ClinicalTrials.gg
Active, not recruitingNCT06852989Updated Feb 28, 2025

Shared Interactive Book Reading in Preschool Children with Neurodevelopmental Disorders: Effects on Language Development and Reading Habits

An observational study in Neurodevelopmental Disorders, Autism Spectrum Disorder and Intellectual Disabilities, sponsored by Fondazione Don Carlo Gnocchi Onlus. Active, not recruiting at 1 site in Italy. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Fondazione Don Carlo Gnocchi Onlus · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
53
Ages
1 Year to 6 Years
Sex
All
01

Study summary

The goal of this observational retrospective study is to explore the effects of a parent-based book reading intervention on children with neurodevelopmental disorders. The project consisted of interactive lessons for parents and shared reading experiences. It took place between May 2021 and June 2022 in Rome and at the time children were receiving neuropsychomotor and speech therapy sessions based on the developmental profile.

The investigators'primary goal is to investigate lexical quotients of children who participated in the project to explore whether it had an impact on their language development. The secondary goal is to assess shared reading habits.

For both outcome measures, researchers will compare the group who partecipated in the study with a cohort of children with the same characteristics who also attended Fondazione Don Carlo Gnocchi for rehabilitation purposes.

Patients and their family will not be asked for any further engagement because all data will be taken from medical records.

02

Conditions studied

  • Neurodevelopmental Disorders
  • Autism Spectrum Disorder
  • Intellectual Disabilities
  • Language Disorders in Children

Keywords

  • shared reading
  • early literacy
  • neurodevelopmental disorder
  • autism
  • intellectual disability
  • vocabulary
  • shared reading habits
  • language disorders
  • shared interactive book reading
03

In context

Neurodevelopmental Disorders

352 studies on the registry are indexed under Neurodevelopmental Disorders; 141 are open to participants now.

This study's planned enrollment of 53 is below the median of 200 across 133 observational studies indexed under Neurodevelopmental Disorders.

Browse Neurodevelopmental Disorders studies →

Lead sponsor

Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Preschool children with neurodevelopmental disorders attending Fondazione Don Carlo Gnocchi's rehabilitation center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age between 1 and 6 years old
  • having attended at least 2 out of 5 parent training meetings and 2 out of 9 reading aloud sessions
  • at least one caregiver with a good command of the Italian language,
  • having given written consent to participate

Exclusion criteria

Exclusion Criteria for both groups:

  • cerebral palsy or severe sensory disorder (deafness, blindness)
  • limited command of the italian language
  • lack of
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
53 participants (estimated)
Patient registry
No

Groups and cohorts

  • Study group

    27 children with neurodevelopmental disorders

    Other: Shared book reading intervention

  • Comparison group

    26 children with neurodevelopmental disorders

Interventions

  • OtherShared book reading intervention

    The study group participated in a parent training program focusing on shared interactive reading practices and attended nine read-aloud meetings with their children under the supervision of a trained librarian.

    Also known as: Parent-based book reading intervention

06

What researchers measure

Primary outcomes

  1. Lexical quotients (receptive and expressive)

    We will analyze receptive and expressive lexical quotient of both study and comparison group.

    Time frame: February 2025 - August 2025

Secondary outcomes

  1. Non-standardized shared-reading habits questionnaire

    We will analyze the impact of the project on families' shared reading habits through a custom-built self-administered questionnaire. The questionnaire has been delivered at the beginning and at the end of the project.

    Time frame: February 2025 - August 2025

07

Study locations

1 site
  • Fondazione Don Carlo Gnocchi Onlus
    Rome, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06852989
Responsible party
Sponsor
First posted
Feb 28, 2025
Start date
Feb 13, 2025
Primary completion
Aug 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
Feb 28, 2025

Study contacts

Laura Iuvone, Doctor
principal investigator · Fondazione Don Carlo Gnocchi Onlus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion