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| Name | Class |
|---|---|
| TrygFonden, Denmark | INDUSTRY |
| Göteborg University | OTHER |
| University of Aberdeen | OTHER |
| University of Southern Denmark |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FamilieTrivsel | Experimental | Enhanced care as usual in general practice plus training in the use of the online mentalisation programme |
|
| control | Active Comparator | Enhanced care as usual in general practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FamilieTrivsel | Behavioral | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Wilson, DPhil FRCGP | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Region | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38750557 | Derived | Stroyer de Voss S, Wilson PMJ, Kirk Ertmann R, Overbeck G. Increased family psychosocial focus during children's developmental assessments: a study of parents' views. BMC Pediatr. 2024 May 15;24(1):335. doi: 10.1186/s12887-024-04800-4. | |
| 37716967 | Derived | Sorensen ER, Rasmussen IS, Overbeck G, Siersma V, Appel CL, Wilson P. Uptake of signposting to web-based resources: pregnant women's use of a preventive web-based intervention. BMC Prim Care. 2023 Sep 16;24(1):189. doi: 10.1186/s12875-023-02130-5. |
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To be determined
Protocol to be published during recruitment phase. SAP to be published before unblinding.
Open access once published
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| OTHER |
| University of Copenhagen | OTHER |
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.
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| enhanced care as usual | Other | Structured assessments of maternal mental health, child neurodevelopment and parent-child interaction in routine preventive health care in general practice |
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| 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 |
| 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 |
| 36698093 | Derived | de Voss S, Wilson P, Saxild S, Overbeck G. Increasing the psychosocial focus in child developmental assessments: a qualitative study. BMC Pediatr. 2023 Jan 25;23(1):44. doi: 10.1186/s12887-023-03849-x. |
| 36597136 | Derived | Overbeck G, Kragstrup J, Gortz M, Rasmussen IS, Graungaard AH, Siersma V, de Voss S, Ertmann RK, Shahrzad S, Appel CL, Wilson P. Family wellbeing in general practice: a study protocol for a cluster-randomised trial of the web-based resilience programme on early child development. Trials. 2023 Jan 4;24(1):7. doi: 10.1186/s13063-022-07045-7. |