Clinical trial NCT06031701: Neuro-psychosocial Teleassistance for Neuromuscular Diseases
Official title: Effects of a Neuro-psychosocial Teleassistance Programme for Children With Neuromuscular Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Competence
Self Esteem
Quality of Life
Social Skills
Neuromuscular Diseases
Lead sponsor: University of Deusto
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 35
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental pretest-posttest design with a non-equivalent wait list control group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Social cognition - Emotion Recognition
timeFrame: 3 months after the intervention
measure: Social cognition - Theory of mind - NEPSY-II
timeFrame: 3 months after the intervention
measure: Social cognition - Theory of mind - Happé's Strange Stories
timeFrame: 3 months after the intervention
measure: Social cognition - Theory of mind - RMETC
timeFrame: 3 months after the intervention
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 3 months after the intervention
measure: Psychopathology
timeFrame: 3 months after the intervention
measure: Coping strategies - EAN
timeFrame: 3 months after the intervention
measure: Coping strategies - ACS
timeFrame: 3 months after the intervention
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: University of Deusto
state: Bizkaia
Study officials:
affiliation: University of Deusto
name: Oscar Martínez, PhD
role: PRINCIPAL_INVESTIGATOR
References: