Parent-Child RelationsNCT04129359
FamilieTrivsel i Almen Praksis: a Mentalisation Programme for Families With Young Children
A study testing FamilieTrivsel and enhanced care as usual in people with Parent-Child Relations and Child Development, run by Research Unit Of General Practice, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, Child Development, Parenting
- What is being tested?
- FamilieTrivsel and enhanced care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 624 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Oct 2019to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women presenting at their first GP-based antenatal assessment and their families
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FamilieTrivsel i Almen Praksis: A General Practice-based Cluster-randomised Trial of the Impact of the Resilience Programme on Early Child Development
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.
Read the detailed description
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
- Parent-Child Relations, Child Development, Parenting
- Being tested
- FamilieTrivsel, enhanced care as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamilieTrivselBehavioural
Also called Robustbarn.dk (FamilieTrivsel is a customised variant focused on families with young children)
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 usualOther
Also called control
Structured assessments of maternal mental health, child neurodevelopment and parent-child interaction in routine preventive health care in general practice
| Study group | Role | What they receive |
|---|---|---|
| FamilieTrivsel | Experimental | Enhanced care as usual in general practice plus training in the use of the online mentalisation programme Receives: Behavioral: FamilieTrivsel; Other: enhanced care as usual |
| control | Active comparator | Enhanced care as usual in general practice Receives: Other: enhanced care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strengths and Difficulties Questionnaire Total Difficulties Score
Child psychiatric symptom score, range from 0-40, parent complete, lower scores indicate better outcome.
Measured: 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
Measured: 30 months postnatal
Secondary outcomes (5)
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.
Measured: 30 months post natal
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
Measured: 30 months postnatal
Service and societal costs
Within-trial costs of participants' service use and out of pocket expenses - collected by parental questionnaire
Measured: 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
Measured: 30 months postnatal
EQ VAS (EuroQol Visual Analog Scale)
Maternal self rated health - range 0-100 - high scores indicate better outcome.
Measured: 30 months postnatal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start15 Oct 2019
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 624 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Unit Of General Practice, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark, Göteborg University, University of Aberdeen, University of Southern Denmark, University of Copenhagen
- Responsible party
- Principal investigator, Jakob Kragstrup, Research Unit Of General Practice, Copenhagen
- Investigators
- Philip Wilson, DPhil FRCGP, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129359
- Sponsor's protocol ID
- 0001
- Status last verified
- Dec 2022
- First submitted
- 8 Oct 2019
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To be determined
Publications
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.
PubMed 38750557Sorensen 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.
PubMed 37716967de 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.
PubMed 36698093Overbeck 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.
PubMed 36597136
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FamilieTrivsel i Almen Praksis: A General Practice-based Cluster-randomised Trial of the Impact of the Resilience Programme on Early Child Development
- ClinicalTrials.gov ID
- NCT04129359
- Acronym / sponsor ID
- 0001
- Conditions
- Parent-Child Relations, Child Development, Parenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 624 participants (actual)
- Lead sponsor
- Research Unit Of General Practice, CopenhagenUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark, Göteborg University, University of Aberdeen, University of Southern Denmark, University of Copenhagen
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| FamilieTrivsel | Experimental | Behavioral: FamilieTrivsel, Other: enhanced care as usualEnhanced care as usual in general practice plus training in the use of the online mentalisation programme |
| control | Active comparator | Other: enhanced care as usualEnhanced care as usual in general practice |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant women presenting at their first GP-based antenatal assessment and their families
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FamilieTrivselAlso: Robustbarn.dk (FamilieTrivsel is a customised variant focused on families with young children)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. | Behavioural | FamilieTrivsel |
| enhanced care as usualAlso: controlStructured assessments of maternal mental health, child neurodevelopment and parent-child interaction in routine preventive health care in general practice | Other | FamilieTrivsel, control |
Primary outcome
Strengths and Difficulties Questionnaire Total Difficulties Score
Time frame: 30 months postnatal
Child psychiatric symptom score, range from 0-40, parent complete, lower scores indicate better outcome.
MacArthur-Bates Communicative Development Inventory (100 word Danish version)
Time frame: 30 months postnatal
Child expressive language measure - range 0-100 - parent complete - higher scores indicate better outcomes
5 secondary outcomes
Child-Adult Relationship Observation (CARO)
Time frame: 30 months post natal
Hospital Anxiety and Depression Scale
Time frame: 30 months postnatal
Service and societal costs
Time frame: 30 months postnatal
EQ-5D-5L (EuroQol 5-Dimension 5-Level)
Time frame: 30 months postnatal
EQ VAS (EuroQol Visual Analog Scale)
Time frame: 30 months postnatal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Derived from this study: PubMed 38750557Stroyer 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.
- Derived from this study: PubMed 37716967Sorensen 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.
- Derived from this study: PubMed 36698093de 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.
- Derived from this study: PubMed 36597136Overbeck 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.
- Individual participant dataSharing planned: Yes. To be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Wilson, DPhil FRCGP principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FamilieTrivsel and enhanced care as usual in people with Parent-Child Relations and Child Development, run by Research Unit Of General Practice, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and Difficulties Questionnaire Total Difficulties Score (time frame: 30 months postnatal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04129359, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.