Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder
13. august 2018 opdateret af: Ru-Lan Hsieh, Taipei Medical University
Treatment Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder and Developmental Delay
Using a single blind, randomized controlled design to study the additional therapeutic effects of cognitive training on traditional rehabilitation programs for children with attention deficit hyperactivity disorder and developmental delays.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A total of 30 children with attention deficit hyperactivity disorder and developmental delays who are receiving traditional rehabilitation programs will be enrolled.
The participants will be randomized into two groups, including study group (traditional rehabilitation program with additional cognitive training: 2 times per week, 15 min per session, a total of 24 sessions) and control group (traditional rehabilitation program without additional cognitive training).
Memory related functions, quality of life, and physical function evaluations will be performed at baseline, 3 months and 6 months later, respectively.
Evaluator will be blinded to the group's classification during the whole course of study.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Taipei, Taiwan, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
4 år til 8 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- children diagnosed with attention deficit hyperactivity disorder with developmental delay receiving regular rehabilitation programs intelligence quotient 70 or greater
Exclusion Criteria:
- age less than 4 years or elder than 8 years children diagnosed with attention deficit hyperactivity disorder receiving regular rehabilitation programs intelligence quotient less than 70
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: study group
3 months of individualized interactive cognitive training, 2 times per week, 15 min per session, a total of 24 sessions, in addition to traditional rehabilitation programs.
|
Using interactive brain club system training to children with attention deficit hyperactivity disorder with developmental delay
|
|
Ingen indgriben: control group
3 months of traditional rehabilitation programs, without individualized interactive cognitive training.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
change of attention
Tidsramme: scores change from baseline to 3 months of treatment, and 3 months after treatment
|
score assessed by Swanson, Nolan and Pelham questionnaire
|
scores change from baseline to 3 months of treatment, and 3 months after treatment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
change of visual motor integration
Tidsramme: scores change from baseline to 3 months of treatment, and 3 months after treatment
|
score assessed by Beery-Buktenica Visual Motor Integration Test
|
scores change from baseline to 3 months of treatment, and 3 months after treatment
|
|
change of sensory integration
Tidsramme: scores change from baseline to 3 months of treatment, and 3 months after treatment
|
score assessed by Sensory Profile questionnaire
|
scores change from baseline to 3 months of treatment, and 3 months after treatment
|
|
change of intelligence
Tidsramme: scores change from baseline to 3 months of treatment, and 3 months after treatment
|
score assessed by Wechsler Intelligence Scale for Children, including verbal, performance and total scores, the average score is 100, with higher scores indicating higher than average intelligence and lower scores indicating lower levels of intelligence
|
scores change from baseline to 3 months of treatment, and 3 months after treatment
|
|
change of functional performance
Tidsramme: changes from baseline to 3 months of treatment, and 3 months after treatment
|
score assessed by Pediatric Outcome Data Collection Instrument
|
changes from baseline to 3 months of treatment, and 3 months after treatment
|
|
change of health-related quality of life
Tidsramme: changes from baseline to 3 months of treatment, and 3 months after treatment
|
score assessed by Pediatric Quality of Life Inventory-Generic Core Scales, including physical, psychosocial, and total scores, with higher scores representing better health-related quality of life
|
changes from baseline to 3 months of treatment, and 3 months after treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. august 2018
Primær færdiggørelse (Forventet)
1. marts 2019
Studieafslutning (Forventet)
1. marts 2019
Datoer for studieregistrering
Først indsendt
13. juli 2018
Først indsendt, der opfyldte QC-kriterier
13. august 2018
Først opslået (Faktiske)
15. august 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. august 2018
Sidst verificeret
1. august 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2018SKHADR028
Plan for individuelle deltagerdata (IPD)
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