5] 464229 0
Infant's functional capacity
Timepoint [5] 464229 0
Baseline and 2 years corrected age (CA)
Secondary outcome [6] 464230 0
Early visual behaviour.
Timepoint [6] 464230 0
Baseline. Post intervention (after completion of the 15 fortnightly sessions)
Secondary outcome [7] 464231 0
Pre-verbal Visual assessment
Timepoint [7] 464231 0
Baseline, Post intervention (after completion of the 15 fortnightly sessions) and 2 years corrected age (CA)
Secondary outcome [8] 464232 0
Quality and quantity of stimulation in the home -a composite measure
Timepoint [8] 464232 0
Baseline and 2 years corrected age (CA)
Secondary outcome [9] 464233 0
Parent self efficacy and capacity
Timepoint [9] 464233 0
Baseline, Post intervention (after completion of the 15 fortnightly sessions) and 2 years corrected age (CA)
Secondary outcome [10] 464234 0
Health Resource Use
Timepoint [10] 464234 0
Baseline, Post intervention (after completion of the 15 fortnightly sessions) and 2 years corrected age (CA)
Secondary outcome [11] 464235 0
Cerebral Palsy diagnosis
Timepoint [11] 464235 0
2 years corrected age (CA)
Secondary outcome [12] 465270 0
Anthropometry will be used as a measure of infant nutritional status: weight in kgs to the nearest 100g (converted into z-scores according to WHO guidelines).
Timepoint [12] 465270 0
Baseline, Fortnight 4 and 11 of intervention and 2 years corrected age (CA).
Secondary outcome [13] 465277 0
Anthropometry will be used as a measure of infant nutritional status, mid-upper arm circumference, to nearest millimetre.
Timepoint [13] 465277 0
Baseline, Fortnight 4 and 11 of intervention and 2 years corrected age (CA)
Secondary outcome [14] 465281 0
Anthropometry will be used as a measure of infant nutritional status, head circumference, to the nearest millimetre.
Timepoint [14] 465281 0
Baseline, Fortnight 4 and 11 of intervention and 2 years corrected age (CA)
Secondary outcome [15] 465282 0
Caregiver mental wellbeing
Timepoint [15] 465282 0
Baseline, Post intervention (after completion of the 15 fortnightly sessions) and 2 years corrected age (CA)
Secondary outcome [16] 465283 0
Program sustainability. To determine key factors influencing the sustainability of the early detection and early identification of infants at risk of Cerebral Palsy.
Timepoint [16] 465283 0
The PSAT will be completed at the commencement of recruitment, mid point of the recruitment and at the conclusion of the project.
Secondary outcome [17] 465286 0
Cost and Consequence Analysis of implementation of the interventions.
Timepoint [17] 465286 0
Step1: Early detection: after 6 months of recruitment Step 2: Early intervention: Baseline, Post intervention (after completion of the 15 fortnightly sessions) and 2 years corrected age (CA).
Secondary outcome [18] 465289 0
Implementation Factors influencing the completion rate of the intervention.
Timepoint [18] 465289 0
Mid point of the recruitment and at the conclusion of the project.

Eligibility
Key inclusion criteria
Infants must live in one of the study geographical areas, be aged 12-52 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 therapist administering the eligibility assessment (GMA/HINE) and /or CHW's and scored by certified General Movements (GMs) assessors or Hammersmith Infant Neurological Examination trained assessors. Infants will be determined at risk if:
- Aged 12-18 weeks corrected age (CA) with aberrant general movements (absent/sporadic, abnormal fidgety movements (98% predictive of CP) and/or a Motor Optimality Score (MOS-R) <20 as scored by an advanced certified GM Assessor. AND/OR
- Aged 18-52 weeks CA and scored as less than the Cerebral Paly cut off scores for age or greater than or equal to 5 asymmetries ‘(90% predictive of CP) AND/OR
Neuroimaging: MRI consistent with motor injury or IVH grade III-IV.
Each eligible infant will have a primary caregiver who will provide the outcome data on behalf of the infant and family as required. This caregiver will be the caregiver who is participating in the service delivery of the programs. There is no upper age limitation for the primary caregiver.



