Actively Recruiting

Phase Not Applicable
Age: 1Year - 3Years
All Genders
NCT06795347

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

Led by University of Southern Denmark · Updated on 2025-01-28

120

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

U

University of Southern Denmark

Lead Sponsor

R

Region of Southern Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 will be tested in a randomized clinical trial comparing the intervention "Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline" (VIPP-SD) delivered online to Care As Usual. Our hypothesis is, that children in the Intervention Group will display lower levels of behavioral problems and increased attachment security compared to children in the Care As Usual Group. The study will be conducted in the department of Child and Adolescent Psychiatry, Mental Health Services in the Region of Southern Denmark. Participants are mothers with a diagnosis of schizophrenia, bipolar disorder, emotionally unstable personality disorder or moderate to severe depression living in the Region of Southern Denmark with their 1-3 years old child, and the father/cohabitating partner. Participants will be recruited via psychiatric outpatient clinics in the region or on the basis of information from health registers. The primary outcome of the study is child behavioral problems. Secondary child outcomes are attachment security and mental health. Parental outcomes are parental stress and quality of life. Child cognition, parental psychiatric symptoms, childhood trauma, sensitivity, parental reflective functioning and service use data are also assessed in the study. Data are collected at baseline as well as 5 and 11 months after randomization. All participants will have the opportunity to receive feedback on their child's cognitive functioning and mental health status at baseline and at the end of the study. After baseline assessments, participants will be randomized to either intervention or the control group. The intervention, VIPP-SD, is delivered online apart from the first session, which is conducted as a home visit. VIPP-SD is based on attachment and social learning theory. It is manualized and consists of 12 individual sessions alternating between video-recording of mother and child in pre-defined everyday situations and review/discussion of the video recordings with the mother/parents. Focus of the intervention is the childs signals and needs, and how to promote healthy socio-emotional development of the child. VIPP-SD will be carried out by health care professionals trained and certified in VIPP-SD. Participants who are randomized to the control condition, Care As Usual, will continue as they did before enrollment to the study. Care As Usual is defined as any kind of help and support related to the social-emotional development and mental wellbeing of the child in the municipality or mental health services.

CONDITIONS

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

Who Can Participate

Age: 1Year - 3Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child age between 1 year, 0 months and 3 years, 0 months
  • Child lives with mother in the Region of Southern Denmark
  • Mother has a diagnosis of schizophrenia, bipolar disorder, moderate to severe depression, or emotionally unstable personality disorder verified by hospital or clinician records
  • Mother has had at least one in- or outpatient contact with mental health services within 12 months before the child's birth or during the child's lifetime
Not Eligible

You will not qualify if you...

  • Mother is currently an inpatient
  • Mother has current substance or alcohol abuse
  • Mother has insufficient knowledge of Danish and requires an interpreter
  • Child has repeated intrauterine exposure to euphoriants or large amounts of alcohol (≥5 units per time or ≥7 units per week)
  • Child has a known syndrome or autism spectrum disorder
  • Mother or child has sensory impairment
  • A sibling of the child is already participating in the study
  • Family is participating in another closely related research trial involving individualized video-feedback intervention
  • Participant is involved in active court proceedings

AI-Screening

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Trial Site Locations

Total: 1 location

1

Research Unit of Child and Adolescent Psychiatry, Mental Health Services in the Region of Southern Denmark

Odense C, Region Syddanmark, Denmark, 5000

Actively Recruiting

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Research Team

K

Kirstine A Davidsen, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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