Early program for parents of babies with rare genetic developmental disorders
Tests a parent coaching program for infants under one with rare neurogenetic disorders.
Plain-language title generated from the registry record
Registry title: Parent and Infant Inter(X)Action Intervention (PIXI)
Key facts
- Where
- Research Triangle Park, United StatesSee the site
Where in United States
- RTI InternationalResearch Triangle Park, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- RTI International
- Trial code
- NCT03836300
- Record updated
- 13 July 2026
- Original description
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.Read full original descriptionShow less
Piloting an Early Intervention Program for Infants With Rare Neurogenetic Disorders
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.
Inclusion: 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: Infants may not be blind or have a severe hearing impairment as the intervention and assessments are not appropriate for these children.