Telehealth Intervention for Infants with Prodromes of ASD (FIRRST)

February 4, 2025 updated by: IRCCS Fondazione Stella Maris

Fostering Infant Responsivity and Reciprocity - Support to Thrive. a Multisite Randomized Control Trial of a Preemptive Telehealth Intervention for Infants with Early Signs of Autism Spectrum Disorders

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Messina, Italy
      • Messina, Italy
      • Pisa, Italy, 56128
        • Recruiting
        • IRCCS Stella Maris
        • Contact:
        • Contact:
        • Contact:
          • Andrea Guzzetta
        • Contact:
          • Sara Calderoni
        • Contact:
          • Costanza Colombi
      • Rovereto, Italy
        • Active, not recruiting
        • Istituto Italiano Tecnologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FIRRST
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.
Behavioral: FIRRST
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.
Active Comparator: Parent Education
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.
Behavioral: Parent Education
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Development
Time Frame: T0: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.
The Griffiths III, a scale to assess developmental quotients (Green et al., 2016).
T0: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.
ASD Symptom Severity
Time Frame: T0: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.
The Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) Toddler Module, to assess clinical severity of autism (Lord et al., 2012)
T0: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.
Change of Core ASD Symptoms
Time Frame: T0: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.
The Brief Observation of Social Communication Change (BOSCC) to measure change of core ASD symptoms (Gradzinski et al., 2016) in response to intervention.
T0: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent Mental Well-Being
Time Frame: T0: at recruitment: T1: after 6 months since recruitment; T2: after 12 months since recruitment.
The Parenting Stress Index-4 (PSI-4), to evaluate the magnitude of stress in the parent-child system (Abidin, 2016).
T0: at recruitment: T1: after 6 months since recruitment; T2: after 12 months since recruitment.
Parent-Child Interaction
Time Frame: T0: at recruitment; T1: after 6 months since recruitment; after 12 months since recruitment.
The MONSI-CC (Measure of NDBI Strategy Implementation-Caregiver Change) to evaluate changes in parent-child interaction style in response to intervention.
T0: at recruitment; T1: after 6 months since recruitment; after 12 months since recruitment.
Neurophysiological Modifications
Time Frame: To: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.
Modifications in HD-EEG activity in terms of 1/f aperiodic signal.
To: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Fondazione Stella Maris

Collaborators

Istituto Italiano di Tecnologia
Policlinico Hospital/University of Messina
CNR Messina

Investigators

  • Principal Investigator: Andrea Guzzetta, MD, University of Pisa/IRCCS Stella Maris
  • Principal Investigator: Sara Calderoni, MD, University of Pisa/IRCCS Stella Maris
  • Principal Investigator: Costanza Colombi, PhD, IRCCS Stella Maris
  • Principal Investigator: Lilian Ruta, MD, CNR Messina
  • Principal Investigator: Gabriella Di Rosa, MD, University of Messina
  • Principal Investigator: Michale Lombardo, PhD, Istituto Italiano Tecnologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIRRST_VIITA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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