Down Syndrome, Trisomy 21
Conditions
Keywords
executive function, parent-implemented, play based, preschooler, early childhood, developmental
Brief 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.
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.
Interventions
BEHAVIORALEXPO
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.
BEHAVIORALEXPO 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.
BEHAVIORALEXPO 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
Colorado State University
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 design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single: Outcomes Assessors naive to coaching information; Coaches naive to examiner-collected outcome assessment (including direct assessment measures and proxy-report measures)
Intervention model description
Sequential, Multiple Assignment, Randomized Trial (SMART)
Eligibility
Sex/Gender
ALL
Age
36 Months to 72 Months
Healthy volunteers
No
Inclusion criteria
* confirmed medical diagnosis of Down syndrome
Exclusion criteria
* no complete hearing or vision loss * primary exposure to English or Italian
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| iBehavior Ecological Momentary Assessment | From enrollment to the end of treatment, with a 3-month follow-up | — |
| Self ordered pointing: Garage Game | From enrollment to the end of treatment, with a 3-month follow-up | Self-ordered pointing task that requires working memory/updating |
| BRIEF-Preschool Inhibition Domain | From enrollment to the end of treatment, with a 3-month follow-up | Standardized Caregiver Report of Executive Functioning for Preschool aged children |
| Hearts and Flowers | From enrollment to the end of treatment, with a 3-month follow-up | Opposites task that involves matching cards to the opposite type of card |
| Developmental Profiles-4 Adaptive Behavior domain | From enrollment to the end of treatment, with a 3-month follow-up | Growth Scale Values in the Developmental Profiles-4 Adaptive Behavior domain |
| Building Task | From enrollment to the end of treatment, with a 3-month follow-up | Shape design task that involves reproducing a pattern of blocks according to a design produced by the examiner |
Countries
Italy, United States
Contacts
CONTACTKaylyn Van Deusen, MS
CONTACTMiranda Pinks, MS
PRINCIPAL_INVESTIGATORDeborah Fidler
Colorado State University
Outcome results
None listed