Telecare Psychosocial and Cognitive Intervention for Children and Adolescents With Limb-Girdle Muscular Dystrophy (TPCLGMD)

Telecare-Mediated Psychosocial and Cognitive Intervention for Children and Adolescents With Limb-Girdle Muscular Dystrophy

This clinical trial aims to evaluate the efficacy of a telecare-mediated psychosocial and cognitive intervention for children and adolescents aged 7 to 17 with limb-girdle muscular dystrophy. This group-based intervention (comprising 5 participants) consists of 12 weekly one-hour sessions. The objective of the intervention is to improve the participants' quality of life as well as to reduce their symptomatology by targeting areas such as social cognition, emotional and personal management, cognitive restructuring, relaxation strategies, social skills, and coping strategies.

Study Overview

• Status: Recruiting
• Conditions: Social Skills; Self Esteem; Health Related Quality of Life; Limb-Girdle Muscular Dystrophy; Social Competence
• Intervention / Treatment: Behavioral: Neuro-psychosocial teleassistance program

Detailed Description

Development and implementation of a psychosocial and cognitive tele-assistance programme for groups of children and adolescents affected by limb-girdle muscular dystrophy. 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Biscay
    • Bilbao, Biscay, Spain, 48007
      • Recruiting
      • University of Deusto
      • Contact: Óscar Universidad de la Iglesia de Deusto; Phone Number: -34 944139377; Email: oscar.martinez@deusto.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• To be diagnosed with limb-girdle muscular dystrophy
• Being between 7 and 17 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control; Waiting list control group	Behavioral: 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 objective of the intervention is to improve the participants' quality of life as well as to reduce their symptomatology by targeting areas such as social cognition, emotional and personal management, cognitive restructuring, relaxation strategies, social skills, and coping strategies.
Experimental: Intervention; Neuro-psychosocial intervention with 12 groupal sessions is offered	Behavioral: 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 objective of the intervention is to improve the participants' quality of life as well as to reduce their symptomatology by targeting areas such as social cognition, emotional and personal management, cognitive restructuring, relaxation strategies, social skills, and coping strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 - 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 - 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months after the intervention
Health-related quality of life neuromuscular	How an individual's health status impacts their physical well-being and ability to communicate their disease The perception of HRQoL is assessed in both healthy and chronically ill children using the Spanish version of the Pediatric Quality of Life Inventory Neuromuscular (PedsQLTM Neuromuscular) (Varni et al., 2001). We used the self-report questionnaire in this study for three age ranges: 5-7, 8-12, and 13-18. Neuromuscular disease, communication and family functioning are the three dimensions covered by the 25-item assessment. The PedsQL Neuromuscular provides a physical and a communication skills 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.	3 months after the intervention
Children's Depression Inventory-Short	Depression symptoms The Children's Depression Inventory-Short (Kovacs, 1992; Spanish version: Barrio et al. 2012) measures key signs of depression such as sadness, sleep issues, and low self-esteem in just a few. It is a 10-item self-report questionnaire designed to quickly screen for depressive symptoms in youths aged 7 to 17. Each choice is scored from 0 to 2, with higher scores reflecting greater symptom severity.	3 months after the intervention
Child Medical Fear	To what children have fear in a medical context The Child Medical Fear scale (Broome et al., 1988; Spanish version: San Martin-Rodriguez et al., 2021) is an assessment tool used to measure a child's anxiety and fear regarding medical events and healthcare environments. It has 17 items in total, and the scores are rated on a 3-point Likert scale: Not at all (0 points), A little (1 point), and A lot (2 points). It helps pediatricians and psychologists identify specific triggers-such as physical pain or loss of control-so they can tailor medical care to reduce a child's stress.	3 months after the intervention
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.	3 months after the intervention
Strengths and Difficulties Questionnaire	Mental, emotion and behaviour health possible problems The Strengths and Difficulties Questionnaire (Goodman, 1997; Spanish version: García et al., 2000) is a brief behavioral and emotional screening tool for children and adolescents aged 2 to 17. It uses 25 questions across five categories (emotional symptoms, conduct problems, hyperactivity, peer relationship problems and prosocial behavior) to assess both psychological problems and positive social behaviors.	3 months after the intervention

Collaborators and Investigators

• Sponsor: University of Deusto

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Muscular Disorders, Atrophic; Muscular Dystrophies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Social Behavior; Muscular Dystrophies, Limb-Girdle; Social Skills
• Other Study ID Numbers: PI2026090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This plan is open to other reserchers to contact the principal investigator of the study.
• IPD Sharing Time Frame: The data is available from now until 2029.
• IPD Sharing Access Criteria: This plan is open to other reserchers to contact the principal investigator of the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No