Efficacy of a Brief Behavioral Intervention to Treat ADHD and Disruptive Behaviors In Preschoolers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Parent Behavioral Assessment System for Children- 2nd Edition (BASC2) Externalizing Score
研究概览
简要总结
The purpose of this study is to test the intervention using a more rigorous randomized controlled trial design in order to demonstrate its efficacy compared to a wait-list control, thus ensuring that change in behavior does not occur due to the passage of time alone. Using this design will also allow us to improve upon our prior clinical research by facilitating obtainment of post-treatment and follow-up data (as families in the clinical-only service stop attending treatment when behavior improves, and have often not followed-up for booster sessions or measure completion).
详细描述
This pilot study will employ a randomized controlled clinical trial design comparing symptoms of children who complete the Brief Behavioral Intervention to a wait-list control. Children in the wait-list control will be waitlisted for four months prior to initiation of treatment, which is a typical wait for clinical care. Treatment will then be offered to the children on the wait-list.
All parts of the intervention and all measures of behavior and family functioning are part of standard clinical care. The parts of this protocol that are not standard clinical care are the following: 1. Randomization process with half of the patients on a waitlist for four months. Randomization will be block randomization stratified by gender. 2. Booster sessions for problem solving at three months and six months after last treatment session. In standard clinical care this occurs only if the patient calls and requests. 3. Collection of behavior and family functioning measures at three months and six months after the active treatment component.
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
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-5 years
- •Subject diagnosed with a Disruptive Behavior Disorder
- •Subject who has an English-speaking parent willing to take part in intervention.
- •Subject must meet criteria for a Diagnostic and Statistical Manual (DSM-IV) Disruptive Behavior Disorder (ADHD and/or ODD) based upon history, clinical interview, and clinically significant cut-off scores on parent rating forms. Parent and teacher of each child will also be involved.
排除标准
- •Parents who are not fluent in English
- •Subjects with a diagnosed anxiety disorder, pervasive developmental disorder, intellectual disability, adjustment disorder, mood disorder or language disorder will also be excluded and referred for more appropriate services.
- •Children with less severe behavior problems will not be included in the study but will be referred for more appropriate services.
- •Patients taking medication to treat behavior and patients who have previously received treatment will be excluded from the study.
结局指标
主要结局
Parent Behavioral Assessment System for Children- 2nd Edition (BASC2) Externalizing Score
时间窗: 3 months
The primary outcome measure is the parent BASC2 Externalizing score at 3 months post-treatment. The mean score in the control group at 3 months is expected to be about 70 points with a standard deviation of 10 based on previous research. Assuming a 10 unit difference in scores is clinically significant (effect size = 1.0), 17 patients per group will be required to detect a statistically significant difference between groups with 80% power assuming an alpha = 0.05 level of significance.
次要结局
- Improved overall family functioning(12 months)
研究者
Marni Axelrad
Associate Professor
Baylor College of Medicine