What side effects are associated with this type of intervention?

The most common treatments for Rett Syndrome that align with the Parent and Infant Inter(X)action Intervention (PIXI) include parent education, direct parent coaching, and family/parent well-being support. These interventions are generally considered safe and focus on improving parent-child interactions and developmental outcomes. Known side effects are minimal and primarily involve the emotional and psychological strain on parents as they learn and implement new strategies. There may also be a temporary increase in stress or anxiety as families adjust to the new routines and expectations. However, these interventions do not carry significant medical risks and are designed to support the overall well-being of both the child and the family.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Rett Syndrome. However, treatment approaches often focus on managing symptoms and improving quality of life through supportive therapies. These include physical therapy, speech therapy, and occupational therapy, which align with the goals of the PIXI trial in enhancing parent-child interactions and developmental outcomes. The PIXI trial's emphasis on parent education, direct parent coaching, and family well-being support is crucial in managing the complex needs of children with Rett Syndrome.

What other types of research exist?

Promising, novel alternatives to the Parent and Infant Inter(X)action Intervention (PIXI) for Rett Syndrome patients in 2024 include: 1) The TEACCH program, which provides structured teaching and support for both parents and children with autism spectrum disorders, emphasizing individualized interventions and parent training. 2) Joint Attention Symbolic Play Engagement and Regulation (JASPER), which focuses on improving social communication skills through parent-mediated interventions. 3) Early Start Denver Model (ESDM), an evidence-based early intervention approach that integrates behavioral and developmental principles, involving parents as active participants in their child's learning. 4) Online parent training programs for executive function intervention, which offer accessible, flexible training options for parents to support their child's development. These alternatives provide comprehensive support and have shown effectiveness in enhancing developmental outcomes and parent-child interactions.

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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 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

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

0 / 1Eligibility criteria met

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.