Computerized Working Memory Training in Very-low-birth-weight Children at Preschool Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01518452
First received: January 10, 2012
Last updated: February 27, 2014
Last verified: February 2014

January 10, 2012
February 27, 2014
April 2011
June 2012   (final data collection date for primary outcome measure)
working memory capacity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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)
Same as current
Complete list of historical versions of study NCT01518452 on ClinicalTrials.gov Archive Site
  • behavioral function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Vineland adaptive behaviour scales (survey form)
  • executive function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The ADHD Rating Scale-IV (parents report)
  • anxiety as judged by parents [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The Screen for Child Anxiety Related Emotional Disorders (SCARED- parent report); Preschool Anxiety Scale (parent report)
Same as current
Not Provided
Not Provided
 
Computerized Working Memory Training in Very-low-birth-weight Children at Preschool Age
Computerized Working Memory Training Evaluated With Clinical Assessments and Quantitative EEG in Very-low-birth-weight (VLBW) Children at Preschool Age

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Infant, Very Low Birth Weight
  • Behavioral: Cogmed JM working memory training
    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
  • Behavioral: Cogmed JM working memory training after waiting
    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
  • Experimental: working memory training
    Cogmed JM working memory training
    Intervention: Behavioral: Cogmed JM working memory training
  • Experimental: delayed working memory training
    Cogmed JM working memory training after 8 weeks waiting
    Intervention: Behavioral: Cogmed JM working memory training after waiting
Grunewaldt KH, Løhaugen 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
4 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01518452
2011/532
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
Not Provided
Study Director: Jon Skranes, PhD prof Norwegian University of Science and Technology
Norwegian University of Science and Technology
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP