The Effects of a Peer Co-led Educational Programme for Parents of Children With ADHD: A Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
ADHD is associated with a substantial burden on families, and systems pertaining to health, social care, and criminal justice, and there is a need for more knowledge of the effects of non-pharmacological interventions. Educational and parental activation interventions may improve ADHD symptoms, and may enhance parent activation. Although the results of these studies are promising, few interventions have been carried out in collaboration with user representatives, which is required by Norwegian legislation. As such, there is a need for clinical studies that document the effects of educational group interventions based on user involvement that seeks to improve parental activation. Furthermore, it is not clear which type of educational intervention that should be offered, and which aspects of parenting behaviour to focus on. There is a lack of studies investigating whether adding an intervention designed specifically for families of children with ADHD will be more effective than treatment as usual (TAU). The purpose of the present study is to determine the feasibility and expected size of a substantive randomized controlled trial comparing an ADHD peer co-led educational programme added to TAU.
详细描述
The primary objective of this trial is to evaluate the acceptability and feasibility of the intervention, to assure that procedures are adequate for a subsequent full size randomized controlled trial (RCT), and to determine the likely size of the trial comparing an ADHD specific parenting peer co-led intervention for parents of children with ADHD symptoms.
Specific objectives are:
(I) investigate whether parents of children recently diagnosed with ADHD are willing to be randomized to the intervention, (II) whether sufficient numbers of families can be recruited and retained such that a full-scale RCT is likely to be feasible, (III) whether research procedures and efficacy measures are feasible and acceptable to participating families and the outpatient clinics, and (IV) whether families participating in the intervention are satisfied with the intervention.
This feasibility study is not designed to detect a treatment effect, therefore a maximum of 50 parents will be recruited. The measurements will be taken in the children (at baseline and 3 months) and parents (at baseline, two weeks, pre-post intervention and 3 months follow-up) to determine the feasibility and acceptability. These measures are chosen because they address key components of the intervention (activation, quality of life and psychological well-being). Multiple measures of similar constructs will be administered where possible (e.g., psychological well-being and quality of life) to determine which measure to include in the definitive trial according to feasibility, acceptability, and sensitivity.
Feasibility assessments:
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents of children aged 6 - 12 with a formal diagnosis of ADHD, following a standardised assessment.
排除标准
- •Participants already taking part in research on a parenting intervention will also be ineligible to participate.
- •Families attending other parenting groups
结局指标
主要结局
Feasibility of recruitment
时间窗: Over a two year study period
Feasibility of recruitment will be assessed by determining the recruitment rate, by monitoring patient screening and subsequent agreement to participate.
Parental activation
时间窗: From baseline to 12- and 52-weeks follow-up
Parental activation will be measure with the P-PAM-13. The 13-items P-PAM has four possible response options ranging from (1) strongly disagree, to (4) strongly agree, and an additional 'not applicable' option.
Satisfaction with the intervention
时间窗: From baseline to 12- and 52-weeks follow-up
Parent satisfaction will be measured by means of the client satisfaction Questionnaire, CSQ-3 as it applies to the group-based educational programme. The scale comprises three items measured on a scale from 1 (not satisfied) to 4 (very satisfied).
次要结局
- Parental well-being(From baseline to 12- and 52-weeks follow-up)
- Beliefs about medicines(From baseline to 12- and 52-weeks follow-up)
- ADHD Scale Parent Version(From baseline to 12- and 52-weeks follow-up)
- Parental quality of life(From baseline to 12- and 52-weeks follow-up)
- Shared decision making(From baseline to 12- and 52-weeks follow-up)
- Parental involvement in treatment decision(From baseline to 12- and 52-weeks follow-up)
- Adherence(From baseline to 12- and 52-weeks follow-up)
- Level of functioning of children in Child(From baseline to 12- and 52-weeks follow-up)