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

NCT ID: NCT03836300

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2026-12-31

Brief 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.

Detailed Description

The primary goal of the proposed project is to develop and test, through an iterative process, an intervention to address and support the development of infants with a rare neurogenetic condition (e.g., fragile X, Angelman, Prader-Willi, Dup15q, Phelan-McDermid, Rhett, Smith Magenis, Williams, Turner, Kleinfelter, Down syndromes, Duchenne muscular dystrophy) identified prior to emergence of symptoms. PiXI aims to utilize the foundational knowledge available around the development of and early intervention for at-risk infants to both understand the needs of and provide intervention services for families of infants diagnosed pre-symptomatically with rare neurogenetic disorders.

The investigators aim to 1) develop PIXI with a pilot sample of families, 2) test the preliminary effects of PIXI on infant and parent outcomes

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Infants with a rare neurogenetic condition and their parent/primary caregiver(s)

PIXI

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: lead

Responsible Party

Anne Wheeler

Senior Public Health Research Analyst

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Wheeler, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

RTI International

Research Triangle Park, North Carolina, United States

Countries

United States

Other Identifiers

18-2079

Identifier Type: -

Identifier Source: org_study_id