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Modeling and Testing Change in Mental Abilities in Childhood

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ClinicalTrials.gov Identifier: NCT02459873
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
University of Southern California

Brief 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.


Condition or disease Intervention/treatment Phase
Low Executive Function in Children Behavioral: Computer games to assess change in executive function skills Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Modeling and Testing Change in Mental Abilities in Childhood Through Computer-based Interventions
Study Start Date : June 2015
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : August 31, 2016

Arm Intervention/treatment
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
Children get access to computer games for 10 weeks for an hour each week.
Other Name: Difficult / Easy games

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
Children get access to computer games for 10 weeks for an hour each week.
Other Name: Difficult / Easy games




Primary Outcome Measures :
  1. Change in working memory skills assessed through Executive Function Battery and NIH ToolBox [ Time Frame: 3 months ]
    Children will be assessed both on Executive Function Battery and the NIH Toolbox battery to examine change in working memory skills.

  2. Change in processing speed skills assessed through Executive Function Battery and NIH ToolBox [ Time Frame: 3 months ]
    Children will be assessed both on Executive Function Battery and the NIH Toolbox battery to examine change in processing speed skills.


Secondary Outcome Measures :
  1. Change in school grades in science, reading and math. [ Time Frame: 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

  2. Change in parent reported behavior as assessed through BRIEF and CBCL questionnaires [ Time Frame: 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



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Ages Eligible for Study:   84 Months to 132 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Understands and speaks English

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459873


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Prapti Gautam, PhD University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02459873     History of Changes
Other Study ID Numbers: 15-01767
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017