Neuro-psychosocial Teleassistance for Neuromuscular Diseases

NCT ID: NCT06031701

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-02

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Social Competence Self Esteem Quality of Life Social Skills Neuromuscular Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Quasi-experimental pretest-posttest design with a non-equivalent wait list control group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Neuro-psychosocial intervention with 12 grupal sessions is offered

Group Type EXPERIMENTAL

Neuro-psychosocial teleassistance program

Intervention Type BEHAVIORAL

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.

Control

Waiting list control group

Group Type EXPERIMENTAL

Neuro-psychosocial teleassistance program

Intervention Type BEHAVIORAL

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.

Interventions

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Neuro-psychosocial teleassistance program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Deusto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oscar MartĂ­nez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Deusto

Locations

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University of Deusto

Bilbao, Bizkaia, Spain

Site Status

Countries

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Spain

Other Identifiers

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Neuro-e-Motion NMD

Identifier Type: -

Identifier Source: org_study_id

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