Psychoeducational program for children with rare diseases
Official title: Education & Care in RARE - Efficacy of Targeted Psychoeducational Intervention to Improve Knowledge About Rare Diseases and to Promote Mental Health Among Pediatric Rare Disease Patients
Run by Medical University of Vienna · NCT06729554 · Data updated 2026-11-12
This study is testing a new educational program to see if it helps children with rare diseases understand their condition better and feel happier.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 20 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 7 sites (Graz, Austria and 6 other locations) |
| Status | Recruiting |
| Started | December 15, 2024 |
| Main results expected | December 1, 2028 |
| Study ends | December 1, 2028 |
| Registry record updated | July 28, 2026 |
| Trial ID | NCT06729554 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children and adolescents aged 5-20 years with a confirmed diagnosis of a rare disease.
✕Probably not a fit
Patients with moderate to severe cognitive impairment or those receiving high-frequency psychotherapeutic interventions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of a structured psychoeducational program called Education & Care in RARE for children and adolescents diagnosed with rare diseases. It is a multicenter, randomized, controlled trial where participants are divided into an intervention group receiving the psychoeducation and a waiting list control group. The program aims to enhance knowledge about rare diseases and improve mental health well-being among pediatric patients. Participants will complete identical questionnaires to assess the outcomes of the intervention.
Why it matters
Potential benefit: If successful, this program could significantly improve the mental health and understanding of rare diseases among pediatric patients.
How similar studies have gone: While psychoeducational interventions are common, this specific approach for pediatric rare disease patients is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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's running
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Medical University of Graz
Graz, Austria, Austria Recruiting -
Medical University of Innsbruck
Innsbruck, Austria, Austria Recruiting -
The Faculty of Medicine JKU Linz
Linz, Austria, Austria Recruiting -
Salk Pmu
Salzburg, Austria, Austria Recruiting -
WIGEV Klinikum Favoriten
Vienna, Austria, Austria Recruiting -
Ordensklinikum Linz
Linz, Austria Recruiting
Show 1 more location
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Medical University of Vienna
Vienna, Austria Recruiting
Study contacts
- Study coordinator: Julia Vodopiutz, MD apProf
- Email: julia.vodopiutz@meduniwien.ac.at
- Phone: +4314040032320
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.