UnknownNot Applicable

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

Denmark624 participantsStarted 2019-10-15

Plain-language 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.

Who can participate

Age range

16 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Strengths and Difficulties Questionnaire Total Difficulties Score

Timeframe: 30 months postnatal

MacArthur-Bates Communicative Development Inventory (100 word Danish version)

Timeframe: 30 months postnatal

Trial details

NCT IDNCT04129359

SponsorResearch Unit Of General Practice, Copenhagen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-15

View on ClinicalTrials.gov More Parent-Child Relations trials