VIVE - The Danish Centre of Applied Social Science
Copenhagen, 1052, Denmark
NCT Number: NCT03495895
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.
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Notify Me15 year and older
Female
Interventional
Not applicable
Copenhagen, 1052, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Visits are carried out on an alternating basis by a team made up of a nurse practitioner (NP) and social worker.
Usual care condition
Time frame: at child age 24 months
Maternal sensitivity
Time frame: Child age 12 months
Maternal sensitivity
Time frame: child age 12 and 24 months
Parent child relationship Subscales: Intrusiveness, Limit setting, Involvement, Withdrawal, Reciprocity, Negative states
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.
Time frame: 3, 12 , 24 months
Depression Total score range 0-30. Low score is better
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.
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
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)
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.
Time frame: 12 ,24 months
Parental stress Total score range 18-90 low score is better
Time frame: 3 months
Child development
Time frame: 12 and 24 months
Singing and reading Total score range 0-70. High score is better.
Time frame: 12 months
Family profile
Time frame: 12 and 24 months
Parent Behavior. Two subscales Supportive/Engaged and Hostile/Coercive.
Time frame: 3 months
Maternal confidence. Total score range 0-39. Low score is better
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)
Time frame: Baseline, 12 and 24 months
A Short PTSD Inventory. Total score range 8-32, low score is better
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)
VIVE - The Danish Center for Social Science Research
Other
Acronym: MTB
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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