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临床试验/NCT06795347
NCT06795347招募中不适用

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

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Preschool Parental Account of Children's symptoms (P-PACS)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
1 Year 至 3 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Intervention (VIPP-SD)

Experimental

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

干预措施: Online VIPP-SD (Behavioral)

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.

干预措施: Care As Usual (Behavioral)

结局指标

主要结局

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

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

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.

次要结局

  • 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.)
  • Parental Sensitivity(Sensitivity will be assessed at T0 and T1.)
  • Parental Reflective Functioning Questionnaire (PRFQ)(The PRFQ will be completed by both (cohabitating) parents at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.)
  • EQ-5D-5L(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)(The SCL-90-R is completed at baseline (T0), 5 months (T1) and 11 months (T2) after randomization.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kirstine Agnete Davidsen

Principal Investigator

University of Southern Denmark

研究点 (1)

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