Minimum age
12 Weeks
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key 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 preventing safe child active participation in training

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 a 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)
Block randomisation (group n=6), randomly allocated in 1:1 ratio, stratified by neurological severity HINE (<40/40+) based on computer generated sequences.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary hypothesis is that the community-based LEAP-CP intervention will improve children’s scores on the PDMS-2 at 2 years CA compared to the Health Advice Intervention. Based on pilot data from the GAME RCT (ACTRN 12611000572965) there was an effect size of 0.5 on the PDMS-2. The present study recruits infants with limited 'care as usual' access to treatment and as such, the intervention is expected to result in greater between group differences than the GAME trial. A total of 39 children/group will enable an effect size of 0.65 on the PDMS-2 to be detected with 80% power. Assuming 20% attrition during the year, this would equate to 49 children per group (total recruitment n=98).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/08/2026
Actual
Date of last participant enrolment
Anticipated
1/02/2028
Actual
Date of last data collection
Anticipated
1/11/2029
Actual
Sample size
Target
98
Accrual to date
Final
Recruitment outside Australia
Country [1] 28279 0
Bangladesh
State/province [1] 28279 0
Mymensingh Division

Funding & Sponsors
Funding source category [1] 322039 0
Charities/Societies/Foundations
Name [1] 322039 0
Service Fellowship International
Country [1] 322039 0
Australia
Funding source category [2] 322317 0
Charities/Societies/Foundations
Name [2] 322317 0
Symbiosis Bangladesh
Country [2] 322317 0
Bangladesh
Primary sponsor type
University
Name
University of Queensland: Queensland Cerebral Palsy and Rehabilitation Research Centre
Address
Country
Australia
Secondary sponsor category [1] 325234 0
None
Name [1] 325234 0
Address [1] 325234 0
Country [1] 325234 0
Other collaborator category [1] 284012 0
Hospital
Name [1] 284012 0
Community Based Medical College
Address [1] 284012 0
Country [1] 284012 0
Bangladesh
Other collaborator category [2] 284013 0
Other
Name [2] 284013 0
Joyramkura Garo Baptist Convention Christian Health Project
Address [2] 284013 0
Country [2] 284013 0
Bangladesh

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320570 0
Bangladesh Medical Research Council (NREC)
Ethics committee address [1] 320570 0
Ethics committee country [1] 320570 0
Bangladesh
Date submitted for ethics approval [1] 320570 0
23/12/2025
Approval date [1] 320570 0
14/05/2026
Ethics approval number [1] 320570 0
registration #: 67305022026
Ethics committee name [2] 320821 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [2] 320821 0
Ethics committee country [2] 320821 0
Australia
Date submitted for ethics approval [2] 320821 0
27/05/2026
Approval date [2] 320821 0
11/06/2026
Ethics approval number [2] 320821 0
2026/HE011217
Ethics committee name [3] 320822 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [3] 320822 0
Ethics committee country [3] 320822 0
Australia
Date submitted for ethics approval [3] 320822 0
15/12/2025
Approval date [3] 320822 0
16/12/2025
Ethics approval number [3] 320822 0
HREC/20/QCHQ/639006

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

Contacts
Principal investigator
Name 150918 0
Dr Katherine Benfer
Address 150918 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 150918 0
Australia
Phone 150918 0
+61 730697372
Fax 150918 0
Email 150918 0
[email protected]
Contact person for public queries
Name 150919 0
Katherine Benfer
Address 150919 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 150919 0
Australia
Phone 150919 0
+61 730697372
Fax 150919 0
Email 150919 0
[email protected]
Contact person for scientific queries
Name 150920 0
Katherine Benfer
Address 150920 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 150920 0
Australia
Phone 150920 0
+61 730697372
Fax 150920 0
Email 150920 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• This data will be made available for researchers with a methodologically sound proposal.

Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 3 years
Where can requests to access individual participant data be made, or data be obtained directly?
• The proposal should be made to the corresponding author(s) for consideration. Katherine Benfer ([email protected]), Roslyn Boyd ([email protected]) or Michelle Allen (m27.allen @qut.edu.au)

Are there extra considerations when requesting access to individual participant data?
No


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
No additional documents have been identified.