It also recommends checking for coexisting health problems and providing support for family members and carers. In March , a correction was made to the wording of recommendation 1. We checked this guideline in March We found no new evidence that affects the recommendations in this guideline. How we develop NICE guidelines. After the initial mail, the research team will invite all families by phone to an information meeting about the study. Moreover, parents who fit the inclusion criteria can be directly referred to the study from in- or outpatient clinics in the municipalities.
If there are children in the family who are not aged between 6 and 12, they are included in the activities of the intervention, but the assessment prior to randomization and at follow-up will involve only children within the defined age group at baseline. The ill parent does not need to live with the other parent or with the child if the child lives in the municipalities of Frederiksberg or Copenhagen. In these cases and when the parents share custody of the child, the first step is to ask the ill parent for permission to invite the child and the other parent.
Randomization is carried out by a member of the intervention team situated away from the research assessors. The team member assigns participants to interventions. The allocation concealment mechanism is performed by a computer algorithm saved in REDCap [ 54 ]. The randomization process cannot be influenced by the person who makes the randomization or any other person.
The randomization sequence is set in a preset concealed block size order with an allocation ratio The randomization is stratified solely by diagnostic group. Outcome assessors, data analysts, and researchers will be blinded throughout the study, including during the statistical analysis.
In addition, researchers are blinded to block size and frequencies. It is not possible to blind the participants nor those providing the intervention.
Psychosis and schizophrenia in adults: prevention and management
The VIA Family intervention takes place at a site away from the assessors, data analysts, and researchers, which combined with the minimal interaction and communication between the intervention team and the assessors, aims to minimize the risk of unblinding. If unblinding occurs during the study, it will be registered and another assessor will perform the outcome assessment at the follow-up for the family whose treatment allocation has been revealed.
In theory, no circumstances should necessitate unblinding of the assessors or researchers, since all relevant information and clinical evaluations will be available to the research manager AAET and members of the intervention team, who can intervene in an emergency. Families are assessed with a range of diagnostic interviews, neurocognitive tests, interviews, and questionnaires at baseline and at the month follow-up Fig. The assessment at baseline takes approximately 8 h in total for a family of two adults and one child. The 9-month follow-up consists of a mid-phase telephone call by an independent research assistant.
This contact seeks to decrease the risk of attrition from the study. Data will be collected from all participants independently of compliance to treatment. Only trained clinical psychologists administer the neurocognitive tests. All diagnoses are confirmed at clinical conferences with a child and adolescent psychiatrist being present.
All data, including all personal information about potential and enrolled participants, are entered directly into the data entry system REDCap [ 54 ] by the assessors on site, except for a few neurocognitive tests that can only be made on paper. Self-report surveys for adults are either answered electronically on site or at home and in rare cases on paper if need be e.
The surveys answered on paper are entered into the data entry system REDCap using double data entry. All surveys for children are read out to the child. All tests will be two-tailed. The primary outcome analysis will be by intention to treat. Multiple imputations will be used to handle missing data if any. The imputations will be based on a linear regression model with imputations and 20 iterations.
Pooled analyses will subsequently be used for our analysis. All distributions of continuous outcome variables will be assessed for normality using a visual inspection of histograms with a normal probability curve and Q—Q plots. If a variable is not normally distributed, the variable will be transformed e. For dichotomous outcomes, we will perform multiple logistic regressions with TAU as the reference and stratification variables as covariates after having imputed missing values if any using a logistic regression model.
If we find a significant correlation, a model that is equivalent to the approach for continuous variables will be used. The second per protocol analysis is likely to cause severe selection bias, as the VIA Family group would include the participants with the highest level of motivation. Therefore, it is considered meaningful to report only negative results from this analysis. The study does not have a data monitoring committee.
All study participants randomized to VIA Family are monitored for harmful events by the intervention team or, in cases of hospitalization, by their general practitioner or a doctor from the Mental Health Center. If necessary, the principal investigator will make the final decision to terminate the trial. All study participants will be asked to report voluntarily all adverse events or other unintended effects of the trial at the 9-month and month follow-ups. The study will be audited weekly by the principal investigator group, who are not involved in the day-to-day work of the study and are independent of the sponsors.
There is an urgent need for visionary strategies and preventive interventions in mental health services. Currently, we do not have a specific approach for preventing mental illness in children who are born with a well-documented familial-based increased risk. The VIA Family study is an innovative study attempting to investigate the effects of an early, family-based, flexible, and multidisciplinary intervention for families with children who are known to have a significantly increased risk for developing a mental illness later in life. Further, evidence from qualitative studies and experience from large clinical studies show that these families often struggle with everyday problems to a much greater extent than other families [ 5 ].
