Attention Deficit Hyperactivity DisorderNCT01352468
Development of a Multi-faceted Cognitive Training Program for Children With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Multifaceted cognitive training in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
After decades of Attention Deficit Hyperactivity Disorder (ADHD) intervention research, only two intervention approaches (i.e., psychopharmacology, behavioral treatment) have a "well-established" evidence-base supporting their efficacy for children with ADHD. Both of these interventions have inherent limitations. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Multifaceted cognitive training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Consent: The family must provide signature of informed consent by parents or legal guardians.
- Age at time of Screening: 7 to 12 years of age, inclusive.
- Gender: includes male and female children.
- ADHD Diagnostic Status: ADHD patients must meet DSM-IV criteria for ADHD-PIT or ADHD-CT subtype. Section D.4 below describes in detail the diagnostic process for arriving at diagnosis.
- Cognitive Functioning: IQ of greater than 80 as estimated by the Wechsler Intelligence Scale for Children Fourth Edition.
- Learning Disability: Children must score 75 or above on two of the Wechsler Individual Achievement Test (WIAT) subtests (Reading \& Numerical Operations).
- School: Children must be enrolled in a school setting from which teacher ratings can be obtained.
- History of Psychiatric Medications: Children may be taking psychiatric medications. However, they must present with significant ADHD inattention symptoms while on medication in order to be included in the study. We will ask that children on ADHD medications to refrain from altering the dosage for 10 weeks from study enrollment to after the immediate post-intervention follow-up. In order to screen for possible medication adjustments, all parents will be asked during the initial phone screen if their child is on an ADHD medication and if they anticipate a change in that medication dosage. If they answer that they anticipate a dosage change, they will be excluded from the study.
Who cannot join
- Understanding Level. The patient and parent cannot understand or follow instructions given in the study.
- Exclusionary Psychiatric Conditions: Children who meet diagnostic criteria on the K-SADS for OCD, any psychotic disorder, major depressive disorder or bipolar disorder will be excluded from participation.
- Developmental Disabilities. Patients will be excluded if they are deemed to be significantly developmentally delayed or have a pervasive developmental disorder. Developmental delay will be operationally defined as an IQ score below 80. Children scoring 80 or above will be included. A semi-structured interview, the CAARTE, will be used to screen for autism.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Development of a Multi-faceted Cognitive Training Program for Children With ADHD
After decades of Attention Deficit Hyperactivity Disorder (ADHD) intervention research, only two intervention approaches (i.e., psychopharmacology, behavioral treatment) have a "well-established" evidence-base supporting their efficacy for children with ADHD. Both of these interventions have inherent limitations. Recently multiple studies have demonstrated that cognitive training may improve neuropsychological and behavioral functioning in children with ADHD. The magnitude of treatment effects for cognitive training has been comparable to treatment effects for behavioral treatment for ADHD (i.e., small to moderate effect sizes). A limitation of existing cognitive training programs that may limit their efficacy is that each has employed a unifaceted approach. Each intervention program has targeted a single cognitive domain (e.g., working memory). This is problematic since as a group, children with ADHD have multiple areas of cognitive deficit (i.e., working memory, attention, response inhibition, delay aversion, intra-individual variability) and thus a unifaceted intervention does not address the multifaceted array of cognitive dysfunction in children with ADHD. Also, because individuals with ADHD each have unique patterns of cognitive deficits, a unifaceted cognitive training approach may target areas which are non-deficient and miss areas of significant deficit in individual patients depending on their ideographic cognitive profile. The primary goal of the proposed research is to develop and test a multifaceted cognitive training intervention that addresses a comprehensive array of ADHD-related cognitive deficits thereby ensuring that children's unique areas of cognitive deficit are targeted. During Phase I (R21 grant), software and a manual will be developed consisting of four training tasks targeting response inhibition, verbal working memory, attention, and delay aversion. Each task will possess advancing levels of difficulty. On each task, children will receive feedback on performance accuracy as well as on intra-individual variability in reaction times. The software will be pilot tested in Phase I to determine performance thresholds and intervention duration. Also, focus groups will be conducted to obtain patient perceptions of each task's difficulty and interest level. In Phase II (R33 grant), a preliminary randomized clinical trial will be conducted in order to obtain initial estimates of treatment efficacy. Pre-, post-, and follow up outcomes will be collected on a wide range of neuropsychological, behavioral, and academic measures. Effect size estimates across outcomes will be used to guide sample size determinations for future clinical trials of multifaceted cognitive training.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Multifaceted cognitive training
- Keywords
- ADHD, cognitive training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted cognitive trainingOther
Four computerized training tasks
| Study group | Role | What they receive |
|---|---|---|
| Multifaceted Cognitive Training | Experimental | Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency. Receives: Other: Multifaceted cognitive training |
| Sham Cognitive Training | Sham comparator | Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training Receives: Other: Multifaceted cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale
Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0="Never"; 1="Occasionally"; 2="Often"; 3="Very often"); higher scores indicate higher severity of ADHD symptoms.
