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

Summary

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

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

Interventions

BEHAVIORAL

Parent-Infant Inter(X)action Intervention (PIXI)

Psychoeducation around the diagnosed disorder, early development, and service navigation along with parent-child interaction activities, parent coaching, and family/parent well-being support.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill

  collaborator OTHER

• RTI International

  lead OTHER

Principal Investigators

• Anne Wheeler, PhD · RTI International

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-11-30

Primary Completion

2026-06-30

Completion

2026-12-31

Countries

• United States

Study Locations