Gjøde, I. C. T., Müller, A. D., Hjorthøj, C., Hemager, N., Ingversen, S., Moszkowicz, M., Christensen, S. H., Mikkelsen, L. J., Nielsen, S. S., Melau, M., Forman, J., Nordentoft, M., & Thorup, A. A. E. (2025). Effects on family functioning and the home environment of a family-based preventive intervention for children of parents with severe mental illness: A randomized controlled trial. Journal of Consulting and Clinical Psychology, 93(4), 267–280. https://doi.org/10.1037/ccp0000924
Key Takeaways
- Focus: The study explored the effects of a family-based preventive intervention on family functioning and home environments for families with parents who have severe mental illness.
- Aims: The study aimed to determine if the VIA Family intervention could significantly improve family functioning and home environment quality compared to usual treatments.
- Method: The study used a pragmatic, randomized controlled superiority trial design with assessments at baseline and after 18 months. Participants included families where parents had schizophrenia, bipolar disorder, or recurrent major depressive disorder.
- Findings: No significant differences were found between VIA Family and usual treatment groups for improvements in family functioning or home environment.
- Implications: The findings suggest that while VIA Family intervention is well-received and potentially beneficial, tailored preventive approaches should be further explored for distinct subgroups.
Rationale
Children of parents with severe mental illness face a two- to four-fold increased risk of developing psychiatric disorders due to interacting genetic and environmental factors (Duffy et al., 2023).
Selective preventive interventions targeting family functioning and home environment may enhance resilience and disrupt intergenerational transmission of risk (Fusar-Poli et al., 2021).
Existing evidence supports child-focused outcomes in parental mood disorders (Havinga et al., 2021) but lacks trials for parental psychotic disorders.
By integrating systemic family therapy, psychoeducation, and evidence-based parenting programs (e.g., Triple P), VIA Family addresses key mediators of risk such as affective responsiveness and behavioral control (Epstein et al., 1983).
This trial fills a gap by rigorously testing a long-term, tailored approach in a register-based cohort.
VIA Family
- VIA Family is a structured, family‐based preventive program for school‐aged children of parents with severe mental illness, delivered over 18 months by a multidisciplinary team.
- Collaborative Care Model: Each family is assigned a case manager (clinical psychologist, mental health nurse, social worker, and pedagogue), supervised by a child and adolescent psychiatrist, who coordinates all intervention components.
- Flexible, Individually Tailored Intervention: No single manual governs the program; instead, families choose which modules to engage in based on shared decision‐making with their case manager. Core manualized components include:
- Psychoeducation about mental illness and emotions (6–8 sessions).
- Positive Parenting Program (Triple P) Levels 2–5 and Stepping Stones for parents of children with disabilities or mental disorders (3–10 sessions).
- Separate support groups for children and for parents (≈8 sessions each).
- Child‐focused cognitive behavioral therapy for those showing signs of mental health difficulties.
- Practical/financial counseling and relapse safety planning to bolster the home environment.
- Process: Families begin with 2–6 introductory alliance‐building sessions, then receive ~16 months of tailored modules. “Fidelity” is defined pragmatically as having at least 15 sessions with the VIA Family team.
- This design aims to reduce stressors and enhance protective factors in the family system – communication, emotional responsiveness, and behavioral control – to disrupt the intergenerational transmission of risk.
Method
The study was a pragmatic, assessor-masked, parallel-group randomized controlled superiority trial conducted in Copenhagen, Denmark.
Families were recruited via national health registers and local mental health and social services between 2018–2021.
After eligibility screening (one parent aged 18–60 with a DSM-5/ICD-10 schizophrenia spectrum disorder, bipolar disorder, or recurrent major depressive disorder; at least one child aged 6–12 living at home; Danish‐speaking), 95 families were randomized 1:1 to:
- VIA Family (n = 47): an 18-month, tailored, multicomponent intervention including psychoeducation, a parenting program (Triple P/Stepping Stones), support groups, child‐focused CBT, practical/financial counseling, and relapse safety planning. Participants received 2–6 introductory sessions followed by modules chosen to match family needs.
- Usual Treatment (n = 48): standard mental health, social, private, and NGO services without additional protocolized support.
Outcome assessors—blinded to allocation—conducted baseline and 18-month follow-up evaluations using standardized interviews and questionnaires.
Randomization employed concealed block allocation stratified by parental diagnosis.
Primary outcomes (family functioning and home environment) were analyzed by ANCOVA, adjusting for baseline score, diagnostic stratum, and gender, under an intent-to-treat framework with multiple imputation for missing data.
Sensitivity analyses included complete-case, outlier exclusion, and per-protocol approaches.
Measures
- McMaster Family Assessment Device (FAD): 60‐item self‐report of general family functioning (scale 1–4).
- HOME‐MC/EA: 59–60 item assessor-rated home stimulation/support (0–1 per item; range 0–60).
- Client Satisfaction Questionnaire (CSQ-8): 8‐item satisfaction (8–32).
- Negative Effects Questionnaire (NEQ-20): 20‐item adverse effects (0–100).
- Parental Stress Scale (PSS): 18 items (18–90).
- Personal and Social Performance Scale (PSP): Interview of daily functioning (0–100).
- Social Provision Scale (SPS): 24 items of social support (24–96).
- Parenting and Family Adjustment Scales (PAFAS): 18-item parenting (0–54) and 12-item family adjustment (0–36).
- Parenting Scale (PS): 30 items on discipline behaviors (1–7)
Results
- Hypothesis 1 – Family Functioning (FAD):
- Parents: No significant difference between VIA Family and usual treatment (adjusted mean difference = 0.11; 95% CI [–0.10, 0.31]; p = .296).
