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

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. 2 versions Re-verified since Jul 28, 2025, no change to tracked fieldsv9-v10
  2. Primary completion date: Dec 31, 2024 to Jun 30, 2026
    • Study completion date: Jun 30, 2025 to Dec 31, 2026
    v8
  3. Eligibility criteria revised
    • Study title expanded, about 2 words
    v7
  4. Primary completion date: Dec 1, 2022 to Dec 31, 2024
    • Study completion date: Dec 31, 2022 to Jun 30, 2025
    v6
  5. Primary endpoints: 2 to 4v5 Show 6 more changesShow less
    • Study completion date: Dec 1, 2022 to Dec 31, 2022
    • Interventions: Parent-Infant fragile x Intervention (PIXI) (Behavioral) to Parent-Infant Inter(X)action Intervention (PIXI) (Behavioral)
    • Eligibility criteria expanded, about 67 words
    • Secondary endpoints: 8 to 7
    • Study description shortened, about 115 words
    • Study title shortened, about 4 words
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Primary endpoints: 4 to 2
    • Secondary endpoints: details revised at 1 of 8 entries
    v3
  3. Primary endpoints revised (4)
    • Secondary endpoints revised (8)
    • Study description expanded, about 1 word
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03836300
Lead Sponsor RTI International
Collaborators: University of North Carolina, Chapel Hill
Conditions
(from sponsor)		 Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, Dup15Q Syndrome, Duchenne Muscular Dystrophy, Phelan-McDermid Syndrome, Rett Syndrome, Smith Magenis Syndrome +6 more
Related terms Angelman Syndrome, Developmental Disabilities, DiGeorge Syndrome, Down Syndrome, Fragile X Syndrome, Klinefelter Syndrome, Muscular Dystrophy, Duchenne, Prader-Willi Syndrome, Rett Syndrome, Smith-Magenis Syndrome, Telomeric 22q13 Monosomy Syndrome, Tuberous Sclerosis, Turner Syndrome, Williams Syndrome
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov