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

NCT04129359 | Unknown DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 1

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.

Conditions

Parent-Child Relations; Child Development; Parenting

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Child-Adult Relationship Observation (CARO)

  30 months post natal

• Hospital Anxiety and Depression Scale

  30 months postnatal

• Service and societal costs

  30 months postnatal

• EQ-5D-5L (EuroQol 5-Dimension 5-Level)

  30 months postnatal

• EQ VAS (EuroQol Visual Analog Scale)

  30 months postnatal

Other Outcomes (3)

• Child-Adult Relationship Observation (CARO)

  15 months postnatal

• Maternal Hospital Anxiety and Depression Scale

  15 months postnatal

• Service and societal costs

  15 months postnatal

Study Arms (2)

FamilieTrivsel

EXPERIMENTAL

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

Behavioral: FamilieTrivsel; Other: enhanced care as usual

control

ACTIVE COMPARATOR

Enhanced care as usual in general practice

Other: enhanced care as usual

Interventions

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.

Also known as: Robustbarn.dk (FamilieTrivsel is a customised variant focused on families with young children)

FamilieTrivsel

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

Also known as: control

FamilieTrivsel; control

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women presenting at their first GP-based antenatal assessment and their families

You may not qualify if:

• 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
• Second pregnancies among already-participating families

Sponsors & Collaborators

• Research Unit Of General Practice, Copenhagen: lead
• TrygFonden, Denmark: collaborator
• Göteborg University: collaborator
• University of Aberdeen: collaborator
• University of Southern Denmark: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Capital Region

Copenhagen, Denmark

Location

Related Publications (4)

• 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.

  PMID: 38750557 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.

  PMID: 37716967 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.

  PMID: 36698093 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.

  PMID: 36597136 DERIVED

Study Officials

• Philip Wilson, DPhil FRCGP

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General Practice

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 16, 2019
• Study Start: October 15, 2019
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Protocol to be published during recruitment phase. SAP to be published before unblinding.
• Access Criteria: Open access once published

Locations

DK (1)