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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parent-Child Relations, Child Development, Parenting

Intervention / Treatment
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* Behavioral: FamilieTrivsel
* Other: enhanced care as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster RCT in general practices, which will recruit successive pregnant women. All practices will receive training in data recording and assessment, and half will receive additional training in use of the online intervention. Our original sample size calculation required 1,000 participants, in 100 clusters of 10 participants per practice. This would allow us to detect a difference of two points in the SDQ Total Difficulties Scale score (an effect size of 0.3) with 90% power at a 2.5% significance level assuming the intraclass correlation coefficient was 0.06. We continued to recruit practices until COVID-19 restrictions prevented further recruitment of practices. We then made a decision to increase the cluster size, allowing participating practices to recruit up to 30 participants. We were also able to adjust our original estimate of the intra-class correlation coefficient based on our baseline data from 0.06 to 0.02 allowing us to reduce our target sample size from 1000 to 624.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FamilieTrivsel<br>Enhanced care as usual in general practice plus training in the use of the online mentalisation programme | Behavioral: FamilieTrivsel<br>* 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.<br>* Other names: Robustbarn.dk (FamilieTrivsel is a customised variant focused on families with young children);Other: enhanced care as usual<br>* Structured assessments of maternal mental health, child neurodevelopment and parent-child interaction in routine preventive health care in general practice<br>* Other names: control;|
| Active Comparator: control<br>Enhanced care as usual in general practice | Other: enhanced care as usual<br>* Structured assessments of maternal mental health, child neurodevelopment and parent-child interaction in routine preventive health care in general practice<br>* Other names: control;|

What is the study measuring?
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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 |