ClinicalTrials.gov record NCT03836300

Parent and Infant Inter(X)Action Intervention (PIXI)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Piloting an Early Intervention Program for Infants With Rare Neurogenetic Disorders

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
AgeUp to 99 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This pilot study develops and tests a parent-focused early intervention called PIXI for infants diagnosed with rare neurogenetic conditions and their parents/caregivers. The program combines parent education, parent coaching around parent–child interaction, and family well-being support. Investigators will run an iterative pilot to assess feasibility, acceptability, and preliminary child and parent outcomes.

What it is studying. Whether the PIXI program can be developed and delivered to families, is acceptable and feasible, and how it relates to early infant and parent outcomes (measured here as preliminary effects).

What the researchers hope to learn. To develop the PIXI intervention, measure its feasibility and acceptability to families, assess intervention fidelity and parent engagement, and collect preliminary data on infant developmental and autism‑related outcomes.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The objective is to develop and test, through an iterative process, an intervention to address and support the development of infants with a confirmed diagnosis of a neurogenetic disorder with associated developmental delays or intellectual and developmental disabilities. The proposed project will capitalize and expand upon existing empirically based interventions designed to improve outcomes for infants with suspected developmental delays. Participants will be infants with a confirmed diagnosis of a neurogenetic disorder (e.g., fragile X, Angelman, Prader-Willi, Dup15q, Phelan-McDermid, Rhett, Smith Magenis, Williams, Turner, Kleinfelter, Down syndromes, Duchenne muscular dystrophy) within the first year of life and their parents/caregivers. The intervention, called the Parent and Infant Inter(X)action Intervention (PIXI) is a comprehensive program inclusive of parent education about early infant development and the neurogenetic disorder for which they were diagnosed, direct parent coaching around parent-child interaction, and family/parent well-being support. The protocol includes repeated comprehensive assessments of family and child functioning, along with an examination of feasibility and acceptability of the program.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Behavioral
  • Parent-Infant Inter(X)action Intervention (PIXI)

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

The primary goal of the proposed project is to develop and test, through an iterative process, an intervention to address and support the development of infants with a rare neurogenetic condition (e.g., fragile X, Angelman, Prader-Willi, Dup15q, Phelan-McDermid, Rhett, Smith Magenis, Williams, Turner, Kleinfelter, Down syndromes, Duchenne muscular dystrophy) identified prior to emergence of symptoms. PiXI aims to utilize the foundational knowledge available around the development of and early intervention for at-risk infants to both understand the needs of and provide intervention services for families of infants diagnosed pre-symptomatically with rare neurogenetic disorders. The investigators aim to 1) develop PIXI with a pilot sample of families, 2) test the preliminary effects of PIXI on infant and parent outcomes

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Families take part in the Parent and Infant Inter(X)action Intervention (PIXI), which includes parent education about the diagnosed condition and early development, direct parent coaching on parent–child interaction activities, and family/parent well‑being support and service navigation. Parents and infants are expected to attend intervention sessions (the protocol references a target of about 20 sessions across two phases) and complete repeated assessments of child and family functioning, parent questionnaires, and qualitative interviews about feasibility and acceptability. Some assessments may be done remotely (telehealth) and some are directly administered to the infant by study staff. The record does not list any invasive procedures (for example, no lumbar punctures or biopsies are described).

How the study is structured. Interventional single-group pilot: all enrolled families receive the PIXI behavioral intervention (parent education, coaching, and family support). The study is not masked and uses repeated assessments over time to examine feasibility, acceptability, fidelity, parent engagement, and early developmental and autism-related measures.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says participants are enrolled by invitation. Who decides who is invited, and how?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Rett syndrome

This trial is also listed on this site under Angelman syndrome, fragile X syndrome, Prader-Willi syndrome and tuberous sclerosis complex.

Clinical trials20 trials listed for Rett syndromeEvery trial the registry lists for Rett syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Rett syndrome researchLatest monthly update: September 2026. Includes: Seizure add-on drug. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Nov 30, 2018
Primary completion
Jun 30, 2026 (estimated)
Study completion
Dec 31, 2026 (estimated)
Target enrollment
120 participants (estimated)
Last updated on registry
Jul 13, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
RTI International
Principal investigator
Anne Wheeler, Senior Public Health Research Analyst
RTI International
Collaborators
  • University of North Carolina, Chapel Hill

Participating sites (1)

  • RTI International

    Research Triangle Park, North Carolina, 27709 · United States

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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