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Executive Function Play Opportunities for Children With Down Syndrome (EXPO)

25 августа 2026 г. обновлено: Colorado State University

Executive Function Intervention for Young Children With Down Syndrome

The Executive Function Play Opportunities (EXPO) study is a sequential, multiple assignment, randomized trial (SMART) evaluating adaptive caregiver-mediated intervention pathways for improving executive function (EF) in children with Down syndrome (DS). At baseline, participants will be randomized in a 1:4 ratio to receive either a delayed-treatment control condition or the EXPO intervention. After 4 weeks of standard EXPO intervention in stage 1, participants in the EXPO condition will be assessed for response to the intervention based on prespecified criteria for improvement in laboratory-based EF performance. Early responders will continue with the standard EXPO intervention in stage 2. Slower responders will be randomized to either the EXPO Extended or EXPO Foundations pathway. All participants will complete laboratory and parent-report measures of EF immediately post-intervention and 3 months later. Participants in the delayed-treatment control condition will complete the same assessments as the EXPO groups and will be offered the EXPO intervention after completion of the 3-month follow-up.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

The Executive Function Play Opportunities (EXPO) study is a sequential, multiple assignment, randomized trial (SMART) evaluating adaptive caregiver-mediated intervention pathways for improving executive function (EF) in children with Down syndrome (DS). At baseline, all participants will complete an assessment including laboratory-based measures of EF, parent-report measures of EF, and intensive ecological measurement of EF using the iBehavior app. Participants will then be randomized in a 1:4 ratio to receive either a delayed-treatment control condition or the EXPO intervention, with a target total sample size of 150.

During stage 1, participants in the EXPO condition will complete 4 weeks of standard EXPO intervention. The initial weeks of EXPO consist of 2 weeks of EXPO Ready activities followed by 2 weeks of Working Memory activities, and all participants in the EXPO intervention receive ongoing support from an EXPO coach.

At the stage 1 evaluation, conducted 4 weeks after starting EXPO, all participants will complete the laboratory-based EF assessment battery. EXPO participants will be assessed for response to the intervention and classified as early or slower responders based on prespecified criteria for improvement in laboratory-based EF performance.

Early responders will be assigned to the standard EXPO intervention in stage 2 and continue with activities targeting inhibition, cognitive flexibility, planning, and consolidation of skills for a total of 12 weeks. Slower responders will be randomly assigned in a 1:1 ratio to either the EXPO Extended or EXPO Foundations pathway. The EXPO Extended pathway will include the same core activities as the EXPO standard pathway but will provide additional intervention time, for a total of 18 weeks. The EXPO Foundations pathway will begin with a block of activities targeting early social communication and regulation to provide a foundation for activity engagement, followed by more foundational versions of activities targeting inhibition and cognitive flexibility. The EXPO Foundations pathway will continue for a total of 12 weeks.

All participants will complete laboratory and parent-report measures of EF immediately post-intervention and 3 months later. Participants in the delayed-treatment control condition will not receive EXPO during the initial study period but will complete the same assessments as participants in the EXPO intervention. Following completion of the 3-month follow-up, participants in the delayed-treatment control condition will be offered the EXPO intervention.

Тип исследования

Интервенционный

Регистрация (Оцененный)

150

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Учебное резервное копирование контактов

Места учебы

  • Италия
    • CO
      • Padova, CO, Италия, 80526
        • University of Padova
        • Контакт:
  • Соединенные Штаты
    • Colorado
      • Fort Collins, Colorado, Соединенные Штаты, 80523
        • Colorado State University
        • Главный следователь:
          • Deborah Fidler, PhD
        • Контакт:
        • Контакт:
        • Младший исследователь:
          • Nathaniel Riggs, Phd
        • Младший исследователь:
          • Susan Hepburn, PhD
        • Младший исследователь:
          • Lisa Daunhauer, ScD

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  • confirmed medical diagnosis of Down syndrome

Exclusion Criteria:

  • no complete hearing or vision loss
  • primary exposure to English or Italian

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Последовательное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Без вмешательства: Delayed-Treatment Control
Participants do not receive EXPO during the initial study period and complete the same EF assessments as participants in the EXPO intervention pathways. Participants are offered the EXPO intervention following completion of the 3-month follow-up.
Экспериментальный: EXPO Standard Pathway
Early responders to EXPO at the stage 1 evaluation are assigned to the standard, 12 -week intervention with activities refined from EXPO 2.0.
Поведенческий: EXPO
EXPO is a novel intervention that targets the development of EF through play-based opportunities for children with DS and their primary caregivers. EXPO is a 'syndrome-informed' intervention in that all activities are tailored to phenotypic strengths and challenges associated with DS, accounting for cognitive, language, and motor presentations frequently observed in this population. EXPO is also designed to elicit maximal engagement and enjoyment for children and their caregivers by embedding opportunities to strengthen EF component processes in the context of play and games.
Другие имена:
  • Executive Function Play Opportunities
Активный компаратор: Adaptive Pathway 1/EXPO Extended
Half of participants classified as slower responders to EXPO at the stage 1 evaluation are randomly assigned to EXPO Extended. EXPO Extended provides the standard pathway activities with an extended 18-week schedule.
Поведенческий: EXPO Extended
Alternative EXPO pathway that extends the length of the EXPO intervention from 12 to 18 weeks to provide more time and opportunity for skill acquisition.
Активный компаратор: Adaptive Pathway 2/EXPO Foundations
Half of participants classified as slower responders to EXPO at the stage 1 evaluation are randomly assigned to EXPO Foundations. EXPO Foundations provides a more foundational pathway with simplified activities, and additional activities that emphasize early communication and regulatory processes.
Поведенческий: EXPO Foundations
An augmented version of EXPO that places a greater emphasis on precursors to EXPO activity engagement, including an increased number of social routine activities, enhanced presses for social communication behaviors like joint attention, enhanced focus on early self-regulation skills, and adaptations of all EXPO activities in each block that emphasize more foundational aspects of play.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Adapted Reverse Categorization
Временное ограничение: From enrollment to the end of treatment, with a 3-month follow-up
Rule switch task that involves sorting by color, and then reversing the sort rule
From enrollment to the end of treatment, with a 3-month follow-up
Zoo Animal Switch
Временное ограничение: From enrollment to the end of treatment, with a 3-month follow-up
Rule switch task that involves sorting large and small animal pairs by size into large and small buckets, then reversing the rule to put large animals into the small bucket, and small animals into the large bucket
From enrollment to the end of treatment, with a 3-month follow-up
Developmental Profiles-4 Cognitive domain
Временное ограничение: From enrollment to the end of treatment, with a 3-month follow-up
Growth Scale Values in the Developmental Profiles-4 Cognitive domain
From enrollment to the end of treatment, with a 3-month follow-up
Developmental Profiles-4 Social-emotional domain
Временное ограничение: From enrollment to the end of treatment, with a 3-month follow-up
Growth Scale Values in the Developemental Profiles-4 Social-Emotional domain
From enrollment to the end of treatment, with a 3-month follow-up

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
iBehavior Ecological Momentary Assessment
Временное ограничение: From enrollment to the end of treatment, with a 3-month follow-up
From enrollment to the end of treatment, with a 3-month follow-up
Self ordered pointing: Garage Game
Временное ограничение: From enrollment to the end of treatment, with a 3-month follow-up
Self-ordered pointing task that requires working memory/updating
From enrollment to the end of treatment, with a 3-month follow-up
BRIEF-Preschool Inhibition Domain
Временное ограничение: From enrollment to the end of treatment, with a 3-month follow-up
Standardized Caregiver Report of Executive Functioning for Preschool aged children
From enrollment to the end of treatment, with a 3-month follow-up
Hearts and Flowers
Временное ограничение: From enrollment to the end of treatment, with a 3-month follow-up
Opposites task that involves matching cards to the opposite type of card
From enrollment to the end of treatment, with a 3-month follow-up
Developmental Profiles-4 Adaptive Behavior domain
Временное ограничение: From enrollment to the end of treatment, with a 3-month follow-up
Growth Scale Values in the Developmental Profiles-4 Adaptive Behavior domain
From enrollment to the end of treatment, with a 3-month follow-up
Building Task
Временное ограничение: From enrollment to the end of treatment, with a 3-month follow-up
Shape design task that involves reproducing a pattern of blocks according to a design produced by the examiner
From enrollment to the end of treatment, with a 3-month follow-up

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Colorado State University

Соавторы

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Los Angeles
University of Southern California
University of Padova

Следователи

  • Главный следователь: Deborah Fidler, Colorado State University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 сентября 2026 г.

Первичное завершение (Оцененный)

31 августа 2029 г.

Завершение исследования (Оцененный)

30 ноября 2029 г.

Даты регистрации исследования

Первый отправленный

17 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

25 августа 2026 г.

Первый опубликованный (Действительный)

28 августа 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

28 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

25 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 7190 (CTEP)
  • R61HD115161 (Грант/контракт NIH США)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Upon completion of this study, and annually throughout the thre-year project period, our team will share all developmental and behavioral with the NIH INCLUDE Data Coordinating Center.

Data will also be collected from a parent or guardian via questionnaire and the iBehavior smartphone application. Data that will be preserved and shared include demographic information, developmental assessments composite scores, caregiver rating composite scores for behavioral dimensions, and caregiver-reported iBehavior composite data. The data transformation approach for all aggregate-level data will be specified in detail in a protocol manual for reproducibility. Information regarding data content, format, and organization will be available to any research colleagues accessing the DCC database. All shared data will be formatted in accordance with current standards and norms in the field of

Сроки обмена IPD

Nov 30, 2029

Критерии совместного доступа к IPD

Data will be made available within the NIH INCLUDE DCC system, allowing researchers to access it in accordance with their approved access level. All data and secondary analyses will be included in the DCC. The DCC will use its current policies and procedures for access by interested research teams.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП
  • МКФ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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