Wellbeing and Resilience Among 1-3 Years Old Children of Mothers with Complex Mental Health Problems: a Pragmatic Clinical Trial of Online VIPP-SD Vs. Care As Usual

Launched by UNIVERSITY OF SOUTHERN DENMARK · Jan 25, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on helping young children, aged 1 to 3, whose mothers have serious mental health issues, such as schizophrenia, bipolar disorder, or severe depression. Researchers want to see if an online program called VIPP-SD, which teaches mothers how to interact positively with their children, can improve the children’s behavior and emotional well-being compared to regular care. The trial aims to see if children whose mothers participate in the program will have fewer behavioral problems and feel more securely attached to their mothers than those who continue with usual care.

To be eligible for this study, mothers must live in Southern Denmark with their child, who is between 1 and 3 years old, and have a diagnosed mental health disorder. Participants will be randomly assigned to either the VIPP-SD program or the usual care group, which means some mothers will receive the intervention while others will continue with their current support. Throughout the study, mothers will receive feedback on their child's development and mental health. This trial is an important step in finding ways to support families where mothers have mental health challenges, ultimately aiming to promote healthier development for their children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • child age 1 year, 0 months until 3 years, 0 months
• • living with their mother in the Region of Southern Denmark
• • mother has a mental disorder (Schizophrenia ICD-10: F20-29, Bipolar disorder ICD-10: F30-31, Moderate to severe depression ICD-10: F32-33 or Emotionally unstable personality disorder F60.3) verified in the Danish National Hospital Register-Psyk/the Danish Psychiatric Central Research Register or by a clinician at the mental health services via the patient record
• • mother has had at least one in- or outpatient contact with mental health services within 12 months before birth of the child or during the child's lifetime verified in the Danish National Hospital Register or by a clinician at the mental health services via the patient record
• Exclusion Criteria:
• • current in-patient status of the mother
• • current substance or alcohol abuse of the mother
• • mother has insufficient knowledge of Danish (interpreter required)
• • repeated intrauterine exposure to euphoriants or large amounts of alcohol (≥5 units per time or ≥7units per week) of the child
• • known syndrome or autism spectrum disorder of the child
• • mother or child has sensory impairment
• • sibling participating in study
• • family participating in another closely related research trial receiving an individualized video-feedback intervention
• • participating in active court proceedings