VIA Family-a family-based early intervention versus treatment as usual for familial high-risk children: a study protocol for a randomized clinical trial

Abstract

Background: Children born to parents with a severe mental illness, like schizophrenia, bipolar disorder, or major recurrent depression, have an increased risk of developing a mental illness themselves during life. These children are also more likely to have developmental delays, cognitive disabilities, or social problems, and they may have a higher risk than the background population of experiencing adverse life events. This is due to both genetic and environmental factors, but despite the well-documented increased risk for children with a familial high risk, no family-based early intervention has been developed for them. This study aims to investigate the effect of an early intervention that focuses on reducing risk and increasing resilience for children in families where at least one parent has a severe mental illness.

Methods/design: The study is a randomized clinical trial with 100 children aged 6-12 with familial high risk. It is performed in the context of the Danish health-care system. Families will be recruited from registers or be referred from the primary sector or hospitals. The children and their parents will be assessed at baseline and thereafter randomized and allocated to either treatment as usual or VIA Family. The intervention group will be assigned to a multidisciplinary team of specialists from adult mental health services, child and adolescent mental health services, and social services. This team will provide the basic treatment elements: case management, psychoeducation for the whole family, parental training, a safety plan, and potentially an early intervention if the child has mental problems. The study period is 18 months for both groups, and all participants will be assessed at baseline and after 18 months. The primary outcome measure will be daily functioning of the child, and the secondary measures are the psychopathology of the child, days of absence from school, family functioning, child's home environment, and parental stress.

Discussion: This study is to our knowledge the first to explore the effects of a multidisciplinary team intervention that provides an intensive and flexible support to match the families' needs for children with a familial high risk for severe mental illness. The study will provide important knowledge about the potential for increasing resilience and reducing risk for children by supporting the whole family. However, a longer follow-up period may be needed.

Trial registration: ClinicalTrials.gov, NCT03497663 . Registered on 13 April 2018.

Keywords: Bipolar disorder; Child mental health; Early intervention; Familial high-risk; Family-based intervention; Multidisciplinary; Offspring; Parental training; Recurrent depression; Schizophrenia.

Conflict of interest statement

Ethics approval and consent to participate

The study has been approved by the Regional Committee on Health Research Ethics (DNVK) for the Capital Region of Denmark (H-17000450). The research team will obtain oral and written informed consent to participate in the study from all adult participants before enrolment. Each child’s guardians will give consent for the child to participate (i.e., if custody is shared, both parents need to give their informed consent). Guardians will also be asked to consent to the researchers’ contacting the child’s teacher to obtain information from the child’s school.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Model for multidisciplinary resources in the team

Fig. 2

Schedule of enrolment, interventions, and assessments (SPIRIT Figure). *Clinical rating, **semi-structured interview, ***self-report on use of treatment and intervention facilities in private and public institutions (by any family member) 1 Days of absence from school (registry, parents report, and teachers report). 2 Neurocognitive tests: RIST; Wechsler Intelligence Scale for Children, 4th Edition (Coding); Rey Complex Figure Test and Recognition Trial; and Test of Memory and Learning, 2nd Edition (Memory of Stories). 3 Clinical Rating: TOF is in ASEBA. 4 CBCL is in ASEBA. 5 TRF is in ASEBA. ACES Adverse Childhood Experiences, ADHD-RS Attention Deficit Hyperactivity Disorder Rating Scale, ASEBA Achenbach System of Empirically Based Assessment, BRIEF Behavior Rating Inventory of Executive Function, CALS Children’s Affective Lability Scale, CBCL Child Behavior Checklist, CGAS Children’s Global Assessment Scale, CTS Childhood Trauma Screener, CYRM Child and Youth Resilience Measurement, ERC Emotion Regulation Checklist, FAD Family Assessment Device, FMSS Five-Minute Speech Sample, HOME Home Observation for Measurement of the Environment, K-SADS-PL Kiddie Schedule for Affective Disorders and Schizophrenia: Present and Lifetime, MACA Multidimensional Assessment of Caring Activities Checklist, PAFAS Parenting and Family Adjustment Scale, PANOC Positive and Negative Outcomes of Caring Questionnaire, PS Parenting Scale, PSP Personal and Social Performance Scale, PSS Parental Stress Scale, RIST Reynolds Intellectual Screening Test, SCAN Schedules for Clinical Assessment in Neuropsychiatry, SDQ Strengths and Difficulties Questionnaire, SPS Social Provision Scale, SRS Social Responsiveness Scale, TAU-SR Treatment as Usual Self Report, TOF Test Observation Forms

Fig. 3

CONSORT flowchart for participants in the VIA Family study. TAU treatment as usual