Telecare Psychosocial and Cognitive Intervention for Children and Adolescents With Limb-Girdle Muscular Dystrophy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neuro-psychosocial teleassistance program.
- Who it may be relevant to
- Registry conditions: Limb-Girdle Muscular Dystrophy, Social Competence, Self Esteem, Health Related Quality of Life. Basic parameters: 7 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Telecare-Mediated Psychosocial and Cognitive Intervention for Children and Adolescents With Limb-Girdle Muscular Dystrophy
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Social cognition - Emotion Recognition [Time frame: 3 months after the intervention]
- Social cognition - Theory of mind - NEPSY-II [Time frame: 3 months after the intervention]
- Social cognition - Theory of mind - Happé's Strange Stories [Time frame: 3 months after the intervention]
Secondary outcome measures (6)
- Health-related quality of life [Time frame: 3 months after the intervention]
- Health-related quality of life neuromuscular [Time frame: 3 months after the intervention]
- Children's Depression Inventory-Short [Time frame: 3 months after the intervention]
- Child Medical Fear [Time frame: 3 months after the intervention]
- Psychopathology [Time frame: 3 months after the intervention]
- Strengths and Difficulties Questionnaire [Time frame: 3 months after the intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- University of Deusto — Bilbao
Identifiers
NCT: NCT07711730 · PI2026090