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

The Effectiveness of MInding the Baby in a Danish Community Sample (MTB)

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: NCT03495895
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : June 26, 2018
Sponsor:
Collaborators:
Yale University
Metodecentret - Center for Effective Innovation in Social Services
Information provided by (Responsible Party):
Maiken Pontoppidan, VIVE - The Danish Centre of Applied Social Science

Brief Summary:
Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable or high risk mothers. MTB is delivered by an interdisciplinary team. Ten Danish sites will be randomized to training at time 1 or 2 and recruit usual care control families before they receive the training. Families are assessed before they give birth and when their child is three months, one and two years old with a range of assessments including maternal sensitivity, parent mental Health, child development, and health related register data. The aim of the trial is to assess the effectiveness of Minding the Baby to improve mother-child relations and the mental health of parents and children.

Condition or disease Intervention/treatment Phase
Family Pregnancy, High Risk Behavioral: Minding the Baby Behavioral: Usual Care Not Applicable

Detailed Description:

Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable or high risk mothers. The focus of the intervention is to reduce negative infant and maternal outcomes and strengthen the attachment relationship. MTB is delivered by an interdisciplinary team of highly skilled practitioners, who have health and social work experience, integrating advanced practice nursing and mental health care for mothers and infants. In the proposed Randomised Control Trial (RCT) the investigators will study the efficacy of this innovative intervention across ten Danish sites. Site staff will be trained at two sessions one year apart. Sites are randomized to training at time 1 or 2. All sites will recruit treatment as usual control families before they receive the training and start offering the intervention to all families. Potential participants will be approached by a local front staff member (e.g. midwife, helath visitor or social worker) who will inform mothers of the project in the early pregnancy. Consenting eligible participants will be assessed before they give birth and when their child is three months, one and two years old.

The effectiveness of the MTB programme will be evaluated by assessing a range of maternal and infant outcomes, including maternal sensitivity, parent mental Health, child development, and register data on e.g. infant maltreatment and neglect, hospitalization, income, immunization. By combining parent report, observational and register data researchers will get a unique opportunity to advance knowledge regarding effective ways to support some of the youngest and most vulnerable children in Denmark.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Masking Description: As the intervention is a home visiting intervention participants and care providers cannot be blinded. Outcome assessor and data analyst will be blinded.
Primary Purpose: Treatment
Official Title: The Effectiveness of MInding the Baby in a Danish Community Sample
Actual Study Start Date : June 10, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: Minding the Baby
Families are visited weekly beginning in the mother's third trimester of pregnancy up through the child's first birthday, at which point visits take place biweekly up through the child's second birthday.
Behavioral: Minding the Baby
Visits are carried out on an alternating basis by a team made up of a nurse practitioner (NP) and social worker.

Control
Usual care control condition. Families in the control Group receive the usual care that is offered to families in the target group
Behavioral: Usual Care
Usual care condition




Primary Outcome Measures :
  1. Maternal sensitivity measured by the CIB (Coding Interactive Behavior) [ Time Frame: at child age 24 months ]
    Maternal sensitivity


Secondary Outcome Measures :
  1. Maternal sensitivity measured by the CIB (Coding Interactive Behavior) [ Time Frame: Child age 12 months ]
    Maternal sensitivity

  2. Coding interactive bahavior (CIB) [ Time Frame: child age 12 and 24 months ]
    Parent child relationship Subscales: Intrusiveness, Limit setting, Involvement, Withdrawal, Reciprocity, Negative states

  3. Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2) [ Time Frame: 3, 12 and 24 months ]
    Child social-emotional Development Total score range 0-150 ( 3 months 15 items), 0-260 (12 months 26 items), 0-300 (24 months 30 items). Low score is better.

