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NCT07792382
Executive Function Play Opportunities for Children With Down Syndrome
Conditions: Down Syndrome, Trisomy 21
Sex: All
Ages: 36 Months – 72 Months
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Colorado State University
Location: Colorado State University Fort Collins Colorado
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.
Eligibility Criteria
Inclusion Criteria:
* confirmed medical diagnosis of Down syndrome
Exclusion Criteria:
* no complete hearing or vision loss
* primary exposure to English or Italian
Source: ClinicalTrials.gov (NCT07792382). StuddyBuddy aggregates publicly available trial information.