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Can coaching parents boost social skills in kids with disabilities?

NCT ID NCT06666777

Symptom relief Sponsor: IRCCS Eugenio Medea Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a speech therapy that involves parents can improve early social and communication skills in children aged 6 months to 5 years with neurodevelopmental disabilities. One group gets the parent-focused therapy, while the other gets standard speech therapy. Researchers will compare changes in social skills, language development, and parenting behaviors after eight weekly sessions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
behavioral intervention (parent-involved speech therapy focusing on early social and communication skills)
What this could lead to
If it works, this could offer a better way to help children with neurodevelopmental disabilities develop early social and communication skills, potentially improving their long-term language and interaction abilities.
What could go wrong
This is a small early-stage trial with only 60 participants, so results may not apply to all children. The intervention is behavioral, so effects may be modest and hard to measure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 59 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: For children: * Age between 6 months (corrected age in cases of prematurity) and 5 years. * Documented developmental delay and/or socio-communicative difficulties, based on clinical signs or standardized developmental scales (e.g., Griffiths Scales). * Mental age of at least 6 months. * Diagnosis of neurodevelopmental disability, including cerebral palsy, genetic syndromes, rare diseases with non-progressive neurological impairments, or congenital disorders of undetermined nature. For parents: * Adult age (≥ 18 yo) * Good knowledge and fluency in Italian. * No manifest psychiatric conditions. * No documented intellectual disability. Exclusion criteria: For children: * Age greater than 5 years at the time of recruitment. * Mental age below 6 months. * Absence of developmental delay (developmental quotient \> 85) and socio-communicative difficulties. * Diagnosis of neurodevelopmental disability resulting from neurodegenerative diseases or brain tumor outcomes. * Severe sensory impairments (profound deafness and/or blindness). For Parents: * Inability to speak Italian. * Documented psychiatric conditions or intellectual disability.

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Conditions

The condition(s) this trial relates to.

communication disorder developmental disability hereditary disease Language Development Disorders language disorder neurodevelopmental disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Developmental delays Genetic syndrome Language development disorders Neurodevelopmental disability Neurological impairments

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale

    RECRUITING

    Como, Como, 22100, Italy

  • Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale e Diurno (CDC)

    RECRUITING

    Ponte Lambro, Como, 22037, Italy

  • Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale, Diurno (CDC) e Domiciliare

    RECRUITING

    Lecco, Lecco, 23900, Italy

  • Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale, Diurno (CDC) e Residenziale

    RECRUITING

    Bosisio Parini, Lecco, 23842, Italy

  • Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale

    RECRUITING

    Sesto San Giovanni, Milano, 20099, Italy

  • Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale

    RECRUITING

    Carate Brianza, Monza E Brianza, 20841, Italy

  • Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale

    RECRUITING

    Cislago, Varese, 21040, Italy

  • Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale, Diurno (CDC)

    RECRUITING

    Vedano Olona, Varese, 21040, Italy

  • Associazione La Nostra Famiglia - IRCCS E. Medea

    RECRUITING

    Bosisio Parini, Lecco, 23842, Italy

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