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

Research Unit Of General Practice, Copenhagen

Status: Active, not recruiting

Conditions: Child Development; Parenting; Parent-Child Relations

Treatments: Behavioral: FamilieTrivsel; Other: enhanced care as usual

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04129359

0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 624 patients

Sex: Female

Ages: 16 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

624 participants in 2 patient groups

FamilieTrivsel

Experimental group

Description:

Enhanced care as usual in general practice plus training in the use of the online mentalisation programme

Treatment:

Other: enhanced care as usual

Behavioral: FamilieTrivsel

control

Active Comparator group

Description:

Enhanced care as usual in general practice

Treatment:

Other: enhanced care as usual