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Autism Spectrum Disorder (ASD)FIRRSTNCT06817746

Telehealth Intervention for Infants With Prodromes of ASD

A study testing FIRRST and Parent Education in people with Autism Spectrum Disorder (ASD), run by IRCCS Fondazione Stella Maris at 4 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Autism Spectrum Disorder (ASD) is a complex neurodevelopmental disorder characterized by social-communication and interaction deficits and restricted, repetitive patterns of interests and behavior. Read more about this study

Who is it for?
Ages 9 to 17 months
Conditions the study is for
Autism Spectrum Disorder (ASD)
What is being tested?
FIRRST and Parent Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
4 sitesItaly
Study dates
1 Nov 2024to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 17 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Andrea Guzzetta, MD contact

andrea.guzzetta@fsm.unipi.it

Costanza Colombi, PhD contact

050 886382

costanza.colombi@fsm.unipi.it

Italy4 sites, 3 recruiting

  • CNR

    Messina

    Liliana Ruta, MD, 3387638295, liliana.ruta@irib.cnr.it

    Recruiting

  • University of Messina

    Messina

    Gabriella Di Rosa, 349 7386079, gabriella.dirosa@unime.it

    Recruiting

  • IRCCS Stella Maris

    Pisa, Italy, 56128

    Costanza Colombi, PhD, 050 886382, firrst@fsm.unipi.it

    Natasha Chericoni, PsyD, firrst@fsm.unipi.it

    Recruiting

  • Istituto Italiano Tecnologia

    Rovereto, Italy

    Active, not recruiting

Other trials in Italy

About this study

Official title: 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.

Read more

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.

Being tested
FIRRST, Parent Education
Keywords
Autism Spectrum Disorder (ASD), ASD Prodromes, Infants, Support, Pre-emptive, Parent Mediated
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FIRRSTBehavioural

    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.

  • Parent EducationBehavioural

    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.

Study groups in NCT06817746
Study groupRoleWhat they receive
FIRRSTExperimentalFIRRST 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.
Receives: Behavioral: FIRRST
Parent EducationActive comparatorFamilies 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.
Receives: Behavioral: Parent Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infant Development

    The Griffiths III, a scale to assess developmental quotients (Green et al., 2016).

    Measured: T0: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.

  2. ASD Symptom Severity

    The Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) Toddler Module, to assess clinical severity of autism (Lord et al., 2012)

    Measured: T0: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.

  3. Change of Core ASD Symptoms

    The Brief Observation of Social Communication Change (BOSCC) to measure change of core ASD symptoms (Gradzinski et al., 2016) in response to intervention.

    Measured: T0: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.

Secondary outcomes (3)

  1. Parent Mental Well-Being

    The Parenting Stress Index-4 (PSI-4), to evaluate the magnitude of stress in the parent-child system (Abidin, 2016).

    Measured: T0: at recruitment: T1: after 6 months since recruitment; T2: after 12 months since recruitment.

  2. Parent-Child Interaction

    The MONSI-CC (Measure of NDBI Strategy Implementation-Caregiver Change) to evaluate changes in parent-child interaction style in response to intervention.

    Measured: T0: at recruitment; T1: after 6 months since recruitment; after 12 months since recruitment.

  3. Neurophysiological Modifications

    Modifications in HD-EEG activity in terms of 1/f aperiodic signal.

    Measured: To: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2025
  2. Study start1 Nov 2024
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06817746
Sponsor's protocol ID
FIRRST_VIITA
Acronym
FIRRST
Status last verified
Feb 2025
First submitted
21 Jan 2025
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Xiao Y, Wen TH, Kupis L, Eyler LT, Taluja V, Troxel J, Goel D, Lombardo MV, Pierce K, Courchesne E. Atypical functional connectivity of temporal cortex with precuneus and visual regions may be an early-age signature of ASD. Mol Autism. 2023 Mar 10;14(1):11. doi: 10.1186/s13229-023-00543-8.

    PubMed 36899425

  • Bertelsen N, Landi I, Bethlehem RAI, Seidlitz J, Busuoli EM, Mandelli V, Satta E, Trakoshis S, Auyeung B, Kundu P, Loth E, Dumas G, Baumeister S, Beckmann CF, Bolte S, Bourgeron T, Charman T, Durston S, Ecker C, Holt RJ, Johnson MH, Jones EJH, Mason L, Meyer-Lindenberg A, Moessnang C, Oldehinkel M, Persico AM, Tillmann J, Williams SCR, Spooren W, Murphy DGM, Buitelaar JK; EU-AIMS LEAP group; Baron-Cohen S, Lai MC, Lombardo MV. Imbalanced social-communicative and restricted repetitive behavior subtypes of autism spectrum disorder exhibit different neural circuitry. Commun Biol. 2021 May 14;4(1):574. doi: 10.1038/s42003-021-02015-2.

    PubMed 33990680

  • Loth E, Charman T, Mason L, Tillmann J, Jones EJH, Wooldridge C, Ahmad J, Auyeung B, Brogna C, Ambrosino S, Banaschewski T, Baron-Cohen S, Baumeister S, Beckmann C, Brammer M, Brandeis D, Bolte S, Bourgeron T, Bours C, de Bruijn Y, Chakrabarti B, Crawley D, Cornelissen I, Acqua FD, Dumas G, Durston S, Ecker C, Faulkner J, Frouin V, Garces P, Goyard D, Hayward H, Ham LM, Hipp J, Holt RJ, Johnson MH, Isaksson J, Kundu P, Lai MC, D'ardhuy XL, Lombardo MV, Lythgoe DJ, Mandl R, Meyer-Lindenberg A, Moessnang C, Mueller N, O'Dwyer L, Oldehinkel M, Oranje B, Pandina G, Persico AM, Ruigrok ANV, Ruggeri B, Sabet J, Sacco R, Caceres ASJ, Simonoff E, Toro R, Tost H, Waldman J, Williams SCR, Zwiers MP, Spooren W, Murphy DGM, Buitelaar JK. The EU-AIMS Longitudinal European Autism Project (LEAP): design and methodologies to identify and validate stratification biomarkers for autism spectrum disorders. Mol Autism. 2017 Jun 23;8:24. doi: 10.1186/s13229-017-0146-8. eCollection 2017.

