Evaluation of The Effectiveness of The SAFE Early Intervention Program

Gazi University

Status: Completed

Conditions: Preterm; Cerebral Palsy; Sensory Disorders

Treatments: Behavioral: early intervention approach based on neurodevelopmental treatment; Behavioral: Safe early intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06930482

91610558-302.08.01-122723

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 3 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

SAFE Early Intervention Group

Experimental group

Treatment:

Behavioral: Safe early intervention

Behavioral: early intervention approach based on neurodevelopmental treatment

Control Group

Other group

Treatment:

Behavioral: Safe early intervention

Behavioral: early intervention approach based on neurodevelopmental treatment