- Coparents: No significant difference (adjusted mean difference = –0.07; 95% CI [–0.27, 0.13]; p = .482).
- Hypothesis 2 – Home Environment (HOME-MC/EA):
- No significant improvement for VIA Family versus usual treatment (adjusted mean difference = 1.79; 95% CI [–0.37, 3.95]; p = .104).
- Secondary Outcomes:
- Parent Satisfaction (CSQ-8): Significantly higher in VIA Family (p = .013).
- Coparent Family Adjustment (PAFAS): Improved in VIA Family (p = .002).
- Negative Effects (NEQ-20): No difference in reported adverse effects.
- Parental Stress (PSS), Daily Functioning (PSP), Social Support (SPS), Parenting Behaviors (PS): No significant group differences.
- Sensitivity Analyses:
- Complete-case, outlier-excluded, and per-protocol analyses all confirmed the primary null findings for FAD and HOME-MC/EA.
Insights
Despite rigorous design, the null effects on family functioning and home environment suggest that tailored, nonmanualized interventions may require greater intensity, longer duration, or stepped-care models to outperform standard services.
The significant increase in parental satisfaction indicates acceptability, which is crucial for engagement.
These findings extend prior child-focused trials (Compas et al., 2009) by evaluating whole-family outcomes and underscore the need for subgroup analyses to identify families most likely to benefit.
Further research might test manualized components separately, explore moderators such as illness severity, and assess long-term preventive impacts via register linkage.
Clinical Implications
- Enhancing Engagement: High user satisfaction with VIA Family suggests that offering families a menu of supportive modules—rather than a rigid protocol—can improve buy-in. Clinicians should collaboratively select components based on family preferences and perceived needs to maintain motivation.
- Stepped-Care Implementation: Given the null effects on family functioning, services could adopt a stepped-care framework: start with low-intensity psychoeducation and case management, then escalate to manualized parenting programs or family therapy for families showing limited progress.
- Resource Allocation: Policymakers should ensure adequate funding for flexible, multicomponent services that can tailor support without compromising fidelity. Training frontline staff across disciplines (social work, psychology, psychiatry) in each module can optimize delivery.
- Integration with Existing Services: Embedding VIA Family elements into routine community mental health and child welfare services can reduce fragmentation. For example, social workers might deliver brief Triple P sessions during home visits, while child psychologists run CBT groups on-site.
- Monitoring and Evaluation: Implement simple, ongoing outcome tracking (e.g., quarterly FAD short form) to identify families needing stepped-up support. Data-driven adjustments can help allocate intensive resources to those at greatest risk.
- Addressing Barriers: Anticipate challenges such as scheduling conflicts, transportation, and stigma. Provide home-based or telehealth options, offer childcare during sessions, and involve peer mentors to normalize participation.
- Policy Recommendations: To scale such interventions, fund pilot implementations with built-in process evaluations, and incentivize cross-sector collaboration through joint commissioning between health and social services.
- Long-Term Prevention: Encourage longitudinal follow-up studies via health registers to assess whether early engagement with family-based supports reduces psychiatric incidence in offspring, informing future investment in preventive care.
References
Gjøde, I. C. T., Müller, A. D., Hjorthøj, C., Hemager, N., Ingversen, S., Moszkowicz, M., Christensen, S. H., Mikkelsen, L. J., Nielsen, S. S., Melau, M., Forman, J., Nordentoft, M., & Thorup, A. A. E. (2025). Effects on family functioning and the home environment of a family-based preventive intervention for children of parents with severe mental illness: A randomized controlled trial. Journal of Consulting and Clinical Psychology, 93(4), 267–280. https://doi.org/10.1037/ccp0000924
Duffy, A., Goodday, S. M., Christiansen, H., Patton, G., Thorup, A. A. E., Preisig, M., Vandeleur, C., Weissman, M., & de Girolamo, G. (2023). The well-being of children at familial risk of severe mental illness: An overlooked yet crucial prevention and early intervention opportunity. Nature Mental Health, 1(8), 534–541. https://doi.org/10.1038/s44220-023-00090-4
Fusar-Poli, P., Correll, C. U., Arango, C., Berk, M., Patel, V., & Ioannidis, J. P. A. (2021). Preventive psychiatry: A blueprint for improving the mental health of young people. World Psychiatry, 20(2), 200–221. https://doi.org/10.1002/wps.20869
Havinga, P. J., Maciejewski, D. F., Hartman, C. A., Hillegers, M. H. J., Schoevers, R. A., & Penninx, B. W. J. H. (2021). Prevention programmes for children of parents with a mood/anxiety disorder: Systematic review of existing programmes and meta-analysis of their efficacy. British Journal of Clinical Psychology, 60(2), 212–251. https://doi.org/10.1111/bjc.12277
Epstein, N. B., Baldwin, L. M., & Bishop, D. S. (1983). The McMaster family assessment device. Journal of Marital and Family Therapy, 9(2), 171–180. https://doi.org/10.1111/j.1752-0606.1983.tb01497.x
Socratic Questions
- How might the heterogeneity in family functioning at baseline have influenced the null findings?
- Could manualizing certain VIA Family components enhance measurable effects without compromising flexibility?
- What role did COVID-19 adaptations play in intervention fidelity and outcomes?
- How would you design a subgroup analysis to identify families most responsive to this intervention?
- In what ways could qualitative data illuminate why parents reported higher satisfaction despite null quantitative effects?
- How might cultural factors influence the acceptability and effectiveness of similar family-based interventions in other contexts?
