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Trial registered on ANZCTR


Registration number
ACTRN12624001417572p
Ethics application status
Submitted, not yet approved
Date submitted
31/10/2024
Date registered
2/12/2024
Date last updated
2/12/2024
Date data sharing statement initially provided
2/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of VIP (Very early Intensive enrichment Program) for infants at high risk of cerebral palsy
Scientific title
Effectiveness of a Very early Intensive Enrichment Program (VIP) on Infant Development and Parent Wellbeing in Cerebral Palsy: Pragmatic Randomized Controlled Trial
Secondary ID [1] 313186 0
Nil known
Universal Trial Number (UTN)
Trial acronym
VIP trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High risk of Cerebral Palsy 335470 0
Cerebral Palsy 335473 0
Condition category
Condition code
Neurological 332032 332032 0 0
Other neurological disorders
Musculoskeletal 332236 332236 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVENTION: In this trial, infant-parent dyads will receive either experimental home-based VIP intervention or usual care (parent education and developmental monitoring and advice) until the infant is 6 months corrected age. Infants at high risk of cerebral palsy (CP) will be enrolled in the study between 0-4-week corrected age. Infants randomised to the VIP intervention arm of the study will begin the intervention within one week of enrolment. After 6 months (primary endpoint) all infants will receive standard of care treatment and then be followed up at 12 months (study completion) to evaluate medium term effects of the VIP program.
The early intervention program has been co-designed with parents of infants with CP who previously experienced early intervention after their baby had been cared for in a Neonatal Intensive Care Unit (NICU). The program combines very early home-based enrichment focused therapy delivered by an allied health team with psychological support to promote responsive parenting and parent wellbeing. Essential elements of the program:
• Parent support: Trained health professionals will provide wellbeing support to parents. This will including checking in regarding parent mental health and supporting parents to understand and respond to their baby’s needs. Additional supports will be offered if mental health or parent-child attachment concerns are identified. Psychology interventions offered may include cognitive behavioural therapy (CBT) or Parent Acceptance and Commitment Therapy (PACT). Information and support around the key issues of sleep, settling and feeding will be provided, graded according to identified needs and challenges of each individual participant.
• Parent coaching in environmental enrichment: Parents will be coached in how to provide stimulating and age-appropriate activities to support development. Coaching is focussed on parent empowerment and is embedded within a parent responsiveness framework. It will be customised to the family’s culture, education and parenting preferences.
• Environmental enrichment: VIP is provided in the natural home environment where training is personalised to the infant’s enjoyment – translating to more intense, specific and relevant practice. VIP intervention enriches the: (a) physical environment by setting up the home with activities and materials to entice infant-generated practice at the appropriate level of challenge; (b) cognitive environment by encouraging infant problem solving and self-correction of errors plus interactive reading with children which has been proven to advance IQ; (c) sensory environment by providing evidence-based interventions that improve backdrop capacity for learning, including: pain management, feeding interventions that ensure adequate nutrition for attention and sleep management that produces a wakeful state for learning; and (d) social environment by coaching parents to be sensitive, responsive and communicative to infant cues.
• Customised motor training: The heterogeneity of CP requires a customised motor program according to likely severity, topography of motor impairment and type of movement disorder. The VIP program will design the motor training program according to the likely CP trajectory (based on early clinical data, specifically MRI and clinical presentation) and responsively adapt as the infants motor skills progress. For example, if an infant presents with an asymmetric brain lesion the infant will be offered modified Constraint Induced Movement Therapy (CIMT) or bimanual training (BIM) depending on their early grasp and reach skills..
• Customised Home program: VIP includes a home program with a focus on parent set goals. The home program will be developed collaboratively in conjunction with families and customised to include the individual needs and preferences of the parent, the infant and family’s home environment. It will include photos and videos of the infant and parent practicing goals and include activities to support parental mental health and wellbeing. The home program will be updated regularly to reflect the current goals in therapy.

