Here is the design of a clinical trial:

Official Title: FamilieTrivsel i Almen Praksis: A General Practice-based Cluster-randomised Trial of the Impact of the Resilience Programme on Early Child Development

Included conditions:
- Parent-Child Relations
- Child Development
- Parenting

Study Armgroups:
- {'label': 'FamilieTrivsel', 'type': 'EXPERIMENTAL', 'description': 'Enhanced care as usual in general practice plus training in the use of the online mentalisation programme', 'interventionNames': ['Behavioral: FamilieTrivsel', 'Other: enhanced care as usual']}
- {'label': 'control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Enhanced care as usual in general practice', 'interventionNames': ['Other: enhanced care as usual']}

Interventions:
- {'type': 'BEHAVIORAL', 'name': 'FamilieTrivsel', 'description': "FamilieTrivsel is a modular internet-based low-cost and brief psychoeducation intervention based on the Robusthed (Resilience) programme (RP). Mentalisation approaches are used to increase resilience and ability to handle the challenges of life. The programme is licence free and can be used with low or high intensity and it can be combined with any other interventions. RP provides simple explanations and tools that can be used to discover, understand and regulate one's own thoughts and feelings by activating mental and physical resources and it provides examples and exercises that may promote communication about mental states between parents and the child. The content has been developed to include video-based training sessions based on different stages of pregnancy and early childrearing. RP appears suitable for use in general practice, where the GP sees young parents regularly and thus can direct patients towards components of the programme when need appears greatest.", 'armGroupLabels': ['FamilieTrivsel'], 'otherNames': ['Robustbarn.dk (FamilieTrivsel is a customised variant focused on families with young children)']}
- {'type': 'OTHER', 'name': 'enhanced care as usual', 'description': 'Structured assessments of maternal mental health, child neurodevelopment and parent-child interaction in routine preventive health care in general practice', 'armGroupLabels': ['FamilieTrivsel', 'control'], 'otherNames': ['control']}

Primary Outcomes:
- {'measure': 'Strengths and Difficulties Questionnaire Total Difficulties Score', 'description': 'Child psychiatric symptom score, range from 0-40, parent complete, lower scores indicate better outcome.', 'timeFrame': '30 months postnatal'}
- {'measure': 'MacArthur-Bates Communicative Development Inventory (100 word Danish version)', 'description': 'Child expressive language measure - range 0-100 - parent complete - higher scores indicate better outcomes', 'timeFrame': '30 months postnatal'}

Please estimate the sample size based on the assumption: 
80% power, 2.5% significance level, intra-class correlation coefficient (ICC) of 0.02, 22% attrition rate.
Sample size
        A total sample of children was estimated to be needed to find a difference of two points in the SDQ Total Difficulties Scale score (an effect size of 0.3) with 80% power at a 2.5% significance level. The estimate of 488 was based on the assumption of an intra-class correlation coefficient (ICC) of 0.02 in 60 clinics (an average of eight children per clinic). Allowing for 22% attrition we therefore aimed to recruit 488/0.78â=â624 children in 60 clusters (of on average 11 children per GP). The ICC estimate was based on the distribution of HADS scores at baseline, suggesting that the impact of clustering effect by practice was modest.
        
          Allocation, sequence generation, and concealment
          The study is a cluster randomised controlled trial with the general practice as the unit of randomisation. General practices were randomised on a 1:1 basis to intervention or control groups using a computer algorithm. The computer randomised allocation sequence was concealed until all general practices were assigned.
        
        
          Blinding (masking)
          The design is open label with only the study statistician being blinded under the dataset locked after collection of primary outcome data so un-blinding will not occur.