Psychoeducational program for children with rare diseases

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 5 Years to 20 Years
• Sex: All
• Sponsor: Medical University of Vienna (other)
• Locations: 7 sites (Graz, Austria and 6 other locations)
• Trial ID: NCT06729554 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are children and adolescents aged 5-20 years with a confirmed diagnosis of a rare disease.

Not a fit: Patients with moderate to severe cognitive impairment or those receiving high-frequency psychotherapeutic interventions may not benefit from this study.

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 performed: While psychoeducational interventions are common, this specific approach for pediatric rare disease patients is novel and has not been extensively tested in prior studies.

Eligibility 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 this trial is running

Graz, Austria and 6 other locations

• 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)
• Medical University of Vienna — Vienna, Austria (RECRUITING)

Study contacts

• Study coordinator: Julia Vodopiutz, MD apProf

Conditions: Orphan Diseases, Rare Disorders, Pediatric Diseases, Inborn Errors of Metabolism Disorders, Rare diseases, ultra-rare diseases, psychoeducation in pediatrics, psychoeducation for alle rare diseases