Telehealth Intervention for Infants with Prodromes of ASD (FIRRST)

IRCCS Fondazione Stella Maris

Status: Enrolling

Conditions: Autism Spectrum Disorder (ASD)

Treatments: Behavioral: FIRRST; Behavioral: Parent Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06817746

FIRRST_VIITA

Details and patient eligibility

About

Autism Spectrum Disorder (ASD) is a complex neurodevelopmental disorder characterized by social-communication and interaction deficits and restricted, repetitive patterns of interests and behavior. It is frequently associated with heterogeneous comorbidities including physical, mental, and neurodevelopmental disorders, which can result in a substantial burden on individuals, families, and society.

Early prodromal signs of ASD emerge during the first year of life, a time when brain plasticity is at its maximum level, and may consist of diminished social orienting, responsivity and reciprocity combined with the presence of prolonged visual fixation and repetitive use of objects. Developmental immaturities in communication and motor skills are often present too. Pre-emptive Intervention (PI) for infants with prodromal signs of ASD was shown to improve outcomes, in comparison to later starts, by improving developmental skills, reducing ASD symptoms and, in some cases, preventing the full blown symptoms of ASD. Moreover, access to early evidence-based interventions may reduce the elevated levels of stress, anxiety and depressive symptoms experienced by caregivers of children with signs of ASD.

Despite this evidence, professionals tend to have a 'wait to see' approach, rather than targeting areas of impairment with early intervention. Moreover, the vast majority of current clinical models of ASD services require a diagnosis to receive services, while the identification of prodromal signs of the disorders generally is not sufficient to access early intervention. There is an urgent need for a paradigm shift in ASD treatment.

The proposed Project aims to evaluate the efficacy of FIRRST, a parent-mediated PI for infants with early signs of ASD. We will conduct a multisite RCT of telehealth PI by recruiting 132 symptomatic infants between 9-14 months and randomly assigning them to receive either FIRSST (experimental group), or Parent Education (control group). Developmental skills, ASD symptomatology, caregiver well-being and brain changes on High-Density EEG will be assessed with in-presence evaluations at three time points: 1. baseline; 2. after 24 weeks of intervention; 3. follow-up after 24 weeks from the end of intervention.

If funded, The proposed study will be the first well-powered RCT evaluating developmental, symptom and neurophysiological changes in response to a parent-mediated PI conducted in Europe. The ultimate goal for translational research in ASD lies in the optimization of clinical outcomes through the most effective, targeted, and timely treatments. The proposed RCT has the potential to significantly impact current access to services by reducing the age of starting intervention, thereby promoting optimal developmental outcomes, as well as reducing burden and high health costs to families and society.

Enrollment: 132 estimated patients

Sex: All

Ages: 9 to 17 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• risk-range score at SACS-R;
• Italian as one of the languages spoken at home;
• age below 18 months (corrected) at the time of identification;
• available device with webcam and home internet access.

Exclusion criteria

• presence of a known genetic disorder, brain damage or other relevant neurological or chronic disorders;
• severe visual, auditory and/or motor impairment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 2 patient groups

FIRRST

Experimental group

Description:

FIRRST is based on the principles of Naturalistic Developmental Behavioral Interventions (NDBIs), and more specifically on the principles of Infant Start and iBASIS. FIRRST targets ASD prodromes including diminished eye contact, diminished communicative intent, diminished social orientation, and unusual pattern of object exploration. Additionally, it also targets motor immaturity, frequent in infants at risk for ASD. FIRRST is a systemic approach, integrated within the family dynamics and culture. The program will address the five elements identified in efficacious very early intervention: 1) parent involvement, 2) frequency and length of intervention, 3) individualized, developmentally appropriate activities, 4) beginning the interventions as early as possible, and 5) increasing parental sensitivity and responsivity to infant cues. FIRRST will be delivered by experienced licensed health professionals trained by the developer of the intervention.

Treatment:

Behavioral: FIRRST

Parent Education

Active Comparator group

Description:

Families will receive written educational material focused on supporting child development and targeting ASD specific immaturities and atypicalities. Additionally, parent education families will receive counseling once per month for 6 months delivered by a licensed health professional aiming at supporting the family well being and helping the family to connect with the local public health services.

Treatment:

Behavioral: Parent Education