The Effect and Experience of the Brief Parental Program AFFEKT Within Primary Health Care - for Parents of Children With Externalizing Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Change in disruptive behavior as assessed by the ECBI
研究概览
简要总结
This project is the first to evaluate the effect and experience of the parent program AFFEKT, through a randomized controlled trial and qualitative study, within primary health care. The project will recruit 200 parents of children with externalizing behaviors, and evaluate the effect of AFFEKT and psychoeducation versus psychoeducation alone, on children's behaviors and mental health, and the parent's strategies and mental health. Through interviews the experience of AFFEKT will be investigated.
详细描述
Externalizing behaviors is a common problem among children. There are several parent programs for parents of children with externalizing behaviors, but many of these programs are time consuming. Within Medtanken Group AB a new brief parent program called AFFEKT has been developed. The clinical experience of the program has been promising, yet there are no previous randomized controlled trials or qualitative studies of AFFEKT.
The overall aim of this project is to examine the efficacy of the brief parenting program AFFEKT for parents of children with externalizing behaviors, and the parents experience of participating in AFFEKT. The project includes a quantitative study, including a randomized controlled trial (RCT), and a qualitative study.
Main aim and research question of the RCT part of the project:
The main aim of the RCT is to evaluate the efficacy of the brief parenting program AFFEKT. Is AFFEKT and psychoeducation targeting the parents more effective in changing the child's externalizing behaviors and mental health than psychoeducation alone? Primary research questions of the RCT
- Will the outcome concerning the children's problematic behaviors improve statistically and significantly more in the experiment group (psychoeducation + AFFEKT) than in the control group (psychoeducation alone) post treatment?
- Will there be statistical and significant effects of AFFEKT + psychoeducation on the children's problematic behaviors over time (6 and 12months after baseline)?
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigators providing the psychoeducation and collecting the data at the information meeting (baseline) will be blinded since the randomization is carried out after that meeting and by an independent researcher.
The individuals conducting the statistical analyses on the data from the RCT study will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent (or primary caregiver) to a child 6-12 years with externalizing issues
- •Can communicate in Swedish
排除标准
- •Attending other parental programs
- •Non-communicable in Swedish
研究组 & 干预措施
Experiment group
The experiment group will receive written psychoeducation about children with externalizing behaviors, and start their parental program AFFEKT approximately one week from the information meeting (baseline).
干预措施: AFFEKT - a manual based brief parent program for parents of children (aged 6-12 years) with externalizing behaviors. (Behavioral)
Control group
The control group will receive written psychoeducation about children with externalizing behaviors, and start their parental program AFFEKT approximately seven weeks from the information meeting (when the experiment group has finished their AFFEKT program).
干预措施: AFFEKT - a manual based brief parent program for parents of children (aged 6-12 years) with externalizing behaviors. (Behavioral)
结局指标
主要结局
Change in disruptive behavior as assessed by the ECBI
时间窗: The ECBI is measured at baseline for both groups, pre AFFEKT (+7 weeks) for the control group, post AFFEKT (+6 weeks) for the experiment group and (+11 weeks) for the control group, and at follow-up (+6 months and +1 year) for both groups.
The Eyberg Child Behavior Inventory (ECBI; Eyberg \& Ross, 1978) measures disruptive behavior problems in children through 36 items.
次要结局
- Symptoms and social deficits associated with autism spectrum disorders as assessed by the SRS-2(The SRS-2 is measured at baseline for both groups.)
- Change in general mental ill-health and health as assessed by the GHQ-12(The GHQ-12 is measured at baseline for both groups, pre AFFEKT (+7 weeks) for the control group, post AFFEKT (+6 weeks) for the experiment group and (+11 weeks) for the control group, and at follow-up (+6 months and +1 year) for both groups)
- Change in symptoms associated with ADHD as assessed by the SNAP-IV(The SNAP-IV is measured at baseline for both groups, pre AFFEKT (+7 weeks) for the control group, post AFFEKT (+6 weeks) for the experiment group and (+11 weeks) for the control group, and at follow-up (+6 and +1 year) for both groups.)
- Change in quality of life as assessed by the BBQ(The BBQ is measured at baseline for both groups, pre AFFEKT (+7 weeks) for the control group, post AFFEKT (+6 weeks) for the experiment group and (+11 weeks) for the control group, and at follow-up (+6 months and +1 year) for both groups.)
- Change in global stress as assessed by the PSS -14(The PSS is measured at baseline for both groups, pre AFFEKT (+7 weeks) for the control group, post AFFEKT (+6 weeks) for the experiment group and (+11 weeks) for the control group, and at follow-up (+6 months and +1 year) for both groups.)
- Treatment satisfaction as assessed by the CSQ-8(The CSQ-8 is measured post AFFEKT (+6 weeks) for the experiment group and (+11 weeks) for the control group.)