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

Not Applicable

Active, not recruiting

• Conditions: Parenting; Parent-Child Relations; Child Development
• Interventions: Other: enhanced care as usual; Behavioral: FamilieTrivsel

• Registration Number: NCT04129359
• Lead Sponsor: Research Unit Of General Practice, Copenhagen

Brief 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.

Study Timeline

• Study First Submitted: 2019-10-08
• Study Start: 2019-10-15
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-16
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-21
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 624

Inclusion Criteria

• Pregnant women presenting at their first GP-based antenatal assessment and their families

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	enhanced care as usual	Enhanced care as usual in general practice
FamilieTrivsel	FamilieTrivsel	Enhanced care as usual in general practice plus training in the use of the online mentalisation programme
FamilieTrivsel	enhanced care as usual	Enhanced care as usual in general practice plus training in the use of the online mentalisation programme

Primary Outcome Measures

Name	Time	Method
MacArthur-Bates Communicative Development Inventory (100 word Danish version)	30 months postnatal	Child expressive language measure - range 0-100 - parent complete - higher scores indicate better outcomes
Strengths and Difficulties Questionnaire Total Difficulties Score	30 months postnatal	Child psychiatric symptom score, range from 0-40, parent complete, lower scores indicate better outcome.

Secondary Outcome Measures

Name	Time	Method
EQ VAS (EuroQol Visual Analog Scale)	30 months postnatal	Maternal self rated health - range 0-100 - high scores indicate better outcome.
Service and societal costs	30 months postnatal	Within-trial costs of participants' service use and out of pocket expenses - collected by parental questionnaire
Child-Adult Relationship Observation (CARO)	30 months post natal	Event-based scoring system counting rates of positive and negative parenting behaviours in a home-based video of a caring episode (eg mealtime). Blinded rater. Positive and negative scores 0-6, high positive scores and low negative scores are better outcomes.
Hospital Anxiety and Depression Scale	30 months postnatal	Scores for anxiety and depression (parent self-complete) - separate scores for anxiety and depression - both scales range 0-21 - on both scales low scores indicate better outcome
EQ-5D-5L (EuroQol 5-Dimension 5-Level)	30 months postnatal	Maternal health-related quality of life - parental self-complete - range 5-25 - low scores indicate better outcome

Trial Locations

Locations (1)

Capital Region; 🇩🇰 Copenhagen, Denmark