FamilieTrivsel i Almen Praksis: A General Practice-based Cluster-randomised Trial of the Impact of the Resilience Programme on Early Child Development
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 624
- 试验地点
- 1
- 主要终点
- MacArthur-Bates Communicative Development Inventory (100 word Danish version)
研究概览
简要总结
This cluster randomised trial aims to establish the effectiveness of an online intervention designed to improve the ability of parents to 'mentalise' - in other words to understand their own mental states and that of others including their partners and young children. Effects on maternal mental state, the quality of parent-child interaction and child language, social and emotional development will be assessed.
详细描述
This is a cluster randomised trial based in Danish general practice. A number of general practitioners will be recruited, each of which will recruit successive women at their first routine antenatal appointment. All practices will receive standardised training in assessing maternal mental health, neurodevelopmental assessment of the child and assessment of the quality of parent-child interaction as well as in completion of an enhanced pregnancy or child development record.
Practices will be randomised either to receive additional training in the principles of mentalisation and in the use of an online resource (Robusthed) that parents can use to improve their mentalisation skills (https://robustbarn.dk) or not to receive this extra training. The trial is therefore comparing Robusthed plus enhanced care as usual with enhanced care as usual alone.
Baseline measures will be taken at recruitment into the trial and outcomes will be collected when the child is 15 and 30 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women presenting at their first GP-based antenatal assessment and their families
排除标准
- •Non-Danish speaking women
- •Families planning to move to a new general practice during the pregnancy or shortly after the birth of the child
- •Mother has already participated in the trial (e.g., second eligible baby within life of the study)
- •Presentation to the GP after the time for the third scheduled antenatal visit
- •Miscarriage or other pregnancy loss after recruitment to the study will lead to late exclusion from the study
- •Second pregnancies among already-participating families
结局指标
主要结局
MacArthur-Bates Communicative Development Inventory (100 word Danish version)
时间窗: 30 months postnatal
Child expressive language measure - range 0-100 - parent complete - higher scores indicate better outcomes
Strengths and Difficulties Questionnaire Total Difficulties Score
时间窗: 30 months postnatal
Child psychiatric symptom score, range from 0-40, parent complete, lower scores indicate better outcome.
次要结局
- EQ VAS (EuroQol Visual Analog Scale)(30 months postnatal)
- Service and societal costs(30 months postnatal)
- Child-Adult Relationship Observation (CARO)(30 months post natal)
- Hospital Anxiety and Depression Scale(30 months postnatal)
- EQ-5D-5L (EuroQol 5-Dimension 5-Level)(30 months postnatal)
研究者
Jakob Kragstrup
Professor of General Practice
Research Unit Of General Practice, Copenhagen