Improving wellbeing in young children of mothers with mental health issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of an online intervention called Video-feedback Intervention to promote sensitive parenting among mothers with severe mental disorders. The study focuses on children aged 1 to 3 years who are at an increased risk of developing mental health issues due to their mother's condition. By comparing the intervention group to a control group receiving care as usual, the trial seeks to determine if enhanced parenting techniques can positively impact the socio-emotional development of these children. The trial is conducted in the Region of Southern Denmark, utilizing a randomized clinical trial design.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Unit of Child and Adolescent Psychiatry, Mental Health Services in the Region of Southern Denmark
  Odense C, Region Syddanmark, Denmark Recruiting

Study contacts

• Principal investigator: Davi — Region of Southern Denmark
• Study coordinator: Kirstine A Davidsen, PhD
• Email: kirstine.agnete.davidsen@rsyd.dk
• Phone: +4599448681

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.