The Effectiveness of MInding the Baby in a Danish Community Sample
- Conditions
- FamilyPregnancy, High Risk
- Interventions
- Behavioral: Usual CareBehavioral: Minding the Baby
- Registration Number
- NCT03495895
- Lead Sponsor
- VIVE - The Danish Center for Social Science Research
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 256
- Pregnant vulnerable women
- Current severe substance abuse
- Severe psychotic illness
- Profound or severe learning disabilities
- Life-threatening illness in parent or child
- Non-Danish speaking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Control Usual Care Usual care control condition. Families in the control Group receive the usual care that is offered to families in the target group Minding the Baby 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.
- Primary Outcome Measures
Name Time Method Maternal sensitivity measured by the CIB (Coding Interactive Behavior) at child age 24 months Maternal sensitivity
- Secondary Outcome Measures
Name Time Method Coding interactive bahavior (CIB) child age 12 and 24 months Parent child relationship Subscales: Intrusiveness, Limit setting, Involvement, Withdrawal, Reciprocity, Negative states
Maternal sensitivity measured by the CIB (Coding Interactive Behavior) Child age 12 months Maternal sensitivity
Parental Stress Scale (PSS) 12 ,24 months Parental stress Total score range 18-90 low score is better
SEAM Family profile 12 months Family profile
Parent behavior Inventory (PBI) 12 and 24 months Parent Behavior. Two subscales Supportive/Engaged and Hostile/Coercive.
Edinburgh Postnatal depression Scale (EPDS) 3, 12 , 24 months Depression Total score range 0-30. Low score is better
Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2) 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.
Parental reflective functioning questionnaire (PRFQ-1) 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.
Hospital Anxiety and Depression Scale (HADS) Baseline, 3, 12,24 months Two subscales Anxiety (range 0-21 low score is better) and depression (range 0-21 low score is better)
Being a Mother (BAM-13) 3 months Maternal confidence. Total score range 0-39. Low score is better
Warwick-Edinburgh Mental Well-being Scale 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.
2-5 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
Prenatal Parental reflective functioning questionnaire (P-PRFQ) 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)
Ages and Stages Questionnaire 3 (ASQ:3) 3 months Child development
Acitvities with child 12 and 24 months Singing and reading Total score range 0-70. High score is better.
PTSD-8 Baseline, 12 and 24 months A Short PTSD Inventory. Total score range 8-32, low score is better
Experiences in Close Relationship Scale-Short Form (ECR-S) Baseline, 12, 24 months Two subscales Anxiety (range 1-42 low score is better) and Avoidance (range 1-42 low score is better)
Trial Locations
- Locations (1)
VIVE - The Danish Centre of Applied Social Science
🇩🇰Copenhagen, Denmark