Plain English Summary
Background and study aims
The objective of the study is to comprehensively evaluate the near and far-transfer short and long-term effects of computerized working memory training. Near-transfer effects refer to a gain in skill within the same training context, whereas far-transfer effects refer to learning that is transferable to other training contexts. Proponents of computerized working memory training propose that PC-based training programs can be used as an alternative to medication to improve cognitive performance and behaviour. This is a very controversial proposition, with inconsistent support in existing research.
Who can participate?
The candidates for participation are children in the age range of 10-12 years previously diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD).
What does the study involve?
A total of between 70-80 children will be randomly allocated to one of two groups: a control and a training group. They will be assessed extensively with questionnaires and neuropsychological tests before, after and six months after the testing. By comparing the results on the various measures of the training group with that of the control group, the aim is to investigate whether the training has resulted in any effect.
What are the possible benefits and risks of participating?
The study does not involve any danger for the participants, and any participants who are allocated to the control group will have the opportunity to participate in the training program after the end of the study period. All of the children in the study will also be followed up in a regular way by child health specialist services during the course of the study.
Where is the study run from?
Telemark and Vestfold hospitals (Norway).
When is the study starting and how long is it expected to run for?
The study ran between August 2008 and December 2010.
Who is funding the study?
The study was funded with grants from the Centre for Child and Adolescent Mental Health, Eastern & Southern Norway and from the Nowregian Resource Center for ADHD, Tourette and Narcolepsy.
Who is the main contact?
Professor Jens Egeland
jens.egeland@siv.no
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jens Egeland
ORCID ID
Contact details
Boks 2267
Tønsberg
3103
Norway
+47 - 33 31 80 26
jens.egeland@siv.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2009/252
Study information
Scientific title
Near and far-transfer effects of Working Memory training in ADHD: a randomized study
Acronym
Study hypothesis
Various studies indicate that daily training sessions using PC-based programs lasting five weeks may improve working memory for persons diagnosed with Attention Deficit/Hyperactivity Disorder (AD/HD). In this collaborative project between the child psychiatric health services in Vestfold and Telemark, the short-term and long-term effects of training 10- and 11-year-old children diagnosed with AD/HD will be investigated.
The study will test the hypothesis that a five-week computerized working memory program will lead to improvements in performance on neuropsychological tasks and improvements in behaviour as rated by the children's parents and teachers.
Ethics approval
The study was approved by the Regional Committee for Medical and Health Research Ethics (REK sør-øst) in Norway. Ref. no. 2009/252. Approval was issued on 18.06.2009, with Project start: 01.08.2009 and Project end: 31.12.2010.
The regional ethics committee (there are four of them in Norway) serves the same purpose as an international registry in that all projects that are accepted by one of the committees are listed on their homepage and publicly accessible. The text is in Norwegian (a translation may be provided on request). The web-address where information about the study and details about the approval prior to inclusion of participants is published at the following: https://helseforskning.etikkom.no/ikbViewer/page/prosjekterirek/prosjektregister?_ikbLanguageCode=us&p_dim=34977&9F508B87E7D8620DE040F28156A418DC.p_search_id=26503
Study design
Randomized study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Attention Deficit/Hyperactivity Disorder
Intervention
The study will take place at two hospitals - Telemark and Vestfold hospitals.
The participants will be assessed with various questionnaires, as well as neuropsychological testing before, after and a half year after completing the training.
Participants meeting the inclusion criteria will be randomized into an experimental group (5-week PC-based working memory training program) or a comparable control group receiving treatment as usual. Both groups will continue receiving their pre-existing school and health care follow up, which may include medication. Participants will be tested immediately before the start of the training period, immediately after, and six months later. Children assigned to the control group will be offered the opportunity to participate in the training program after completion of the study.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Neuropsychological measures: Digit span, Leiter International Performance Scale-Revised, Letter-Number Sequencing task, Sentence span task, Color Word and Trail Making (from Delis-Kaplan Executive Function System), Conners' Continuous Performance Test-II, Children's Auditory Verbal Learning Test-2, BVRT, Key Math and LOGOS.
Administered immediately before the 5-week training program , after the training program and six months later.
Secondary outcome measures
Parent reported behavior rating scales: ADHD-Rating Scale IV, Strengths and Difficulties Questionnaire and Behavior Rating Inventory of Executive Function.
Administered immediately before the 5-week training program , after the training program and six months later.
Overall trial start date
01/08/2009
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Between 70-80 children aged 10-12 years will be invited to participate in the study.
2. All participants must have been previously diagnosed with F90.0 Hyperkinetic disorder (ICD-10) equivalent to the DSM-IV diagnosis of ADHD combined type and be in treatment for ADHD within the Departments for Child and Adolescent Psychiatry in Vestfold or Telemark Hospital Trusts.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
70-80
Participant exclusion criteria
1. IQ below 70 (WISC-III or WISC-IV), or
2. A comorbid diagnosis of Pervasive Developmental Disorder, Tourette's Disorder, Bipolar Disorder, Conduct Disorder or evidence of psychosis
Recruitment start date
01/08/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Norway
Trial participating centre
Boks 2267
Tønsberg
3103
Norway
Sponsor information
Organisation
Vestfold Hospital Trust (Norway)
Sponsor details
Attn. Jens Egeland
Research Department
Boks 2267
Tønsberg
3103
Norway
+47 - 33 31 80 26
jens.egeland@siv.no
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Centre for Child and Adolescent Mental Health, Eastern & Southern Norway
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Norwegian Resource Center for ADHD, Tourette and Narcolepsy
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24124503
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24352414
Publication citations
-
Results
Egeland J, Aarlien AK, Saunes BK, Few effects of far transfer of working memory training in ADHD: a randomized controlled trial., PLoS ONE, 2013, 8, 10, e75660, doi: 10.1371/journal.pone.0075660.
-
Results
Hovik KT, Saunes BK, Aarlien AK, Egeland J, RCT of working memory training in ADHD: long-term near-transfer effects., PLoS ONE, 2013, 8, 12, e80561, doi: 10.1371/journal.pone.0080561.