Tele-care intervention performed by parents involving specific task- environment- participation (STEP protocol) for infants at risk for developmental delay: protocol of randomized controlled clinical trial

Author(s)

Lima, Camila Resende Gambaro ^[1] ; dos Santos, Adriana Neves ^[2] ; dos Santos, Mariana Martins ^[1] ; Morgan, Catherine ^[3] ; Rocha, Nelci Adriana Cicuto Ferreira ^[1]

Affiliation

^[1] Univ Fed Sao Carlos, Neuropediat Sect, Dept Physiotherapy, Rd Washington Luis, Km 235, BR-13565905 Sao Carlos, SP - Brazil

^[2] Univ Fed Santa Catarina, Dept Hlth Sci, Rd Governador Jorge Lacerda, 3201 Km 35, 4, BR-88905355 Ararangua, SC - Brazil

^[3] Sch Med Paediat & Child Hlth, Sydney, NSW - Australia

• Document type: Journal article
• Source: BMC PEDIATRICS; v. 22, n. 1 JAN 20 2022.
• Web of Science Citations: 0

Abstract

Background: With the implementation of social distancing due to the Covid-19 pandemic, many at-risk infants are without therapy. An alternative mode of therapy in this situation is tele-care, a therapy in which assessments and interventions are carried out online, in the home environment. We describe a tele-care protocol involving parent delivered task and context specific movement training, participation and environmental adaptation for infants at risk for developmental delay. Methods: Randomized controlled trial. Infants at risk, with 3 to 9 months corrected age, will be included, and randomized into two groups: control group (conventional guidelines) and experimental group (task, environment and participation in context-specific home program). Infants will be assessed for motor capacity (Infant Motor Profile and Alberta Infant Motor Scale); participation (Young Children's Participation and Environment Measure) and environment factors (Parent-Child Early Relational Assessment; Affordances in the Home Environment for Motor Development). The intervention period will be 10 weeks, and evaluations will be carried out before and after that period. All the assessment and intervention procedures will be carried out online, with instructions to parents for home therapy. The statistical analysis will be guided according to the distribution of the data, and a significance level of 5% will be adopted. All ethical approvals were obtained by the Ethics Committee of the University of Sao Carlos (Case number 31256620.5.0000.5504). The protocol will follow the SPIRIT statement. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences. Discussion: The results of this study will describe the effectiveness of a home intervention, focusing on specific activities, participation and environmental changes. These results will support the implementation of a remote protocol, with lower financial costs and focused on the particularities of the family. This type of care model can possibly help public policies to ensure equal access to evidence-based quality healthcare. (AU)

• FAPESP's process: 20/02818-4 - Tele-care in times of social isolation: effect of a home intervention protocol directed at activity, participation and the environmental context on the functionality of infants at biological risk: randomized controlled clinical trial
• Grantee: Camila Resende Gâmbaro Lima
• Support Opportunities: Scholarships in Brazil - Doctorate