Clinical trial NCT04129359: FamilieTrivsel i Almen Praksis: a Mentalisation Programme for Families With Young Children
Official title: FamilieTrivsel i Almen Praksis: A General Practice-based Cluster-randomised Trial of the Impact of the Resilience Programme on Early Child Development
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parent-Child Relations
Child Development
Parenting
Lead sponsor: Research Unit Of General Practice, Copenhagen
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: Göteborg University
name: University of Aberdeen
name: University of Southern Denmark
name: University of Copenhagen
First posted: 2019-10-16
Enrollment: 624
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Strengths and Difficulties Questionnaire Total Difficulties Score
timeFrame: 30 months postnatal
measure: MacArthur-Bates Communicative Development Inventory (100 word Danish version)
timeFrame: 30 months postnatal
Secondary outcomes:
measure: Child-Adult Relationship Observation (CARO)
timeFrame: 30 months post natal
measure: Hospital Anxiety and Depression Scale
timeFrame: 30 months postnatal
measure: Service and societal costs
timeFrame: 30 months postnatal
measure: EQ-5D-5L (EuroQol 5-Dimension 5-Level)
timeFrame: 30 months postnatal
measure: EQ VAS (EuroQol Visual Analog Scale)
timeFrame: 30 months postnatal
Other outcomes:
measure: Child-Adult Relationship Observation (CARO)
timeFrame: 15 months postnatal
measure: Maternal Hospital Anxiety and Depression Scale
timeFrame: 15 months postnatal
measure: Service and societal costs
timeFrame: 15 months postnatal
Locations:
city: Copenhagen
country: Denmark
facility: Capital Region
Study officials:
affiliation: University of Copenhagen
name: Philip Wilson, DPhil FRCGP
role: PRINCIPAL_INVESTIGATOR
References: