PIXI for Neurogenetic Disorders

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: RTI International

Disqualifiers: Blindness, Severe hearing impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Parent and Infant Inter(X)action Intervention (PIXI), a program designed to support infants with neurogenetic disorders, such as Down syndrome or fragile X syndrome, who experience developmental delays. The program educates parents about early development, coaches them on parent-child interactions, and supports family well-being. Infants suitable for this trial should have a confirmed neurogenetic disorder diagnosis within their first year of life and reside in a household where English is the primary language. As an unphased trial, this study offers families the chance to contribute to groundbreaking research that could enhance early developmental support for infants with neurogenetic disorders.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that the Parent-Infant Inter(X)Action Intervention (PIXI) is safe for infants with neurogenetic disorders?

Research has shown that the Parent and Infant Inter(X)action Intervention (PIXI) has been tested in early studies to assess its acceptance and safety for infants with genetic disorders affecting the brain. These studies examine how parents and infants interact and support each other. So far, no serious side effects have been reported, suggesting that PIXI is well-tolerated by both parents and infants. The main goal of PIXI is to educate and support parents while helping infants develop better skills. Since this program involves education and coaching rather than medication, it generally poses a low risk of harm. Overall, the available data suggests that PIXI is a safe choice for families seeking to improve developmental outcomes in infants with certain genetic conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parent-Infant Inter(X)Action Intervention (PIXI) because it offers a unique approach to addressing neurogenetic disorders in infants. Unlike traditional treatments that often focus on medication or physical therapy, PIXI emphasizes the importance of interaction between infants and their primary caregivers. This method aims to enhance developmental outcomes by leveraging the natural bond between parent and child, potentially leading to more personalized and effective care. The focus on early intervention and the relational aspect of treatment is what sets PIXI apart from existing options.

What evidence suggests that the Parent-Infant Inter(X)Action Intervention (PIXI) is effective for neurogenetic disorders?

Research has shown that early intervention can improve outcomes for babies with genetic brain disorders. The Parent and Infant Inter(X)action Intervention (PIXI), provided to participants in this trial, aims to strengthen the bond between parents and their babies and support family well-being. Early results from similar programs suggest improvements in child development and family relationships. Although specific data on PIXI is not yet available, it is based on proven methods. The program focuses on teaching parents how to interact with their babies, a practice shown to benefit infant development. ^{1 2 3 6 7}

Who Is on the Research Team?

Anne Wheeler, PhD

Principal Investigator

RTI International

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My infant was diagnosed through screening, not just because of my concerns.

English is the main language spoken in my home.

Exclusion Criteria

My child is not blind and does not have severe hearing loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Intervention

Development and testing of the PIXI intervention with a pilot sample of families, focusing on parent education and direct parent coaching

Approximately 6 months

20 sessions

Phase 2 Intervention

Continuation of the PIXI intervention, focusing on family and child functioning assessments and examining feasibility and acceptability

Approximately 6 months

Follow-up

Participants are monitored for early developmental outcomes and autism symptoms

Approximately 30 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview 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.

How Is the Trial Designed?

Group I: Infants with a rare neurogenetic condition and their parent/primary caregiver(s) Experimental Treatment 1 Intervention

PIXI

Who Is Running the Clinical Trial?

RTI International

Lead Sponsor

Trials

201

Recruited

942,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03836300

Parent and Infant Inter(X)Action Intervention (PIXI) Participants will be infants with a confirmed diagnosis of a neurogenetic disorder (e.g., fragile X, Angelman, Prader-Willi, Dup15q, Phelan-McDermid, Rhett, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10159119/

Pilot protocol for the Parent and Infant Inter(X)action ... This paper provides the detailed protocol for a pilot study testing the feasibility, acceptability, and initial efficacy of a targeted two-phase ...

3. trials.tscalliance.org trials.tscalliance.org/trials/NCT03836300

Parent and Infant Inter(X)Action Intervention (PIXI) - Tuberous ... 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 ...

4. withpower.com withpower.com/trial/phase-fragile-x-syndrome-10-2018-cdd1b

PIXI for Neurogenetic Disorders · Info for Participants The PIXI treatment is designed to help parents support their infants with neurogenetic conditions, and while direct effectiveness data is not available, similar ...

5. angelman.org angelman.org/clinical_trials/parent-and-infant-interxaction-intervention-pixi/

Parent and Infant Inter(X)Action Intervention (PIXI) The objective is to develop and test, through an iterative process, an intervention to address and support the development of infants with a confirmed.

6. medrxiv.org medrxiv.org/content/10.1101/2022.06.07.22276083v1.full-text

Pilot Protocol for the Parent and Infant Inter(X)action ... This paper provides the detailed protocol for a pilot study testing the feasibility, acceptability, and initial efficacy of a targeted ...

7. rti.org rti.org/publication/pilot-protocol-parent-infant-inter-x-action-intervention-pixi-feasibility-study

Pilot protocol for the parent and infant inter(X)action ... The Parent and Infant Inter(X)action Intervention (PIXI) is designed to support parents and infants with a NGC diagnosed in the first year of life. PIXI is ...