Play-based program to support thinking skills in young children with Down syndrome

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for young children with a confirmed medical diagnosis of Down syndrome. It tests play activities, led by a caregiver, that aim to improve thinking skills such as planning and self-control.

Age

36 Months to 72 Months

Sex

All sexes can join.

Main reasons for not taking part

• Complete hearing loss or complete vision loss.
• The record lists "primary exposure to English or Italian" under the exclusion criteria. It is unclear whether this means the child's main language must be English or Italian.

The registry criteria, word for word

What the trial wants to find out

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.

The 4 groups in the trial

• Delayed-Treatment ControlNo study treatment, for comparison

  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.

• EXPO Standard PathwayTreatment being tested

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

  Treatment: EXPO

• Adaptive Pathway 1/EXPO ExtendedExisting treatment, for comparison

  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.

  Treatment: EXPO Extended

• Adaptive Pathway 2/EXPO FoundationsExisting treatment, for comparison

  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.

  Treatment: EXPO Foundations