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

Child Development 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04129359
• Other study ID #: 0001
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: April 15, 2025

Study information

• Verified date: December 2022
• Source: Research Unit Of General Practice, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 624
• Est. completion date: April 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Parent-Child Relations
• Parenting

Intervention

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

Locations

Country	Name	City	State
Denmark	Capital Region	Copenhagen

Sponsors (6)

Lead Sponsor	Collaborator
Research Unit Of General Practice, Copenhagen	Göteborg University, TrygFonden, Denmark, University of Aberdeen, University of Copenhagen, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child-Adult Relationship Observation (CARO)	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.	15 months postnatal
Other	Maternal Hospital Anxiety and Depression Scale	separate scores for anxiety and depression (parent self-complete) - both scales range 0-21 - on both scales low scores indicate better outcome	15 months postnatal
Other	Service and societal costs	Within-trial costs of participants' service use and out of pocket expenses - collected by parental questionnaire	15 months postnatal
Primary	Strengths and Difficulties Questionnaire Total Difficulties Score	Child psychiatric symptom score, range from 0-40, parent complete, lower scores indicate better outcome.	30 months postnatal
Primary	MacArthur-Bates Communicative Development Inventory (100 word Danish version)	Child expressive language measure - range 0-100 - parent complete - higher scores indicate better outcomes	30 months postnatal
Secondary	Child-Adult Relationship Observation (CARO)	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.	30 months post natal
Secondary	Hospital Anxiety and Depression Scale	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	30 months postnatal
Secondary	Service and societal costs	Within-trial costs of participants' service use and out of pocket expenses - collected by parental questionnaire	30 months postnatal
Secondary	EQ-5D-5L (EuroQol 5-Dimension 5-Level)	Maternal health-related quality of life - parental self-complete - range 5-25 - low scores indicate better outcome	30 months postnatal
Secondary	EQ VAS (EuroQol Visual Analog Scale)	Maternal self rated health - range 0-100 - high scores indicate better outcome.	30 months postnatal