Improving wellbeing in young children of mothers with mental health issues
Wellbeing and Resilience Among 1-3 Years Old Children of Mothers with Complex Mental Health Problems: a Pragmatic Clinical Trial
This study tests if an online program can help mothers with serious mental health issues improve their parenting skills and support the emotional development of their young children aged 1 to 3.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 1 Year to 3 Years |
| Sex | All |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 1 site (Odense C, Region Syddanmark) |
| Trial ID | NCT06795347 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1 to 3 years living with their mothers who have a verified severe mental disorder.
Not a fit: Patients who may not benefit from this study include those whose mothers are currently hospitalized or have substance abuse issues.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health outcomes and socio-emotional development of young children at risk due to their mother's mental health challenges.
How similar studies have performed: Other studies have shown promising results with similar interventions aimed at improving parenting skills in the context of parental mental health issues.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Odense C, Region Syddanmark
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.