    PubMed 28649312

  • Garces P, Baumeister S, Mason L, Chatham CH, Holiga S, Dukart J, Jones EJH, Banaschewski T, Baron-Cohen S, Bolte S, Buitelaar JK, Durston S, Oranje B, Persico AM, Beckmann CF, Bougeron T, Dell'Acqua F, Ecker C, Moessnang C, Charman T, Tillmann J, Murphy DGM, Johnson M, Loth E, Brandeis D, Hipp JF; EU-AIMS LEAP group authorship. Resting state EEG power spectrum and functional connectivity in autism: a cross-sectional analysis. Mol Autism. 2022 May 18;13(1):22. doi: 10.1186/s13229-022-00500-x.

    PubMed 35585637

  • Santocchi E, Guiducci L, Fulceri F, Billeci L, Buzzigoli E, Apicella F, Calderoni S, Grossi E, Morales MA, Muratori F. Gut to brain interaction in Autism Spectrum Disorders: a randomized controlled trial on the role of probiotics on clinical, biochemical and neurophysiological parameters. BMC Psychiatry. 2016 Jun 4;16:183. doi: 10.1186/s12888-016-0887-5.

    PubMed 27260271

  • Aiello S, Leonardi E, Cerasa A, Servidio R, Fama FI, Carrozza C, Campisi A, Marino F, Scifo R, Baieli S, Corpina F, Tartarisco G, Vagni D, Pioggia G, Ruta L. Video-Feedback Approach Improves Parental Compliance to Early Behavioral Interventions in Children with Autism Spectrum Disorders during the COVID-19 Pandemic: A Pilot Investigation. Children (Basel). 2022 Nov 8;9(11):1710. doi: 10.3390/children9111710.

    PubMed 36360438

  • Whitehouse AJO, Varcin KJ, Pillar S, Billingham W, Alvares GA, Barbaro J, Bent CA, Blenkley D, Boutrus M, Chee A, Chetcuti L, Clark A, Davidson E, Dimov S, Dissanayake C, Doyle J, Grant M, Green CC, Harrap M, Iacono T, Matys L, Maybery M, Pope DF, Renton M, Rowbottam C, Sadka N, Segal L, Slonims V, Smith J, Taylor C, Wakeling S, Wan MW, Wray J, Cooper MN, Green J, Hudry K. Effect of Preemptive Intervention on Developmental Outcomes Among Infants Showing Early Signs of Autism: A Randomized Clinical Trial of Outcomes to Diagnosis. JAMA Pediatr. 2021 Nov 1;175(11):e213298. doi: 10.1001/jamapediatrics.2021.3298. Epub 2021 Nov 1.

    PubMed 34542577

  • Rogers SJ, Vismara L, Wagner AL, McCormick C, Young G, Ozonoff S. Autism treatment in the first year of life: a pilot study of infant start, a parent-implemented intervention for symptomatic infants. J Autism Dev Disord. 2014 Dec;44(12):2981-95. doi: 10.1007/s10803-014-2202-y.

    PubMed 25212413

  • Lombardo MV, Busuoli EM, Schreibman L, Stahmer AC, Pramparo T, Landi I, Mandelli V, Bertelsen N, Barnes CC, Gazestani V, Lopez L, Bacon EC, Courchesne E, Pierce K. Pre-treatment clinical and gene expression patterns predict developmental change in early intervention in autism. Mol Psychiatry. 2021 Dec;26(12):7641-7651. doi: 10.1038/s41380-021-01239-2. Epub 2021 Aug 2.

    PubMed 34341515

  • Bosl WJ, Tager-Flusberg H, Nelson CA. EEG Analytics for Early Detection of Autism Spectrum Disorder: A data-driven approach. Sci Rep. 2018 May 1;8(1):6828. doi: 10.1038/s41598-018-24318-x.

    PubMed 29717196

  • Jones W, Klin A. Attention to eyes is present but in decline in 2-6-month-old infants later diagnosed with autism. Nature. 2013 Dec 19;504(7480):427-31. doi: 10.1038/nature12715. Epub 2013 Nov 6.

    PubMed 24196715

  • Colombi C, Calderoni S, Chericoni N, Conti E, Costanzo V, Marchi V, Di Rosa G, Lombardo MV, Ruta L, Guzzetta A. Fostering Infant Responsivity and Reciprocity - Support to Thrive (FIRRST): a multisite randomized control trial of a pre-emptive telehealth intervention for infants with early signs of Autism Spectrum Disorders in Italy. Trials. 2026 Apr 18;27(1):403. doi: 10.1186/s13063-026-09694-4.

    PubMed 42001120

Questions about this trial

What is this clinical trial studying?

A study testing FIRRST and Parent Education in people with Autism Spectrum Disorder (ASD), run by IRCCS Fondazione Stella Maris at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrea Guzzetta, MD (andrea.guzzetta@fsm.unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infant Development (time frame: T0: at recruitment; T1: after 6 months since recruitment; T2: after 12 months since recruitment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06817746, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.

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