Actively Recruiting

Phase Not Applicable
Age: 5Years - 20Years
All Genders
NCT06729554

Education & Care in RARE: Efficacy of Targeted Psychoeducational Intervention Among Pediatric Rare Disease Patients

Led by Medical University of Vienna · Updated on 2025-05-13

100

Participants Needed

7

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

"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.

CONDITIONS

Official Title

Education & Care in RARE: Efficacy of Targeted Psychoeducational Intervention Among Pediatric Rare Disease Patients

Who Can Participate

Age: 5Years - 20Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children and adolescents aged 5 to 20 years with developmental age of 5 to 18 years
  • Confirmed diagnosis of a rare disease
  • Receiving medical care at a participating study center for the rare disease
  • Voluntary participation with informed consent
  • Ability to complete questionnaires
  • Ability to actively participate in the psychoeducation intervention
Not Eligible

You will not qualify if you...

  • Moderate or severe cognitive impairment
  • Currently admitted to a setting with high-frequency psychotherapeutic treatment (e.g., psychosomatic medicine or child and adolescent psychiatry)
  • No informed consent
  • Language barrier preventing participation
  • Expected low compliance making attendance to all study appointments unlikely

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 7 locations

1

Medical University of Graz

Graz, Austria, Austria, 8010

Actively Recruiting

2

Medical University of Innsbruck

Innsbruck, Austria, Austria, 6020

Actively Recruiting

3

The Faculty of Medicine JKU Linz

Linz, Austria, Austria, 4020

Actively Recruiting

4

SALK PMU

Salzburg, Austria, Austria, 5020

Actively Recruiting

5

WIGEV Klinikum Favoriten

Vienna, Austria, Austria, 1100

Actively Recruiting

6

Ordensklinikum Linz

Linz, Austria, 4010

Actively Recruiting

7

Medical University of Vienna

Vienna, Austria, 1090

Actively Recruiting

Loading map...

Research Team

J

Julia Vodopiutz, MD apProf

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here