NCT03836300Enrolling by invitation
Parent and Infant Inter(X)Action Intervention (PIXI)
Piloting an Early Intervention Program for Infants With Rare Neurogenetic Disorders
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 7 Feb 2019
- Start date
- 30 Nov 2018
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- RTI International
- Diseases
- Duchenne muscular dystrophy
- NCT number
- NCT03836300
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 30 Nov 2018 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- \- Infants may not be blind or have a severe hearing impairment as the intervention and assessments are not appropriate for these children.
Who the study is looking for
- 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.
Age in the registry: - to 99 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RTI International Coordinator of this site? Confirm its status | Research Triangle Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.