Effects of Attention Training on Children
4 maj 2020 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Taipei, Taiwan, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
4 år till 8 år (Barn)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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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Inget ingripande: Control group
3 months of conventional rehabilitation programs without interactive attention training programs
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
changes of symptoms of attention deficit hyperactivity disorder
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
changes of sensory integration
Tidsram: 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
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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
Tidsram: 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
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
|
changes of intelligence
Tidsram: 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
Tidsram: 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
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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
Tidsram: 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
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score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
|
changes of family impact
Tidsram: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
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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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Ru-Lan Ru-Lan, MD, Shin Kong Wu Ho-Su Memorial Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 maj 2020
Primärt slutförande (Förväntat)
31 december 2020
Avslutad studie (Förväntat)
31 december 2020
Studieregistreringsdatum
Först inskickad
29 april 2020
Först inskickad som uppfyllde QC-kriterierna
4 maj 2020
Första postat (Faktisk)
5 maj 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 maj 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 maj 2020
Senast verifierad
1 maj 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2019SKHADR038
Plan för individuella deltagardata (IPD)
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NEJ
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