Executive Function Play for Down Syndrome
(EXPO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a program called EXPO, designed to improve executive function—skills like memory and problem-solving—in children with Down syndrome. Participants will be divided into groups: some will start the program immediately, while others will join later. Researchers will assess the program's effectiveness by comparing these groups and adapting the program based on each child's progress. The trial suits children with Down syndrome who do not have complete hearing or vision loss and primarily speak English or Italian. As an unphased trial, it offers a unique opportunity for children to potentially enhance their cognitive skills through a tailored program.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the EXPO treatment, which uses play-based activities to enhance memory, planning, and self-control, is generally safe for children with Down syndrome. Studies have found that these activities, lasting only 5 to 15 minutes, require no special toys or materials and easily integrate into daily routines, resulting in a low risk of negative effects.
For the EXPO Extended pathway, which involves a longer duration of activities, similar studies have observed slight improvements in these skills without major safety concerns, indicating that the extended activities are also safe.
Regarding the EXPO Foundations pathway, which emphasizes early communication, specific safety data is limited. However, given the nature of the activities in the overall EXPO treatment, a similar level of safety is expected.
Overall, evidence suggests that EXPO activities are safe for children with Down syndrome, offering a positive and engaging experience with minimal risk.12345Why are researchers excited about this trial?
Researchers are excited about the EXPO treatments for Down syndrome because they focus on enhancing executive function through structured play, which is a novel approach compared to traditional therapies that often focus on improving physical or speech abilities. The EXPO Standard Pathway offers a targeted 12-week intervention refined from previous versions, aiming for early and notable improvements. Meanwhile, the Adaptive Pathways cater to slower responders by extending the intervention to 18 weeks or by simplifying activities to emphasize early communication and regulation. This adaptability and focus on cognitive skills mark a promising shift from conventional treatments.
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stage 1 Treatment
Participants receive 4 weeks of standard EXPO intervention, including EXPO Ready and Working Memory activities
Stage 2 Treatment - EXPO Standard
Early responders continue with the standard EXPO intervention targeting inhibition, cognitive flexibility, planning, and consolidation of skills
Stage 2 Treatment - EXPO Extended
Slower responders receive extended intervention with additional time for core activities
Stage 2 Treatment - EXPO Foundations
Slower responders receive foundational activities targeting early social communication and regulation
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments immediately post-intervention and 3 months later
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
Citations
Assessing Behavioral Challenges in Down syndrome
This study looks at how thinking skills, especially executive functioning (like memory, planning, and self-control), may play a role in these behaviors.
Caregiver Report of Executive Functioning in a Population ...
Background Individuals with Down syndrome (DS) demonstrate difficulties with aspects of executive function (EF) and adaptive behaviour across the lifespan.
The Role of Executive Functions in Social Cognition ...
Children with Down syndrome (DS) show deficits both in social cognition and in some subcomponents of executive functions. However this link has ...
Performance and Ratings Based Measures of Executive ...
Performance and Ratings Based Measures of Executive Function in School-Aged Children With Down Syndrome ; Available. Developmental Neuropsychology ; Author ...
Profiles of Everyday Executive Functioning in Young Children ...
We investigated executive functioning (EF) in children with Down syndrome (DS; n = 25) and typically developing (TD) children matched for mental age (MA; ...
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