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CompletedNCT02459873Updated Apr 18, 2017

Modeling and Testing Change in Mental Abilities in Childhood

An interventional study of Computer games to assess change in executive function skills in Low Executive Function in Children, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 84 Months to 132 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-18.

Sponsored by University of Southern California · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
84 Months to 132 Months
Sex
All
01

Study summary

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.

02

Conditions studied

  • Low Executive Function in Children
03

In context

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
84 Months to 132 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Understands and speaks English

Exclusion criteria

Exclusion Criteria:

  • Diagnosed psychological disorder
  • Head trauma with loss of consciousness of >5 minutes
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Computer games to assess change in executive function skills

    Children in Intervention group get to train using executive function games at more difficult levels.

    Behavioral: Computer games to assess change in executive function skills

  • Active comparator
    Easy games as active comparators for executive function skills

    Children in Non-intervention group get to play executive function games at an easy level.

    Behavioral: Computer games to assess change in executive function skills

Interventions

  • BehavioralComputer games to assess change in executive function skills

    Children get access to computer games for 10 weeks for an hour each week.

    Also known as: Difficult / Easy games

06

What researchers measure

Primary outcomes

  1. Change in working memory skills assessed through Executive Function Battery and NIH ToolBox

    Children will be assessed both on Executive Function Battery and the NIH Toolbox battery to examine change in working memory skills.

    Time frame: 3 months

  2. Change in processing speed skills assessed through Executive Function Battery and NIH ToolBox

    Children will be assessed both on Executive Function Battery and the NIH Toolbox battery to examine change in processing speed skills.

    Time frame: 3 months

Secondary outcomes

  1. Change in school grades in science, reading and math.

    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

    Time frame: 3-6 months

  2. Change in parent reported behavior as assessed through BRIEF and CBCL questionnaires

    Parental reports on BRIEF (Behavior Rating Inventory of Executive Function) and CBCL (Child Behavior Checklist) questionnaires will be used to assess change in behavior

    Time frame: 3-6 months

07

Study locations

1 site
  • University of Southern California
    Los Angeles, California 90089, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02459873
Lead sponsor
University of Southern California
Responsible party
Sponsor
First posted
Jun 2, 2015
Start date
Jun 2015
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016
Last update
Apr 18, 2017

Study contacts

Prapti Gautam, PhD
principal investigator · University of Southern California

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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