Telecare Psychosocial and Cognitive Intervention for Children and Adolescents With Limb-Girdle Muscular Dystrophy (TPCLGMD)
2026년 7월 13일 업데이트: 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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
30
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Biscay
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Bilbao, Biscay, 스페인, 48007
- 모병
- University of Deusto
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연락하다:
- Óscar Universidad de la Iglesia de Deusto
- 전화번호: -34 944139377
- 이메일: oscar.martinez@deusto.es
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 제어
대기자 명단 통제 그룹
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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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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사회인지 - 마음이론 - NEPSY-II
기간: 개입 후 3개월
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스페인어판 NEPSY-II의 사회적 인식 영역에 대한 정신 이론 하위 테스트(Korkman et al., 2014)는 비유적 언어, 모방 기술, 다른 사람의 생각, 아이디어 및 신념을 이해하는 능력을 평가합니다. 감정이 사회적 맥락과 어떻게 관련되는지 이해하는 개인의 능력을 평가합니다.
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개입 후 3개월
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Social cognition - Emotion Recognition
기간: 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
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Health-related quality of life
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 3월 1일
기본 완료 (추정된)
기본 완료
2026년 12월 30일
연구 완료 (추정된)
연구 완료
2027년 6월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 13일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 13일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 17일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 13일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- PI2026090
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
This plan is open to other reserchers to contact the principal investigator of the study.
IPD 공유 기간
The data is available from now until 2029.
IPD 공유 액세스 기준
This plan is open to other reserchers to contact the principal investigator of the study.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .