A Longitudinal Study on Family Adaptation and Relationship Dynamics in Pediatric Rare Diseases

ConditionRare Diseases
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorMarkus A. Landolt

About this trial

Rare diseases in children can affect not only the child's health but also the well-being and relationships within the entire family. Parents often experience stress, uncertainty, and emotional strain, which may in turn influence their child's mental health and quality of life. However, little is known about how families adapt over time to living with a rare disease or how daily experiences and family interactions shape this process.

This study aims to better understand how children with rare diseases and their caregivers adjust psychologically and emotionally over time. It will examine how factors such as parental stress, uncertainty, coping strategies, and family communication are linked to the mental health and quality of life of both children and parents.

The study will include children and adolescents (ages 1-18) with a diagnosed rare disease and their caregivers. Participants will complete online questionnaires at four time points over one year. A subgroup of families will also take part in a two-week smartphone-based assessment, where parents report their daily experiences, such as stress, emotions, and worries, several times per day. Some children and adolescents will additionally participate in interviews to share their own perspectives.

The main outcomes of interest are the child's mental health and quality of life. The study will also assess parental well-being and family functioning to understand how these factors influence each other over time.

By combining long-term and daily data, this study will provide a detailed picture of how families cope with rare diseases in everyday life. The findings may help improve psychological support and guide the development of targeted interventions for families affected by rare pediatric conditions.

Eligibility criteria

Qualifiers

Diagnosed with an RD listed in Table 2.

Age between 8 and 18 years.

Sufficient knowledge of the German language.

Declaration of informed consent must be signed by at least one legal guardian for all participants under 18; adolescents aged 14 - 17 additionally provide their own written consent.

Disqualifiers

The child is affected by an RD other than listed in Table 2.

Age under 8 or over 18 years.

Not sufficient knowledge of the German language.

Lack of informed consent from at least one legal guardian (required for all participants under 18); and, for adolescents aged 14 - 17, absence of adolescent's own written consent.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators

Markus A. Landolt

Lead sponsor

University Children's Hospital, Zurich

Sponsor institution