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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parent-Child Relations; Parenting; Child Development
• Intervention / Treatment: Behavioral: FamilieTrivsel; Other: enhanced care as usual

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 Type: Interventional
• Enrollment (Actual): 624
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Capital Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 48 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FamilieTrivsel; Enhanced care as usual in general practice plus training in the use of the online mentalisation programme	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 Names: Robustbarn.dk (FamilieTrivsel is a customised variant focused on families with young children); 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; Other Names: control
Active Comparator: control; Enhanced care as usual in general practice	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; Other Names: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Service and societal costs	Within-trial costs of participants' service use and out of pocket expenses - collected by parental questionnaire	30 months postnatal
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
EQ VAS (EuroQol Visual Analog Scale)	Maternal self rated health - range 0-100 - high scores indicate better outcome.	30 months postnatal

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Service and societal costs	Within-trial costs of participants' service use and out of pocket expenses - collected by parental questionnaire	15 months postnatal

Collaborators and Investigators

• Sponsor: Research Unit Of General Practice, Copenhagen
• Collaborators: Göteborg University; University of Copenhagen; University of Southern Denmark; TrygFonden, Denmark; University of Aberdeen
• Investigators: Principal Investigator: Philip Wilson, DPhil FRCGP, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Anticipated): April 15, 2025
• Study Completion (Anticipated): April 15, 2025

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 0001 (Cancer Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: To be determined
• IPD Sharing Time Frame: Protocol to be published during recruitment phase. SAP to be published before unblinding.
• IPD Sharing Access Criteria: Open access once published
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No