Computerized Working Memory Training in Very-low-birth-weight Children at Preschool Age
Primary Purpose
Infant, Very Low Birth Weight
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cogmed JM working memory training
Cogmed JM working memory training after waiting
Sponsored by
About this trial
This is an interventional treatment trial for Infant, Very Low Birth Weight focused on measuring working memory training, computerized, clinical assessment, quantitative EEG, child, preschool
Eligibility Criteria
Inclusion Criteria:
- VLBW (birth weight ≤ 1500 grams)
- preschool child
- born at St. Olav's University Hospital in Trondheim in 2005 and 2006
Exclusion Criteria:
- birth weight >1500 grams
- diagnosed genetic syndromes
- severe cerebral palsy with totally impaired bilateral hand function (GMFCS - gross motor function classification scale level V)
- blindness
Sites / Locations
- St Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
working memory training
delayed working memory training
Arm Description
Cogmed JM working memory training
Cogmed JM working memory training after 8 weeks waiting
Outcomes
Primary Outcome Measures
working memory capacity
Automated Working Memory Assessment (AWMA)(visual working memory); digit span (from WISC-IV); Repetition of scentences (from NEPSY battery); Remembering and oral story (from NEPSY battery); Remembering faces (from NEPSY battery)
Secondary Outcome Measures
behavioral function
Vineland adaptive behaviour scales (survey form)
executive function
The ADHD Rating Scale-IV (parents report)
anxiety as judged by parents
The Screen for Child Anxiety Related Emotional Disorders (SCARED- parent report); Preschool Anxiety Scale (parent report)
Full Information
NCT ID
NCT01518452
First Posted
January 10, 2012
Last Updated
June 13, 2017
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT01518452
Brief Title
Computerized Working Memory Training in Very-low-birth-weight Children at Preschool Age
Official Title
Computerized Working Memory Training Evaluated With Clinical Assessments and Quantitative EEG in Very-low-birth-weight (VLBW) Children at Preschool Age
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main aim of this prospective interventional study is to compare quantitative EEG findings and cognitive and neuropsychological test results before and after training with the Cogmed JM program in a group of very-low-birth-weight children in preschool age, i.e. ages 5-6 years. The investigators hypothesize that the children in the study may respond positively to the computerized training and improve working memory, but probably to different degrees depending on the underlying neurological condition. The investigators also hypothesize that training may benefit additional executive functions.
Detailed Description
Children born preterm are at increased risk of neurological disabilities due to perinatal brain damage. During the last ten years an increasing number of especially extremely low birth weight (ELBW: BW ≤ 1000g) children has survived, and one might wonder whether this has lead to increased amount of brain pathology and impairments among survivors. Major impairments including cerebral palsy, mental retardation and impaired vision and hearing are most common in children born extremely preterm (gestational age below 28 weeks). In addition to this, a large part of survivors after preterm birth will experience motor problems, cognitive dysfunctions, psychiatric and behavioural problems of varying severity.
In our previous research we have found significant deficits in working memory in very preterm born children, and this seems to have a strong influence on cognitive functioning. During the last years, several studies have shown that working memory skills can be trained, and training working memory to improve cognition and executive functions is regarded as one of the major steps forward in neuroscience in recent years.
The working memory training program version for preschoolers, Cogmed JM, has recently been launched. Healthy preschoolers trained on working memory improved significantly on trained tasks but also on non-trained tests of spatial and verbal working memory, as well as transfer effects on attention. The preschool version of the program has not yet been administered to preterm born or other neurologic high risk children in this age group.
The main aim of this prospective interventional study is to compare quantitative EEG findings and cognitive and neuropsychological test results before and after training with the Cogmed JM program in a group of very-low-birth-weight children in preschool age, i.e. ages 5-6 years. We hypothesise that the children in the study may respond positively to the computerized training and improve working memory, but probably to different degrees depending on the underlying neurological condition. We also hypothesise that training may benefit additional executive functions.
The children in the study will be divided into two subgroups (15/15 children). Subgroup A will start training, while subgroup B waits during this first training period. Subgroup B will therefore act as a control group. After 8 weeks subgroup B will then start training. This is in agreement with the so-called Stepped Wedge design (Brown and Lilford 2006).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Very Low Birth Weight
Keywords
working memory training, computerized, clinical assessment, quantitative EEG, child, preschool
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
working memory training
Arm Type
Experimental
Arm Description
Cogmed JM working memory training
Arm Title
delayed working memory training
Arm Type
Experimental
Arm Description
Cogmed JM working memory training after 8 weeks waiting
Intervention Type
Behavioral
Intervention Name(s)
Cogmed JM working memory training
Intervention Description
daily training for 5 weeks on a computerized program for training working memory; a total of 25 training sessions. Program: Cogmed JM - preschool version of program: 15-20 minutes training per day
Intervention Type
Behavioral
Intervention Name(s)
Cogmed JM working memory training after waiting
Intervention Description
Waiting after baseline testing for 8 weeks. Daily training on a computerized program for training working memory for 5 weeks. 25 training sessions in total. Program: Cogmed JM - preschool version of program: 15-20 minutes training per day
Primary Outcome Measure Information:
Title
working memory capacity
Description
Automated Working Memory Assessment (AWMA)(visual working memory); digit span (from WISC-IV); Repetition of scentences (from NEPSY battery); Remembering and oral story (from NEPSY battery); Remembering faces (from NEPSY battery)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
behavioral function
Description
Vineland adaptive behaviour scales (survey form)
Time Frame
6 months
Title
executive function
Description
The ADHD Rating Scale-IV (parents report)
Time Frame
6 months
Title
anxiety as judged by parents
Description
The Screen for Child Anxiety Related Emotional Disorders (SCARED- parent report); Preschool Anxiety Scale (parent report)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
VLBW (birth weight ≤ 1500 grams)
preschool child
born at St. Olav's University Hospital in Trondheim in 2005 and 2006
Exclusion Criteria:
birth weight >1500 grams
diagnosed genetic syndromes
severe cerebral palsy with totally impaired bilateral hand function (GMFCS - gross motor function classification scale level V)
blindness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Skranes, PhD prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
23400616
Citation
Grunewaldt KH, Lohaugen GC, Austeng D, Brubakk AM, Skranes J. Working memory training improves cognitive function in VLBW preschoolers. Pediatrics. 2013 Mar;131(3):e747-54. doi: 10.1542/peds.2012-1965. Epub 2013 Feb 11.
Results Reference
result
PubMed Identifier
26140426
Citation
Grunewaldt KH, Skranes J, Brubakk AM, Lahaugen GC. Computerized working memory training has positive long-term effect in very low birthweight preschool children. Dev Med Child Neurol. 2016 Feb;58(2):195-201. doi: 10.1111/dmcn.12841. Epub 2015 Jul 3.
Results Reference
result
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Computerized Working Memory Training in Very-low-birth-weight Children at Preschool Age
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