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

Official title

Wellbeing and Resilience Among 1-3 Years Old Children of Mothers with Complex Mental Health Problems: a Pragmatic Clinical Trial

Overview

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.

Interventions

• Behavioral Online VIPP-SD
  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 th
• Behavioral Care As Usual
  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.

Primary outcome measures

• Preschool Parental Account of Children's symptoms (P-PACS) [Time frame: The P-PACS will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.]

Secondary outcome measures (9)

• Child Behavior Check List/1 ½-5 (CBCL/1 ½-5) [Time frame: 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) [Time frame: C-TRF will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.]
• Baby-DIPS [Time frame: Baby-DIPS will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.]
• the Brief Attachment Scale-16 (BAS-16) [Time frame: The BAS-16 will be administered at baseline (T0) and 11 months (T2) after randomization.]
• Parental Stress Scale (PSS) [Time frame: The Parental Stress Scale will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.]
• Parental Sensitivity [Time frame: Sensitivity will be assessed at T0 and T1.]
• Parental Reflective Functioning Questionnaire (PRFQ) [Time frame: The PRFQ will be completed by both (cohabitating) parents at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.]
• EQ-5D-5L [Time frame: EQ-5D-5L will be administered at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.]
• Symptom Checklist-90-revised (SCL-90-R) [Time frame: The SCL-90-R is completed at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Denmark · 1 center

• Research Unit of Child and Adolescent Psychiatry, Mental Health Services in the Region of — Odense C

Identifiers

NCT: NCT06795347 · S-20240007 · 158789

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