Community-based early detection and parent delivered early intervention for infants at high risk of Cerebral Palsy: Learning through Everyday Activities with Parents (LEAP-CP).

The LEAP-CP intervention has two Steps. Step 1: Community Based early detection of infants 'at risk of cerebral palsy' is a multidomain, parent delivered early intervention program 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 Health Worker (CHW/peer trainer) will (i) gather feedback and troubleshoot 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 program specific to this study to facilitate their use of the strategies each day during the upcoming fortnight. Therapeutic Modules: The therapeutic modules are first modelled with the infant by the CHW, and then the caregiver encouraged to engage with their infant, with CHW 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 CHW 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 CHW 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. 3. Parent Educational Modules: Parent education focuses on building caregiver understanding and capacity around (i) how babies learn (ii) responsive caregiving and self-care (iii) feeding, nutrition and health. 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 CHW visit with the caregiver and infant (1 hour per fortnight, to a total program dose of 15 hours. While the CHW 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 Corrected Age (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 Health Workers (CHW) A community member will be trained as a Community Health Worker (CHW) to deliver the intervention (peer to peer). One community member will be employed as a CHW for each community cluster (approximately six-eight infants). They will receive a ten day training package at the onset of the program (with the Chief Investigator, an Australian PhD candidate and Physiotherapist and the Clinical Coordinator, a Bengali Physiotherapist). 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 CHWs will also receive training for 3 hours each fortnight with the Community Coordinator (Bangladesh trained 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 CHW on the Health Resource Utilisation form during their fortnightly visit. Fidelity: Intervention dose will be routinely measured by (1) Caregiver recordings on a calendar (2) videoed activities by the CHW to quantify the use of the previous fortnight’s strategies by the caregiver (3) CHW feedback including successes and challenges to implementation. In addition, Specific Fidelity Checklists will be used at 3-6 months and 18-21 months of the trial commencement. Frequency and duration of access to local therapy services will be recorded fortnightly on the Health Resource Use Form (HRU) and included in the analysis. Adaptations. The presence and type of adaptations will be intentionally evaluated at several points throughout the trial. For Step 1: Early detection: Between 3-6 months of the trial commencement. Step 2: Early Intervention: Between 3-6 months of the trial commencement and again between 18-21 months of the trial commencement using specific adaptation checklists based on the FRAME (Stirman et al 2019). Adaptations may be co-designed with caregivers, CHW's and Clinical coordinators such as scripts used to introduce the project to Families/caregivers. Adaptations may also be made in response to CHW training outcomes, such as the addition of further visual information to support and consolidate understanding of checklists which are used to identify potential participants.