Executive Function Play Opportunities for Children With Down Syndrome

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.

Conditions

• Down Syndrome
• Trisomy 21

Interventions

BEHAVIORAL

EXPO

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.

BEHAVIORAL

EXPO Extended

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.

BEHAVIORAL

EXPO Foundations

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.

Sponsors & Collaborators

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

  collaborator NIH

• University of Padova

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Colorado State University

  lead OTHER

Principal Investigators

• Deborah Fidler · Colorado State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

36 Months

Max Age

72 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2029-08-31

Completion

2029-11-30

Countries

• United States
• Italy

Study Locations