Effects of Attention Training on Children
4. mai 2020 oppdatert 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.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Taipei, Taiwan, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
4 år til 8 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
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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|
Ingen inngripen: Control group
3 months of conventional rehabilitation programs without interactive attention training programs
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
changes of symptoms of attention deficit hyperactivity disorder
Tidsramme: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome
|
score assessed by Swanson, Nolan and Pelham questionnaire
|
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
changes of sensory integration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
|
changes of functional performance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
|
changes of walking speed
Tidsramme: time change from baseline to 3 months of treatment, and 3 months after treatment
|
walking speed
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time change from baseline to 3 months of treatment, and 3 months after treatment
|
|
changes of chair climbing speed
Tidsramme: time change from baseline to 3 months of treatment, and 3 months after treatment
|
stairs climbing speed
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time change from baseline to 3 months of treatment, and 3 months after treatment
|
|
changes of balance
Tidsramme: time change from baseline to 3 months of treatment, and 3 months after treatment
|
one leg standing time
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time change from baseline to 3 months of treatment, and 3 months after treatment
|
|
changes of coordination
Tidsramme: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
|
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
|
|
changes of balance and coordination
Tidsramme: time change from baseline to 3 months of treatment, and 3 months after treatment
|
timed up and go test
|
time change from baseline to 3 months of treatment, and 3 months after treatment
|
|
changes of physical performance
Tidsramme: time change from baseline to 3 months of treatment, and 3 months after treatment
|
5 time sit to stand test
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time change from baseline to 3 months of treatment, and 3 months after treatment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ru-Lan Ru-Lan, MD, Shin Kong Wu Ho-Su Memorial Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. mai 2020
Primær fullføring (Forventet)
31. desember 2020
Studiet fullført (Forventet)
31. desember 2020
Datoer for studieregistrering
Først innsendt
29. april 2020
Først innsendt som oppfylte QC-kriteriene
4. mai 2020
Først lagt ut (Faktiske)
5. mai 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. mai 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. mai 2020
Sist bekreftet
1. mai 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2019SKHADR038
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