Parent and Infant Inter(X)Action Intervention (PIXI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parent-Infant Inter(X)action Intervention (PIXI).
- Who it may be relevant to
- Registry conditions: Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, Dup15Q Syndrome. Basic parameters: up to 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Piloting an Early Intervention Program for Infants With Rare Neurogenetic Disorders
Overview
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
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.
Primary outcome measures
- Social Validity and Acceptability [Time frame: Completion of Phase 1 (approximately six months of age)]
- Social Validity and Acceptability [Time frame: Completion of Phase 2 (approximately twelve months of age)]
- Fidelity [Time frame: Completion of Phase 1 (approximately six months of age)]
- Fidelity [Time frame: Completion of Phase 2 (approximately twelve months of age)]
Secondary outcome measures (7)
- Parent Implementation and Engagement [Time frame: Across phase 1 and phase 2 engagement (approximately ages 6-months through 1-year of age)]
- Early Developmental Outcomes [Time frame: Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)]
- Autism Symptoms [Time frame: Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)]
- Autism Symptoms [Time frame: Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)]
- Autism Symptoms [Time frame: Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)]
- Autism Symptoms [Time frame: Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)]
- Autism Symptoms [Time frame: Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- RTI International — Research Triangle Park
Identifiers
NCT: NCT03836300 · 18-2079