NCT07792382

Brief Summary

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.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
40mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2029

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2029

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

3 years

First QC Date

June 17, 2026

Last Update Submit

August 25, 2026

Conditions

Down SyndromeTrisomy 21

Keywords

executive functionparent-implementedplay basedpreschoolerearly childhooddevelopmental

Outcome Measures

Primary Outcomes (4)

  • Adapted Reverse Categorization

    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

    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

    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

    Growth Scale Values in the Developemental Profiles-4 Social-Emotional domain

    From enrollment to the end of treatment, with a 3-month follow-up

Secondary Outcomes (6)

  • iBehavior Ecological Momentary Assessment

    From enrollment to the end of treatment, with a 3-month follow-up

  • Self ordered pointing: Garage Game

    From enrollment to the end of treatment, with a 3-month follow-up

  • BRIEF-Preschool Inhibition Domain

    From enrollment to the end of treatment, with a 3-month follow-up

  • Hearts and Flowers

    From enrollment to the end of treatment, with a 3-month follow-up

  • Developmental Profiles-4 Adaptive Behavior domain

    From enrollment to the end of treatment, with a 3-month follow-up

  • +1 more secondary outcomes

Study Arms (4)

Delayed-Treatment Control

NO INTERVENTION

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.

EXPO Standard Pathway

EXPERIMENTAL

Early responders to EXPO at the stage 1 evaluation are assigned to the standard, 12 -week intervention with activities refined from EXPO 2.0.

Behavioral: EXPO

Adaptive Pathway 1/EXPO Extended

ACTIVE COMPARATOR

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.

Behavioral: EXPO Extended

Adaptive Pathway 2/EXPO Foundations

ACTIVE COMPARATOR

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.

Behavioral: EXPO Foundations

Interventions

EXPOBEHAVIORAL

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.

Also known as: Executive Function Play Opportunities
EXPO Standard Pathway
EXPO ExtendedBEHAVIORAL

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.

Adaptive Pathway 1/EXPO Extended
EXPO FoundationsBEHAVIORAL

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.

Adaptive Pathway 2/EXPO Foundations

Eligibility Criteria

Age36 Months - 72 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • confirmed medical diagnosis of Down syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

University of Padova

Padova, CO, 80526, Italy

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Deborah Fidler

    Colorado State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaylyn Van Deusen, MS

CONTACT

9704911969kaylyn.van_deusen@colostate.edu

Miranda Pinks, MS

CONTACT

970-4911969miranda.pinks@colostate.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single: Outcomes Assessors naive to coaching information; Coaches naive to examiner-collected outcome assessment (including direct assessment measures and proxy-report measures)
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Sequential, Multiple Assignment, Randomized Trial (SMART)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2026

First Posted

August 28, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

November 30, 2029

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Nov 30, 2029
Access Criteria
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.

Locations

IT(1)US(1)