DOSE: VIP will involve a minimum of two intervention sessions per week. One session will be focussed on the infant, provided by a physiotherapist or occupational therapist in the participants home. The other session will focus on parent wellbeing, provided virtually by a psychologist. Each session will last approximately 45 to 60 minutes. Session will be tailored to meet the individual needs of each infants and family. All infants will be reviewed by a speech pathologist, with speech pathology intervention being offered if indicated. For example, if an infant has feeding difficulties. Parent peer support will be offered virtually once per month.

Intervention adherence will be monitored via Parent Early Support Access Survey, this will be collected by the research team conducting assessments at T2, T3, and T4 timepoints. We will ask questions about:
• The type of allied health interventions accessed (frequency, location and dose)
• Home program practice (on a daily basis, how often do you practice intervention ideas with your baby)
• Sleep, pain, vision, reading, parent- child interactions
• Peer support services accessed.

WHO: VIP intervention will be provided by a psychologist, occupational therapist, physiotherapist and speech pathologist.
Intervention code [1] 329758 0
Rehabilitation
Comparator / control treatment
USUAL CARE: Usual care includes the follow-up and therapeutic interventions provided to infants identified as high risk for cerebral palsy upon discharge from the hospital. The type, frequency, and location of therapy provided are not standardised and can vary among service providers. Infants may access therapy through hospital follow-up programs or private therapy providers. While the timing and frequency of these interventions depend on service availability, infants are generally seen quickly due to their young age. Typical interventions may include parent education, developmental monitoring and guidance, and early interventions focused on motor skill development.
Control group
Active

Outcomes
Primary outcome [1] 339631 0
Any change in the General Development Index (GDI) on the Developmental Assessment of Young Children (DAYC-2)
Timepoint [1] 339631 0
Baseline; 3-4 months corrected age, 6 months corrected age (primary timepoint) and 12 months corrected age (study completion)
Secondary outcome [1] 440669 0
Infant Gross Motor Skills
Timepoint [1] 440669 0
Baseline, 3-4 months corrected age, 6 months corrected age and 12 months corrected age (study completion)
Secondary outcome [2] 440670 0
Infant Fine Motor Skills
Timepoint [2] 440670 0
Baseline, 3-4 months corrected age, 6 months corrected age and 12 months corrected age (study completion)
Secondary outcome [3] 440671 0
Infant Cognitive Skills
Timepoint [3] 440671 0
Baseline, 3-4 months corrected age, 6 months corrected age and 12 months corrected age (study completion)
Secondary outcome [4] 440672 0
Infant Receptive Language Skills
Timepoint [4] 440672 0
Baseline, 3-4 months corrected age, 6 months corrected age and 12 months corrected age (study completion)
Secondary outcome [5] 440673 0
Infant Expressive Language Skills
Timepoint [5] 440673 0
Baseline, 3-4 months corrected age, 6 months corrected age and 12 months corrected age (study completion)
Secondary outcome [6] 440674 0
Infant Adaptive Behavior Skills
Timepoint [6] 440674 0
Baseline, 3-4 months corrected age, 6 months corrected age and 12 months corrected age (study completion)
Secondary outcome [7] 440675 0
Infant Social Emotional skills
Timepoint [7] 440675 0
Baseline, 3-4 months corrected age, 6 months corrected age and 12 months corrected age (study completion)
Secondary outcome [8] 440676 0
Parent Responsiveness
Timepoint [8] 440676 0
Baseline, 3-4 months corrected age, 6 months corrected age and 12 months corrected age (study completion)
Secondary outcome [9] 440677 0
Parent Self-Efficacy
Timepoint [9] 440677 0
baseline; secondary measures at 3-4 months corrected age, primary measures at 6 months corrected of age and study completion at 12 months corrected age
Secondary outcome [10] 441596 0
Infant Quality of Life
Timepoint [10] 441596 0
6 months corrected age and 12 months corrected age (study completion)
Secondary outcome [11] 441597 0
Parent Depression
Timepoint [11] 441597 0
Baseline, 3-4 months corrected age, 6 months corrected age and 12 months corrected age (study completion
Secondary outcome [12] 441598 0
Parent Anxiety
Timepoint [12] 441598 0
Baseline, 3-4 months corrected age, 6 months corrected age and 12 months corrected age (study completion)
Secondary outcome [13] 441599 0
Parent Stress
Timepoint [13] 441599 0
Baseline, 3-4 months corrected age, 6 months corrected age and 12 months corrected age (study completion)

