Neuro-psychosocial Teleassistance for Neuromuscular Diseases

NCT06031701 | Completed

• 1 other identifier: Neuro-e-Motion NMD
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Competence; Self Esteem; Quality of Life; Social Skills; Neuromuscular Diseases

Outcome Measures

Primary Outcomes (4)

• Social cognition - Emotion Recognition

  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

  3 months after the intervention

• Social cognition - Theory of mind - NEPSY-II

  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.

  3 months after the intervention

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

  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.

  3 months after the intervention

• Social cognition - Theory of mind - RMETC

  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.

  3 months after the intervention

Secondary Outcomes (4)

• Health-related quality of life

  3 months after the intervention

• Psychopathology

  3 months after the intervention

• Coping strategies - EAN

  3 months after the intervention

• Coping strategies - ACS

  3 months after the intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Neuro-psychosocial intervention with 12 grupal sessions is offered

Behavioral: Neuro-psychosocial teleassistance program

Control

EXPERIMENTAL

Waiting list control group

Behavioral: Neuro-psychosocial teleassistance program

Interventions

Neuro-psychosocial teleassistance program 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; Intervention

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Deusto: lead

Study Sites (1)

University of Deusto

Bilbao, Bizkaia, 48007, Spain

Location

MeSH Terms

Conditions

Social Skills; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Nervous System Diseases

Study Officials

• Oscar Martínez, PhD

  University of Deusto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Quasi-experimental pretest-posttest design with a non-equivalent wait list control group

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: September 11, 2023
• Study Start: November 2, 2021
• Primary Completion: November 30, 2022
• Study Completion: June 30, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data is available from now until 2025.
• Access Criteria: The plan is open for other researchers to contact the principal investigator of the study.

Locations

ES (1)