The Effectiveness of MInding the Baby in a Danish Community Sample (MTB)
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|ClinicalTrials.gov Identifier: NCT03495895|
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Family Pregnancy, High Risk||Behavioral: Minding the Baby Behavioral: Usual Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|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.|
|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|
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.
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
- Maternal sensitivity measured by the CIB (Coding Interactive Behavior) [ Time Frame: at child age 24 months ]Maternal sensitivity
- Maternal sensitivity measured by the CIB (Coding Interactive Behavior) [ Time Frame: Child age 12 months ]Maternal sensitivity
- Coding interactive bahavior (CIB) [ Time Frame: child age 12 and 24 months ]Parent child relationship Subscales: Intrusiveness, Limit setting, Involvement, Withdrawal, Reciprocity, Negative states
- 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.
- Edinburgh Postnatal depression Scale (EPDS) [ Time Frame: 3, 12 , 24 months ]Depression Total score range 0-30. Low score is better
- 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.
- 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
- 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)
- 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.
- Parental Stress Scale (PSS) [ Time Frame: 12 ,24 months ]Parental stress Total score range 18-90 low score is better
- Ages and Stages Questionnaire 3 (ASQ:3) [ Time Frame: 3 months ]Child development
- Acitvities with child [ Time Frame: 12 and 24 months ]Singing and reading Total score range 0-70. High score is better.
- SEAM Family profile [ Time Frame: 12 months ]Family profile
- Parent behavior Inventory (PBI) [ Time Frame: 12 and 24 months ]Parent Behavior. Two subscales Supportive/Engaged and Hostile/Coercive.
- Being a Mother (BAM-13) [ Time Frame: 3 months ]Maternal confidence. Total score range 0-39. Low score is better
- 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)
- PTSD-8 [ Time Frame: 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) [ 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)
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
|Contact: Maiken Pontoppidan, Ph.D.||+firstname.lastname@example.org|
|VIVE - The Danish Centre of Applied Social Science||Recruiting|
|Copenhagen, Denmark, 1052|
|Contact: Maiken Pontoppidan, ph.d. +4533697720 email@example.com|
|Principal Investigator: Maiken W Pontoppidan, Ph.D|
|Principal Investigator:||Maiken Pontoppidan, Ph.D.||VIVE|