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

NCT06795347 | Recruiting

• 2 other identifiers: S-20240007158789
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Child Mental Health; Behavioral Symptoms; Child of Impaired Parents

Keywords

Parental psychiatric disorder; Child mental disorders; Prevention; Socio-emotional development; Child behavioral problems; Child externalizing problems; Parental sensitivity

Outcome Measures

Primary Outcomes (1)

• Preschool Parental Account of Children's symptoms (P-PACS)

  The P-PACS is a semistructured researcher-led interview administered to the mother, assessing level of child behavioral problems. Change in level of child behavioral problems is the primary outcome of the study.

  The P-PACS will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.

Secondary Outcomes (9)

• Child Behavior Check List/1 ½-5 (CBCL/1 ½-5)

  CBCL/1 ½-5 will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.

• Caregiver-Teacher Report Form (C-TRF)

  C-TRF will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.

• Baby-DIPS

  Baby-DIPS will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.

• the Brief Attachment Scale-16 (BAS-16)

  The BAS-16 will be administered at baseline (T0) and 11 months (T2) after randomization.

• Parental Stress Scale (PSS)

  The Parental Stress Scale will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.

Study Arms (2)

Intervention (VIPP-SD)

EXPERIMENTAL

Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) delivered online

Behavioral: Online VIPP-SD

Care As Usual

OTHER

Care As Usual is defined as any kind of help and support the parents may receive related to the socio-emotional development and mental wellbeing of their child in the municipality or the mental health services.

Behavioral: Care As Usual

Interventions

Online VIPP-SD BEHAVIORAL

The Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline is delivered online in this study. VIPP-SD is a manualized parenting intervention. The online version consists of 12 individual sessions, where the first and hereafter every second session consists of video recordings of mother and child in pre-defined everyday situations. The recordings are reviewed and discussed with the mother/parents during subsequent video-feedback sessions, where positive sequences in the interaction are pointed out by the intervener and form the basis of a discussion of pre-defined themes regarding child signals, attachment, child development, limit setting and sensitive parenting. The 12 sessions are conducted within five months from randomization with weekly or bi-weekly intervals.

Intervention (VIPP-SD)

Care As Usual BEHAVIORAL

Care As Usual is defined as any kind of help and support the parents may receive related to the socio-emotional development and mental wellbeing of their child in the municipality or the mental health services.

Care As Usual

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify 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 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

You may not qualify 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
• sibling participating in study
• family participating in another closely related research trial receiving an individualized video-feedback intervention
• participating in active court proceedings

Sponsors & Collaborators

• University of Southern Denmark: lead
• Region of Southern Denmark: collaborator

Study Sites (1)

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

Odense C, Region Syddanmark, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Behavioral Symptoms; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders

Study Officials

• Davi

  Region of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirstine A Davidsen, PhD

CONTACT

+4599448681; kirstine.agnete.davidsen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 28, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)