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Brain Training in Preterm Children at Risk for Inattention, Hyperactivity, and Executive Function Impairment

2. august 2019 opdateret af: Irene M. Loe, MD, Stanford University

Randomized Controlled Trial of Executive Function Training in Preterm Children at Risk for Inattention, Hyperactivity and Executive Function Impairment

The purpose of this study is to determine if different forms of child-friendly, computer-based puzzles and games ("brain training") targeting executive function (EF) skills (i.e., thinking, problem-solving) result in improvements in EF in preschool children at risk for EF problems due to premature birth. The investigators hypothesize that children receiving active "brain training" will show greater improvements in EF and related skills immediately after treatment than children receiving passive "brain training." The investigators are also interested in whether any improvements in EF and related skills occur or are maintained at 3 and 6 months after completion of brain training.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Detailed description:

  • Investigators will talk to you by telephone to determine if your child might be eligible for the study.
  • Children complete two baseline testing sessions to evaluate executive function (EF) and related skills
  • Parents complete a packet of information, including questionnaires about the child's behavior, EF, and functional skills.
  • After completion of the baseline testing, we will inform you of eligibility for the "Brain Training" phase.
  • During "Brain Training" children play online computer games for 25-30 minutes/day (can range from 15-45 minutes/day depending on your child's attention, training version received, number and length of breaks needed), 5 days a week, for 5-7 weeks to complete a total of 25 sessions.
  • Children return for 3 more time points, immediately after the completion of "Brain Training" (1 session), and also at 3 months (1 session) and 6 months (2 sessions) after completion of "Brain Training."

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

57

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
    • California
      • Stanford, California, Forenede Stater, 94305
        • Stanford University School of Medicine

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

4 år til 5 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 4 or 5 years
  • Born prematurely at <33 weeks gestation
  • Able to comprehend task instructions
  • EF impairment on standardized questionnaire (t-score of 60 or greater) or EF battery (lower quartile)

Exclusion Criteria:

  • Major neurosensory impairment (i.e., blind, deaf) or technology dependence (i.e., ventilator dependent) that interferes with testing
  • Genetic syndrome
  • Inability to comprehend task instructions

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Active Brain Training
The children in this arm receive one type of "Brain Training" with online computer games that actively matches their skill level.
Adfærdsmæssigt: Brain Training (Active)
Online computer games targeting attention, EF, and problem-solving match the child's skill level.
Eksperimentel: Passive Brain Training
The children in this arm receive one type of "Brain Training" with online computer games that are at a consistent skill level.
Adfærdsmæssigt: Brain Training (Passive)
Online computer games targeting attention, EF, and problem solving are set to a consistent level.
Andet: Cross-over
Following completion of the 6-month follow-up sessions after completion of "Brain Training", each group is allowed to cross-over to the other arm of "Brain Training" (open-label extension).
Adfærdsmæssigt: Brain Training (Active or Passive)
Online computer games targeting attention, EF, and problem-solving either match the child's level or are set to a consistent level depending on which version the child has already completed.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline on Executive Function Composite Measure at 2 months
Tidsramme: 2 months
EF composite measured post "Brain Training."
2 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline on Executive Function Composite Measure at 5 months
Tidsramme: 5 months
EF composite measured 3-months post "Brain Training" and 5 months from baseline
5 months
Change from baseline on Executive Function Composite Measure at 8 months
Tidsramme: 8 months
EF composite measured 6-months post "Brain Training" and 8 months from baseline
8 months
Change from baseline on Early Academic Skills Measures at 8 months
Tidsramme: 8 months
Composite scores from standardized measures of pre-academic skills and early literacy and numeracy measures at 6-months post "Brain Training" and 8 months from baseline
8 months
Change from 8-month Executive Function Composite Measure at 10 months (cross over groups)
Tidsramme: 2 months
Children who cross-over to the other "Brain Training" intervention arm after the 8 month follow-up visit, will be re-assessed at the completion of the alternate version of "Brain Training"
2 months

Samarbejdspartnere og efterforskere

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

Sponsor

Stanford University

Samarbejdspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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. oktober 2015

Primær færdiggørelse (Faktiske)

1. december 2018

Studieafslutning (Faktiske)

30. december 2018

Datoer for studieregistrering

Først indsendt

26. oktober 2015

Først indsendt, der opfyldte QC-kriterier

26. oktober 2015

Først opslået (Skøn)

27. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 30874
  • K23HD071971 (U.S. NIH-bevilling/kontrakt)

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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