Can early parent coaching help infants with rare genetic disorders thrive?

NCT ID NCT03836300

Disease control Sponsor: RTI International Source: ClinicalTrials.gov ↗

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests a program called PIXI that coaches parents of infants diagnosed with rare neurogenetic disorders (such as Fragile X, Angelman, or Down syndrome) during the first year of life. The program combines education about the disorder, guided parent-child interaction activities, and support for family well-being. Researchers are checking whether families find the program helpful and practical, and whether it can be delivered consistently.

What this could mean

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

Active substance: Parent-Infant Inter(X)action Intervention (PIXI)
What this could lead to: If successful, this program could provide a practical, supportive model for families of infants with rare neurogenetic disorders, potentially improving early development and parent-child interaction.
What could go wrong: This is a small pilot study focused on feasibility and acceptability, not on proving medical benefit. Results may not apply to all families or disorders, and the intervention may not show clear developmental gains.

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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 120 people

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

Started

Nov 2018

Expected to finish

Dec 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

Up to 99 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Infants 15 months of age or younger who have received a diagnosis which was not sought solely due to parental concerns about the infant (e.g. diagnosis due to prenatal or newborn screening, cascade testing following diagnosis of a family member). * English must be the primary language spoken in the home because all assessment measures and intervention protocol are in English. Exclusion Criteria: \- Infants may not be blind or have a severe hearing impairment as the intervention and assessments are not appropriate for these children.

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Conditions

The condition(s) this trial relates to.

Angelman syndrome developmental disability DiGeorge syndrome Down syndrome Duchenne muscular dystrophy fragile X syndrome Klinefelter syndrome Phelan-McDermid syndrome Prader-Willi syndrome Rett syndrome Smith-Magenis syndrome tuberous sclerosis Turner syndrome velocardiofacial syndrome Williams syndrome

As listed by the trial registrant

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

Angelman syndrome Chromosome 22q11.2 deletion syndrome Down syndrome Duchenne muscular dystrophy DUP15Q syndrome Fragile X syndrome Klinefelter syndrome Phelan-mcdermid syndrome Prader-Willi syndrome Rett syndrome Smith Magenis syndrome Tuberous sclerosis Turner syndrome Williams syndrome

How to take part

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

The places running it

1 site. The list below names each one and where it is.
The official record

The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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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.

Can early parent coaching help infants with rare genetic disorders thrive?

What the study statuses mean