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临床试验/NCT02518711
NCT02518711已完成不适用

A Randomized Controlled Trial Into the Effectiveness of a Behavioral Teacher Program Targeting ADHD Symptoms

VU University of Amsterdam0 个研究点目标入组 114 人开始时间: 2011年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
114
主要终点
Change from Baseline in Strengths and Weaknesses of ADHD-symptoms and Normal Behavior Scale (SWAN; Young, Levi, Martin, & Hay, 2009)

研究概览

简要总结

The goal of this study was to investigate the effectiveness of a behavioral teacher program addressing symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) in the classroom.

详细描述

Background:

Most behavioral teacher programs involve intensive and expensive teacher trainings by health care specialists, which may limit successful large-scale implementation. This behavioral program, on the contrary, involves a self-containing manual that does not require expert training in order to increase the likelihood of successful implementation (if proven effective). The aim was to investigate the program's effects on behavioral, socio-emotional and school functioning in primary school children.

Methods:

Children with ADHD symptoms were randomly assigned at school level to the intervention condition (receiving the program during 18 weeks) or control group (not receiving the program but who were allowed to receive care as usual).

Measures to assess program's effectiveness:

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
None

入排标准

年龄范围
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • sub-threshold or clinical level of ADHD symptoms as observed by participant's teacher through the Dutch version of the Disruptive Behavior Disorders Rating Scale (Pelham, Gnagy, Greenslade, & Milich, 1992)
  • at least one clinical and three sub-threshold ADHD symptoms as measured by the Teacher Telephone Interview (Holmes et al., 2004), a semi-structured interview which is based on the Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association, 2000)

排除标准

  • (medication) treatment for ADHD at study entry or in preceding 6 months;
  • neurological or severe physical condition
  • IQ < 80 based on a short version of the Wechsler Intelligence Scale for Children (Block Design and Vocabulary; Legerstee, van der Reijden-Lakeman, Lechner-van der Noort, & Ferdinand, 2004; Hrabok, Brooks, Fay-McClymont, & Sherman, 2014)
  • participant enrolled in a daily contingency management program or other teacher program targeting behavior or social problems at study entry or in the preceding month
  • Maximum of 2 children per classroom and 5 classrooms per school (in order to limit teachers' burden and increase heterogeneity of teacher and classroom settings)

结局指标

主要结局

Change from Baseline in Strengths and Weaknesses of ADHD-symptoms and Normal Behavior Scale (SWAN; Young, Levi, Martin, & Hay, 2009)

时间窗: 6 weeks and 18 weeks after baseline assessment

The teacher and parent version of the SWAN were used

Change from Baseline in Strengths and Difficulties Questionnaire (SDQ; Van Widenfelt, Goedhart, Treffers, & Goodman, 2003)

时间窗: 6 weeks and 18 weeks after baseline assessment

The teacher and parent-version of the SDQ were administered, using the following subscales: ADHD, Conduct Problems, Internalizing Behavior (combining Emotional Symptoms and Peer Problems), and Impact On Daily Functioning

Change from Baseline in Disruptive Classroom Behavior measured by the Classroom Observation Code (COC; Abikoff, Gittelman, & Klein, 1980)

时间窗: 6 weeks and 18 weeks after baseline assessment

The observation was performed by well-trained psychology students not involved in treatment delivery. Each participant was observed twice on the same school day for 8 minutes, using the average score as outcome measure

Change from Baseline in hyperactivity during school hours using Actigraphy (Cambridge Neurotechnology, 2008)

时间窗: 6 weeks and 18 weeks after baseline assessment

It concerned an actigraph worn on the wrist of the non-dominated hand during 5 school days

次要结局

  • Change from Baseline in Sociometric Measure (Bukowski, Cillessen, & Velasquez, 2012)(6 weeks and 18 weeks after baseline assessment)
  • Teacher's treatment fidelity averaged over 18 similar checklists (self-constructed), containing 13 items on a 3-point Likert scale regarding the use of each intervention element (0=not used or inadequate use, 1=adequate use, and 2=good use)(1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 weeks after start of the intervention)
  • Change from Baseline in Spence Children's Anxiety Scale (SCAS)(6 weeks and 18 weeks after baseline assessment)
  • Change from Baseline in Performance on Dutch Writing Test (PI-dictee; Geelhoed & Reitsma, 2000)(6 weeks and 18 weeks after baseline assessment)
  • Change from Baseline in Performance on Dutch Arithmetic Test (Tempo-Test Rekenen; De Vos, 1992)(6 weeks and 18 weeks after baseline assessment)
  • Change from Baseline in Social Skills Scale of the Social Skills Rating Scale (SSRS; Merrell & Popinga, 1994)(6 weeks and 18 weeks after baseline assessment)
  • Change from Baseline in Performance on Dutch Reading Test (Drie-Minuten Toets; Verhoeven, 1995)(6 weeks and 18 weeks after baseline assessment)

研究者

发起方
VU University of Amsterdam
申办方类型
Other
责任方
Principal Investigator
主要研究者

Betty Veenman

MSc

VU University of Amsterdam

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