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.

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 São 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.

TRIAL REGISTRATION

Brazilian Clinical Trials Registry: RBR8xrzjs , registered September 1, 2020.