A Randomized Controlled Effectiveness Trial of a Transdiagnostic Parent Training Intervention to Prevent Childhood Mental Health Problems in Norwegian Frontline Services
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Change in child problem behaviors measured by Eyberg Child Behavior Inventory
研究概览
简要总结
The aim of this clinical trial is to test the effectiveness of the parent training intervention Supportive Parents - Coping Kids (SPARCK) for prevention of childhood mental health problems. The main research questions are:
• Is SPARCK effective in preventing and reducing negative outcomes and promoting positive outcomes for eligible children and parents compared with regular care practice?
In addition, investigators will conduct an implementation study to examine relations between implementation determinants and implementation and clinical outcomes in the SPARCK intervention condition
Participants in the effectiveness trial will be randomized to receive either the SPARCK intervention or active regular care practices provided by professionals in the Norwegian frontline services. Researchers will test the effectiveness of the SPARCK intervention at post treatment and six months follow-up.
详细描述
SPARCK is a novel transdiagnostic and preventive parent intervention targeting parents with children aged 4 to 12 years with elevated, yet subclinical, symptoms of anxiety, depression (internalizing) and/or behavioral problems (externalizing). In this project, investigators will conduct a randomized effectiveness trial with families randomized to SPARCK or regular care practices in the Norwegian frontline services, e.g. child welfare services, health services, and school health services. Investigators will study potential effects of SPARCK primarily on a) child symptoms when compared with regular care, and secondary on b) parenting practices, self-efficacy and stress, c) parent and child stress regulation as indexed by stress hormones (cortisol and DHEA) in hair, d) referrals to specialized services and CWS, and e) child and parent subjective quality of life. Additionally, Investigators will study facilitators and barriers to successful implementation and the relation between implementation and clinical outcomes.
Design: Two-armed parallel group randomized controlled trial. Families will be assessed at three time points: At pre intervention, at post (intervention termination), and at follow-up six months after post assessment. In cases were intervention exceeds 24 weeks, we will assess post at week 25. In such cases, follow-up will be assessed six months after week 25. Stress hormones will be collected at pre intervention and four weeks after intervention termination.
Despite a relatively heterogeneous target group, investigators expect a balanced design in terms of symptom domains and comorbidity across internalizing and externalizing symptoms. However, there is some uncertainty regarding the frequency of children with depressive symptoms exclusively (in contrast to symptoms of anxiety or behavioral problems). Our primary outcomes reflect the transdiagnostic feature of SPARCK; targeting anxiety, depression, and externalizing symptoms. Eligible children may display symptoms symptoms in ether one, two, or across all three symptom domains. Accordingly, investigators do only expect change in a relevant symptom domain if children display elevated levels at pre intervention.
Data will be inspected the data halfway through the data collection to monitor various issues, such as the distribution of symptoms of study families at intake and potential harm to study families. For instance, if children with depressive symptoms exclusively is low-frequent at intake, investigators may modify relevant hypotheses and accompanying primary outcome. An external researcher which is not part of the project will oversee the process.
To investigate the implementation part of the project, investigators will include a quantitative data gathering amongst SPARCK practitioners and their service leaders over three time points; intervention time point 1 (iT1; at project start), iT2 (after one year of data collection), and iT3 (after two years of data collection.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants are to be masked to what treatment condition they are assigned to, whether they receive the treatment or control condition. Treatment conditions are termed group 1 and group 2.
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children displaying elevated symptoms of internalizing or/and externalizing problems
排除标准
- •Child is referred to or receives ongoing help in the specialized mental health services for problems in the internalizing or externalizing domains
- •Child is diagnosed with psychosis, mental retardation or pervasive developmental disorder
- •Acute suicide risk
- •Documented or probable ongoing physical or sexual abuse
- •Child or caretakers receives other systematic interventions targeting internalizing or externalizing problems while enrolled in the study (prior to 6 month follow-up)
结局指标
主要结局
Change in child problem behaviors measured by Eyberg Child Behavior Inventory
时间窗: Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)
Parent reported 36-items instrument tapping children's frequency of problem behaviors on a 7 point Likert-scale. Higher scores indicates more problem behavior.
Change in symptoms of child anxiety and depression measured by Revised Child Anxiety and Depression Scale
时间窗: Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment)
Parent reported 47-items instrument tapping children's anxiety and depressive symptoms on a 4-point numeric scale ranging from 1 to 4. A higher score indicates more symptoms
次要结局
- Change in parenting practices measured by Parenting and Family Adjustment Scale (PAFAS)(Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment))
- Change in child social and emotional problems measured by the Strengths and difficulties questionnaire (SDQ(Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment))
- Change in parenting stress measured by the Perceived Stress Scale(Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment))
- Change in stress hormones cortisol and dehydroepiandrosterone (DHEA)(Pre intervention (at respondent study inclusion and post intervention (4 weeks after treatment termination))
- Change in parental perceived life quality measured by Satisfaction With Life Scale (SWLS)(Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment))
- Change in parental self-efficacy measured by Me as a Parent (MaaP)(Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment))
- Change in parent stress hormones cortisol and dehydroepiandrosterone (DHEA)(Pre intervention (at respondent study inclusion and post intervention (4 weeks after treatment termination))
- Change in child stress hormones cortisol and dehydroepiandrosterone (DHEA)(Pre intervention (at respondent study inclusion and post intervention (4 weeks after treatment termination))
- Prevention of mental health and child protection service use(Two and five years after post intervention (treatment termination))
- Change in tendency to school refusal measured by SPARCK school refusal scale(Pre (at respondent study inclusion), post (at treatment termination or up to 25 weeks), and follow-up (6 months after post assessment))
- Change in child subjective quality of life measured by Kid-KINDL(Pre intervention (at respondent study inclusion and post intervention (4 weeks after treatment termination))