Condition category
Mental and Behavioural Disorders
Date applied
09/04/2013
Date assigned
17/04/2013
Last edited
30/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24124503
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24352414

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes