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

NCT03836300 | Enrolling By Invitation

• 1 other identifier: 18-2079
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

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

Keywords

Early intervention; Parent-Child interaction; Rare Neurogenetic Conditions; Intellectual and Developmental Disabilities

Outcome Measures

Primary Outcomes (4)

• Social Validity and Acceptability

  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.

  Completion of Phase 1 (approximately six months of age)

• Social Validity and Acceptability

  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. Qualitative interviewing will be also be conducted to examine parent perceptions of feasibility and acceptability.

  Completion of Phase 2 (approximately twelve months of age)

• Fidelity

  Overall intervention fidelity will be measured by determining if the following goals were achieved: Enrollment target of 10-15 families 80% retention rate with at least 75% completing the 20 sessions across Phase 1 and Phase 2

  Completion of Phase 1 (approximately six months of age)

• Fidelity

  Overall intervention fidelity will be measured by determining if the following goals were achieved: Enrollment target of 10-15 families 80% retention rate with at least 75% completing the 20 sessions across Phase 1 and Phase 2

  Completion of Phase 2 (approximately twelve months of age)

Secondary Outcomes (7)

• Parent Implementation and Engagement

  Across phase 1 and phase 2 engagement (approximately ages 6-months through 1-year of age)

• Early Developmental Outcomes

  Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)

• Autism Symptoms

  Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)

• Autism Symptoms

  Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)

• Autism Symptoms

  Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)

Study Arms (1)

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

EXPERIMENTAL

PIXI

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

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.

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

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Infants may not be blind or have a severe hearing impairment as the intervention and assessments are not appropriate for these children.

Sponsors & Collaborators

• RTI International: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

RTI International

Research Triangle Park, North Carolina, 27709, United States

Location

MeSH Terms

Conditions

Fragile X Syndrome; Angelman Syndrome; Prader-Willi Syndrome; Muscular Dystrophy, Duchenne; Telomeric 22q13 Monosomy Syndrome; Rett Syndrome; Smith-Magenis Syndrome; Williams Syndrome; Turner Syndrome; Klinefelter Syndrome; DiGeorge Syndrome; Tuberous Sclerosis; Down Syndrome; Developmental Disabilities

Condition Hierarchy (Ancestors)

X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Heredodegenerative Disorders, Nervous System; Movement Disorders; Central Nervous System Diseases; Abnormalities, Multiple; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Chronobiology Disorders; Aortic Stenosis, Supravalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Gonadal Disorders; Endocrine System Diseases; Hypogonadism; 22q11 Deletion Syndrome; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Lymphatic Abnormalities; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypoparathyroidism; Parathyroid Diseases; Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Neurocutaneous Syndromes; Neurodegenerative Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Anne Wheeler, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Public Health Research Analyst

Model Details: The intervention, called Parent-infant Interaction Intervention (PIXI) is a comprehensive intervention provided across the first year of life for parents/caregivers of infants identified with a rare neurogenetic disorder. It includes psychoeducation around the disorder, early development, and service navigation along with parent-child interaction activities, parent coaching, and family/parent well-being support.

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 11, 2019
• Study Start: November 30, 2018
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)