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

25 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

150

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Colorado
      • Fort Collins, Colorado, Stany Zjednoczone, 80523
        • Colorado State University
        • Główny śledczy:
          • Deborah Fidler, PhD
        • Kontakt:
        • Kontakt:
        • Pod-śledczy:
          • Nathaniel Riggs, Phd
        • Pod-śledczy:
          • Susan Hepburn, PhD
        • Pod-śledczy:
          • Lisa Daunhauer, ScD
  • Włochy
    • CO
      • Padova, CO, Włochy, 80526

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • confirmed medical diagnosis of Down syndrome

Exclusion Criteria:

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: 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.
Eksperymentalny: 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.
Behawioralne: 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.
Inne nazwy:
  • Executive Function Play Opportunities
Aktywny komparator: 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.
Behawioralne: 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.
Aktywny komparator: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Adapted Reverse Categorization
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
iBehavior Ecological Momentary Assessment
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Colorado State University

Współpracownicy

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

Śledczy

  • Główny śledczy: Deborah Fidler, Colorado State University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

31 sierpnia 2029

Ukończenie studiów (Szacowany)

30 listopada 2029

Daty rejestracji na studia

Pierwszy przesłany

17 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

25 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

28 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 7190 (CTEP)
  • R61HD115161 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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

Ramy czasowe udostępniania IPD

Nov 30, 2029

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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