  4. Edinburgh Postnatal depression Scale (EPDS) [ Time Frame: 3, 12 , 24 months ]
    Depression Total score range 0-30. Low score is better

  5. Warwick-Edinburgh Mental Well-being Scale [ Time Frame: Baseline, 3, 12 , 24 months ]
    Maternal mental Health 7 items. A total score i calculated by summing the 7 items and converting the raw score according to a published conversion table. Raw score range 7- 35. Converted score range 7-35. High is better outcome.

  6. 2-5 [ Time Frame: 24 months ]
    The name of the measure is 2-5 and measures child Development. Subscales included: Perception (7 items) low score is better, Language (10 items) low score is better

  7. Prenatal Parental reflective functioning questionnaire (P-PRFQ) [ Time Frame: Baseline ]
    Parental reflective functioning for pregnant women. Total score range 14-98. Higher score is better. Three subscales: Opacity of mental states (4 items), reflecting on the fetus-baby (3 items) and Dynamic of mental states (5 items)

  8. Parental reflective functioning questionnaire (PRFQ-1) [ Time Frame: 12 and 24 months ]
    Parental reflective functioning Three subscales score range 6-42: Pre-Mentalizing Modes (PRFQ-PM) 6 items. low score is better. Certainty about Mental States (PRFQ-CMS) 6 items high score is better. Interest and curiosity in mental states PRFQ-IC 6 items high score is better.

  9. Parental Stress Scale (PSS) [ Time Frame: 12 ,24 months ]
    Parental stress Total score range 18-90 low score is better

  10. Ages and Stages Questionnaire 3 (ASQ:3) [ Time Frame: 3 months ]
    Child development

  11. Acitvities with child [ Time Frame: 12 and 24 months ]
    Singing and reading Total score range 0-70. High score is better.

  12. SEAM Family profile [ Time Frame: 12 months ]
    Family profile

  13. Parent behavior Inventory (PBI) [ Time Frame: 12 and 24 months ]
    Parent Behavior. Two subscales Supportive/Engaged and Hostile/Coercive.

  14. Being a Mother (BAM-13) [ Time Frame: 3 months ]
    Maternal confidence. Total score range 0-39. Low score is better

  15. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 3, 12,24 months ]
    Two subscales Anxiety (range 0-21 low score is better) and depression (range 0-21 low score is better)

  16. PTSD-8 [ Time Frame: Baseline, 12 and 24 months ]
    A Short PTSD Inventory. Total score range 8-32, low score is better

  17. Experiences in Close Relationship Scale-Short Form (ECR-S) [ Time Frame: Baseline, 12, 24 months ]
    Two subscales Anxiety (range 1-42 low score is better) and Avoidance (range 1-42 low score is better)



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:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Pregnant vulnerable women

Exclusion Criteria:

  • Current severe substance abuse
  • Severe psychotic illness
  • Profound or severe learning disabilities
  • Life-threatening illness in parent or child
  • Non-Danish speaking

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): NCT03495895


Contacts
Layout table for location contacts
Contact: Maiken Pontoppidan, Ph.D. +4533697720 mpo@vive.dk

Locations
Layout table for location information
Denmark
VIVE - The Danish Centre of Applied Social Science Recruiting
Copenhagen, Denmark, 1052
Contact: Maiken Pontoppidan, ph.d.    +4533697720    mpo@vive.dk   
Principal Investigator: Maiken W Pontoppidan, Ph.D         
Sponsors and Collaborators
VIVE - The Danish Centre of Applied Social Science
Yale University
Metodecentret - Center for Effective Innovation in Social Services
Investigators
Layout table for investigator information
Principal Investigator: Maiken Pontoppidan, Ph.D. VIVE
Layout table for additonal information
Responsible Party: Maiken Pontoppidan, Researcher, VIVE - The Danish Centre of Applied Social Science
ClinicalTrials.gov Identifier: NCT03495895    
Other Study ID Numbers: VIVE
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There will be few participants from each local authority and data can therefore not be made publicly available due to protect participant privacy

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maiken Pontoppidan, VIVE - The Danish Centre of Applied Social Science:
Disadvantaged families
Pregnancy
Intervention
Minding the Baby