TEDI-Prem: Telehealth for Early Developmental Intervention in babies born very preterm

Brief name: TEDI-Prem Why: Infants in the intervention group will be treated through collaboration between a physiotherapist/occupational therapist and one (or both, if available) parent. The principles and goals of the intervention are related to the deficits commonly seen in infants born preterm, with large doses of practice to support postural control and learning, visual, motor, and object interactions. TEDI-Prem is designed to facilitate parents to promote sensorimotor exploration during play, following training and support over the first year of life beginning in the NICU and extending into the home based upon successful interventions. What, where, when and how much: The intervention will be delivered in 3 phases: Phase 1: 4 face-to-face, one-on-one, sessions in hospital for 30-45min. Topics will centre around understanding and responding to infant behaviour, promoting development through enhanced parent child interaction and demonstrating intervention activities. Toys will be used to facilitate motor, cognitive and language development with parents coached on appropriate interactions. If the infant is transferred to another hospital during the intervention, sessions will be delivered at the new hospital (if a participating study site) via telehealth or face-to-face. If the infant is discharged home or transferred to a non-participating hospital prior to completion of Phase 1, it will be delivered by telehealth. Phase 2: 6 sessions, at home via telehealth, one-on-one, for 45-60min up to 6 months’ corrected age (CA) (0.25, 1, 2, 3, 4, 6 months’ CA). During these sessions, the therapist will coach the parent to deliver intervention activities with their infant for a minimum of 20 minutes per day, 5 times per week. Parents will be coached to establish a routine for developmental play, including recognising when their child is ready to interact socially and their child’s responses to interactions. Sessions will focus on advancing the parent-provided interventions with a focus on gross motor skills. Phase 3: 3 sessions, at home via telehealth, one-on-one, for 45-60min, up to 12 months’ CA (8, 10, 11.5 months’ CA). Sessions will focus on integration into local services depending on the needs of the infant and family. Parents will be coached to establish a routine for developmental play, including different types of play (e.g. fine motor, language and cognitive). All phases include psychosocial education and content to promote parental well-being and support parental mental health, and have been developed by a multidisciplinary team including psychologists. Further, parent/s will have access to a website (purpose built) which will contain study specific content on intervention activities and supplemental content to facilitate the sessions. The website will include short videos, information handouts and their home program. The website can be accessed at anytime throughout the program, with parents encouraged to view content during each TEDI-Prem session. The time needed to complete online content will be dependant on the family, with a minimum of 10 minutes for each session across all phases. Telehealth will include video-consults so that the therapist can see the infant and coach the parent/s on appropriate early intervention based upon the infant and family’s goals and needs. Who provided: Physiotherapist/Occupational therapist who has completed training specific to delivering TEDI-Prem (which includes online modules and face-face training). These therapists will have >2 years experience in paediatrics. Tailoring: the intervention has core principles which are individualised to the infant and family needs. How well: To measure parent compliance with TEDI-Prem, at the beginning of each session the parent will be asked what has been successful since the last visit and whether there have been any challenges with delivering the intervention. Parents of infants in both groups will complete questionnaires on play positions to monitor whether they are implementing play throughout the day in a variety of positions as part of their intervention program for TEDI-Prem or as part of usual care. Access to other interventions, including discipline and dosage, will be assessed at baseline, 3, 6, 12, 18 and 24 months for both groups. Website analytics, including number of times and duration parents spend on the TEDI-Prem website will be collected for participants in the intervention group. Fidelity of the therapists delivering TEDI-Prem will be assessed in a variety of ways. All therapists in this study will complete an on-line training module. Fidelity will be facilitated through regular staff meetings and audit of home programs and progression. Adherence of therapists to the intervention outlined in the study protocol will be assessed using three video-recorded sessions , one for Phase 1, one for Phase 2 and one for Phase 3 for each infant. Adherence will be measured by the frequency with which the intervention therapist demonstrates, talks about, or brainstorms with a parent about the TEDI-Prem key principles and strategies.