Effectiveness of VIP (Very early Intensive enrichment Program) for infants at high risk of cerebral palsy

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.