Cognitive Training in Children With Attention Deficit/ Hyperactivity Disorder (ADHD)

NCT01752530 | Completed

• 1 other identifier: S-20120096
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine the effect of computer program C8 on specific cognitive functions, symptoms and functional outcome compared to treatment as usual in children with ADHD. Furthermore, if the effect is sustained 12 and 24 weeks after training. In addition, it will be investigated, whether younger children benefit more from training than older children.

Conditions

ADHD

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing probability of hit.

  Assesment after the 8 week intervention

Secondary Outcomes (4)

• Behavior Rating Inventory of Executive Functions (BRIEF)

  After the 8 week intervention

• ADHD-Rating scale

  After the 8 week intervention

• CANTAB: Attention Switching Task (AST)

  After the 8 week intervention

• Cambridge Neuropsychological Test Automated Battery (CANTAB): Rapid Visual Information Processing

  After 8 weeks of intervention

Other Outcomes (25)

• CANTAB: Match to sample: visual search.

  After 8 weeks of intervention

• CANTAB: Choice reaction time.

  After 8 weeks of intervention

• CANTAB: Stop Signal Task.

  After 8 weeks of intervention

Study Arms (2)

Computer program C8 + treatment as usual

EXPERIMENTAL

Computer program C 8 + treatment as usual. Subjects in the intervention group will be playing a special computer program C8 for 40 min a day, 6 times a week for 8 weeks in addition to treatment as usual.

Other: Computer program C8; Other: Treatment as usual

Treatment as usual

OTHER

Treatment as usual at the clinic

Other: Treatment as usual

Interventions

Computer program C8 OTHER

Experimental: Computer program C8 + treatment as usual: Playing a special computer program C8 40 min a day for 6 days a week for 8 weeks.

Also known as: C8, ADHD, Cognitive training

Computer program C8 + treatment as usual

Treatment as usual OTHER

Treatment as usual at the clinic

Also known as: TAU

Computer program C8 + treatment as usual; Treatment as usual

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ADHD- diagnosis
• age 6-13 years
• Patient has access to computer og internet from home
• Informed consent

You may not qualify if:

• Comorbidity: conduct disorder, autism spectrum disorders, depression, or schizophrenia
• Head trauma or neurological disease
• Intelligence quotient (IQ) \< 80
• Motoric or perceptual handicap
• Medical disease requiring treatment
• No informed consent

Sponsors & Collaborators

• Region Syddanmark: lead

Study Sites (3)

Child and Adolescent Mental Health Services Aabenraa

Aabenraa, 6200, Denmark

Location

Child and Adolescent Mental Health Services Augustenborg

Augustenborg, 6440, Denmark

Location

Child and Adolescent Mental Health Services Kolding

Kolding, 6000, Denmark

Location

Related Publications (2)

• Bikic A, Leckman JF, Christensen TO, Bilenberg N, Dalsgaard S. Attention and executive functions computer training for attention-deficit/hyperactivity disorder (ADHD): results from a randomized, controlled trial. Eur Child Adolesc Psychiatry. 2018 Dec;27(12):1563-1574. doi: 10.1007/s00787-018-1151-y. Epub 2018 Apr 11.

  PMID: 29644473 DERIVED

• Bikic A, Leckman JF, Lindschou J, Christensen TO, Dalsgaard S. Cognitive computer training in children with attention deficit hyperactivity disorder (ADHD) versus no intervention: study protocol for a randomized controlled trial. Trials. 2015 Oct 24;16:480. doi: 10.1186/s13063-015-0975-8.

  PMID: 26499057 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Training; Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Aida Bikic, Ph.D

  Child and Adolescent Mental Health Services

  PRINCIPAL INVESTIGATOR

• Søren Dalsgaard, MD, Ph.D.

  Department of Economics and Business - CIRRAU - Centre for Integrated Register-based Research, Aarhus University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: psychologist, Ph.D. student

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 19, 2012
• Study Start: February 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: September 1, 2016
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

DK (3)