None listed
Conditions
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 infant outcomes will be measured post intervention and at 2 years corrected age using the Peabody Developmental Motor Scales and Bailey Scales of Infant Development; and primary caregiver outcomes on the Depression Anxiety and Stress Scale. 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.
Interventions
The LEAP-CP project involves the implementation of early screening (early detection sub-study) and intervention for Aboriginal and Torres Strait Islander infants at risk of CP and/or adverse Neurodevelopmental outcomes. The early detection sub-study will implement early detection programs for 'at risk' Aboriginal and/ or Torres Strait Islander infants born in Queensland (birth years 2020-2022). Eligible infants are those aged 0-9 months corrected age (CA) who are at risk of later adverse neurodevelopmental outcomes due to a history of any of the following factors; birth or pregnancy complications, preterm birth, low birth weight, maternal risk factors, admission to neonatal intensive care unit or special care nursery or post-neonatal complications (infection, head injury, stroke). Participants will be recruited from study geographical sites prior to 9 months CA and will be screened at two time points, (i) birth to 5 months CA (2x5 minute observational videos which can be taken at home on a mobile phone), and (ii) 4 to 9 months CA (1 hour visit with a health professional for neurological and developmental assessment). Medical information collected is consistent with the intervention study (as described in the outcomes). Infants can enter the study at any time between birth and 9 months CA, and will commence the relevant screening protocol based on their age at study entry. Outcome measures will be completed at 12 months. Eligible infants (based on early screening results) will commence the LEAP-CP intervention. 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.
Sponsors
Study design
Eligibility
Inclusion criteria
Infants aged 0-9 months CA (early detection sub-study) and 3 to 12 months +2 weeks CA (intervention study), residing in a study geographical area, with one or both parents identifying as Aboriginal or Torres Strait Islander, who are at risk of later adverse neurodevelopmental outcomes due to a history of any of the following factors; birth or pregnancy complications, preterm birth, low birth weight, maternal risk factors, admission to neonatal intensive care unit or special care nursery or post-neonatal complications (infection, head injury, stroke) will be recruited to this study. Infants will be screened and 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) ‘Absent’ or ‘abnormal’ fidgety on General Movements Assessment for infants aged 12-17 weeks; OR GMA ‘fidgety’ with segmental asymmetries; AND (ii) ‘Suboptimal score’ (score<57 at 3m, <60 at 6m, <63 at 9m, <67 at 12m) on the Hammersmith Infant Neurological Examination (90% predictive of CP) if aged >18 weeks; OR ‘normal’ HINE score with 5 or more asymmetries (with confirmation from Hand Assessment in Infants with a 3 point difference between limbs).18 If infants enter the study after 18 weeks CA (ie no GMs assessment), eligibility will be achieved by a score indicating risk on the HINE/ 5 or more asymmetries PLUS a clinical history congruent with a diagnosis of CP; OR (iii) ‘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 AND (i) OR (ii). The Rapid Neurodevelopmental Assessment (4-9 months CA), Ages and Stages Questionnaire - Aboriginal adaptation (4-9 months CA) and General movements assessment motor optimality score (3-5 months CA) will also be conducted for participants in the early detection sub-study to use in concurrent and predictive validity data for other disabilities. Infants will be screened for eligibility for study inclusion until target of n=86 is reached
Exclusion criteria
Infants with complex medical conditions requiring acute medical care will be excluded