protocolSection identificationModule nctId: NCT06312410, orgStudyIdInfo id: H-23067714, briefTitle: The VIA Family 2.0 - a Family Based Intervention for Families With Parental Mental Illness, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Mental Health Services in the Capital Region, Denmark, class: OTHER, collaborators name: Aalborg Psychiatric Hospital, collaborators name: TrygFonden, Denmark, collaborators name: Novo Nordisk A/S, collaborators name: Lundbeck Foundation, collaborators name: Liljeborgfonden, collaborators name: Ebbefos Fonden, collaborators name: KV Fonden, descriptionModule briefSummary: VIA Family 2.0 - a Family Based Intervention for families with parental mental illnessBackground: Children born to parents with mental illness have consistently been shown to have increased risks for a range of negative life outcomes including increased frequencies of mental disorders, somatic disorders, poorer cognitive functioning, social, emotional and behavioral problems and lower quality of life. Further these children are often overlooked by both society and mental health services, although they represent a potential for prevention and early intervention.A collaboration between researchers and clinicians from two regions, the Capital Region and the North Region Denmark has been established as the Research Center for Family Based Interventions. The research center is an umbrella for a series of research activities, all focusing on children and adolescents in families with parental mental illness.Method: A large randomized, controlled trial (RCT) for families with parental mental illness will be conducted in order to evaluate the effect of a two-year multidisciplinary, holistic team intervention (the VIA Family 2.0 team intervention) against treatment as usual (TAU). Inclusion criteria will be biological children 0-17 of parents with any mental disorder treated in the secondary sector at any time of their life and receiving treatment in primary or secondary sector within the previous three years. A total of 870 children or approx. 600 families will be included from two sites. Primary outcomes will be changes in child well being, parental stress, family functioning and quality of the home environment, .Time plan: The RCT will start including families from March 1st, 2024 to Dec 2025 (or later if needed). All families will be assessed at baseline and at end of treatment, i.e. after 24 months and after 36 months. Baseline data will inform the intervention team about each family's needs, problems, and motivation. TAU will be similar in the two regions, which means three family meetings and option for children to participate in peer groups.Challenges: final funding is being applied for. Recruitment of families can be challenging but we have decades of experience in conducting research in the field. Since both the target group, their potential problems and the intervention is complex, primary outcome is difficult to determine., conditionsModule conditions: Child, conditions: Parents, conditions: Mental Disorder, conditions: Child of Impaired Parents, conditions: Preventive Health Services, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1452, type: ESTIMATED, armsInterventionsModule interventions name: VIA Family 2.0, outcomesModule primaryOutcomes measure: Change in Strengths and Difficulties Questionnaire (SDQ), primaryOutcomes measure: Change in Bayley-4 Bayley Scales Test for Infant and Toddler Development, primaryOutcomes measure: Change in Family Assessment Device - General Function Scale (FAD-GF), primaryOutcomes measure: Change in Parental Stress Scale (PSS), secondaryOutcomes measure: Change in Home Observation for Measurement of the Environment (HOME), secondaryOutcomes measure: Change in Parenting and Family Adjustment Scales (PAFAS), secondaryOutcomes measure: Change in Children's Global Assessment Scale (CGAS), secondaryOutcomes measure: Change in Perceived Stress Scale (PSS), secondaryOutcomes measure: Client Satisfaction Scale (CSQ), otherOutcomes measure: Change in Vineland Adaptive Behavior Scales-Second Edition (Vineland-II), otherOutcomes measure: Change in children's quality of life (KIDSCREEN-27), otherOutcomes measure: Change in Ages and Stages Questionnaire:SE-2 (ASQ-SE), otherOutcomes measure: Change in Daily Life Stressor Scale (DLSS), otherOutcomes measure: Change in Child and Youth Resilience Measure (CYRM-R), otherOutcomes measure: Alarm Distress Baby Scale (ADBB), otherOutcomes measure: Change in Personal and Social Performance Scale (PSP), otherOutcomes measure: Change in Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), otherOutcomes measure: Change in Global Assessment of Function - Symptoms (GAF-S), otherOutcomes measure: Change in Kessler Psychological Distress Scale, K10, otherOutcomes measure: Change in General Self-Efficacy Scale (GSE), otherOutcomes measure: Change in Social Provision Scale-short form (SPS), otherOutcomes measure: Change in Quality-adjusted life year (EQ-5D), otherOutcomes measure: Change in Self-Stigma of Mental Illness Scale - short form (SSMIS-SF), otherOutcomes measure: Change in The Questionnaire about the Process of Recovery (QPR), eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False