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

Part of paid clinical trials in Research Triangle Park, North Carolina.

Sponsor
RTI International
Study ID
NCT03836300
Status
Enrolling By Invitation

Conditions

  • Angelman Syndrome
  • Chromosome 22q11.2 Deletion Syndrome
  • Down Syndrome
  • Duchenne Muscular Dystrophy
  • Dup15Q Syndrome
  • Fragile X Syndrome
  • Klinefelter Syndrome
  • Phelan-McDermid Syndrome
  • Prader-Willi Syndrome
  • Rett Syndrome
  • Smith Magenis Syndrome
  • Tuberous Sclerosis
  • Turner Syndrome
  • Williams Syndrome

Eligibility Criteria

Sex
ALL
Age
N/A - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Parent-Infant Inter(X)action Intervention (PIXI) — BEHAVIORAL
    Psychoeducation around the diagnosed disorder, early development, and service navigation along with parent-child interaction activities, parent coaching, and family/parent well-being support.

Study Details

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.

Key Dates

Start date
Nov 30, 2018
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Infants with a rare neurogenetic condition and their parent/primary caregiver(s)
    PIXI

Primary Outcome Measure

Social Validity and Acceptability [ Time Frame: Completion of Phase 1 (approximately six months of age) ]

Locations (1)

FacilityCityStateZIPSite coordinators
RTI InternationalResearch Triangle ParkNorth Carolina27709-

Find similar trials in Research Triangle Park, NC

By condition
Duchenne muscular dystrophy
By specialty
Pediatrics
By research site
RTI International· Research Triangle Park, NC

Related Studies