LEAP-CP: Learning through Everyday Activities with Parents for infants at high risk of Cerebral Palsy in a low-income country

The LEAP-CP intervention is a multidisciplinary family-centred intervention 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 Disability Worker (peer trainer) will (i) gather feedback and troubleshoots 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 three modules each fortnight to facilitate their use of the strategies each day during the upcoming fortnight. Therapeutic Modules: The therapeutic modules are first modeled with the infant by the CDW, and then the caregiver encouraged to engage with their infant, with CDW 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 CDW 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 CDW 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. Parent Educational Modules (one per fortnight): Module 1. Building rapport and program overview (Novak 2006) - Introduction of CDW, caregiver and infant - Building rapport and general observation of preferred play activity - What does the LEAP/ SC program cover (frequency of visits, content) Module 2. Setting goals and problem solving approach (Novak 2006) - Identify infant and family strengths/ abilities - Discuss caregiver’s needs and priorities for their infant and family (development and care) - Goal setting with the COPM - Introduction of a problem solving approach and caregiver coaching Module 3. Living a meaningful life (Whittingham 2013, 2014) - Dealing with grief - Finding hope to live a meaningful life - Parent self-care Module 4. Breastfeeding (WHO 1993) - Importance of exclusive breastfeeding - What is optimal breastfeeding - Observation of a feed (with support strategies) Module 5. Parent-infant bonding and interaction (Care for Child Development modules; Whittingham 2013, 2014) - Increasing caregiver’s awareness of infant movements and behaviours (reading their cues) - Building a warm connection between caregiver and infant - Responding consistently and positively to the infant (praise and advise the caregiver on care practices) Module 6. Encouraging your baby’s active and independent play (Law 2011) - Importance of infant being active in task engagement. - How to encourage active play: activity selection (just right challenge) and providing appropriate physical support and cues Module 7. Introduction of complementary feeding (WHO 2004) - Importance of complementary feeding - Family beliefs and community practices - Preparing safe and nutritious early foods - Foods for energy and specific nutrients - Observation of a snack (with support strategies) Module 8. Infant health (WHO, 2014) - Reflux: signs, basic management and when to seek help - Epilepsy: signs and when to seek help - Diarrhoeal disease: basic management and when to seek help - Other common health concerns and health seeking behaviour Module 9. Growth monitoring (WHO 2009) - Growth measures - 24 hour recall of dietary intake - Counselling regarding recommended daily intake (food groups). Module 10. Adding repetition and variability to your baby’s play (Fetters 2010) - Building on parent observation skills - Moving and sitting - How to set up the infant’s environment to encourage repetition and variable practice - How much variability is beneficial to learning, and how much is too much? Module 11. Creating enriched environments to encourage independent play (Morgan 2013) - How to create an enriched environment at home, using home-based objects and toys - Choosing the right toy for the right skill - Using hands for reaching - Making home-made toys Module 12. Responding to your baby’s cues and communication (Pepper & Weitzman 2004) - Child lead interaction - Observe, Wait, Listen - Adding language to interaction - Creating communication opportunities Module 13. Finding joy in your baby (Whittingham 2013, 2014) - Creating space for positive emotions with your baby: mindfulness - Become an accepting space for your baby Module 14. Sharing books with your baby (Pepper & Weitzman 2004) - Why reading is important, even with babies - How to read (with and without literacy) - Making your own books Module 15. Connecting with your community (Nakamanya 2015, Whittingham 2015) - CDW discusses feasibility of facilitating a local parent support network with other mothers in the program. - Maximising social support from family and friends - Exploring connection to universal services in the community, such as playgroups. - Access to health and therapy services. 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 CDW visit with the caregiver and infant (1 hour per fortnight, to a total program dose of 15 hours. While the CDW 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 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 Disability Workers (CDW) A caregiver enrolled in the intervention will be trained as a Community Disability Worker (CDW) to deliver the intervention (peer to peer). One caregiver will be employed as a CDW for each community cluster (approximately six infants). They will receive a five day training package at the onset of the program (with the Chief Investigator, an Australian Post-doctoral fellow and speech pathologist). 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 CDWs will also receive training for 3 hours each fortnight with the Community Coordinator (Bangladesh trained therapist or 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 CDW on the HRU form during their fortnightly visit. Adverse events: Any adverse events associated with the program will be screened at 6 and 12 months using open-ended questions by non-treating personnel. Fidelity: Intervention dose will be measured by (1) token counting; (2) videoed activities; (3) CDW feedback. Two fortnights per caregiver will be randomly selected to estimate the frequency the caregiver applies the intervention strategies. Caregivers are asked to put a token in the jar for every 10 minute interaction with their infant, to estimate the total fortnightly interaction time. Caregivers with literacy will complete a paper version. In addition, 10 minutes of interaction will be videoed by the CDW to quantify the use of the previous fortnight’s strategies by the caregiver. The CDW will also record feedback from the caregiver, including successes and challenges to implementation. Frequency and duration of access to local therapy services will be recorded fortnightly on the Health Resource Use Form, and included in the analysis.