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Clinical Trials/NCT06031701
NCT06031701
Completed
Not Applicable

Effects of a Neuro-psychosocial Teleassistance Programme for Children With Neuromuscular Diseases

University of Deusto1 site in 1 country35 target enrollmentNovember 2, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Social Competence
Sponsor
University of Deusto
Enrollment
35
Locations
1
Primary Endpoint
Social cognition - Emotion Recognition
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This is a clinical trial to assess the effect of a neuropsychosocial intervention by means of telecare aimed at children and adolescents aged 7-16 years with neuromuscular diseases. The intervention is carried out in groups of 5 participants and is organised in 12 sessions: 1 session per week of 1h duration. The intervention is aimed at strengthening aspects of social cognition, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being.

Detailed Description

Development of a neuro-psychosocial tele-assistance programme for groups of children and adolescents affected by various neuromuscular diseases, including Duchenne/Becker muscular dystrophy, limb-girdle dystrophy, etc. In this project the variables of interest and intervention include social cognition, quality of life, psychological symptomatology and coping strategies. The aim of this study is to test whether this programme improves the indicators in the mentioned variables.

Registry
clinicaltrials.gov
Start Date
November 2, 2021
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • To be diagnosed with a neuromuscular disease by a specialist
  • Being between 7 and 16 years old
  • Having signed an informed consent form through their legal guardians prior to participation in the study
  • Having Spanish as one of their main languages
  • Having access to a computer (with a camera, microphone and speakers integrated) and Internet connection to take part in the videoconferences

Exclusion Criteria

  • Presence of any other diagnosis or sensory deficit that would prevent the application of the tests or hinder the correct performance of the intervention´s activities
  • Being illiterate

Outcomes

Primary Outcomes

Social cognition - Emotion Recognition

Time Frame: 3 months after the intervention

Affect Recognition subtest of the Social Perception Domain of the NEPSY-II in the Spanish edition (Korkman et al., 2014) measures the capacity to identify emotions (happy, sad, neutral, afraid, irrationally angry, and disgust) in various images of children

Social cognition - Theory of mind - Happé's Strange Stories

Time Frame: 3 months after the intervention

The Happé's Strange Stories Test is a well-known test of ToM (Happé, 1994; Spanish version: Pousa, 2002). In this study, we used the White et al. (2009) version that has eight story-types. This test evaluates participants capacity to comprehend nonliteral meanings through the reading of brief vignettes.

Social cognition - Theory of mind - RMETC

Time Frame: 3 months after the intervention

The Reading the Mind in the Eyes test Child version (RMETC) (Baron-Cohen et al., 2001; Spanish version: Rueda et al., 2013), is a TOM test that features 28 photos of individuals. The participant's task is to match the picture with one of the four adjectives that best describes the feelings and thoughts of the person in the picture.

Social cognition - Theory of mind - NEPSY-II

Time Frame: 3 months after the intervention

Theory of Mind subtest of the Social Perception Domain of the NEPSY-II in the Spanish edition (Korkman et al., 2014) assesses figurative language, imitation skills, and the capacity to comprehend the thoughts, ideas, and beliefs of others and it also evaluates a person's capacity to comprehend how emotions relate to the social context.

Secondary Outcomes

  • Coping strategies - EAN(3 months after the intervention)
  • Psychopathology(3 months after the intervention)
  • Health-related quality of life(3 months after the intervention)
  • Coping strategies - ACS(3 months after the intervention)

Study Sites (1)

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