Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-02 @ 10:07 PM
Study NCT ID:
NCT04129359
Status:
UNKNOWN
Last Update Posted:
2022-12-21
First Post:
2019-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FamilieTrivsel i Almen Praksis: a Mentalisation Programme for Families With Young Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 624}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-19', 'studyFirstSubmitDate': '2019-10-08', 'studyFirstSubmitQcDate': '2019-10-15', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Child-Adult Relationship Observation (CARO)', 'timeFrame': '15 months postnatal', 'description': '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.'}, {'measure': 'Maternal Hospital Anxiety and Depression Scale', 'timeFrame': '15 months postnatal', 'description': 'separate scores for anxiety and depression (parent self-complete) - both scales range 0-21 - on both scales low scores indicate better outcome'}, {'measure': 'Service and societal costs', 'timeFrame': '15 months postnatal', 'description': "Within-trial costs of participants' service use and out of pocket expenses - collected by parental questionnaire"}], 'primaryOutcomes': [{'measure': 'Strengths and Difficulties Questionnaire Total Difficulties Score', 'timeFrame': '30 months postnatal', 'description': 'Child psychiatric symptom score, range from 0-40, parent complete, lower scores indicate better outcome.'}, {'measure': 'MacArthur-Bates Communicative Development Inventory (100 word Danish version)', 'timeFrame': '30 months postnatal', 'description': 'Child expressive language measure - range 0-100 - parent complete - higher scores indicate better outcomes'}], 'secondaryOutcomes': [{'measure': 'Child-Adult Relationship Observation (CARO)', 'timeFrame': '30 months post natal', 'description': '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.'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '30 months postnatal', 'description': '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'}, {'measure': 'Service and societal costs', 'timeFrame': '30 months postnatal', 'description': "Within-trial costs of participants' service use and out of pocket expenses - collected by parental questionnaire"}, {'measure': 'EQ-5D-5L (EuroQol 5-Dimension 5-Level)', 'timeFrame': '30 months postnatal', 'description': 'Maternal health-related quality of life - parental self-complete - range 5-25 - low scores indicate better outcome'}, {'measure': 'EQ VAS (EuroQol Visual Analog Scale)', 'timeFrame': '30 months postnatal', 'description': 'Maternal self rated health - range 0-100 - high scores indicate better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parent-Child Relations', 'Child Development', 'Parenting']}, 'referencesModule': {'references': [{'pmid': '38750557', 'type': 'DERIVED', 'citation': "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': '37716967', 'type': 'DERIVED', 'citation': "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': '36698093', 'type': 'DERIVED', 'citation': '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': '36597136', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nPractices 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.\n\nBaseline measures will be taken at recruitment into the trial and outcomes will be collected when the child is 15 and 30 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women presenting at their first GP-based antenatal assessment and their families\n\nExclusion Criteria:\n\n* Non-Danish speaking women\n* Families planning to move to a new general practice during the pregnancy or shortly after the birth of the child\n* Mother has already participated in the trial (e.g., second eligible baby within life of the study)\n* Presentation to the GP after the time for the third scheduled antenatal visit\n* Miscarriage or other pregnancy loss after recruitment to the study will lead to late exclusion from the study\n* Second pregnancies among already-participating families'}, 'identificationModule': {'nctId': 'NCT04129359', 'briefTitle': 'FamilieTrivsel i Almen Praksis: a Mentalisation Programme for Families With Young Children', 'organization': {'class': 'OTHER', 'fullName': 'Research Unit Of General Practice, Copenhagen'}, 'officialTitle': 'FamilieTrivsel i Almen Praksis: A General Practice-based Cluster-randomised Trial of the Impact of the Resilience Programme on Early Child Development', 'orgStudyIdInfo': {'id': '0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FamilieTrivsel', 'description': 'Enhanced care as usual in general practice plus training in the use of the online mentalisation programme', 'interventionNames': ['Behavioral: FamilieTrivsel', 'Other: enhanced care as usual']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'Enhanced care as usual in general practice', 'interventionNames': ['Other: enhanced care as usual']}], 'interventions': [{'name': 'FamilieTrivsel', 'type': 'BEHAVIORAL', 'otherNames': ['Robustbarn.dk (FamilieTrivsel is a customised variant focused on families with young children)'], 'description': "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.", 'armGroupLabels': ['FamilieTrivsel']}, {'name': 'enhanced care as usual', 'type': 'OTHER', 'otherNames': ['control'], 'description': 'Structured assessments of maternal mental health, child neurodevelopment and parent-child interaction in routine preventive health care in general practice', 'armGroupLabels': ['FamilieTrivsel', 'control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Capital Region', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Philip Wilson, DPhil FRCGP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Protocol to be published during recruitment phase. SAP to be published before unblinding.', 'ipdSharing': 'YES', 'description': 'To be determined', 'accessCriteria': 'Open access once published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Unit Of General Practice, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'TrygFonden, Denmark', 'class': 'INDUSTRY'}, {'name': 'Göteborg University', 'class': 'OTHER'}, {'name': 'University of Aberdeen', 'class': 'OTHER'}, {'name': 'University of Southern Denmark', 'class': 'OTHER'}, {'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of General Practice', 'investigatorFullName': 'Jakob Kragstrup', 'investigatorAffiliation': 'Research Unit Of General Practice, Copenhagen'}}}}