Neurodevelopmental DisordersNCT06852989
Shared Interactive Book Reading in Preschool Children With Neurodevelopmental Disorders: Effects on Language Development and Reading Habits
An observational study of Neurodevelopmental Disorders and Autism Spectrum Disorder, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Intellectual Disabilities
- What is being tested?
- Shared book reading intervention
- How many people
- 53 participants
- Where
- 1 siteItaly
- Study dates
- 13 Feb 2025to Aug 2025
- Phase
- Observational
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Preschool children with neurodevelopmental disorders attending Fondazione Don Carlo Gnocchi's rehabilitation center
Who may be able to join
- 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
Who cannot join
- cerebral palsy or severe sensory disorder (deafness, blindness)
- limited command of the italian language
- lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Intellectual Disabilities, Language Disorders in Children
- Being tested
- Shared book reading intervention
- Keywords
- shared reading, early literacy, neurodevelopmental disorder, autism, intellectual disability, vocabulary, shared reading habits, language disorders, shared interactive book reading
- Medical subject headings
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Intellectual Disability, Literacy, Autistic Disorder, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared book reading interventionOther
Also called Parent-based 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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | 27 children with neurodevelopmental disorders Receives: Other: Shared book reading intervention | |
| Comparison group | 26 children with neurodevelopmental disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lexical quotients (receptive and expressive)
We will analyze receptive and expressive lexical quotient of both study and comparison group.
Measured: 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.
Measured: February 2025 - August 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start13 Feb 2025
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Iuvone, Doctor, Principal investigator, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852989
- Sponsor's protocol ID
- SIBR-PN
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Interactive Book Reading in Preschool Children With Neurodevelopmental Disorders: Effects on Language Development and Reading Habits
- ClinicalTrials.gov ID
- NCT06852989
- Acronym / sponsor ID
- SIBR-PN
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Shared book reading intervention27 children with neurodevelopmental disorders |
| Comparison group | – | –26 children with neurodevelopmental disorders |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preschool children with neurodevelopmental disorders attending Fondazione Don Carlo Gnocchi's rehabilitation center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- cerebral palsy or severe sensory disorder (deafness, blindness)
- limited command of the italian language
- lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared book reading interventionAlso: Parent-based book reading interventionThe 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 | Study group |
Primary outcome
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.
1 secondary outcome
Non-standardized shared-reading habits questionnaire
Time frame: February 2025 - August 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Iuvone, Doctor principal investigator
Fondazione Don Carlo Gnocchi ETS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Disorders and Autism Spectrum Disorder, run by Fondazione Don Carlo Gnocchi ETS at 1 site 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 3 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: under way, not looking for participants, as of the sponsor's last update on 28 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 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lexical quotients (receptive and expressive) (time frame: February 2025 - August 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2025.