Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    wilson familietrivsel
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04129359
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : September 23, 2020
Sponsor:
Collaborators:
TrygFonden, Denmark
Göteborg University
University of Aberdeen
University of Southern Denmark
University of Copenhagen
Information provided by (Responsible Party):
Jakob Kragstrup, Research Unit Of General Practice, Copenhagen

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.

Condition or disease Intervention/treatment Phase
Parent-Child Relations Child Development Parenting Behavioral: FamilieTrivsel Other: enhanced care as usual Not Applicable

Detailed Description:

This is a cluster randomised trial based in Danish general practice. 100 general practices will be recruited, each of which will recruit 10 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster RCT in 100 general practices, each of which will recruit 10 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: FamilieTrivsel i Almen Praksis: A General Practice-based Cluster-randomised Trial of the Impact of the Resilience Programme on Early Child Development
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : April 15, 2024
Estimated Study Completion Date : April 15, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FamilieTrivsel
Enhanced care as usual in general practice plus training in the use of the online mentalisation programme
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 Name: Robustbarn.dk (FamilieTrivsel is a customised variant focused on families with young children)

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
Other Name: control

Active Comparator: control
Enhanced care as usual in general practice
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
Other Name: control




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Child-Adult Relationship Observation (CARO) [ Time Frame: 30 months post natal ]
    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.

  2. Hospital Anxiety and Depression Scale [ Time Frame: 30 months postnatal ]
    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

  3. Service and societal costs [ Time Frame: 30 months postnatal ]
    Within-trial costs of participants' service use and out of pocket expenses - collected by parental questionnaire

  4. EQ-5D-5L (EuroQol 5-Dimension 5-Level) [ Time Frame: 30 months postnatal ]
    Maternal health-related quality of life - parental self-complete - range 5-25 - low scores indicate better outcome

  5. EQ VAS (EuroQol Visual Analog Scale) [ Time Frame: 30 months postnatal ]
    Maternal self rated health - range 0-100 - high scores indicate better outcome.


Other Outcome Measures:
  1. Child-Adult Relationship Observation (CARO) [ Time Frame: 15 months postnatal ]
    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.

  2. Maternal Hospital Anxiety and Depression Scale [ Time Frame: 15 months postnatal ]
    separate scores for anxiety and depression (parent self-complete) - both scales range 0-21 - on both scales low scores indicate better outcome

  3. Service and societal costs [ Time Frame: 15 months postnatal ]
    Within-trial costs of participants' service use and out of pocket expenses - collected by parental questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129359


Contacts
Layout table for location contacts
Contact: Gritt Overbeck, PhD + 45 3533 7520 grio@sund.ku.dk
Contact: Anette Graungaard, MD PhD +45 35 33 75 19 angra@sund.ku.dk

Locations
Layout table for location information
Denmark
Capital Region Recruiting
Copenhagen, Denmark
Contact: Gritt Overbeck, PhD    + 45 3532 7171    grio@sund.ku.dk   
Sponsors and Collaborators
Research Unit Of General Practice, Copenhagen
TrygFonden, Denmark
Göteborg University
University of Aberdeen
University of Southern Denmark
University of Copenhagen
Investigators
Layout table for investigator information
Principal Investigator: Philip Wilson, DPhil FRCGP University of Copenhagen
Layout table for additonal information
Responsible Party: Jakob Kragstrup, Professor of General Practice, Research Unit Of General Practice, Copenhagen
ClinicalTrials.gov Identifier: NCT04129359    
Other Study ID Numbers: 0001
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To be determined
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Protocol to be published during recruitment phase. SAP to be published before unblinding.
Access Criteria: Open access once published

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No