Executive Function Play Opportunities for Children With Down Syndrome

Conditions

• Down Syndrome
• Trisomy 21

Eligibility Criteria

Sex

ALL

Age

36 Months - 72 Months

Healthy Volunteers

Not accepted

Interventions

• EXPO — BEHAVIORAL
  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.
• EXPO Extended — BEHAVIORAL
  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.
• EXPO Foundations — BEHAVIORAL
  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.

Study Details

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.

Key Dates

First listed

Aug 28, 2026

Start date

Sep 1, 2026

Status verified

Aug 2026

Primary completion

Aug 31, 2029

Completion

Nov 30, 2029

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• No Intervention: 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.
• Experimental: 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.
• Active Comparator: 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.
• Active Comparator: 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.

Primary Outcome Measure

Adapted Reverse Categorization [ Time Frame: From enrollment to the end of treatment, with a 3-month follow-up ]

Central Contacts

• Kaylyn Van Deusen, MS
  9704911969
  [email protected]
• Miranda Pinks, MS
  970-4911969
  [email protected]

Locations (1)

Find similar trials in Fort Collins, CO

Related Studies

• DS-Connect®: The Down Syndrome Registry
  Recruiting · University of Colorado, Denver · Aurora, Colorado
• The Human Trisome Project
  Recruiting · University of Colorado, Denver · Denver, Colorado
• Trial-Ready Cohort-Down Syndrome (TRC-DS)
  Recruiting · University of Southern California · Phoenix, Arizona
• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
  Recruiting · Duke University · Palo Alto, California