Executive Function Intervention for Young Children With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Adapted Reverse Categorization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single: Outcomes Assessors naive to coaching information; Coaches naive to examiner-collected outcome assessment (including direct assessment measures and proxy-report measures)
入排标准
- 年龄范围
- 36 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed medical diagnosis of Down syndrome
排除标准
- •no complete hearing or vision loss
- •primary exposure to English or Italian
研究组 & 干预措施
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.
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.
干预措施: EXPO (Behavioral)
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.
干预措施: EXPO Extended (Behavioral)
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.
干预措施: EXPO Foundations (Behavioral)
结局指标
主要结局
Adapted Reverse Categorization
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From enrollment to the end of treatment, with a 3-month follow-up
Growth Scale Values in the Developemental Profiles-4 Social-Emotional domain
次要结局
- 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)
- BRIEF-Preschool Inhibition Domain(From enrollment to the end of treatment, with a 3-month follow-up)
- Hearts and Flowers(From enrollment to the end of treatment, with a 3-month follow-up)
- Developmental Profiles-4 Adaptive Behavior domain(From enrollment to the end of treatment, with a 3-month follow-up)
- Building Task(From enrollment to the end of treatment, with a 3-month follow-up)