Parental Coping With Challenging Behavior in Mucopolysaccharidosis Type I-III

Coping Behavior Clinical Trial

Official title:

Behavioral Challenges in Children With Mucopolysaccharidosis Type I-III and Parental Coping Strategies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161171
• Other study ID #: 01
• Status: Completed
• Phase: N/A
• First received: April 24, 2017
• Last updated: December 11, 2017
• Start date: July 6, 2017
• Est. completion date: November 13, 2017

Study information

• Verified date: December 2017
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study quantitates behavioral challenges in mucopolysaccharidosis type I-III and parental coping strategies

Description:

This is a prospective, cross-sectional, observational study quantitatively assessing

1. challenging behavior in children with MPS, an orphan, progressive, neurodegenerative metabolic disorder, and

2. parental coping strategies for this challenging behavior.

Patients registered at the German Society for Mucopolysacchardoses giving written informed consent are eligible. The study is based on questionnaires. IRB approval was obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 13, 2017
• Est. primary completion date: November 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Diagnosis of mucopolysaccharidosis type I, II or III

• Written informed consent

• Patient is registered at the German Society for Mucopolysaccharidosis

Exclusion Criteria:

• Patient / Family does not give written informed consent.

Related Conditions & MeSH terms

• Behavior Disorders
• Coping Behavior
• Mental Disorders
• Mucopolysaccharidoses
• Mucopolysaccharidosis I
• Mucopolysaccharidosis II
• Mucopolysaccharidosis III
• Mucopolysaccharidosis Type I
• Mucopolysaccharidosis Type II
• Mucopolysaccharidosis Type III

Intervention

Other:
• This is an observational study
This is an observational study

Locations

Country	Name	City	State
Germany	University of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coping strategies for challenging behavior and for family burden in mucopolysaccharidosis type I-III	assessed by visual analogue scale	10 minutes
Secondary	Quantity of behavioral abnormalities in children with mucopolysaccharidosis type I-III	assessed by visual analogue scale	10 minutes
Secondary	Intensity of behavioral abnormalities in children with mucopolysaccharidosis type I-III	assessed by visual analogue scale	10 minutes
Secondary	Psychosocial burden in families with mucopolysaccharidosis type I-III	assessed by visual analogue scale	10 minutes
Secondary	Psychosocial burden in families with mucopolysaccharidosis type I-III	assessed by Likert scale	10 minutes