Clinical trial · Interventional
Parent and Infant Inter(X)Action Intervention (PIXI)
Piloting an Early Intervention Program for Infants With Rare Neurogenetic Disorders
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Angelman Syndrome | — | UNRESOLVED | — |
| Chromosome 22q11.2 Deletion Syndrome | — | UNRESOLVED | — |
| Down Syndrome | — | UNRESOLVED | — |
| Duchenne Muscular Dystrophy | — | UNRESOLVED | — |
| Dup15Q Syndrome | — | UNRESOLVED | — |
| Fragile X Syndrome | — | UNRESOLVED | — |
| Klinefelter Syndrome | — | UNRESOLVED | — |
| Phelan-McDermid Syndrome | — | UNRESOLVED | — |
| Prader-Willi Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Parent-Infant Inter(X)action Intervention (PIXI) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Infants with a rare neurogenetic condition and their parent/primary caregiver(s)
- description
- PIXI
- interventionNames
- Behavioral: Parent-Infant Inter(X)action Intervention (PIXI)
Primary outcomes (4)
- measure
- Social Validity and Acceptability
- timeFrame
- Completion of Phase 1 (approximately six months of age)
- description
- A social validity measure will be completed to better understand to inquire about family satisfaction with aspects of the intervention including curriculum, timing, goals targeted, and perceived effects of the intervention.
- measure
- Social Validity and Acceptability
- timeFrame
- Completion of Phase 2 (approximately twelve months of age)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available