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

2026年7月13日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • スペイン
    • Biscay
      • Bilbao、Biscay、スペイン、48007
        • 募集
        • University of Deusto
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：コントロール
待機リスト制御グループ
行動：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.
実験的：Intervention
Neuro-psychosocial intervention with 12 groupal sessions is offered
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
社会的認知 - 心の理論 - NEPSY-II
時間枠：介入から3ヶ月後
スペイン語版の NEPSY-II の社会認識領域の心の理論 (Korkman et al., 2014) では、比喩的な言語、模倣スキル、他者の思考、アイデア、信念を理解する能力を評価します。感情が社会的状況とどのように関係しているかを理解する人の能力を評価します。
介入から3ヶ月後
Social cognition - Emotion Recognition
時間枠：3 months after the intervention
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 - Happé's Strange Stories
時間枠：3 months after the intervention
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

二次結果の測定

結果測定
メジャーの説明
時間枠
Health-related quality of life
時間枠：3 months after the intervention
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.
3 months after the intervention
Health-related quality of life neuromuscular
時間枠：3 months after the intervention
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.
3 months after the intervention
Children's Depression Inventory-Short
時間枠：3 months after the intervention
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.
3 months after the intervention
Child Medical Fear
時間枠：3 months after the intervention
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.
3 months after the intervention
Psychopathology
時間枠：3 months after the intervention
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.
3 months after the intervention
Strengths and Difficulties Questionnaire
時間枠：3 months after the intervention
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.
3 months after the intervention

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Deusto

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年3月1日

一次修了 (推定)

2026年12月30日

研究の完了 (推定)

2027年6月1日

試験登録日

最初に提出

2026年7月13日

QC基準を満たした最初の提出物

2026年7月13日

最初の投稿 (実際)

2026年7月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月17日

QC基準を満たした最後の更新が送信されました

2026年7月13日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • PI2026090

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

This plan is open to other reserchers to contact the principal investigator of the study.

IPD 共有時間枠

The data is available from now until 2029.

IPD 共有アクセス基準

This plan is open to other reserchers to contact the principal investigator of the study.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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