Executive Function Play for Down Syndrome

(EXPO Trial)

Not yet recruiting at 1 trial location
MP
KV
Overseen ByKaylyn Van Deusen, MS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Colorado State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

DF

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

I have been diagnosed with Down syndrome.

Exclusion Criteria

Primary exposure to English or Italian
I do not have complete hearing or vision loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Participants receive 4 weeks of standard EXPO intervention, including EXPO Ready and Working Memory activities

4 weeks

Stage 2 Treatment - EXPO Standard

Early responders continue with the standard EXPO intervention targeting inhibition, cognitive flexibility, planning, and consolidation of skills

12 weeks

Stage 2 Treatment - EXPO Extended

Slower responders receive extended intervention with additional time for core activities

18 weeks

Stage 2 Treatment - EXPO Foundations

Slower responders receive foundational activities targeting early social communication and regulation

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments immediately post-intervention and 3 months later

3 months

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

Group I: EXPO Standard PathwayExperimental Treatment1 Intervention
Group II: Delayed-Treatment ControlActive Control1 Intervention
Group III: Adaptive Pathway 1/EXPO ExtendedActive Control1 Intervention
Group IV: Adaptive Pathway 2/EXPO FoundationsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials
138
Recruited
38,200+

University of Padova

Collaborator

Trials
286
Recruited
209,000+

University of California, Los Angeles

Collaborator

Trials
1,594
Recruited
10,430,000+

University of Southern California

Collaborator

Trials
956
Recruited
1,609,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

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; ...