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

NCT ID: NCT01752530

Last Updated: 2017-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Computer program C8 + treatment as usual

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.

Group Type EXPERIMENTAL

Computer program C8

Intervention Type 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.

Treatment as usual

Intervention Type OTHER

Treatment as usual at the clinic

Treatment as usual

Treatment as usual at the clinic

Group Type OTHER

Treatment as usual

Intervention Type OTHER

Treatment as usual at the clinic

Interventions

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Computer program C8

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.

Intervention Type OTHER

Treatment as usual

Treatment as usual at the clinic

Intervention Type OTHER

Other Intervention Names

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C8 ADHD Cognitive training TAU

Eligibility Criteria

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Inclusion Criteria

1. ADHD- diagnosis
2. age 6-13 years
3. Patient has access to computer og internet from home
4. Informed consent

Exclusion Criteria

1. Comorbidity: conduct disorder, autism spectrum disorders, depression, or schizophrenia
2. Head trauma or neurological disease
3. Intelligence quotient (IQ) \< 80
4. Motoric or perceptual handicap
5. Medical disease requiring treatment
6. No informed consent
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Syddanmark

OTHER

Sponsor Role lead

Responsible Party

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Aida Bikic

psychologist, Ph.D. student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aida Bikic, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Child and Adolescent Mental Health Services

Søren Dalsgaard, MD, Ph.D.

Role: STUDY_CHAIR

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

Locations

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Child and Adolescent Mental Health Services Aabenraa

Aabenraa, , Denmark

Site Status

Child and Adolescent Mental Health Services Augustenborg

Augustenborg, , Denmark

Site Status

Child and Adolescent Mental Health Services Kolding

Kolding, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 29644473 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26499057 (View on PubMed)

Other Identifiers

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S-20120096

Identifier Type: -

Identifier Source: org_study_id

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