Down SyndromeEXPONCT07792382
Executive Function Play Opportunities for Children With Down Syndrome
A study testing EXPO, EXPO Extended and EXPO Foundations in people with Down Syndrome and Trisomy 21, run by Colorado State University at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 36 to 72 months
- Conditions the study is for
- Down Syndrome, Trisomy 21
- What is being tested?
- EXPO, EXPO Extended and EXPO Foundations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2026to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- confirmed medical diagnosis of Down syndrome
Who cannot join
- no complete hearing or vision loss
- primary exposure to English or Italian
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
Colorado State University
Fort Collins, Colorado, 80523
Deborah Fidler, PhD, 9702194288, Deborah.fidler@colostate.edu
Kaylyn Van Deusen, MS, 970-4911969, kaylyn.Van_Deusen@colostate.edu
Italy1 site
University of Padova
Padova, CO, 80526
Silvia Lanfranchi, PhD, 9702194288, silvia.lanfranchi@unipd.it
About this study
Official title: Executive Function Intervention for Young Children With Down Syndrome
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.
Read the detailed description
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, all participants will complete an assessment including laboratory-based measures of EF, parent-report measures of EF, and intensive ecological measurement of EF using the iBehavior app. Participants will then be randomized in a 1:4 ratio to receive either a delayed-treatment control condition or the EXPO intervention, with a target total sample size of 150.
During stage 1, participants in the EXPO condition will complete 4 weeks of standard EXPO intervention. The initial weeks of EXPO consist of 2 weeks of EXPO Ready activities followed by 2 weeks of Working Memory activities, and all participants in the EXPO intervention receive ongoing support from an EXPO coach.
At the stage 1 evaluation, conducted 4 weeks after starting EXPO, all participants will complete the laboratory-based EF assessment battery. EXPO participants will be assessed for response to the intervention and classified as early or slower responders based on prespecified criteria for improvement in laboratory-based EF performance.
Early responders will be assigned to the standard EXPO intervention in stage 2 and continue with activities targeting inhibition, cognitive flexibility, planning, and consolidation of skills for a total of 12 weeks. Slower responders will be randomly assigned in a 1:1 ratio to either the EXPO Extended or EXPO Foundations pathway. The EXPO Extended pathway will include the same core activities as the EXPO standard pathway but will provide additional intervention time, for a total of 18 weeks. The EXPO Foundations pathway will begin with a block of activities targeting early social communication and regulation to provide a foundation for activity engagement, followed by more foundational versions of activities targeting inhibition and cognitive flexibility. The EXPO Foundations pathway will continue for a total of 12 weeks.
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 not receive EXPO during the initial study period but will complete the same assessments as participants in the EXPO intervention. Following completion of the 3-month follow-up, participants in the delayed-treatment control condition will be offered the EXPO intervention.
- Conditions
- Down Syndrome, Trisomy 21
- Being tested
- EXPO, EXPO Extended, EXPO Foundations
- Keywords
- executive function, parent-implemented, play based, preschooler, early childhood, developmental
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPOBehavioural
Also called Executive Function Play Opportunities
EXPO is a novel intervention that targets the development of EF through play-based opportunities for children with DS and their primary caregivers. EXPO is a 'syndrome-informed' intervention in that all activities are tailored to phenotypic strengths and challenges associated with DS, accounting for cognitive, language, and motor presentations frequently observed in this population. EXPO is also designed to elicit maximal engagement and enjoyment for children and their caregivers by embedding opportunities to strengthen EF component processes in the context of play and games.
EXPO ExtendedBehavioural
Alternative EXPO pathway that extends the length of the EXPO intervention from 12 to 18 weeks to provide more time and opportunity for skill acquisition.
EXPO FoundationsBehavioural
An augmented version of EXPO that places a greater emphasis on precursors to EXPO activity engagement, including an increased number of social routine activities, enhanced presses for social communication behaviors like joint attention, enhanced focus on early self-regulation skills, and adaptations of all EXPO activities in each block that emphasize more foundational aspects of play.
