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

February 24, 2025 updated by: Fondazione Don Carlo Gnocchi Onlus

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

53

Contacts and Locations

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

Study Locations

  • Italy
      • Rome, Italy
        • Fondazione Don Carlo Gnocchi Onlus

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

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion criteria for the study group:

  • 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 for both groups:

  • cerebral palsy or severe sensory disorder (deafness, blindness)
  • limited command of the italian language
  • lack of informed consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
27 children with neurodevelopmental disorders
Other: Shared 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.
Other Names:
  • Parent-based book reading intervention
Comparison group
26 children with neurodevelopmental disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lexical quotients (receptive and expressive)
Time Frame: February 2025 - August 2025
We will analyze receptive and expressive lexical quotient of both study and comparison group.
February 2025 - August 2025

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-standardized shared-reading habits questionnaire
Time Frame: February 2025 - August 2025
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.
February 2025 - August 2025

Collaborators and Investigators

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

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Investigators

  • Principal Investigator: Laura Iuvone, Doctor, Fondazione Don Carlo Gnocchi Onlus

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)

February 13, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 24, 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 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIBR-PN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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