Executive Function Play Opportunities for Children With Down Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age36-72
SponsorColorado State University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
confirmed medical diagnosis of Down syndrome
Disqualifiers
no complete hearing or vision loss
primary exposure to English or Italian
Trial design
Design model
Sequential
Treatments tested in this trial
EXPO
BehavioralEXPO 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
BehavioralAlternative 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
BehavioralAn 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.
Treatment groups
150 Participants
are divided into 4 treatment groupsGroup A: Delayed-Treatment ControlNo intervention 0 interventions
Group B: EXPO Standard PathwayExperimental treatment 1 intervention
Group C: Adaptive Pathway 1/EXPO ExtendedActive comparator 1 intervention
Group D: Adaptive Pathway 2/EXPO FoundationsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adapted Reverse Categorization
Rule switch task that involves sorting by color, and then reversing the sort rule
Time frame
From enrollment to the end of treatment, with a 3-month follow-up2
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
Time frame
From enrollment to the end of treatment, with a 3-month follow-up3
Developmental Profiles-4 Cognitive domain
Growth Scale Values in the Developmental Profiles-4 Cognitive domain
Time frame
From enrollment to the end of treatment, with a 3-month follow-up4
Developmental Profiles-4 Social-emotional domain
Growth Scale Values in the Developemental Profiles-4 Social-Emotional domain
Time frame
From enrollment to the end of treatment, with a 3-month follow-upSecondary outcomes
1
iBehavior Ecological Momentary Assessment
Time frame
From enrollment to the end of treatment, with a 3-month follow-up2
Self ordered pointing: Garage Game
Self-ordered pointing task that requires working memory/updating
Time frame
From enrollment to the end of treatment, with a 3-month follow-up3
BRIEF-Preschool Inhibition Domain
Standardized Caregiver Report of Executive Functioning for Preschool aged children
Time frame
From enrollment to the end of treatment, with a 3-month follow-up4
Hearts and Flowers
Opposites task that involves matching cards to the opposite type of card
Time frame
From enrollment to the end of treatment, with a 3-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Colorado State University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
University of Padova
Collaborator
University of California, Los Angeles
Collaborator
University of Southern California
Collaborator
Source ClinicalTrials.gov
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