| Study group | Role | What they receive |
|---|---|---|
| Delayed-Treatment Control | No intervention | 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. |
| EXPO Standard Pathway | Experimental | Early responders to EXPO at the stage 1 evaluation are assigned to the standard, 12 -week intervention with activities refined from EXPO 2.0. Receives: Behavioral: EXPO |
| Adaptive Pathway 1/EXPO Extended | Active comparator | 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. Receives: Behavioral: EXPO Extended |
| Adaptive Pathway 2/EXPO Foundations | Active comparator | 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. Receives: Behavioral: EXPO Foundations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adapted Reverse Categorization
Rule switch task that involves sorting by color, and then reversing the sort rule
Measured: From enrollment to the end of treatment, with a 3-month follow-up
Zoo Animal Switch
Rule switch task that involves sorting large and small animal pairs by size into large and small buckets, then reversing the rule to put large animals into the small bucket, and small animals into the large bucket
Measured: From enrollment to the end of treatment, with a 3-month follow-up
Developmental Profiles-4 Cognitive domain
Growth Scale Values in the Developmental Profiles-4 Cognitive domain
Measured: From enrollment to the end of treatment, with a 3-month follow-up
Developmental Profiles-4 Social-emotional domain
Growth Scale Values in the Developemental Profiles-4 Social-Emotional domain
Measured: From enrollment to the end of treatment, with a 3-month follow-up
Secondary outcomes (6)
iBehavior Ecological Momentary Assessment
Measured: From enrollment to the end of treatment, with a 3-month follow-up
Self ordered pointing: Garage Game
Self-ordered pointing task that requires working memory/updating
Measured: From enrollment to the end of treatment, with a 3-month follow-up
BRIEF-Preschool Inhibition Domain
Standardized Caregiver Report of Executive Functioning for Preschool aged children
Measured: From enrollment to the end of treatment, with a 3-month follow-up
Hearts and Flowers
Opposites task that involves matching cards to the opposite type of card
Measured: From enrollment to the end of treatment, with a 3-month follow-up
Developmental Profiles-4 Adaptive Behavior domain
Growth Scale Values in the Developmental Profiles-4 Adaptive Behavior domain
Measured: From enrollment to the end of treatment, with a 3-month follow-up
Building Task
Shape design task that involves reproducing a pattern of blocks according to a design produced by the examiner
Measured: From enrollment to the end of treatment, with a 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential, Multiple Assignment, Randomized Trial (SMART)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Padova, University of California, Los Angeles, University of Southern California
- Responsible party
- Sponsor
- Investigators
- Deborah Fidler, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792382
- Sponsor's protocol ID
- 7190
- Other IDs
- R61HD115161
- Acronym
- EXPO
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of this study, and annually throughout the thre-year project period, our team will share all developmental and behavioral with the NIH INCLUDE Data Coordinating Center. Data will also be collected from a parent or guardian via questionnaire and the iBehavior smartphone application. Data that will be preserved and shared include demographic information, developmental assessments composite scores, caregiver rating composite scores for behavioral dimensions, and caregiver-reported iBehavior composite data. The data transformation approach for all aggregate-level data will be specified in detail in a protocol manual for reproducibility. Information regarding data content, format, and organization will be available to any research colleagues accessing the DCC database. All shared data will be formatted in accordance with current standards and norms in the field of
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Function Intervention for Young Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07792382
- Acronym / sponsor ID
- EXPO / 7190
- Conditions
- Down Syndrome, Trisomy 21
- Keywords
- executive function, parent-implemented, play based, preschooler, early childhood, developmental
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Padova, University of California, Los Angeles, University of Southern California
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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, all participants will complete an assessment including laboratory-based measures of EF, parent-report measures of EF, and intensive ecological measurement of EF using the iBehavior app. Participants will then be randomized in a 1:4 ratio to receive either a delayed-treatment control condition or the EXPO intervention, with a target total sample size of 150.
During stage 1, participants in the EXPO condition will complete 4 weeks of standard EXPO intervention. The initial weeks of EXPO consist of 2 weeks of EXPO Ready activities followed by 2 weeks of Working Memory activities, and all participants in the EXPO intervention receive ongoing support from an EXPO coach.
At the stage 1 evaluation, conducted 4 weeks after starting EXPO, all participants will complete the laboratory-based EF assessment battery. EXPO participants will be assessed for response to the intervention and classified as early or slower responders based on prespecified criteria for improvement in laboratory-based EF performance.
Early responders will be assigned to the standard EXPO intervention in stage 2 and continue with activities targeting inhibition, cognitive flexibility, planning, and consolidation of skills for a total of 12 weeks. Slower responders will be randomly assigned in a 1:1 ratio to either the EXPO Extended or EXPO Foundations pathway. The EXPO Extended pathway will include the same core activities as the EXPO standard pathway but will provide additional intervention time, for a total of 18 weeks. The EXPO Foundations pathway will begin with a block of activities targeting early social communication and regulation to provide a foundation for activity engagement, followed by more foundational versions of activities targeting inhibition and cognitive flexibility. The EXPO Foundations pathway will continue for a total of 12 weeks.
