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Completed

NCT Number: NCT06930482

Evaluation of The Effectiveness of The SAFE Early Intervention Program

In this study, it was aimed to examine the effect of SAFE, which is a sensory-based, activity-oriented early intervention approach applied in an enriched environment with family cooperation, on cognitive, language, motor and sensory development in 3-6 months old risky infants. 46 infants with neurodevelopmental risk, whose corrected age was 3 months, were included in the study. Infants were randomly divided into two groups. Infants in the treatment group were included in an early intervention program according to the SAFE approach. Infants in the control group were included in the family education program based on the principles of Neurodevelopmental Therapy (NDT). The intervention was performed for 12 weeks, and all infants were evaluated with Bayley Developmental Scale for Infants and Young Children III (Bayley III) by a blinded investigator before treatment (3rd months) after treatment (6th months) and 12th months.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

• Corrected age of 3 months

  • Any neurodevelopmental risk (perinatal stroke, perinatal asphyxia, HIE, GMK-IVK, PVL or gestational age of 32 and below)

Exclusion criteria

• Having a congenital anomaly

  • Having a genetic syndrome diagnosis (e.g. Down Syndrome)
  • Parents do not speak Turkish

Treatment and study plan

Safe early intervention

Behavioral

The SAFE early intervention approach, an activity-focused, sensory intervention program, was applied to the babies in the intervention group in an enriched environment. As part of the intervention, coaching was provided in collaboration with the family on how to support the baby's development. For this purpose, family visits were made 15 days after the initial assessment and once a month. During these visits, the suggestions given to the family were repeated and all questions about the process were answered. It was discussed how the home environment should be structured in a way that is appropriate for the baby's development. The aims of the approaches applied were explained and information was provided about the follow-up process. In order to follow up on whether the family implemented the intervention, the family was interviewed by phone and the family was asked to keep an activity diary.

early intervention approach based on neurodevelopmental treatment

Behavioral

Within the scope of the study, NGT-based applications were applied to the babies included in the control group by their families. After the first assessment, activities were planned to support skills appropriate to the child's developmental level. The treatment movements, how to facilitate the baby's movements, and how to provide hand contact were demonstrated to the families in practice. The applicability of the intervention program was monitored with weekly phone calls. The babies were called to the clinic environment for a check-up every month to revise the intervention program and teach new movements, and an evaluation was made. Two home visits were made to evaluate the families' home environments and parental attitudes (pre- and post-intervention).

Primary outcomes

  1. Bayley Scales of Development for Infants and Toddlers III (Bayley-III)

    Time frame: 3 months,6 months, 12 months

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Effect of SAFE Early Intervention Program on Neurodevelopmental Outcomes At 1 Year of Age in Infants at Risk of CP

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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