临床试验/NCT01795053

NCT01795053Unknown不适用

Randomized Controlled Trial to Evalualte Effects of Playtraining as Manualized in THOP, a Modulized German ADHD Manual, in 3 to 6 Year Old Children With a Diagnosis of ADHD on ADHD Symptoms and Play Persistence and Intensity

University of Cologne1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2012年2月1日最近更新: 2017年3月15日

适应症

干预措施

试验速览

阶段: 不适用
发起方: University of Cologne
入组人数: 60
试验地点: 1
主要终点: FBB-ADHD-V

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A sample of 60 children is randomly assigned to an intervention and a control condition. The intervention group receives 15 sessions of child-focused treatment with play training to enhance play persistence and intensity. The control group receives the same amount of placebo play sessions. The intervention group receives subsequently 15 sessions of parent training. All children are 3 to 6 years old and meet diagnostic criteria for ADD or ADHD. Main hypothesis are a stronger reduction of ADHD symptoms of the child in different settings in the intervention than in the control group. Play-persistence and -intensity should also increase more in the intervention group. An additional effect of a subsequent parent training shall furthermore be tested.

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 (Care Provider)

入排标准

年龄范围: 3 Years 至 6 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of ADHD or combinde ADHD/ ODD, age 3 to 6, 5 Items regarding play behavior on DSM-IV symptom checklist above 95th percentile, parents motivation to provide 15 to 30 weekly sessions

排除标准

•Autism Spectrum Disorder, IQ below 80, massive actual impairment, that requests sudden in-patient treatment, school entry in less than 2 months

研究组 & 干预措施

playtraining

Experimental

playtraining is a play based intervention that includes techniques of behavioral management as: structuring of play situation, detailled play planning, definition of behavioral tasks, positive reinforcement, token economy. The intervention is designed to enhance play-persistence and intensity and thereby reduce ADHD symptoms

干预措施: Experimental: playtraining (Behavioral)

open play session

Placebo Comparator

the open play sessions are conducted in the same rooms, by the same staff and in the same time frame as the experimental sessions. The therapist plays with the child without structuring the sitauation through behavioral tecniques. The play situation is designed to be ineresting and comfortable for the child.

干预措施: Placebo open play session (Behavioral)

结局指标

主要结局

FBB-ADHD-V

时间窗: 20 minutes

Symptom checklist, rated by parents and preschool teachers. Standardized quesionnaire based on the DSM-IV diagnostic criteria for ADHD. Specific form for preschoolers with norms from the year 2009

次要结局

VBV-EL SUBSCALE play productivity and play-intensity(10 minutes)

研究者

发起方

University of Cologne

申办方类型

Other

责任方

Principal Investigator

主要研究者

Manfred Doepfner

university professor, Phd

University of Cologne

研究点 (1)

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