Modeling and Testing Change in Mental Abilities in Childhood

NCT ID: NCT02459873

Last Updated: 2017-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Executive Function in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Computer games to assess change in executive function skills

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

Group Type EXPERIMENTAL

Computer games to assess change in executive function skills

Intervention Type BEHAVIORAL

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

Easy games as active comparators for executive function skills

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

Group Type ACTIVE_COMPARATOR

Computer games to assess change in executive function skills

Intervention Type BEHAVIORAL

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

Interventions

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Computer games to assess change in executive function skills

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Difficult / Easy games

Eligibility Criteria

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Inclusion Criteria

* Understands and speaks English

Exclusion Criteria

* Diagnosed psychological disorder
* Head trauma with loss of consciousness of \>5 minutes
Minimum Eligible Age

84 Months

Maximum Eligible Age

132 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prapti Gautam, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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15-01767

Identifier Type: -

Identifier Source: org_study_id

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