Step-by-Step: Evaluation of a Stepped Care Model for Anger, Defiant, or Aggressive Behavior in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Parent: Mean change from baseline in oppositional defiant disorder and conduct disorder criteria
研究概览
简要总结
The primary aim of this project is to examine the effectiveness of a stepped care model of interventions for children's defiant or aggressive behavior problems. The stepped model consists of a brief internet-based parenting support program (Step 1). For those with continued need of additional interventions, Step 2 includes access to one of following interventions: b) a Cognitive Behavior Therapy (CBT) -Virtual Reality (VR)-assisted parenting support program, b) a Cognitive Behavior Therapy -Virtual Reality-assisted child intervention, or c) standard interventions/support at the family's unit/clinic and continued access to the study's internet-based parenting support program, after which the family may choose CBT-VR for the child or the parent.
详细描述
Children who exhibit severe aggressive and defiant behavior from an early age are at increased risk of persistent behavioral problems during adolescence and into young adulthood. Additionally, they are more likely to experience difficulties in social contexts, lack prosocial friendships, fall behind academically in school, and have poorer mental well-being.
Parenting support programs are recommended for parents of children under the age of 12 with oppositional defiant disorder or conduct disorder, as well as for parents of adolescents with less severe behavioral problems. Therefore, such programs can serve as a foundation for interventions offered to parents of children with behavioral problems. However, many parenting support programs are delivered in a group format, are not possible to attend for all parents, have challenges related to parental engagement and dropout, and fewer programs have been evaluated for parents of adolescents.
Cognitive behavioral therapy (CBT) for children with behavioral problems, including anger management training, social skills training, and problem-solving training, have been shown to reduce anger and aggressive behavior and may complement parent support programs for children/youth with behavior problems.
However, there still remains a need for effective stepped care interventions for parents and children/youth with behavior problems.
PURPOSE AND RESEARCH QUESTIONS:
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
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Families with children aged 8-16 years who have difficulty controlling anger or exhibit defiant or aggressive behavior. The child/adolescent meets 3 of the diagnostic criteria for Oppositional Defiant Disorder or 2 criteria for Conduct Disorder indicating aggressive behavior.
- •Medication for the child can remain stable.
- •Parents need to be able to read and engage with materials in Swedish
排除标准
- •Families with children younger than 8 years old or who have already turned 17, or who do not exhibit defiant or aggressive behaviors according to the first inclusion criterion.
- •Children with severe depression, suicidal behavior, bipolar disorder, psychosis, eating disorders, severe autism (level 2 and 3), diagnosed intellectual disability, or ongoing criminal behavior assessed to require interventions other than the study's interventions are excluded.
- •Children/adolescents with other ongoing psychological treatments for the same condition or assessed by the clinician in need of other interventions
- •Parents and children with epilepsy or migraines
研究组 & 干预措施
Internet-based parenting support
5 weeks of internet-based parenting support provided as a first step for all parents (Step 1 in the stepped care model).
干预措施: Internet-based parenting support (Behavioral)
"YourSkills" for children/youth
A cognitive-behavioral program for children and youth with up to 10 individual, face-to-face, weekly sessions, where role-plays can be conducted in virtual reality. (Step 2 in the stepped care model)
干预措施: "YourSkills" for children/youth (Behavioral)
Step-by-step parent support
A parent training program with between 6 and 10 individual, face-to-face, weekly sessions with parents. Role-plays may be conducted in virtual reality. (Step 2 in the stepped care model)
干预措施: Step-by-step parent support (Behavioral)
Intervention/supports as usual and prolonged use of internet-based parenting support
Based on other available support at the units and prolonged use of internet-based parenting support program. (Step 2 in the stepped-care model)
干预措施: Intervention/support as usual and prolonged use of internet-based parenting support (Behavioral)
结局指标
主要结局
Parent: Mean change from baseline in oppositional defiant disorder and conduct disorder criteria
时间窗: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
The number of Oppositional defiant disorder criteria (between 0-8) and Conduct disorder criteria (aggressive symptoms; between 0-5). Total number ranges between 0-13 criteria.
Parent: Mean change from baseline in behavior problems on parent-ratings of the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale).
时间窗: Pre-, mid- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.
The oppositional defiant disorder subscale of the Disruptive Behavior Disorder scale is used for assessing children's behavioral problems. The subscale includes 8 items which are rated on a 4-point scale (0 to 3). The total scale sum ranges from 0 to a total maximum sum of 24 with a higher score indicating more behavior problems.
Child/youth: Mean change from baseline in child-ratings of anger on the Anger Expression Scale for children
时间窗: Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program)
The Anger expression scale for children includes 26 questions about anger and anger management and is rated by children on a 4-point Likert scale (from 1 to 4). Two modified sub-scales are used: anger expression (score ranges from 17 to 68) and anger control (score ranges from 9 to 36) with higher scores indicating higher levels of anger expression and anger control.
次要结局
- Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Scale (over-reactivity subscale)(Pre-, mid-, and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.)
- Child/youth: Mean change from baseline in child-ratings of child life quality on the Child Health Utility 9 Dimensions(Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program))
- Parent: Mean change in ratings of satisfaction with the week(Weeks 0 to 15 after baseline. Completed once a week at each session.)
- Child: Mean change in ratings of satisfaction with the week(Weeks 6 to 15 after baseline. Completed once a week at each session.)
- Parental and child experiences of each session(Weeks 6 to 15 after baseline. Completed once a week at each session)
- Parent: Mean change from baseline in parent-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)(Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.)
- Parent: Mean change from baseline in parenting on parent-ratings of the Parenting Children and Adolescents Scale(Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.)
- Parent: Mean change in parent-ratings of family warmth(Pre-, mid-, and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.)
- Parent: Mean change in parent-ratings of family conflicts(Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.)
- Parent: Mean change from baseline in parent-ratings of parental emotion regulation on the Parent Emotion Regulation Scale(Pre-, mid-, and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.)
- Parent: Mean change from baseline in parent-ratings of child callous-unemotional traits on the Inventory of Callous-unemotional traits(Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.)
- Parent: Mean change from baseline in parent-rated child life quality on the Child Health Utility 9 Dimensions(Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.)
- Parent: Mean change from baseline in parental well-being on the Depression Anxiety and Stress Scale-21 (DASS21)(Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.)
- Child/youth: Mean change from baseline in child-ratings of child wellbeing on the Strengths and Difficulties Questionnaire (SDQ)(Pre- and post-interventions (5 and 15 weeks after the initiation of the internet-based parent support program))
- Parent: Inventory of health-related costs(Pre- and post-intervention (15 weeks after the initiation of the internet-based parent support program), and six months after the final intervention.)
研究者
Pia Enebrink
Associate professor
Karolinska Institutet