Executive Function Play for Down Syndrome
(EXPO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Deborah Fidler
Principal Investigator
Colorado State University
Are You a Good Fit for This Trial?
This trial is for children diagnosed with Down syndrome. There are no specific inclusion or exclusion criteria listed, so it appears open to all children with this condition.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- EXPO
- EXPO Extended
- EXPO Foundations
Trial Overview
The study tests different versions of a caregiver-led play program called EXPO, designed to help improve thinking and self-control skills in children with Down syndrome. Children are randomly assigned to various intervention pathways based on their progress.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Early responders to EXPO at the stage 1 evaluation are assigned to the standard, 12 -week intervention with activities refined from EXPO 2.0.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Colorado State University
Lead Sponsor
University of Padova
Collaborator
University of California, Los Angeles
Collaborator
University of Southern California
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
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