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Parent training may ease mental health struggles in kids with rare genetic disorders

NCT ID NCT06125093

Symptom relief Sponsor: Fundació Sant Joan de Déu Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a 22-week online parenting program (Incredible Years) for families of children aged 3-7 with genetic abnormalities and mental health or developmental problems. 53 families were randomly assigned to the program or usual care. The goal was to see if parents would engage with and find the program helpful, potentially improving child behavior and reducing parental stress.

What this could mean

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

Active substance
Incredible Years Autism Spectrum and Language Delays Parent Program (IY-ASLD®) - a behavioral parenting intervention
What this could lead to
If successful, this could provide an evidence-based parenting program to help manage behavioral and developmental symptoms in children with genetic conditions.
What could go wrong
This is a small, early-stage trial (53 participants) focused on feasibility, not a large-scale efficacy study. Results may not apply broadly, and the intervention requires significant time commitment from parents.

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

53 people

The number who actually took part.

Started

Mar 2023

Finished

Sep 2024

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

3 to 7 years

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: 1. Children aged 3.0 - 7.11 years at recruitment 2. Children with a diagnosis or in diagnostic process for high suspicion of a genetic abnormality 3. For children up to 5.11 years with withdrawn (defined as CBCL/1.5-5 scores above the borderline clinical range, T-score\> 65) AND/OR pervasive developmental problems (defined as CBCL/1.5-5 scores above the borderline clinical range, T-score\> 65) AND/OR socialization difficulties (defined as Vineland-III scores below 1SD in the socialization subdomains). 4. For children over 6 years with social problems (defined as CBCL/6-18 scores above the borderline clinical range, T-score\> 65) AND/OR thought problems (defined as CBCL/6-18 scores above the borderline clinical range, T-score\> 65) AND/OR socialization difficulties (defined as Vineland-III scores below 1SD in the socialization subdomains). 5. Parents/caregivers showing good understanding of the Spanish or Catalan language 6. Parents/caregivers consenting to take part in the study and signing the informed consent Exclusion Criteria: 1. Children diagnosed with an Autism Spectrum Disorder 2. Children scoring above diagnostic cut-off for Autism or Autism Spectrum Disorder in the ADOS-2. 3. Attending another structured parenting program 4. Children in the care of their local authority

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Conditions

The condition(s) this trial relates to.

autism autism spectrum disorder hereditary disease Psychological Well-Being

As listed by the trial registrant

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

Autism or autistic traits Genetic syndrome Language development Parenting

Contacts and locations

Locations

  • Hospital Universitari Parc Taulí

    Sabadell, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Sant Joan de Deu

    Esplugues de Llobregat, Barcelona, 08950, Spain

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