Telecare Psychosocial and Cognitive Intervention for Children and Adolescents With Limb-Girdle Muscular Dystrophy (TPCLGMD)
13. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Biscay
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Bilbao, Biscay, Spania, 48007
- Rekruttering
- University of Deusto
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Ta kontakt med:
- Óscar Universidad de la Iglesia de Deusto
- Telefonnummer: -34 944139377
- E-post: oscar.martinez@deusto.es
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Kontroll
Kontrollgruppe på venteliste
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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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sosial kognisjon - Theory of mind - NEPSY-II
Tidsramme: 3 måneder etter inngrepet
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Theory of Mind-deltest av Social Perception Domain of NEPSY-II i den spanske utgaven (Korkman et al., 2014) vurderer figurativt språk, imitasjonsferdigheter og evnen til å forstå andres tanker, ideer og tro. evaluerer en persons evne til å forstå hvordan følelser forholder seg til den sosiale konteksten.
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3 måneder etter inngrepet
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Social cognition - Emotion Recognition
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Health-related quality of life
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2026
Primær fullføring (Antatt)
30. desember 2026
Studiet fullført (Antatt)
1. juni 2027
Datoer for studieregistrering
Først innsendt
13. juli 2026
Først innsendt som oppfylte QC-kriteriene
13. juli 2026
Først lagt ut (Faktiske)
17. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Muskel- og skjelettsykdommer
- Sykdommer i nervesystemet
- Muskelsykdommer
- Nevromuskulære sykdommer
- Genetiske sykdommer, medfødte
- Muskellidelser, atrofisk
- Muskeldystrofier
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Oppførsel
- Sosial oppførsel
- Muskeldystrofier, lem-girdle
- Sosiale ferdigheter
Andre studie-ID-numre
- PI2026090
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
This plan is open to other reserchers to contact the principal investigator of the study.
IPD-delingstidsramme
The data is available from now until 2029.
Tilgangskriterier for IPD-deling
This plan is open to other reserchers to contact the principal investigator of the study.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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