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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

Study Summary

This trial will test the feasibility and effectiveness of PIXI in a sample of infants with neurogenetic disorders.

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.Check my eligibility

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.See study design

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 below

Select...

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fidelity

Social Validity and Acceptability

Secondary outcome measures

Autism Symptoms

Early Developmental Outcomes

Parent Implementation and Engagement

Trial Design

1Treatment groups

Experimental Treatment

Group I: Infants with a rare neurogenetic condition and their parent/primary caregiver(s)Experimental Treatment1 Intervention

PIXI

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER

1,506 Previous Clinical Trials

4,190,441 Total Patients Enrolled

1 Trials studying Rett Syndrome

30,000 Patients Enrolled for Rett Syndrome

RTI InternationalLead Sponsor

188 Previous Clinical Trials

875,844 Total Patients Enrolled

2 Trials studying Rett Syndrome

35,000 Patients Enrolled for Rett Syndrome

Anne Wheeler, PhDPrincipal InvestigatorRTI International

2 Previous Clinical Trials

10 Total Patients Enrolled

Media Library

Parent-Infant Inter(X)Action Intervention (PIXI) Clinical Trial Eligibility Overview. Trial Name: NCT03836300 — N/A

Rett Syndrome Research Study Groups: Infants with a rare neurogenetic condition and their parent/primary caregiver(s)

Rett Syndrome Clinical Trial 2023: Parent-Infant Inter(X)Action Intervention (PIXI) Highlights & Side Effects. Trial Name: NCT03836300 — N/A

Parent-Infant Inter(X)Action Intervention (PIXI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03836300 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current participants in this investigation?

"According to clinicaltrials.gov, this trial is no longer searching for participants; the initial posting date was November 30 2018 and last edit was on February 23rd 2022. Nevertheless, there are an abundance of other studies actively looking for patients at this time with a total count of 1,506 trials."

Answered by AI

What is the aim of this experimental endeavor?

"The principal goal of this research, evaluated over the course of twelve months, is to assess Fidelity. In order to evaluate parent engagement and autism symptoms, internal implementation forms and Repetitive Behavior Scales (RBS) will be used respectively. Lastly, in order to measure potential signs of ASD in infants aged 6-18 months old The Autism Observation Scale for Infants (AOSI) will be employed with a score ranging from 0-38 indicating symptomatology associated with an ASD."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Parent-Infant Inter(X)Action Intervention (PIXI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03836300.

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