Executive Function Play Opportunities for Children With Down Syndrome (NCT07792382)
Executive Function Intervention for Young Children With Down Syndrome
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Colorado State University — Fort Collins, Colorado
Age range: 36 Months to 72 Months
🧪 Interventions in This Study
- EXPO (BEHAVIORAL)
- EXPO Extended (BEHAVIORAL)
- EXPO Foundations (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Colorado State University — Fort Collins, Colorado
- University of Padova — Padova, CO
📞 Contact the Study Coordinator
Phone: (970) 491-1969
Email: kaylyn.van_deusen@colostate.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Down Syndrome
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- Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD) — Ottawa, Ontario
- Escalating Doses of Memantine in Down Syndrome (MEDS-123) — Cleveland, Ohio
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Explore by condition: All Down Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.