The intervention to be tested, VIA Family, is based on both evidence from the existing literature and on the very first results from another Danish study, the Danish High-risk and Resilience Study VIA 7 [ 49 ], as well as on clinical experience and information from focus group interviews with mentally ill parents and their co-parents.
Evidence from the literature has demonstrated that the vulnerability of these children is detectable at a very early age [ 10 , 19 ]. Research and clinical experience have documented the increased risk of trauma, adverse life experiences, and sub-optimal living conditions, including problems with parenting for the children, all factors that we know increase the risk of later mental illness [ 22 ]. In this way, the prevention will help to solve problems that exist here and now.
We have also investigated the large body of literature on resilience and how this can be strengthened in children. Factors like secure attachments, a social network, being part of a community, having positive experiences, and finding meaning in life are mentioned as crucial factors for individuals with a high degree of resilience [ 70 , 71 ]. The intervention being offered to the families is very intensive and flexible, and this should increase our chances of getting conclusive results. It lasts for 18 months and aims to meet almost any kind of problem that the families may struggle with.
It is more intensive than those in most other studies [ 36 ]. Moreover, 18 months is quite a long intervention period. The intervention does not focus on illness and disabilities but more on everyday life in a non-stigmatizing way and is, thus, expected to be acceptable for most families. That the intervention is more intensive and comprehensive than those in other studies may be experienced in a negative way by some.
However, each element has been chosen based on qualitative interviews and very recent results from a Danish cohort study [ 30 , 31 ]. No treatment elements will be introduced before the family approve them and find them relevant and motivating. By using comprehensive Danish registries, we will be able to follow these children in the future and have long term follow-up results, since some outcomes may be in the distant future.
The assessment battery is comprehensive and covers several areas of interest with validated tests.
For many of the tests we have Danish norms. The target groups of people with schizophrenia, bipolar disorder, or major depression were chosen because evidence of the genetic impact in these disorders is well documented. Instead, it is the impact on the parent that is relevant. Parents with diagnoses other than those included in our study may have similar problems or behavior, e. If the results of our study are positive, the next step will be to include families where one of the parents has other serious mental problems, e.
We intend to include families in the study, which, based on the power calculation of our primary outcomes, is a sufficient number of participants for the study to show an effect of the intervention. However, it may be that the intervention is effective at a lower although still clinically relevant level, which would need a larger sample size to be detected.
Moreover, the study design is limited by the absence of data from the pilot phase of the study, which could have contributed to the design and feasibility assessment of the intervention. Although experience from the pilot testing of the intervention and the instruments for assessment, as well as the feedback from the pilot families, were included in the intervention and overall study design, this knowledge cannot contribute to the study of its feasibility.
Hence, this trial will provide data that can be used as pilot data for the development of a revised version of the intervention manual and for future studies in this field. Also, we include children from three different diagnostic categories, although we believe from research evidence that the children born to parents with schizophrenia are the most vulnerable of the three.
In particular, recruitment of families where one of the parents is suffering from schizophrenia may be the most troublesome. Another challenge in all intervention studies is how to avoid attrition, especially from the control group. We hope that the initial feedback from the researchers, the 9-month status contact, and the emphasis on the importance of participating in research will keep the families in the study. The intensive intervention may sound positive, but we should be aware that this could also be experienced as overwhelming or over-involving for some participants.
Further, it may be a problem that 18 months of intervention is too short for the relevant differences to be recognizable. The current protocol is Version 4, December Recruitment will take place from September to March J Behav Health Serv Res. Early Interv Psychiatry.
Socialstyrelsen So. Digital ISBN: —87—; Schizophr Bull. Seidman LJ, Nordentoft M. Genetic liability, prenatal health, stress and family environment: risk factors in the Harvard Adolescent Family High Risk for schizophrenia study. Schizophr Res. Uher R. Gene-environment interactions in common mental disorders: an update and strategy for a genome-wide search. Soc Psychiatry Psychiatr Epidemiol.
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A systematic review and meta-analysis of the psychosis continuum: evidence for a psychosis proneness-persistence-impairment model of psychotic disorder. Psychol Med. Childhood developmental abnormalities in schizophrenia: evidence from high-risk studies. Psychiatric illnesses in families of subjects with schizophrenia-spectrum personality disorders: high morbidity risks for unspecified functional psychoses and schizophrenia.
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