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PIXI for Neurogenetic Disorders
N/A
Waitlist Available
Led By Anne Wheeler, PhD
Research Sponsored by RTI International
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
English must be the primary language spoken in the home because all assessment measures and intervention protocol are in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a program called PIXI, which helps parents of infants with genetic disorders. The program educates parents about their baby's condition, coaches them on how to interact with their baby, and provides family support. The goal is to improve the baby's development and family well-being.
Who is the study for?
This trial is for infants under 12 months old diagnosed with certain neurogenetic disorders, such as Down Syndrome or Duchenne Muscular Dystrophy. The family must primarily speak English at home. Infants who are blind or have severe hearing impairments cannot participate.
What is being tested?
The PIXI program is being tested to support infant development and help parents of children with neurogenetic disorders. It includes parent education, coaching on interaction with their child, and well-being support, along with assessments of the child's and family's progress.
What are the potential side effects?
Since PIXI is a non-medical intervention focusing on education and coaching, there are no direct medical side effects. However, participating families may experience changes in daily routines or emotional responses due to the nature of the intervention.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
English is the main language spoken in my home.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completion of phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fidelity
Social Validity and Acceptability
Secondary study objectives
Autism Symptoms
Early Developmental Outcomes
Parent Implementation and Engagement
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Infants with a rare neurogenetic condition and their parent/primary caregiver(s)Experimental Treatment1 Intervention
PIXI
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Rett Syndrome that align with the Parent and Infant Inter(X)action Intervention (PIXI) approach include physical, occupational, and communication therapies. These treatments focus on enhancing motor skills, promoting purposeful hand use, and improving communication abilities.
Physical therapy helps maintain mobility and balance, occupational therapy encourages the use of hands for functional activities, and communication therapy aims to enhance interaction skills. These interventions are crucial as they support the overall development and quality of life for Rett Syndrome patients by addressing their specific motor and communication challenges, thereby fostering greater independence and social engagement.
Paediatric Autism Communication Therapy-Generalised (PACT-G) against treatment as usual for reducing symptom severity in young children with autism spectrum disorder: study protocol for a randomised controlled trial.
Paediatric Autism Communication Therapy-Generalised (PACT-G) against treatment as usual for reducing symptom severity in young children with autism spectrum disorder: study protocol for a randomised controlled trial.
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillOTHER
1,561 Previous Clinical Trials
4,298,621 Total Patients Enrolled
1 Trials studying Prader-Willi Syndrome
30,000 Patients Enrolled for Prader-Willi Syndrome
RTI InternationalLead Sponsor
196 Previous Clinical Trials
841,986 Total Patients Enrolled
2 Trials studying Prader-Willi Syndrome
30,102 Patients Enrolled for Prader-Willi Syndrome
Anne Wheeler, PhDPrincipal InvestigatorRTI International
2 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant was diagnosed through screening, not just because of my concerns.English is the main language spoken in my home.My child is not blind and does not have severe hearing loss.
Research Study Groups:
This trial has the following groups:- Group 1: Infants with a rare neurogenetic condition and their parent/primary caregiver(s)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.