Telecare Psychosocial and Cognitive Intervention for Children and Adolescents With Limb-Girdle Muscular Dystrophy (TPCLGMD)
13 de julio de 2026 actualizado por: University of Deusto
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Biscay
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Bilbao, Biscay, España, 48007
- Reclutamiento
- University of Deusto
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Contacto:
- Óscar Universidad de la Iglesia de Deusto
- Número de teléfono: -34 944139377
- Correo electrónico: oscar.martinez@deusto.es
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Control
Grupo de control de lista de espera
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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.
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Experimental: Intervention
Neuro-psychosocial intervention with 12 groupal sessions is offered
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cognición social - Teoría de la mente - NEPSY-II
Periodo de tiempo: 3 meses después de la intervención
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El subtest de Teoría de la Mente del Dominio de Percepción Social del NEPSY-II en la edición en español (Korkman et al., 2014) evalúa el lenguaje figurado, las habilidades de imitación y la capacidad de comprender los pensamientos, ideas y creencias de otros y también Evalúa la capacidad de una persona para comprender cómo las emociones se relacionan con el contexto social.
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3 meses después de la intervención
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Social cognition - Emotion Recognition
Periodo de tiempo: 3 months after the intervention
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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.
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3 months after the intervention
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Social cognition - Theory of mind - Happé's Strange Stories
Periodo de tiempo: 3 months after the intervention
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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.
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3 months after the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Health-related quality of life
Periodo de tiempo: 3 months after the intervention
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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.
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3 months after the intervention
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Health-related quality of life neuromuscular
Periodo de tiempo: 3 months after the intervention
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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.
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3 months after the intervention
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Children's Depression Inventory-Short
Periodo de tiempo: 3 months after the intervention
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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.
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3 months after the intervention
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Child Medical Fear
Periodo de tiempo: 3 months after the intervention
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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.
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3 months after the intervention
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Psychopathology
Periodo de tiempo: 3 months after the intervention
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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.
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3 months after the intervention
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Strengths and Difficulties Questionnaire
Periodo de tiempo: 3 months after the intervention
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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.
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3 months after the intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de marzo de 2026
Finalización primaria (Estimado)
30 de diciembre de 2026
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
13 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de julio de 2026
Publicado por primera vez (Actual)
17 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Enfermedades del Sistema Nervioso
- Enfermedades Musculares
- Enfermedades Neuromusculares
- Enfermedades Genéticas Congénitas
- Trastornos Musculares Atróficos
- Distrofias Musculares
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Comportamiento
- Comportamiento social
- Distrofias Musculares, Fajas Extremidades
- Habilidades sociales
Otros números de identificación del estudio
- PI2026090
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
This plan is open to other reserchers to contact the principal investigator of the study.
Marco de tiempo para compartir IPD
The data is available from now until 2029.
Criterios de acceso compartido de IPD
This plan is open to other reserchers to contact the principal investigator of the study.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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