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e-EARLY TOGETHER Intervention for Infants at High Risk of Cerebral Palsy: Randomized Controlled Trial Protocol
Agnes F S Cunha1, Hércules R Leite, Adriana N Santos
1Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil (Ms Cunha); Department of Physical Therapy, Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil (Dr Leite); Department of Health Sciences, Graduate Program in Rehabilitation Sciences, Universidade Federal de Santa Catarina, Florianópolis, Santa Catarina, Brazil (Dr Santos); Department of Physical Therapy, Graduate Program in Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil (Dr Campos); Postdoctoral Research Fellow, Cerebral Palsy Alliance Research Institute, The University of Sydney, Camperdown, New South Wales, Australia (Dr Hines); Department of Physical Therapy, Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil (Dr Camargos).
Insights
This study evaluates e-EARLY TOGETHER, an early intervention program using telehealth for infants at high risk of cerebral palsy in low-income countries. The goal is to improve developmental outcomes and inform clinical practice.
Area of Science:
- Pediatrics
- Developmental Neuroscience
- Global Health
Background:
- Infants at high risk of cerebral palsy (CP) require timely interventions.
- Telehealth approaches offer potential solutions for delivering early intervention in low- and middle-income countries (LMICs).
- Existing early intervention programs may not be accessible or adaptable to LMIC contexts.
Purpose of the Study:
- To evaluate the effectiveness of the e-EARLY TOGETHER intervention for infants at high risk of cerebral palsy.
- To assess the impact of a telehealth-based program combining goal-oriented training, parental coaching, and environmental enrichment.
- To determine the feasibility and outcomes of this intervention in a low- and middle-income country setting.
Main Methods:
- A randomized controlled clinical trial protocol is outlined.
- The e-EARLY TOGETHER intervention will be compared against standard care guidelines.
- Outcomes related to infant development and performance will be measured.
Main Results:
- Results are pending as this is a protocol description.
- The study aims to provide data on the efficacy of the e-EARLY TOGETHER intervention.
- Anticipated findings will highlight the benefits for infant development and performance.
Conclusions:
- This protocol is expected to enhance early intervention practices in LMICs.
- The study aims to contribute to the implementation of effective, sustainable early intervention programs.
- Positive and lasting impacts are anticipated for children, families, and communities.
Purpose:
The purpose of this study is to evaluate the effectiveness of an early intervention program, e-EARLY TOGETHER, that combines goal-oriented training, parental coaching, environmental enrichment in a telehealth approach in a low- and middle-income country.
Methods:
Protocol for a randomized controlled clinical trial to evaluate the effectiveness of e-EARLY TOGETHER intervention compared to standard guidelines on outcomes related to development and performance in infants at high risk of cerebral palsy.
Discussion:
This protocol will inform and enrich clinical practice related to early intervention in low- and middle-income countries. It is expected that the data obtained will contribute to the implementation of effective early intervention programs with positive and lasting results for the child, their family, and the community.
Trial Registration:
Brazilian Registry of Clinical Trials: RBR-7WWJRQ3, registered May 10, 2023; WHO Trial Registration UTN Code U-1111-1286-4639.