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 not receive EXPO during the initial study period but will complete the same assessments as participants in the EXPO intervention. Following completion of the 3-month follow-up, participants in the delayed-treatment control condition will be offered the EXPO intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Sequential, Multiple Assignment, Randomized Trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| Delayed-Treatment Control | No intervention | –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. |
| EXPO Standard Pathway | Experimental | Behavioral: EXPOEarly responders to EXPO at the stage 1 evaluation are assigned to the standard, 12 -week intervention with activities refined from EXPO 2.0. |
| Adaptive Pathway 1/EXPO Extended | Active comparator | Behavioral: EXPO ExtendedHalf 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. |
| Adaptive Pathway 2/EXPO Foundations | Active comparator | Behavioral: EXPO FoundationsHalf 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. |
Who may qualify
- Ages
- 36 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- confirmed medical diagnosis of Down syndrome
Key exclusion criteria (2 listed)
- no complete hearing or vision loss
- primary exposure to English or Italian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXPOAlso: Executive Function Play OpportunitiesEXPO is a novel intervention that targets the development of EF through play-based opportunities for children with DS and their primary caregivers. EXPO is a 'syndrome-informed' intervention in that all activities are tailored to phenotypic strengths and challenges associated with DS, accounting for cognitive, language, and motor presentations frequently observed in this population. EXPO is also designed to elicit maximal engagement and enjoyment for children and their caregivers by embedding opportunities to strengthen EF component processes in the context of play and games. | Behavioural | EXPO Standard Pathway |
| EXPO ExtendedAlternative EXPO pathway that extends the length of the EXPO intervention from 12 to 18 weeks to provide more time and opportunity for skill acquisition. | Behavioural | Adaptive Pathway 1/EXPO Extended |
| EXPO FoundationsAn augmented version of EXPO that places a greater emphasis on precursors to EXPO activity engagement, including an increased number of social routine activities, enhanced presses for social communication behaviors like joint attention, enhanced focus on early self-regulation skills, and adaptations of all EXPO activities in each block that emphasize more foundational aspects of play. | Behavioural | Adaptive Pathway 2/EXPO Foundations |
Primary outcome
Adapted Reverse Categorization
Time frame: From enrollment to the end of treatment, with a 3-month follow-up
Rule switch task that involves sorting by color, and then reversing the sort rule
Zoo Animal Switch
Time frame: From enrollment to the end of treatment, with a 3-month follow-up
Rule switch task that involves sorting large and small animal pairs by size into large and small buckets, then reversing the rule to put large animals into the small bucket, and small animals into the large bucket
Developmental Profiles-4 Cognitive domain
Time frame: From enrollment to the end of treatment, with a 3-month follow-up
Growth Scale Values in the Developmental Profiles-4 Cognitive domain
Developmental Profiles-4 Social-emotional domain
Time frame: From enrollment to the end of treatment, with a 3-month follow-up
Growth Scale Values in the Developemental Profiles-4 Social-Emotional domain
6 secondary outcomes
iBehavior Ecological Momentary Assessment
Time frame: From enrollment to the end of treatment, with a 3-month follow-up
Self ordered pointing: Garage Game
Time frame: From enrollment to the end of treatment, with a 3-month follow-up
BRIEF-Preschool Inhibition Domain
Time frame: From enrollment to the end of treatment, with a 3-month follow-up
Hearts and Flowers
Time frame: From enrollment to the end of treatment, with a 3-month follow-up
Developmental Profiles-4 Adaptive Behavior domain
Time frame: From enrollment to the end of treatment, with a 3-month follow-up
Building Task
Time frame: From enrollment to the end of treatment, with a 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes. Upon completion of this study, and annually throughout the thre-year project period, our team will share all developmental and behavioral with the NIH INCLUDE Data Coordinating Center. Data will also be collected from a parent or guardian via questionnaire and the iBehavior smartphone application. Data that will be preserved and shared include demographic information, developmental assessments composite scores, caregiver rating composite scores for behavioral dimensions, and caregiver-reported iBehavior composite data. The data transformation approach for all aggregate-level data will be specified in detail in a protocol manual for reproducibility. Information regarding data content, format, and organization will be available to any research colleagues accessing the DCC database. All shared data will be formatted in accordance with current standards and norms in the field of
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deborah Fidler principal investigator
Colorado State University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXPO, EXPO Extended and EXPO Foundations in people with Down Syndrome and Trisomy 21, run by Colorado State University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaylyn Van Deusen, MS (9704911969, kaylyn.van_deusen@colostate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adapted Reverse Categorization (time frame: From enrollment to the end of treatment, with a 3-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.