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

NCT ID: NCT04129359

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

624 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2025-04-15

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.

Conditions

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Parent-Child Relations Child Development Parenting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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FamilieTrivsel

Enhanced care as usual in general practice plus training in the use of the online mentalisation programme

Group Type EXPERIMENTAL

FamilieTrivsel

Intervention Type 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.

enhanced care as usual

Intervention Type OTHER

Structured assessments of maternal mental health, child neurodevelopment and parent-child interaction in routine preventive health care in general practice

control

Enhanced care as usual in general practice

Group Type ACTIVE_COMPARATOR

enhanced care as usual

Intervention Type OTHER

Structured assessments of maternal mental health, child neurodevelopment and parent-child interaction in routine preventive health care in general practice

Interventions

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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.

Intervention Type BEHAVIORAL

enhanced care as usual

Structured assessments of maternal mental health, child neurodevelopment and parent-child interaction in routine preventive health care in general practice

Intervention Type OTHER

Other Intervention Names

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Robustbarn.dk (FamilieTrivsel is a customised variant focused on families with young children) control

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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TrygFonden, Denmark

INDUSTRY

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Research Unit Of General Practice, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Jakob Kragstrup

Professor of General Practice

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip Wilson, DPhil FRCGP

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Capital Region

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 38750557 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37716967 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36698093 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36597136 (View on PubMed)

Other Identifiers

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0001

Identifier Type: -

Identifier Source: org_study_id