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临床试验/NCT07784348
NCT07784348招募中不适用

Evaluating the Efficacy of Central Executive Training (CET) For Young Children With ADHD

Florida State University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
ADHD Rating Scale (ADHD-RS)

研究概览

简要总结

Initial non-randomized trial of behavioral parent training (BPT) compared to central executive training (CET), followed by a randomized controlled trial of CET+BPT for young children with ADHD.

详细描述

Initial non-randomized trial of behavioral parent training (BPT) compared to central executive training (CET) [R61 Phase], followed by a randomized controlled trial of CET+BPT for young children with ADHD [R33 Phase].

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • principal ADHD diagnoses (via K-SADS); (b) parent BASC-3 ADHD Problems or ADHD-RS ADHD-Combined scale in clinical/borderline range (>90th percentile) based on age and sex; (c) teacher BASC-3 ADHD Problems or ADHD-RS ADHD-Combined scale in clinical/borderline range based on age and sex

排除标准

  • (a) gross neurological, sensory, or motor impairment; (b) history of seizure disorder, psychosis, bipolar, or severe dysregulation disorders that may interfere with study participation (e.g., disruptive mood dysregulation, conduct, intermittent explosive, reactive attachment); (c) intellectual disability or WPPSI/WISC short-form FSIQ<70; (d) conditions requiring acute intervention, e.g., active suicidality; and (e) non-English speaking child or parent.

研究组 & 干预措施

Central executive training

Experimental

干预措施: Central executive training (Behavioral)

Behavioral parent training

Active Comparator

干预措施: Behavioral parent training (Behavioral)

Central executive training + concurrent behavioral parent training

Other

干预措施: Central executive training (Behavioral)

Central executive training + concurrent behavioral parent training

Other

干预措施: Behavioral parent training (Behavioral)

Treatment as usual/waitlist

No Intervention

结局指标

主要结局

ADHD Rating Scale (ADHD-RS)

时间窗: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion

次要结局

  • Secondary outcomes (T-scores)(Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion)
  • Feasibility/acceptability(Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael J. Kofler

Professor

Florida State University

研究点 (1)

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