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Набор по приглашению NCT03836300

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

Без фазы С лечением Fragile X Syndrome Angelman Syndrome Prader-Willi Syndrome Dup15Q Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Parent-Infant Inter(X)action Intervention (PIXI).
Кому может быть актуально
Состояния в реестре: Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, Dup15Q Syndrome. Базовые параметры: до 99 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Piloting an Early Intervention Program for Infants With Rare Neurogenetic Disorders

Обзор

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 of a neurogenetic disorder with associated developmental delays or intellectual and developmental disabilities. The proposed project will capitalize and expand upon existing empirically based interventions designed to improve outcomes for infants with suspected developmental delays. Participants will be infants with a confirmed diagnosis of a neurogenetic disorder (e.g., fragile X, Angelman, Prader-Willi, Dup15q, Phelan-McDermid, Rhett, Smith Magenis, Williams, Turner, Kleinfelter, Down syndromes, Duchenne muscular dystrophy) within the first year of life and their parents/caregivers. The intervention, called the Parent and Infant Inter(X)action Intervention (PIXI) is a comprehensive program inclusive of parent education about early infant development and the neurogenetic disorder for which they were diagnosed, direct parent coaching around parent-child interaction, and family/parent well-being support. The protocol includes repeated comprehensive assessments of family and child functioning, along with an examination of feasibility and acceptability of the program.

Подробное описание

The primary goal of the proposed project is to develop and test, through an iterative process, an intervention to address and support the development of infants with a rare neurogenetic condition (e.g., fragile X, Angelman, Prader-Willi, Dup15q, Phelan-McDermid, Rhett, Smith Magenis, Williams, Turner, Kleinfelter, Down syndromes, Duchenne muscular dystrophy) identified prior to emergence of symptoms. PiXI aims to utilize the foundational knowledge available around the development of and early intervention for at-risk infants to both understand the needs of and provide intervention services for families of infants diagnosed pre-symptomatically with rare neurogenetic disorders.

The investigators aim to 1) develop PIXI with a pilot sample of families, 2) test the preliminary effects of PIXI on infant and parent outcomes

Вмешательства

  • Поведенческое Parent-Infant Inter(X)action Intervention (PIXI)
    Psychoeducation around the diagnosed disorder, early development, and service navigation along with parent-child interaction activities, parent coaching, and family/parent well-being support.

Первичные конечные точки

  • Social Validity and Acceptability [Срок оценки: Completion of Phase 1 (approximately six months of age)]
  • Social Validity and Acceptability [Срок оценки: Completion of Phase 2 (approximately twelve months of age)]
  • Fidelity [Срок оценки: Completion of Phase 1 (approximately six months of age)]
  • Fidelity [Срок оценки: Completion of Phase 2 (approximately twelve months of age)]
Вторичные конечные точки (7)
  • Parent Implementation and Engagement [Срок оценки: Across phase 1 and phase 2 engagement (approximately ages 6-months through 1-year of age)]
  • Early Developmental Outcomes [Срок оценки: Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)]
  • Autism Symptoms [Срок оценки: Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)]
  • Autism Symptoms [Срок оценки: Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)]
  • Autism Symptoms [Срок оценки: Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)]
  • Autism Symptoms [Срок оценки: Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)]
  • Autism Symptoms [Срок оценки: Completion of Phase 1 (approximately 6-months of age) and completion of follow-up (approximately 36-months of age)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

\- Infants may not be blind or have a severe hearing impairment as the intervention and assessments are not appropriate for these children.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • RTI International — Research Triangle Park

Идентификаторы

NCT: NCT03836300 · 18-2079

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