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临床试验/NCT04454008
NCT04454008招募中不适用

Executive Functioning Family Training for Preschool Children With Attention Deficit Hyperactivity Disorder - a Randomized Controlled Study

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年12月6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
100
试验地点
1
主要终点
ADHD core symptoms

研究概览

简要总结

To explore the effect of executive function family training for preschool children with ADHD, providing early social psychological intervention for aiming the core impairments of ADHD.

详细描述

100 preschool children with ADHD will be randomly divided into the intervention group and the waiting group. The waiting group received regular clinical intervention, while the intervention group received 12-week training. The intervention program includes executive function training for ADHD children and parenting guidance for parents by two therapists respectively, which were carried out in two meeting rooms in Xinhua Hospital. Therapists are psychiatrists with a background in child psychiatry and psychotherapists with training in ADHD area. After 12 weeks, the improvement of ADHD core symptoms and executive function was compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The evaluator was unaware of the subjects' treatment status

入排标准

年龄范围
48 Months 至 71 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Meet the diagnostic criteria for preschool ADHD, based on the the DSM-5 criteria by the attending physician or above;
  • Age 4 months 0 to 5 years 11 months;
  • Total IQ is above 80 assessed by WPPSI.

排除标准

  • Attention deficit disorders resulting from organic neurological diseases, extensive developmental disorders, mental retardation, childhood schizophrenia, mood disorders, epilepsy, and other organic diseases or other primary mental disorders;
  • parent or guardian with a serious mental illness, such as schizophrenia, mood disorder (onset), etc., and Educational level is lower than junior middle school;
  • Participants who failed to attend more than 80% of the intervention sessions (at least 9 sessions).

研究组 & 干预措施

Intervention

Experimental

The intervention group will receive 12 sessions of executive function family training, including executive function training for children and parenting guidance for parents.

干预措施: executive function family training (Behavioral)

waiting

Active Comparator

The waiting group will receive routine clinical intervention, including health education, family support and guidance from outpatient clinic.

干预措施: treat as usual (Behavioral)

结局指标

主要结局

ADHD core symptoms

时间窗: 12 weeks after baseline

ADHD core symptoms are assessed by Swanson, Nolan, and Pelham Rating Scale (SNAP), with the score ranged from 0-54 (the higher the socre, the worse the symptoms)

次要结局

  • Executive function-Inhibition(12 weeks after baseline)
  • Executive function-working memory(12 weeks after baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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