NCT04129359

FamilieTrivsel i Almen Praksis: a Mentalisation Programme for Families With Young Children

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 624 (actual)
• Sponsor: Research Unit Of General Practice, Copenhagen · Academic / Other
• Sex: Female
• Age: 16 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Parent-Child Relations
• Child Development
• Parenting

Interventions

Type	Name	Description
BEHAVIORAL	FamilieTrivsel	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.
OTHER	enhanced care as usual	Structured assessments of maternal mental health, child neurodevelopment and parent-child interaction in routine preventive health care in general practice

Timeline

• Start date: 2019-10-15
• Primary completion: 2025-04-15
• Completion: 2025-04-15
• First posted: 2019-10-16
• Last updated: 2022-12-21

Locations

1 site across 1 country: Denmark