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

NCT04129359 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 624

Last updated 2022-12-21

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

OTHER

enhanced care as usual

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

Sponsors & Collaborators

  • TrygFonden, Denmark

    collaborator INDUSTRY
  • Göteborg University

    collaborator OTHER
  • University of Aberdeen

    collaborator OTHER
  • University of Southern Denmark

    collaborator OTHER
  • University of Copenhagen

    collaborator OTHER
  • Research Unit Of General Practice, Copenhagen

    lead OTHER

Principal Investigators

  • Philip Wilson, DPhil FRCGP · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2025-04-15
Completion
2025-04-15

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04129359 on ClinicalTrials.gov