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

RTI International

Status: Invitation-only

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03836300

18-2079

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: Under 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

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

Experimental group

Description:

PIXI

Treatment:

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