Benfer 2018.
| Study name | Community‐based parent‐delivered early detection and intervention programme for infants at high risk of cerebral palsy in a low‐resource country (Learning through Everyday Activities with Parents (LEAP‐CP)) |
| Methods |
Study design: RCT Country: India |
| Participants | Infants at high risk of cerebral palsy and their parents (caregivers) Inclusion criteria: a. Infants must live in one of the study geographical areas and be 12–40 weeks CA. b. Infants must also have one or more risk factors: maternal infection (antenatal); low birth weight (< 2.5 kg); preterm delivery (< 37 weeks); hypoxic ischaemic encephalopathy; perinatal asphyxia; neonatal jaundice requiring treatment; prolonged hypoglycaemia; seizures after birth; admission to neonatal intensive care unit or special newborn care unit; post‐neonatal complications in infant (infection, head injury, near drowning), altered tone or delayed motor milestones for the infant. To be eligible for the intervention substudy, infants must be assessed in the detection substudy to be at ‘high risk’ of CP based on the GMs or HINE, as follows: at 12–17 weeks CA infants with absent/abnormal fidgety movements on GMs assessment are considered high risk; at 18–40 weeks, CA infants scoring below the established HINE cut‐points will be considered high risk of CP (< 56 points at 3 months (SE 96%; sp 85%), < 59 points at 6 months (SE 90%; sp 89%), < 62 points at 9 months (SE 90%; sp 91%) Exclusion criteria: a. Infants with known or suspected congenital or chromosomal abnormalities which are likely to affect their neurodevelopmental outcome; those diagnosed with neurodegenerative conditions and those that are considered medically fragile Infants who have been screened as ‘low risk’ on the GMs and HINE will not be eligible to participate in the intervention substudy. Stated purpose: 1) to determine the effectiveness of a community‐based parent‐delivered intervention on infant’s developmental outcomes for those at high risk of CP; 2) to determine the effectiveness of a community‐based parent‐delivered intervention on caregiver’s mental health outcomes; 3) to determine the predictive validity of GMs assessment administered at 12–17 weeks for detecting CP at 18 months in high‐risk infants in West Bengal; 4) To determine the predictive validity of the HINE when administered from 18 to 40 weeks for detecting CP at 18 months in high‐risk infants in West Bengal. |
| Interventions |
Intervention: LEAP‐CP: Learning through Everyday Activities with Parents for infants at high risk of Cerebral Palsy The LEAP‐CP intervention is a multi‐domain family‐centred best practice intervention consisting of infant goal‐directed therapeutic strategies and learning games and caregiver educational modules. The components shown necessary for effective interventions for infants with CP include (1) goal‐directed tasks; (2) home‐based delivery and include (3) active motor learning and (4) strategies to enrich the home environment. LEAP‐CP is based on principles of parent coaching which promote caregiver problem‐solving and self‐determination. Specifically, LEAP‐CP includes: a) activity‐based motor and cognitive skills training, based on goals identified by parents; b) enrichment, which facilitates enhanced cognitive, motor and multisensory learning; c) the parent educational modules, evidence‐based discussion topics which cover three broad areas: ‘learn’, ‘grow’ and ‘love’. The LEAP intervention will commence at 3–9 months CA at a dose of 20 min per day for 5 days per week (1.6 hours) up to 6 months CA (total dose 19.2 hours); then graduate to 30 min per day for 5 days per week (2.5 hours per week) from 6 to 9 months CA (total 30 hours); then 40 min per day for 5 days per week (3.3 hours per week) from 9 to 12 months CA (total 40 hours). In addition, there will be approximately 15 hours of direct intervention administered during home visits by either the parent or CDW. The overall dose will be 104.2 hours for the entire intervention up to 18 months corrected age (CA). Control: Usual care: Heath Advice (the Health Advice is based on the WHO’s Integrated Management of Childhood Illness Key Family Practices. This includes counselling on breastfeeding and introduction of complementary nutrition, hygiene practices, vaccination counselling and management of the sick child. It also includes clinical signs indicating the need for referral to existing health services. The same service delivery model and visiting schedule will be used as for the intervention arm (a fortnightly home visit for 15 visits), with a different CDW visiting standard care group families to avoid contamination. There will not be a direct intervention dose delivered to infants in this study arm) Notes: concurrent therapies (care‐as‐usual): Infants from both study arms are able to continue to access medical and therapy support as per their family’s preference. |
| Outcomes |
Participants' outcomes of interest for this review
Economic outcomes Nil Time points: baseline, post‐intervention (immediate post‐intervention and at 18 months CA) |
| Starting date | March 2017 (Field work will be conducted from March 2017 to March 2019) |
| Contact information | Katherine A Benfer, katherine.benfer@uqconnect. edu.au |
| Notes |
Source of funding: Cerebral Palsy Alliance Project Grant (PG6916); Queen Elizabeth II Diamond Jubilee Postdoctoral Scholarship, Endeavour (KB), Australian Commonwealth Government; NHMRC Fellowship (RB); NHMRC Centre for Research Excellence (Australasian Cerebral Palsy Clinical Trials Network) Prospective trial registration number: ANZCTR 12616000653460p |