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NCT03836300

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

Enrolling by Invitation
NAUp to 99InterventionalTreatment
RTI International
~120 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Parent-Infant Inter(X)action Intervention (PIXI)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Social Validity and Acceptability
Measured over Completion of Phase 1 (approximately six months of age)
+3 more outcomes measured

Conditions

Fragile X Syndrome
Angelman Syndrome
Prader-Willi Syndrome
Dup15Q Syndrome
Duchenne Muscular Dystrophy
Phelan-McDermid Syndrome
Rett Syndrome
Smith Magenis Syndrome
Williams Syndrome
Turner Syndrome
Klinefelter Syndrome
Chromosome 22q11.2 Deletion Syndrome
Tuberous Sclerosis
Down Syndrome

Explore related trials

22q11.2 Deletion SyndromeAngelman SyndromeDown SyndromeDuchenne Muscular DystrophyDup15q syndromeFragile X SyndromeKlinefelter SyndromePhelan-McDermid SyndromePrader-Willi SyndromeRare Neurogenetic ConditionsRett SyndromeSmith-Magenis SyndromeTuberous SclerosisTurner SyndromeWilliams Syndrome

NCT03836300

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • RTI International

    Research Triangle Park, North Carolinano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Anne Wheeler, PhD · PRINCIPAL_INVESTIGATOR · RTI International

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Infants 15 months of age or younger who have received a diagnosis which was not sought solely due to parental concerns about the infant (e.g. diagnosis due to prenatal or newborn screening, cascade testing following diagnosis of a family member).
English must be the primary language spoken in the home because all assessment measures and intervention protocol are in English.

What this trial measures

  • Social Validity and AcceptabilityCompletion of Phase 1 (approximately six months of age)

    A social validity measure will be completed to better understand to inquire about family satisfaction with aspects of the intervention including curriculum, timing, goals targeted, and perceived effects of the intervention.

  • Social Validity and AcceptabilityCompletion of Phase 2 (approximately twelve months of age)

    A social validity measure will be completed to better understand to inquire about family satisfaction with aspects of the intervention including curriculum, timing, goals targeted, and perceived effects of the intervention. Qualitative interviewing will be also be conducted to examine parent perceptions of feasibility and acceptability.

  • FidelityCompletion of Phase 1 (approximately six months of age)

    Overall intervention fidelity will be measured by determining if the following goals were achieved: Enrollment target of 10-15 families 80% retention rate with at least 75% completing the 20 sessions across Phase 1 and Phase 2

  • FidelityCompletion of Phase 2 (approximately twelve months of age)

    Overall intervention fidelity will be measured by determining if the following goals were achieved: Enrollment target of 10-15 families 80% retention rate with at least 75% completing the 20 sessions across Phase 1 and Phase 2