Emotion Regulation as a Moderator of Two Different Treatments for Children With Oppositional Defiant Disorder: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)
研究概览
简要总结
The goal of this randomized controlled trial is to is to test emotion regulation as a moderator of two different treatments for children with Oppositional Defiant Disorder (ODD). The main question it aims to answer is whether treatment gains be increased when children with ODD receive a treatment congruent with their emotion regulation skill problems. Participants will be divided into two groups based on their response patterns; a high emotion dysregulation group and a low emotion dysregulation group. Within each group, children will then be randomly assigned to either a behavioral parent training intervention or a child directed treatment involving problem solving and emotion regulation skills.
详细描述
Emotion regulation has been implicated in the development of ODD. Two types of treatment are commonly used for children with ODD, behavioral parent training and child directed cognitive treatments. Parent training focuses on increasing compliance and reducing defiant behaviour while the child directed treatments focus on increasing the child's problem solving skills and emotion regulation. The investigators will assess emotion regulation and emotional lability in children diagnosed with ODD and divide them into two groups based on their response patterns; a high emotion dysregulation group and a low emotion dysregulation group. Within each group, children will then be randomly assigned to either a behavioral parent training intervention or a child directed treatment involving problem solving and emotion regulation skills, which makes it possible to assess the effects of the different interventions for the two distinct groups. Treatment effects will be assessed at pre- and post-treatment as well as at 6 and 18 month follow-up. Comorbid conditions will be tested as moderators.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, care providers and outcomes assessors will be blind to emotion regulation status.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with Oppositional Defiant Disorder
- •Icelandic speaking (child and parent/guardian)
排除标准
- •IQ below 70 (full scale score)
结局指标
主要结局
Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)
时间窗: Pre-treatment; 6-month follow-up; 18-month follow-up.
Diagnostic Interview to assess whether a child changes in diagnostic status, whether child meets DSM-5 diagnostic criteria for mental disorders.
Disruptive Behaviour Rating Scale
时间窗: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Parent and teacher rated questionnaire to assess change in symptoms of ODD.
次要结局
- Social Skills Rating System(Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.)
- Home Situations Questionnaire(Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.)
- Strength and difficulties questionnaire(Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.)
- Parent Stress Index(Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.)
- Pediatric Quality of Life Index(Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.)
研究者
Urdur Njardvik
Professor
University of Iceland