Effects of Attention Training on Children
4 mai 2020 mis à jour par: Ru-Lan Hsieh, Taipei Medical University
Therapeutic Effects of Interactive Attention Training on Children With Attention Deficit Hyperactivity Disorder
Using a double-blind, randomized controlled design to investigate the therapeutic effects of interactive attention training for children with Attention Deficit Hyperactivity Disorder who are receiving conventional rehabilitation programs due to developmental delay.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
A total of 30 children with Attention Deficit Hyperactivity Disorder conducting conventional rehabilitation programs well be enrolled.
The children are randomized into two groups, including study group with conventional rehabilitation programs and interactive attention training: 2 times per week, 15 min per session, with a total of 24 sessions in 3 months; and control group with conventional rehabilitation programs without interactive attention training.
Therapeutic effects, including working memory, attention, functional performance, physical function, health-related quality of life will be evaluated at baseline, and 3 months and 6 months after the intervention.
The evaluator and children will be blinded to the group's allocation during the whole course of the intervention.
Type d'étude
Interventionnel
Inscription (Anticipé)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Taipei, Taïwan, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
4 ans à 8 ans (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- children with a diagnosis of Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient 70 or greater
Exclusion Criteria:
- age less than 4 or greater than 8 of children diagnosed with Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient less than 70
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Study group
3 months of interactive attention training programs, 2 times per week, 15 min per session, a total of 24 sessions, with conventional rehabilitation programs
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using the interactive attention training system to children with Attention Deficit Hyperactivity Disorder
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Aucune intervention: Control group
3 months of conventional rehabilitation programs without interactive attention training programs
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
changes of symptoms of attention deficit hyperactivity disorder
Délai: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome
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score assessed by Swanson, Nolan and Pelham questionnaire
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
changes of sensory integration
Délai: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
score assessed by Sensory Profile
|
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
|
changes of visual motor integration
Délai: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
score assessed by Beery-Buktenica Visual Motor Integration Test
|
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
|
changes of intelligence
Délai: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
score assessed by Wechsler Intelligence Scale for Children
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
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changes of functional performance
Délai: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
score assessed by Pediatric Outcome Data Collection Instrument
|
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
|
changes of health-related quality of life
Délai: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
score assessed by Pediatric Quality of Life Inventory
|
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
|
changes of family impact
Délai: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
Child Health Questionnaire, parent form 28
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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changes of walking speed
Délai: time change from baseline to 3 months of treatment, and 3 months after treatment
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walking speed
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time change from baseline to 3 months of treatment, and 3 months after treatment
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changes of chair climbing speed
Délai: time change from baseline to 3 months of treatment, and 3 months after treatment
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stairs climbing speed
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time change from baseline to 3 months of treatment, and 3 months after treatment
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changes of balance
Délai: time change from baseline to 3 months of treatment, and 3 months after treatment
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one leg standing time
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time change from baseline to 3 months of treatment, and 3 months after treatment
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changes of coordination
Délai: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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Berg Balance Scale
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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changes of balance and coordination
Délai: time change from baseline to 3 months of treatment, and 3 months after treatment
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timed up and go test
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time change from baseline to 3 months of treatment, and 3 months after treatment
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changes of physical performance
Délai: time change from baseline to 3 months of treatment, and 3 months after treatment
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5 time sit to stand test
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time change from baseline to 3 months of treatment, and 3 months after treatment
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Ru-Lan Ru-Lan, MD, Shin Kong Wu Ho-Su Memorial Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 mai 2020
Achèvement primaire (Anticipé)
31 décembre 2020
Achèvement de l'étude (Anticipé)
31 décembre 2020
Dates d'inscription aux études
Première soumission
29 avril 2020
Première soumission répondant aux critères de contrôle qualité
4 mai 2020
Première publication (Réel)
5 mai 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 mai 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 mai 2020
Dernière vérification
1 mai 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2019SKHADR038
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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