Eligibility
Key inclusion criteria
We will include infants who are:
- Age 0 to 4 weeks of age, corrected for prematurity
- Recent or pending discharge home from hospital
- ‘High risk’ of CP, based on brain MRI or cranial US where changes indicate probable CP (for example stroke, white matter injury including Periventricular leukomalacia (PVL) and cystic PVL, basal ganglia and thalamic injury )
Minimum age
0 Weeks
Maximum age
4 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude infants with:
-Medically fragile preventing safe child-active participation in training
-Known metabolic or degenerative conditions; uncontrolled epilepsies
-Known blindness
-Known genetic conditions e.g. down syndrome
-Planned major surgery within the intervention period
-Living in remote location inaccessible by study personnel for home visits.

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)
After consent and baseline measures, infants will be centrally randomised by computer to VIP or control intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
We will recruit 128 infants with CP, with their parent/s (128 parent-infant dyads). They will be randomised to experimental VIP (n = 64) or to the usual care (control group) (n = 64).
Statistical analysis will be conducted in IBM SPSS and R version 4.3.1.  
The primary analysis of the effect of VIP intervention on the study outcomes will be conducted using the full analysis set, comprising all randomised infants for whom outcome data is available, with infants grouped according to their randomised allocations (intention-to-treat).
A pre-planned interim analysis of the study, which will take place after n=64 infants (50% of proposed sample) have been recruited to the trial and reached three months of age.
A modified intention-to-treat analysis will be conducted to investigate the effect of VIP intervention among infants in the confirmed CP analysis set, comprising randomised infants with available outcome data and a confirmed diagnosis of CP, analysed according to their randomised treatment allocation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
4/09/2028
Actual
Date of last data collection
Anticipated
3/09/2029
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27222 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 27226 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 27229 0
John Hunter Children's Hospital - New Lambton
Recruitment hospital [4] 27254 0
Royal Hospital for Women - Randwick
Recruitment hospital [5] 27255 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 43338 0
2747 - Kingswood
Recruitment postcode(s) [2] 43339 0
2050 - Camperdown
Recruitment postcode(s) [3] 43340 0
2305 - New Lambton
Recruitment postcode(s) [4] 43341 0
2031 - Randwick
Recruitment postcode(s) [5] 43342 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 317633 0
Other Collaborative groups
Name [1] 317633 0
Hearts and Minds Investments
Country [1] 317633 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 319981 0
None
Name [1] 319981 0
Address [1] 319981 0
Country [1] 319981 0
Other collaborator category [1] 283261 0
Charities/Societies/Foundations
Name [1] 283261 0
Cerebral Palsy Alliance
Address [1] 283261 0
Country [1] 283261 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316332 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 316332 0
Ethics committee country [1] 316332 0
Australia
Date submitted for ethics approval [1] 316332 0
30/10/2024
Approval date [1] 316332 0
Ethics approval number [1] 316332 0

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

Contacts
Principal investigator
Name 137554 0
Dr Catherine Morgan
Address 137554 0
Cerebral Palsy Alliance Research Institute The University of Sydney PO Box 6427, Frenchs Forest NSW 2086
Country 137554 0
Australia
Phone 137554 0
+61 408205542
Fax 137554 0
Email 137554 0
cmorgan@cerebralpalsy.org.au
Contact person for public queries
Name 137555 0
Emma Stanton
Address 137555 0
Cerebral Palsy Alliance Research Institute The University of Sydney PO Box 6427, Frenchs Forest NSW 2086
Country 137555 0
Australia
Phone 137555 0
+61 407155657
Fax 137555 0
Email 137555 0
estanton@cerebralpalsy.org.au
Contact person for scientific queries
Name 137556 0
Emma Stanton
Address 137556 0
Cerebral Palsy Alliance Research Institute The University of Sydney PO Box 6427, Frenchs Forest NSW 2086
Country 137556 0
Australia
Phone 137556 0
+61 407155657
Fax 137556 0
Email 137556 0
estanton@cerebralpalsy.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.