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New treatment option for Child Mental Health
Official title 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
ClinicalTrials.gov ID: NCT06795347
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 3
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Odense C, Region Syddanmark, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 3 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Odense C, Region Syddanmark, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.