Clinical trial NCT02459873: Modeling and Testing Change in Mental Abilities in Childhood
Official title: Modeling and Testing Change in Mental Abilities in Childhood Through Computer-based Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Executive Function in Children
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 20
Sex: ALL
Minimum age (years): 84
Maximum age (years): 132
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* Understands and speaks English

Exclusion Criteria:

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

Primary outcomes:
measure: Change in working memory skills assessed through Executive Function Battery and NIH ToolBox
timeFrame: 3 months
measure: Change in processing speed skills assessed through Executive Function Battery and NIH ToolBox
timeFrame: 3 months
Secondary outcomes:
measure: Change in school grades in science, reading and math.
timeFrame: 3-6 months
measure: Change in parent reported behavior as assessed through BRIEF and CBCL questionnaires
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Prapti Gautam, PhD
role: PRINCIPAL_INVESTIGATOR
References: