Early Recognition and Intervention in SIBlingS at High Risk for Neurodevelopment Disorders (ERI-SIBS): a controlled trial of an innovative and ecological intervention for siblings of children with autism spectrum disorder.

BACKGROUND

It has been widely demonstrated that siblings of children with autism spectrum disorder (ASD) have an increased risk of abnormal developmental trajectories. In response to this, early recognition protocols have been developed worldwide, aiming to promote early interventions that can positively impact the neurodevelopment of this population. This paper presents the protocol of a controlled trial: ERI-SIBS (Early Recognition and Intervention in SIBlingS at High Risk for Neurodevelopment Disorders) is an innovative and ecological early recognition and intervention program designed specifically for siblings of children with ASD.

METHODS

We aim to recruit siblings at low risk and high risk of neurodevelopmental disorders. Based on clinical evaluation at T0, we will allocate the infants into three groups: Group 1, infants at low risk without any signs of neurodevelopmental disorders; Group 2, infants at high risk without any signs of neurodevelopmental disorders; Group 3: infants at low or high risk with signs suggestive of neurodevelopmental disorders. Children of Group 2 will undergo Active Monitoring (one 90 min session once a month for 6 months), while children of Group 3 will undergo Early Intervention (one 90 min session once a week for 6 months). In both cases, the ERI-SIBS contents are based on a multidimensional and naturalistic approach and always involve caregivers. All recruited children will be evaluated at three different time points (T0 within the 8 months of life of the child, T1 after 6 months and T2 after 12 months) using behavioural, technological, and biological techniques to assess infants' neurodevelopmental functions, parent-infant interaction, and early ASD markers.

DISCUSSION

The ERI-SIBS study will expand knowledge regarding the impact of early intervention on families of infants at risk of neurodevelopmental disorders for the presence of a child with a diagnosis of ASD. The study will have the potential to significantly contribute to future research and the scientific and clinical debate on the best way to implement early intervention in at-risk populations.

CLINICAL TRIAL REGISTRATION

Clinicaltrials.gov identifier (NCT06512649).