Training Resiliency in Youth (TRY) Study (TRY)
6. august 2018 oppdatert av: Pat Arean, University of Washington
The aim of the study is to determine whether a neuroscience-inspired cognitive remediation video game (EVO) that targets the cognitive control network (CCN) will improve executive functioning (EF) and resilience to psychiatric symptoms in typically developing 6th grade students, unselected for specific psychiatric symptoms.
The primary goals are to 1) determine if EVO will result in improved EF and lower internalizing (e.g., mood, anxiety) and externalizing (e.g., attention deficit/hyperactivity disorder, AD/HD) psychiatric symptoms, 2) evaluate whether the benefit experienced by youth changes depending on their level of life stress (e.g., academic or social difficulties), 3) determine if EVO will promote resilience to stress.
The investigators will measure EF, symptoms, and stress using self- and parent-report questionnaires.
Other secondary outcomes include information on behavior in the classroom and academic performance (i.e., grades) that we will collect via school records.
The investigators hypothesize that engagement with EVO 20-minutes per day, 5-days a week across 4-weeks will improve EF, lower psychiatric symptoms, improve academic/behavioral functioning at school, and decrease maladaptive responses to stress.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
46
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Washington
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Seattle, Washington, Forente stater, 98195
- University of Washington
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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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Currently enrolled in 6th grade during the 2017-2018 school year at Lucille Umbarger Elementary School in the Burlington-Edison School District
- Physical ability to use a touchscreen iPad
- Cognitive ability to assent, complete questionnaires, and play EVO game
- English speaking child, English or Spanish speaking parent
- Child has legal parent/guardian (i.e., not a ward of the state)
Exclusion Criteria:
- The child is identified by parent or school as diagnosed with an intellectual disability
- The child is identified by parent or school as diagnosed with a physical disability (i.e., unable to use hands or fingers) that would preclude use of a touchscreen iPad and appropriate engagement with EVO
- The child is identified by parent or school as unlikely to engage for 20 minutes with EVO
- Child unable to read or understand English
- Parent unable to read or understand English/Spanish
- Child is in public (i.e., child welfare) custody
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: EVO
All children receive 4 weeks of EVO 5 days/week for 20 minutes per day in a stepped wedge design.
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EVO (formerly called Neuroracer) is a neuroscience-inspired plasticity trainings in the form of a video driving game that uses adaptive algorithms and dual-tasking paradigms to target the CCN.
Work from our group (Project:EVO) recently showed that 4 weeks of EVO training is associated with increased neural recruitment in brain regions associated with CNN, superior improvement in cognitive control performance (i.e., working memory, sustained attention) when compared to an evidence-based psychotherapy (Problem-Solving Therapy), and improved depression outcomes similar to Problem-Solving Therapy among older adults (Areán, Hallgren, Jordan, Gazzaley, Atkins, Heagerty, & Anguera, 2016; Journal of Medical Internet Research).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Executive Function
Tidsramme: Measured 5 times across 5 months
|
Measuring Executive Function (e.g., attention, working memory) via parent-report of children's symptoms.
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Measured 5 times across 5 months
|
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Behavioral Problems
Tidsramme: Measured 5 times across 5 months
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Measuring difficulties with attention (i.e., attention deficit/hyperactivity disorder), oppositionality, and conduct at home and school as measured by parent-report on children's behavior.
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Measured 5 times across 5 months
|
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Depression
Tidsramme: Measured 5 times across 5 months
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depression symptoms measured with self- and parent- report
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Measured 5 times across 5 months
|
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Anxiety
Tidsramme: Measured 5 times across 5 months
|
Measuring self- and parent-reported symptoms of anxiety.
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Measured 5 times across 5 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Emotion Regulation
Tidsramme: Measured 5 times across 5 months
|
Measuring self-reported cognitive aspects of emotion regulation (e.g., rumination, positive reappraisal).
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Measured 5 times across 5 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Patricia Arean, University of Washington
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 (Faktiske)
16. januar 2018
Primær fullføring (Faktiske)
4. juni 2018
Studiet fullført (Faktiske)
4. juni 2018
Datoer for studieregistrering
Først innsendt
5. februar 2018
Først innsendt som oppfylte QC-kriteriene
5. februar 2018
Først lagt ut (Faktiske)
12. februar 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. august 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. august 2018
Sist bekreftet
1. august 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00003107
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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