Education & Care in RARE: Efficacy of Targeted Psychoeducational Intervention Among Pediatric Rare Disease Patients
Recruiting now · Not applicable
Conditions studied: Orphan Diseases, Rare Disorders, Pediatric Diseases, Inborn Errors of Metabolism Disorders
In brief
"Rare Diseases" is an umbrella term including more than 8.000 different diseases which individually affect only a small percentage of people. Rare diseases predominantly affect children and adolescents and are associated with high medical and psychosocial burden of disease. The investigators invented Education \& Care in RARE - a short-term, structured, resource-oriented and child-friendly psychoeducation program for children and adolescents with rare diseases. This study is a prospective, multicenter, randomized and controlled study with a waiting list. Aim of the study is to investigate the efficacy of Education \& Care in RARE on knowledge about rare diseases and on mental health well-being in pediatric rare disease patients, compared to a control group. In this study participants are randomized in an intervention group and a waiting list control group. Both study groups thus receive the psychoeducation with Education \& Care in RARE and complete the identical questionnaires. Compared to the Intervention group, the waiting list control group receives the intervention with a time delay (8-12 weeks later) and has one additional appointment for questionnaire evaluation before start of the psychoeducation.
Key facts
- Study ID
- NCT06729554
- Run by
- Medical University of Vienna
- People needed
- 100
- Starts
- 2024-12-15
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-07-28
Who can join
Age: 5 and older, up to 20. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children and adolescents with a confirmed diagnosis of a rare disease with
- Age 5-20 years, corresponding to a developmental age of 5-18 years
- Existing medical care at a participating study center because of the rare disease
- Voluntary participation and informed consent
- Ability to complete the questionnaires
- Ability to actively participate the intervention (psychoeducation)
You may not qualify if…
- Moderate or severe cognitive impairment
- Simultaneous admission of the child / adolescent to a setting with high-frequency psychotherapeutic intervention (e.g. admission to psychosomatic medicine, child and adolescent psychiatry)
- No informed consent
- Language barrier of the child / adolescent
- Assumption that compliance is too low to attend all study appointments
Where it is running
- Medical University of Graz — Graz, Austria, Austria (enrolling)
- Medical University of Innsbruck — Innsbruck, Austria, Austria (enrolling)
- The Faculty of Medicine JKU Linz — Linz, Austria, Austria (enrolling)
- SALK PMU — Salzburg, Austria, Austria (enrolling)
- WIGEV Klinikum Favoriten — Vienna, Austria, Austria (enrolling)
- Ordensklinikum Linz — Linz, Austria (enrolling)
- Medical University of Vienna — Vienna, Austria (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.