Executive Function Play Opportunities for Children With Down Syndrome

Browse trials for

• Down Syndrome 438

Keywords

• executive function
• parent-implemented
• play based
• preschooler
• early childhood
• developmental

Down Syndrome

438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.

This study's planned enrollment of 150 is above the median of 37 across 286 interventional studies indexed under Down Syndrome.

Lead sponsor

Colorado State University is the lead sponsor of 117 studies on the registry; 19 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Study arms

• No intervention
  Delayed-Treatment Control

  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.

• Experimental
  EXPO Standard Pathway

  Early responders to EXPO at the stage 1 evaluation are assigned to the standard, 12 -week intervention with activities refined from EXPO 2.0.

  Behavioral: EXPO

• Active comparator
  Adaptive Pathway 1/EXPO Extended

  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.

  Behavioral: EXPO Extended

• Active comparator
  Adaptive Pathway 2/EXPO Foundations

  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.

  Behavioral: EXPO Foundations

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.

  Also known as: Executive Function Play Opportunities

• 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.

Primary outcomes

1. Adapted Reverse Categorization

   Rule switch task that involves sorting by color, and then reversing the sort rule. Scores are calculated as the number of items correctly sorted after reversing the sort rule; scores range from 0 to 10 and a higher score indicates a better outcome.

   Time frame: From enrollment to 12 or 18 weeks (depending on condition) with a 3-month follow-up

2. 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. Scores are calculated as the number of items correctly sorted after reversing the sort rule; scores range from 0 to 10 and a higher score indicates a better outcome.

   Time frame: From enrollment to 12 or 18 weeks (depending on condition) with a 3-month follow-up

3. Developmental Profiles-4 Cognitive domain

   Growth Scale Values in the Developmental Profiles-4 Cognitive domain. Growth scale values (GSV) are vertically scaled scores designed to track real skill gains over time; scores range from approximately 300 to 800 and a higher score indicates a better outcome.

   Time frame: From enrollment to 12 or 18 weeks (depending on condition) with a 3-month follow-up

4. Developmental Profiles-4 Social-emotional domain

   Growth Scale Values in the Developemental Profiles-4 Social-Emotional domain. Growth scale values (GSV) are vertically scaled scores designed to track real skill gains over time; scores range from approximately 400 to 600 and a higher score indicates a better outcome.

   Time frame: From enrollment to 12 or 18 weeks (depending on condition) with a 3-month follow-up

Secondary outcomes

1. iBehavior Ecological Momentary Assessment

   This daily report will be completed in week-long bursts by families. Families respond to a 29-item questionnaire that asks about daily use of executive function skills. A lower score indicates a better outcome.

   Time frame: From enrollment to 12 or 18 weeks (depending on condition) with a 3-month follow-up

2. Self ordered pointing: Garage Game

   Self-ordered pointing task that requires working memory/updating

   Time frame: From enrollment to 12 or 18 weeks (depending on condition) with a 3-month follow-up

3. BRIEF-Preschool Inhibition Domain

   Standardized Caregiver Report of Executive Functioning for Preschool aged children

   Time frame: From enrollment to 12 or 18 weeks (depending on condition) with a 3-month follow-up

4. Hearts and Flowers

   Opposites task that involves matching cards to the opposite type of card

   Time frame: From enrollment to 12 or 18 weeks (depending on condition) with a 3-month follow-up

5. Developmental Profiles-4 Adaptive Behavior domain

   Growth Scale Values in the Developmental Profiles-4 Adaptive Behavior domain

   Time frame: From enrollment to 12 or 18 weeks (depending on condition) with a 3-month follow-up

6. Building Task

   Shape design task that involves reproducing a pattern of blocks according to a design produced by the examiner

   Time frame: From enrollment to 12 or 18 weeks (depending on condition) with a 3-month follow-up

Individual participant data

Plan to share: Yes — Upon completion of this study, and annually throughout the three-year project period, our team will share all developmental and behavioral data with the NIH INCLUDE Data Coordinating Center (DCC). 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Nov 30, 2029

Access criteria: Data will be made available within the National Institutes of Health (NIH) INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Data Coordinating Center (DCC) system, allowing researchers to access it in accordance with their approved access level. All data and secondary analyses will be included in the DCC. The DCC will use its current policies and procedures for access by interested research teams.