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

NCT07497581 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2026-03-27

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Markus A. Landolt

    lead OTHER

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2031-04-01
Completion
2031-04-01

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07497581 on ClinicalTrials.gov