Trial reportChild: care, health and development2025
Effects of SAFE Early Intervention Approach in the First Months of Life in Infants at Risk: A Randomized Controlled Study.
Trial report in Child: care, health and development, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06361134 (Efficacy of Supporting SAFE Early Intervention in the First Months of Life in Infants at Risk), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy of Supporting SAFE Early Intervention in the First Months of Life in Infants at Risk: A Randomized Controlled Trial
Who cites it
2 citing papers in PubMed.
- Effects of Safe Early Intervention Approach: A 3-Year Follow-Up.Brain and behavior · 2026Article
- Early Motor Interventions in Infants and Young Children: A Comprehensive Scoping Review.Children (Basel, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis study aimed to examine the effects of the SAFE early intervention approach (Sensory strategies, Activity-based motor training, Family collaboration, and Environmental Enrichment), developed for at-risk infants, on motor, cognitive, language development, and sensory processing skills in the first 3 months of life.
methodsTwenty-six infants with a corrected age of 42 weeks were included in the study, and the infants were randomly distributed to the treatment and control groups. The SAFE early intervention approach was applied to 14 infants in the treatment group, and the Neurodevelopmental Treatment-based home programme was applied to 12 infants in the control group. All infants included in the study were evaluated at the corrected 42nd week before the intervention and at the corrected 12th week after the intervention by an evaluator blinded to the treatment. Bayley Scales of Infant and Toddler Development III (Bayley-III) to evaluate cognitive and motor development; Test of Infant Motor Performance (TIMP) to evaluate neuromotor development; Infant/Toddler Sensory Profile 2 (ITSP 2) to assess sensory processing t was used. The Infant/Toddler HOME Inventory was used to evaluate the home environment.
resultsThe interaction effects (time × group) revealed significant advantages for the SAFE early intervention group, evidenced by higher scores in the Bayley-III motor composite, TIMP elicited and HOME total assessments (p < 0.05). However, the interaction effects (time × group) showed no differences between the groups in the Bayley-III cognitive and language composite scores, as well as the TIMP observed and TIMP total scores (p > 0.05). The main effect for time was significant in all parameters (p < 0.05). Similarly, the main impact for groups was substantial in all evaluation parameters except the Bayley-III language composite score and TIMP observed score (p < 0.05). The interaction effects (time × group) demonstrated significant differences in favour of the SAFE early intervention group for the general processing score, auditory processing score, tactile processing score and total score of the ITSP 2 (p < 0.05).
conclusionsThe SAFE early intervention approach enhanced motor and sensory outcomes and provided a more enriched home environment than the NDT-based home programme. It was concluded that neurodevelopmental improvement will be achieved with the SAFE early intervention approach in the early period in at-risk infants.
trial registrationNCT06361134.
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