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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

RecruitingNAAges 1 Year - 3 YearsAllUniversity of Southern Denmark
NCT06795347 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Children of parents with severe mental disorders have an increased risk of mental disorders themselves, with more than half of this population diagnosed with a mental health condition during their life time. Already during early childhood, the risk of a mental health diagnosis is elevated by a factor 2-5, compared to children of parents without severe mental disorders. This highlights the need for preventive interventions. Mental health during early childhood is inextricably linked with early parent-child interaction. Sensitive parenting plays a crucial role in the socio-emotional development of the child, and severe parental mental disorders may affect the quality of parent-child interaction. Therefore, we will test the effect of an intervention promoting sensitive parenting on mental health outcomes of 1-3 years old children of parents with severe mental disorders. The intervention w

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📋 Eligibility rules (as published)
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
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What it tests

  • Online VIPP-SD
  • Care As Usual
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Where

1 site
Research Unit of Child and Adolescent Psychiatry, Mental Health Services in the Region of Southern Denmark
Odense C, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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