Evaluation of two family-based intervention programs for children affected by rare disease and their families – research network (CARE-FAM-NET): study protocol for a rater-blinded, randomized, controlled, multicenter trial in a 2x2 factorial design

Background: Families of children with rare diseases (i.e., not more than 5 out of 10,000 people are affected) are often highly burdened with fears, insecurities and concerns regarding the affected child and its siblings. Although families caring for children with rare diseases are known to be at risk for mental disorders, the evaluation of special programs under high methodological standards has not been conducted so far. Moreover, the implementation of interventions for this group into regular care has not yet been accomplished in Germany. The efficacy and cost-effectiveness of a family-based intervention will be assessed. Methods/design: The study is a 2x2 factorial randomized controlled multicenter trial conducted at 17 study centers throughout Germany. Participants are families with children and adolescents affected by a rare disease aged 0 to 21 years. Families in the face-to-face intervention CARE-FAM, online intervention WEP-CARE or the combination of both will be treated over a period of roughly 6 months. Topics discussed in the interventions include coping, family relations, and social support. Families in the control condition will receive treatment as usual. The primary efficacy outcome is parental mental health, measured by the Structured Clinical Interview for DSM-IV (SCID-I) by blinded external raters. Further outcomes will be assessed from the parents’ as well as the children’s perspective. Participants are investigated at baseline, 6, 12 and 18 months after randomization. In addition to the assessment of various psychosocial outcomes, a comprehensive health-economic evaluation will be performed. Discussion: This paper describes the implementation and evaluation of two family-based intervention programs for Children Affected by Rare Disease and their Family’s Network (CARE-FAM-NET) in German standard care. A methodologically challenging study design is used to reflect the complexity of the actual medical care situation. This trial could be an important contribution to the improvement of care for this highly burdened group. Trial registration: German Clinical Trials Register: DRKS00015859 (registered 18 December 2018) and ClinicalTrials.gov: NCT04339465 (registered 8 April 2020). Protocol Version: 15 August 2020 (Version 6.1). Trial status: Recruitment started on 1 January 2019 and will be completed on 31 March 2021. © 2020, The Author(s)

Family Functioning and Psychological Health of Children with Mentally Ill Parents

Parental mental illness can be linked to reduced family functioning, which is associated with more conflicts, less adaptability and cohesion as well as a disorganized pattern of everyday planning. Concurrently, family functioning is an important moderator for the influence of parental mental disorders on the development of the children. Consequently, the current study addresses the correlation of family functioning in families with mentally ill parents and the psychological health of the children. The sample consists of 67 mentally ill parents. Both parents and therapists completed questionnaires related to family functioning and the psychological health of the children. Family functioning was rated as dysfunctional in 38% of the families. The psychological health of the children was classified as clinical or subclinical in 43% of the cases. 52% of the children were rated to have no psychological problems. In families with good family functioning, children were assessed to have less psychological problems than in families with poor functioning. Children outside the clinical range lived in families with good family functioning and vice versa. Significant positive correlations were found between the FB-A scales, the CBCL/4-18 syndrome scales and the CBCL/4–18 total score. Results indicate that family functioning and psychological health of children in families with mentally ill parents correlate closely and represent potential targets for future family interventions