Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03495895
Other study ID # VIVE
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03651843 - Perception of Risks Into Work During Pregnancy Among Post-partum Women in the Lille Metropolis
Recruiting NCT05656352 - Validation of a Non-invasive Hemoglobin Measurement Device in Pregnancy and Postpartum in Kenya, Pakistan, and Zambia
Completed NCT05316415 - The Effects of Music on the Anxiety and Sleep Quality of Pregnant Women on Bed Rest for a High-risk Pregnancy N/A
Not yet recruiting NCT03985618 - The MODE Trial: Planned Caesarean Section Versus Induction of Labour for Women With Class III Obesity N/A
Completed NCT02008097 - Clinical Benefits of B-Flow Ultrasound N/A
Recruiting NCT05922033 - Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes (EMPOWER) Phase 4
Completed NCT03413631 - A Prenatal Mentalization-focused 4D Ultrasound and a Pregnancy Diary Intervention for Substance-abusing Women N/A
Recruiting NCT04861103 - Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH) Phase 4
Completed NCT03334149 - Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension N/A
Completed NCT03646487 - A Randomized Placebo Controlled Pilot Study of Probiotic Supplementation in At-risk Pregnant Women N/A
Recruiting NCT05198206 - Pregnant Women With Pulmonary Hypertension in China
Recruiting NCT05739123 - Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
Recruiting NCT05807256 - Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases
Completed NCT04874285 - Use of Dietary Supplements in Patients at Risk of Abortion Treated With Progesterone. N/A
Not yet recruiting NCT05662462 - Successfully Achieving and Maintaining Euglycemia During Pregnancy for Type 2 Diabetes Through Technology and Coaching N/A
Recruiting NCT03975894 - TAPS2 Transfusion Antenatally in Pregnant Women With SCD Phase 2
Recruiting NCT05597943 - mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM N/A
Recruiting NCT04924504 - Mechanisms Behind Severe Insulin Resistance During Pregnancy in Women With Glucose Metabolic Disorders (SIR-MET)
Completed NCT03467503 - Healthy Diet for Healthy Moms and Babies N/A
Completed NCT03737279 - Daily Meditation Program in Women Admitted to the Antepartum Unit N/A