The Effectiveness of MInding the Baby in a Danish Community Sample

Pregnancy, High Risk Clinical Trial

— MTB  

Official title:

The Effectiveness of MInding the Baby in a Danish Community Sample

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03495895
• Other study ID #: VIVE
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 10, 2018
• Est. completion date: June 2024

Study information

• Verified date: February 2023
• Source: VIVE - The Danish Center for Social Science Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Family
• Pregnancy, High Risk

Intervention

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.
• Usual Care
Usual care condition

Locations

Country	Name	City	State
Denmark	VIVE - The Danish Centre of Applied Social Science	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
VIVE - The Danish Center for Social Science Research	Metodecentret - Center for Effective Innovation in Social Services, Yale University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal sensitivity measured by the CIB (Coding Interactive Behavior)	Maternal sensitivity	at child age 24 months
Secondary	Maternal sensitivity measured by the CIB (Coding Interactive Behavior)	Maternal sensitivity	Child age 12 months
Secondary	Coding interactive bahavior (CIB)	Parent child relationship Subscales: Intrusiveness, Limit setting, Involvement, Withdrawal, Reciprocity, Negative states	child age 12 and 24 months
Secondary	Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2)	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.	3, 12 and 24 months
Secondary	Edinburgh Postnatal depression Scale (EPDS)	Depression Total score range 0-30. Low score is better	3, 12 , 24 months
Secondary	Warwick-Edinburgh Mental Well-being Scale	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.	Baseline, 3, 12 , 24 months
Secondary	2-5	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	24 months
Secondary	Prenatal Parental reflective functioning questionnaire (P-PRFQ)	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)	Baseline
Secondary	Parental reflective functioning questionnaire (PRFQ-1)	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.	12 and 24 months
Secondary	Parental Stress Scale (PSS)	Parental stress Total score range 18-90 low score is better	12 ,24 months
Secondary	Ages and Stages Questionnaire 3 (ASQ:3)	Child development	3 months
Secondary	Acitvities with child	Singing and reading Total score range 0-70. High score is better.	12 and 24 months
Secondary	SEAM Family profile	Family profile	12 months
Secondary	Parent behavior Inventory (PBI)	Parent Behavior. Two subscales Supportive/Engaged and Hostile/Coercive.	12 and 24 months
Secondary	Being a Mother (BAM-13)	Maternal confidence. Total score range 0-39. Low score is better	3 months
Secondary	Hospital Anxiety and Depression Scale (HADS)	Two subscales Anxiety (range 0-21 low score is better) and depression (range 0-21 low score is better)	Baseline, 3, 12,24 months
Secondary	PTSD-8	A Short PTSD Inventory. Total score range 8-32, low score is better	Baseline, 12 and 24 months
Secondary	Experiences in Close Relationship Scale-Short Form (ECR-S)	Two subscales Anxiety (range 1-42 low score is better) and Avoidance (range 1-42 low score is better)	Baseline, 12, 24 months