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Training Resiliency in Youth (TRY) Study (TRY)

6. august 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

46

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: EVO
All children receive 4 weeks of EVO 5 days/week for 20 minutes per day in a stepped wedge design.
Andet: EVO Cognitive Remediation Game
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.
Measured 5 times across 5 months
Behavioral Problems
Tidsramme: Measured 5 times across 5 months
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.
Measured 5 times across 5 months
Depression
Tidsramme: Measured 5 times across 5 months
depression symptoms measured with self- and parent- report
Measured 5 times across 5 months
Anxiety
Tidsramme: Measured 5 times across 5 months
Measuring self- and parent-reported symptoms of anxiety.
Measured 5 times across 5 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Emotion Regulation
Tidsramme: Measured 5 times across 5 months
Measuring self-reported cognitive aspects of emotion regulation (e.g., rumination, positive reappraisal).
Measured 5 times across 5 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Washington

Efterforskere

  • Ledende efterforsker: Patricia Arean, University of Washington

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 (Faktiske)

16. januar 2018

Primær færdiggørelse (Faktiske)

4. juni 2018

Studieafslutning (Faktiske)

4. juni 2018

Datoer for studieregistrering

Først indsendt

5. februar 2018

Først indsendt, der opfyldte QC-kriterier

5. februar 2018

Først opslået (Faktiske)

12. februar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00003107

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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