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Modeling and Testing Change in Mental Abilities in Childhood

14. april 2017 opdateret af: University of Southern California

Modeling and Testing Change in Mental Abilities in Childhood Through Computer-based Interventions

Children with low executive function, working memory and attention skills in childhood not only do poorly at school, but also go on to do poorly on social, health, and financial indicators in adulthood.

The rate of executive function disorders in children is vastly underestimated at 17% , even when taking into account two of the more widely known disorders of Attention Deficit Hyperactivity Disorder (11%) and Fetal Alcohol Spectrum Disorders (6%), but children of lower socioeconomic status are especially vulnerable due to reduced resource availability.

As executive function, working memory and attention skills are central to success in later life, if children with low skills can be given targeted training to improve the skills they fall short on, there is potential to both improve their short-term academic performance, and influence long-term achievement. In fact, poor executive function skills and poor attention and working memory is a large predictor of poor performance even in typically developing children who are doing poorly academically.

Hypothesis 1. Those with lower working memory will also have lower problem solving skills and lower indices of other executive functioning skills such as reasoning/problem solving.

Hypothesis 2. Children that start with lower WM and PS will show the highest gains in training related performance, and such high gains on WM and PS will lead to better performance post-intervention compared to baseline measures of cognitive function.

Hypothesis 3: Those who make the largest gains in WM and PS with training will show more retention of training gains at 6 months compared those who show lower gains.

Aim 1. Assess working memory (WM) and processing speed (PS) skills in children and their inter-relationships with executive functioning skills Aim 2. Examine change in cognitive function in WM and PS after intensive training in WM and PS, during and immediately post-intervention Aim 3. Examine long-term retention of training effects on WM, PS, and executive functions.

The purpose of this study is to establish an effective and targeted working memory and processing speed intervention in children ages 7-10 with low to average executive function skills, by utilizing home-based computer games specifically designed to appeal to children.

Following institution approved consents, 60 low socioeconomic status children from Los Angeles will be recruited and enrolled in the study and be asked to play specific fun, but targeted cognitive computer games for 10 weeks.

The results of this pilot study will establish a protocol for feasibility of improving executive function skills in children with underdeveloped skills and inform on sufficiency of sample sizes, length of interventions, and directly impact computer-based intervention research and cost-effective techniques in children's cognitive development within the next 3-5 years.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • California
      • Los Angeles, California, Forenede Stater, 90089
        • University of Southern California

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

7 år til 11 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Understands and speaks English

Exclusion Criteria:

  • Diagnosed psychological disorder
  • Head trauma with loss of consciousness of >5 minutes

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Computer games to assess change in executive function skills
Children in Intervention group get to train using executive function games at more difficult levels.
Children get access to computer games for 10 weeks for an hour each week.
Andre navne:
  • Difficult / Easy games
Aktiv komparator: Easy games as active comparators for executive function skills
Children in Non-intervention group get to play executive function games at an easy level.
Children get access to computer games for 10 weeks for an hour each week.
Andre navne:
  • Difficult / Easy games

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in working memory skills assessed through Executive Function Battery and NIH ToolBox
Tidsramme: 3 months
Children will be assessed both on Executive Function Battery and the NIH Toolbox battery to examine change in working memory skills.
3 months
Change in processing speed skills assessed through Executive Function Battery and NIH ToolBox
Tidsramme: 3 months
Children will be assessed both on Executive Function Battery and the NIH Toolbox battery to examine change in processing speed skills.
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in school grades in science, reading and math.
Tidsramme: 3-6 months
Parents will be asked for children's school grades at the beginning of the study, during the study, and at the end of the study to assess the effects of the intervention
3-6 months
Change in parent reported behavior as assessed through BRIEF and CBCL questionnaires
Tidsramme: 3-6 months
Parental reports on BRIEF (Behavior Rating Inventory of Executive Function) and CBCL (Child Behavior Checklist) questionnaires will be used to assess change in behavior
3-6 months

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Prapti Gautam, PhD, University of Southern California

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

1. juni 2015

Primær færdiggørelse (Faktiske)

31. august 2016

Studieafslutning (Faktiske)

31. august 2016

Datoer for studieregistrering

Først indsendt

27. maj 2015

Først indsendt, der opfyldte QC-kriterier

1. juni 2015

Først opslået (Skøn)

2. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 15-01767

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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