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Efficacy of the small step program in a randomised controlled trial for infants below age 12 months with clinical
Ann-Christin Eliasson1, Linda Holmström2, Päivikki Aarne3,4
1Department of Women's and Children's Health, Karolinska Institutet, 171 76, Stockholm, Sweden. ann-christin.eliasson@ki.se.
Insights
This study evaluates the Small Step Program for infants at risk of cerebral palsy (CP). The program aims to improve motor function and development through early, intensive intervention, with results pending.
Area of Science:
- Pediatric neurology
- Developmental pediatrics
- Rehabilitation medicine
Background:
- Children with cerebral palsy (CP) experience lifelong motor disorders with limited evidence on early intervention effectiveness.
- Current treatments for CP lack robust data supporting improvements in motor function, activity, and daily life participation.
- The Small Step Program is a novel intervention for infants at risk of CP, grounded in brain plasticity principles.
Purpose of the Study:
- To evaluate the effectiveness of the Small Step Program in infants at risk of developing CP.
- To determine if the program enhances motor function, activity, and participation compared to usual care.
- To assess the program's impact on parental stress and anxiety.
Main Methods:
- A two-group randomized controlled trial involving infants aged 3-8 months at risk of CP.
- Intervention group receives the Small Step Program (individualized, goal-directed, intensive home-based therapy) delivered by trained parents.
- Control group receives usual care. Primary outcome measured by Peabody Developmental Motor Scale (second edition).
Main Results:
- Primary endpoint assessed approximately 35 weeks post-intervention, with secondary endpoints at 2 years of age.
- Outcomes compared between groups using general linear models.
- Secondary assessments include general/specific development, brain pathology, and parental perspectives.
Conclusions:
- The study protocol outlines a rigorous evaluation of an early intervention for infants at risk of CP.
- Findings will inform the efficacy of the Small Step Program in improving child development and parental well-being.
- Results are anticipated to contribute evidence for early intervention strategies in pediatric neurodevelopmental disorders.
Background:
Children with cerebral palsy (CP) have life-long motor disorders, and they are typically subjected to extensive treatment throughout their childhood. Despite this, there is a lack of evidence supporting the effectiveness of early interventions aiming at improving motor function, activity, and participation in daily life. The study will evaluate the effectiveness of the newly developed Small Step Program, which is introduced to children at risk of developing CP during their first year of life. The intervention is based upon theories of early learning-induced brain plasticity and comprises important components of evidence-based intervention approaches used with older children with CP.
Method And Design:
A two-group randomised control trial will be conducted. Invited infants at risk of developing CP due to a neonatal event affecting the brain will be randomised to either the Small Step Program or to usual care. They will be recruited from Astrid Lindgren Children's Hospital at regular check-up and included at age 3-8 months. The Small Step Program was designed to provide individualized, goal directed, and intensive intervention focusing on hand use, mobility, and communication in the child's own home environment and carried out by their parents who have been trained and coached by therapists. The primary endpoint will be approximately 35 weeks after the start of the intervention, and the secondary endpoint will be at 2 years of age. The primary outcome measure will be the Peabody Developmental Motor Scale (second edition). Secondary assessments will measure and describe the children's general and specific development and brain pathology. In addition, the parents' perspective of the program will be evaluated. General linear models will be used to compare outcomes between groups.
Discussion:
This paper presents the background and rationale for developing the Small-Step Program and the design and protocol of a randomized controlled trial. The aim of the Small Step Program is to influence development by enabling children to function on a higher level than if not treated by the program and to evaluate whether the program will affect parent's ability to cope with stress and anxiety related to having a child at risk of developing CP.
Trial Registration:
ClinicalTrials.gov Identifier NCT02166801 . Registered June 12, 2014.
