Changing Developmental Trajectories Through Early Executive Function Intervention in Early Childhood Education
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Early Childhood Behavior Observation of Classroom Function (EC-BOCEF)
研究概览
简要总结
The goal of this clinical trial is to learn if a new school-based, Tier 2 (selective) cognitive-behavioral intervention called Unstuck and On Target for Early Childhood (Unstuck-EC) can treat executive function deficits in young children (ages 4-5). Executive function is a critical set of cognitive abilities that enable individuals to demonstrate skills, effectively complete tsks, and navigate social interactions through flexible regulation of their thinking, behavior, and emotions. All children will be receiving special education services and be identified by their classroom teachers as having problems with flexibility and/or emotion regulation. Unstuck-EC consists of 16 sessions, each lasting about 20 minutes, delivered 1-2 times per week. Unstuck-EC will be adapted in this trial to be delivered by classroom teachers. The main questions it aims to answer are:
- Do special education preschool teachers find Unstuck-EC to be feasible, appropriate, and acceptable for use in their classrooms?
- Do special education preschool teachers trained in Unstuck-EC better understand and support executive function in the classroom?
- Does Unstuck-EC improve children's executive function skills?
Researchers will compare Unstuck-EC (N=45 participants) to a "services as usual" control (N=45 participants). This means that all children will receive usual services at school through their Individualized Education Plan and associated special education supports. Those in Unstuck-EC will also receive the intervention.
Participants in both groups will be followed for the same period of time (minimum of 8 weeks). All child participants will complete a baseline assessment, which include language testing for eligibility, as well as a classroom observation and direct testing of cognitive flexibility. Additionally, parents and case managers will complete behavioral rating scales of children's executive function skills and classroom behavior. All measures will be collected again at the end of the intervention period, with the exception of language testing. Additional measures will also be completed by the teacher to examine knowledge of executive function and use of Unstuck-EC strategies and executive-function supporting strategies. Teachers will also report on their own stress and self-efficacy and will complete ratings of child expulsion risk.
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4-5 years at time of enrollment
- •Enrolled in a participating publicly funded preschool program and eligible for special education services through an Individualized Education Program (IEP), in a classroom placement that includes children who can communicate using verbal speech
- •Ability to speak in at least short sentences and answer simple questions about removed contexts (e.g., events that occurred earlier that day) in English
- •Identified by school staff as having executive function challenges, on basis of written description of sample behaviors and nomination to study participation by school staff/teachers
- •Intact or corrected-to-normal hearing and vision
- •The parents speak and read English or Spanish with sufficient fluency for completion of consent forms and informant questionnaires, as well as understanding family educational materials.
排除标准
- •No longer enrolled at a participating school site
- •Insufficient English fluency or language skills to complete intervention
- •Sensory, neurological, developmental, or other impairment that would prevent the child from participating in the intervention and/or completing study measures
研究组 & 干预措施
Unstuck-EC
干预措施: Unstuck and On Target for Early Childhood (Behavioral)
Services as Usual
结局指标
主要结局
Early Childhood Behavior Observation of Classroom Function (EC-BOCEF)
时间窗: From enrollment to end of treatment (8-20 weeks)
Masked classroom observation of child executive function behaviors. Each behavior is rated as 0 or 1 (0 =no problem, 1 = problem). The scores on 7 behaviors are summed to a total score.
次要结局
- Observation of Teacher Executive Function-Supporting Strategies (OTESS)(Enrollment to end of intervention (8-20 weeks))
- Child Behavior Rating Scale(Enrollment to end of intervention (8-20 weeks))
- Behavior Rating Inventory of Executive Function(Enrollment to end of intervention (8-20 weeks))
- Differential Ability Scales-II: Pattern Construction(Enrollment to end of intervention (8-20 weeks))
- Teacher Executive Function Classroom Knowledge Survey(Enrollment to end of intervention (8-20 weeks))
- Unstuck-EC Knowledge Survey(Enrollment to end of intervention (8-20 weeks))
- Unstuck-EC Self-Reported Strategy Use Survey(Enrollment to end of intervention (8-20 weeks))
研究者
Allison Ratto
Psychologist and Associate Professor
Children's National Research Institute