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Neuro-psychosocial Teleassistance for Neuromuscular Diseases

Primary Purpose

Social Competence, Self Esteem, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neuro-psychosocial teleassistance program
Sponsored by
University of Deusto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Competence

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Deusto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention

Control

Arm Description

Neuro-psychosocial intervention with 12 grupal sessions is offered

Waiting list control group

Outcomes

Primary Outcome Measures

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
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.
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.
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.

Secondary Outcome Measures

Health-related quality of life
How an individual's health status impacts their overall well-being and ability to lead a satisfying life The perception of HRQoL is assessed in both healthy and chronically ill children using the Spanish version of the Pediatric Quality of Life Inventory (PedsQLTM 4.0) (Varni et al., 2001). We used the self-report questionnaire in this study for three age ranges: 5-7, 8-12, and 13-18. Physical functioning, emotional functioning, social functioning, and academic functioning are the four dimensions covered by the 23-item assessment. The PedsQL 4.0 provides a physical and a psychosocial summary score in addition to a total score. It is answered through a likert scale with 5 response options that are then converted into quantitative scores ranging from 0-100 points, with a higher score being a better HRQoL.
Psychopathology
Behavioral and emotional symptoms The Child Behavior Checklist for Ages 6-18 (CBCL/6-18) (Achenbach & Rescorla, 2001) is a multiaxial assessment tool for identifying behavioral and emotional issues in children and adolescents that is aligned with the ASEBA (Achenbach System of Empirically Based Assessment). It has 113 items total, broken down into eight scales for the following syndromes: anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thinking problems, attention problems, rule-breaking behavior and aggressive behavior. Scores for internalizing, externalizing, and overall difficulties are also provided by the items.
Coping strategies - EAN
Different styles to deal with stressful situations Coping Scale for Children (EAN) (Morales-Rodríguez et al., 2012) is a self-report scale assesses coping strategies and is intended for children aged nine to 12 years. In the instrument, four problems related to the family context, health, schoolwork and social relationships are posed. The nine coping strategies assessed are distinguished between problem-focused coping and unproductive coping.
Coping strategies - ACS
Different styles to deal with stressful situations Adolescent Coping Scales (ACS) (3rd edition) (Frydenberg and Lewis, 2000): assesses different coping strategies in adolescents aged 12-18 years to cope with their problems. The inventory assesses 18 different coping strategies and consists of 80 items, 79 closed-ended and one open-ended. Furthermore, the 18 strategies are classified into three basic coping styles: problem-directed coping, coping in relation to others, and unproductive coping.

Full Information

First Posted
July 13, 2023
Last Updated
September 7, 2023
Sponsor
University of Deusto
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1. Study Identification

Unique Protocol Identification Number
NCT06031701
Brief Title
Neuro-psychosocial Teleassistance for Neuromuscular Diseases
Official Title
Effects of a Neuro-psychosocial Teleassistance Programme for Children With Neuromuscular Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Deusto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Competence, Self Esteem, Quality of Life, Social Skills, Neuromuscular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Quasi-experimental pretest-posttest design with a non-equivalent wait list control group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Neuro-psychosocial intervention with 12 grupal sessions is offered
Arm Title
Control
Arm Type
Experimental
Arm Description
Waiting list control group
Intervention Type
Behavioral
Intervention Name(s)
Neuro-psychosocial teleassistance program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social cognition - Emotion Recognition
Description
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
Time Frame
3 months after the intervention
Title
Social cognition - Theory of mind - NEPSY-II
Description
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.
Time Frame
3 months after the intervention
Title
Social cognition - Theory of mind - Happé's Strange Stories
Description
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.
Time Frame
3 months after the intervention
Title
Social cognition - Theory of mind - RMETC
Description
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.
Time Frame
3 months after the intervention
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
How an individual's health status impacts their overall well-being and ability to lead a satisfying life The perception of HRQoL is assessed in both healthy and chronically ill children using the Spanish version of the Pediatric Quality of Life Inventory (PedsQLTM 4.0) (Varni et al., 2001). We used the self-report questionnaire in this study for three age ranges: 5-7, 8-12, and 13-18. Physical functioning, emotional functioning, social functioning, and academic functioning are the four dimensions covered by the 23-item assessment. The PedsQL 4.0 provides a physical and a psychosocial summary score in addition to a total score. It is answered through a likert scale with 5 response options that are then converted into quantitative scores ranging from 0-100 points, with a higher score being a better HRQoL.
Time Frame
3 months after the intervention
Title
Psychopathology
Description
Behavioral and emotional symptoms The Child Behavior Checklist for Ages 6-18 (CBCL/6-18) (Achenbach & Rescorla, 2001) is a multiaxial assessment tool for identifying behavioral and emotional issues in children and adolescents that is aligned with the ASEBA (Achenbach System of Empirically Based Assessment). It has 113 items total, broken down into eight scales for the following syndromes: anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thinking problems, attention problems, rule-breaking behavior and aggressive behavior. Scores for internalizing, externalizing, and overall difficulties are also provided by the items.
Time Frame
3 months after the intervention
Title
Coping strategies - EAN
Description
Different styles to deal with stressful situations Coping Scale for Children (EAN) (Morales-Rodríguez et al., 2012) is a self-report scale assesses coping strategies and is intended for children aged nine to 12 years. In the instrument, four problems related to the family context, health, schoolwork and social relationships are posed. The nine coping strategies assessed are distinguished between problem-focused coping and unproductive coping.
Time Frame
3 months after the intervention
Title
Coping strategies - ACS
Description
Different styles to deal with stressful situations Adolescent Coping Scales (ACS) (3rd edition) (Frydenberg and Lewis, 2000): assesses different coping strategies in adolescents aged 12-18 years to cope with their problems. The inventory assesses 18 different coping strategies and consists of 80 items, 79 closed-ended and one open-ended. Furthermore, the 18 strategies are classified into three basic coping styles: problem-directed coping, coping in relation to others, and unproductive coping.
Time Frame
3 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Martínez, PhD
Organizational Affiliation
University of Deusto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Deusto
City
Bilbao
State/Province
Bizkaia
ZIP/Postal Code
48007
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The plan is open for other researchers to contact the principal investigator of the study.
IPD Sharing Time Frame
The data is available from now until 2025.
IPD Sharing Access Criteria
The plan is open for other researchers to contact the principal investigator of the study.

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Neuro-psychosocial Teleassistance for Neuromuscular Diseases

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