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

NCT07711730 | Recruiting

• 1 other identifier: PI2026090
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Limb-Girdle Muscular Dystrophy; Social Competence; Self Esteem; Health Related Quality of Life; Social Skills

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• Health-related quality of life

  3 months after the intervention

• Health-related quality of life neuromuscular

  3 months after the intervention

• Children's Depression Inventory-Short

  3 months after the intervention

• Child Medical Fear

  3 months after the intervention

• Psychopathology

  3 months after the intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Neuro-psychosocial intervention with 12 groupal 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 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.

Control; Intervention

Eligibility Criteria

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

You may qualify if:

• 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

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, Biscay, 48007, Spain

RECRUITING

MeSH Terms

Conditions

Muscular Dystrophies, Limb-Girdle; Social Skills

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Social Behavior; Behavior

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, 2026
• First Posted: July 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data is available from now until 2029.
• Access Criteria: This plan is open to other reserchers to contact the principal investigator of the study.

Locations

ES (1)