Executive Function Play Opportunities for Children With Down Syndrome

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Adapted Reverse Categorization — 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 — 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 — 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 — From enrollment to the end of treatment, with a 3-month follow-up
  Growth Scale Values in the Developemental Profiles-4 Social-Emotional domain

Trial sites (2)

Other trials for the same condition