NCT06852989

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 19, 2025

Last Update Submit

February 24, 2025

Conditions

Keywords

shared readingearly literacyneurodevelopmental disorderautismintellectual disabilityvocabularyshared reading habitslanguage disordersshared interactive book reading

Outcome Measures

Primary Outcomes (1)

  • Lexical quotients (receptive and expressive)

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

    February 2025 - August 2025

Secondary Outcomes (1)

  • Non-standardized shared-reading habits questionnaire

    February 2025 - August 2025

Study Arms (2)

Study group

27 children with neurodevelopmental disorders

Other: Shared book reading intervention

Comparison group

26 children with neurodevelopmental disorders

Interventions

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
Study group

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Don Carlo Gnocchi Onlus

Rome, Italy

Location

MeSH Terms

Conditions

Neurodevelopmental DisordersAutism Spectrum DisorderIntellectual DisabilityLiteracyAutistic DisorderLanguage Disorders

Condition Hierarchy (Ancestors)

Mental DisordersChild Development Disorders, PervasiveNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCommunicationBehaviorCommunication Disorders

Study Officials

  • Laura Iuvone, Doctor

    Fondazione Don Carlo Gnocchi Onlus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 28, 2025

Study Start

February 13, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

February 28, 2025

Record last verified: 2025-02

Locations