Pilot Study: A Parent-Infant Fragile X Intervention (PIXI)
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/14/2019 |
| Start Date: | November 30, 2018 |
| End Date: | December 1, 2022 |
Piloting an Early Intervention Program for Infants With Fragile X Syndrome
The objective of this study is to develop and test, through an iterative process, an
intervention to address and support the development of infants with a confirmed diagnosis of
fragile X syndrome (FXS). This project will capitalize and expand upon existing empirically
based interventions designed to improve outcomes for infants with suspected developmental and
social delays.
Participants will be newborns with a confirmed diagnosis of FXS.
The intervention, called Parent-infant fragile X Intervention (PiXI) will consist of two
phases. Phase 1 will include parent education about early infant development and FXS. Phase 2
includes direct parent coaching around parent-child interaction based on an empirically based
parent-mediated early intervention and repeated comprehensive assessments of family and child
functioning.
intervention to address and support the development of infants with a confirmed diagnosis of
fragile X syndrome (FXS). This project will capitalize and expand upon existing empirically
based interventions designed to improve outcomes for infants with suspected developmental and
social delays.
Participants will be newborns with a confirmed diagnosis of FXS.
The intervention, called Parent-infant fragile X Intervention (PiXI) will consist of two
phases. Phase 1 will include parent education about early infant development and FXS. Phase 2
includes direct parent coaching around parent-child interaction based on an empirically based
parent-mediated early intervention and repeated comprehensive assessments of family and child
functioning.
Fragile X syndrome (FXS) is the leading known single-gene cause of autism spectrum disorder
(ASD) and the most common inherited form of intellectual disability, resulting in significant
functional impairments. Despite documentation that symptoms emerge in the first year of
life), the average age of diagnosis is 3 years of age for males with FXS. Females with FXS
are often diagnosed even later as they typically have a less severe phenotype. The delay of
diagnosis can reduce timely access to interventions that could have significant consequences
for the developmental trajectories of these children. Furthermore, the delay in diagnosis has
significantly limited the ability of researchers to understand the natural progression of
symptomology and thereby better address treatment options.
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 confirmed
diagnosis of FXS who are identified at birth. 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 FXS.
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. Specific infant outcomes include
communication, motor, cognitive skills and autism spectrum disorder symptoms. Parental
outcomes include parenting efficacy.
(ASD) and the most common inherited form of intellectual disability, resulting in significant
functional impairments. Despite documentation that symptoms emerge in the first year of
life), the average age of diagnosis is 3 years of age for males with FXS. Females with FXS
are often diagnosed even later as they typically have a less severe phenotype. The delay of
diagnosis can reduce timely access to interventions that could have significant consequences
for the developmental trajectories of these children. Furthermore, the delay in diagnosis has
significantly limited the ability of researchers to understand the natural progression of
symptomology and thereby better address treatment options.
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 confirmed
diagnosis of FXS who are identified at birth. 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 FXS.
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. Specific infant outcomes include
communication, motor, cognitive skills and autism spectrum disorder symptoms. Parental
outcomes include parenting efficacy.
Inclusion Criteria:
- Infants identified with FXS prior to 2 months of age with parents/caregivers who speak
English
Exclusion Criteria:
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