Measured: 8 weeks
Secondary outcomes (2)
Reaction Time Variability on go/No-go Task
Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task
Measured: 8 weeks
Proportion of Words Read Accurately Using the AIMSWEB
Number of words read correctly divided by number of words read
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2013
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jeffery N Epstein, Ph.D., Principal investigator, Cincinnati Childrens Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352468
- Sponsor's protocol ID
- R33MH085842
- Other IDs
- R21MH085842
- Status last verified
- Jun 2017
- First submitted
- 24 Mar 2011
- Last updated
- 1 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Multi-faceted Cognitive Training Program for Children With ADHD
- ClinicalTrials.gov ID
- NCT01352468
- Acronym / sponsor ID
- R33MH085842
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Posted 1 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After decades of Attention Deficit Hyperactivity Disorder (ADHD) intervention research, only two intervention approaches (i.e., psychopharmacology, behavioral treatment) have a "well-established" evidence-base supporting their efficacy for children with ADHD. Both of these interventions have inherent limitations. Recently multiple studies have demonstrated that cognitive training may improve neuropsychological and behavioral functioning in children with ADHD. The magnitude of treatment effects for cognitive training has been comparable to treatment effects for behavioral treatment for ADHD (i.e., small to moderate effect sizes). A limitation of existing cognitive training programs that may limit their efficacy is that each has employed a unifaceted approach. Each intervention program has targeted a single cognitive domain (e.g., working memory). This is problematic since as a group, children with ADHD have multiple areas of cognitive deficit (i.e., working memory, attention, response inhibition, delay aversion, intra-individual variability) and thus a unifaceted intervention does not address the multifaceted array of cognitive dysfunction in children with ADHD. Also, because individuals with ADHD each have unique patterns of cognitive deficits, a unifaceted cognitive training approach may target areas which are non-deficient and miss areas of significant deficit in individual patients depending on their ideographic cognitive profile. The primary goal of the proposed research is to develop and test a multifaceted cognitive training intervention that addresses a comprehensive array of ADHD-related cognitive deficits thereby ensuring that children's unique areas of cognitive deficit are targeted. During Phase I (R21 grant), software and a manual will be developed consisting of four training tasks targeting response inhibition, verbal working memory, attention, and delay aversion. Each task will possess advancing levels of difficulty. On each task, children will receive feedback on performance accuracy as well as on intra-individual variability in reaction times. The software will be pilot tested in Phase I to determine performance thresholds and intervention duration. Also, focus groups will be conducted to obtain patient perceptions of each task's difficulty and interest level. In Phase II (R33 grant), a preliminary randomized clinical trial will be conducted in order to obtain initial estimates of treatment efficacy. Pre-, post-, and follow up outcomes will be collected on a wide range of neuropsychological, behavioral, and academic measures. Effect size estimates across outcomes will be used to guide sample size determinations for future clinical trials of multifaceted cognitive training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifaceted Cognitive Training | Experimental | Other: Multifaceted cognitive trainingCognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency. |
| Sham Cognitive Training | Sham comparator | Other: Multifaceted cognitive trainingCognitive Training with 4 different tasks which does not get progressively more difficult throughout training |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Consent: The family must provide signature of informed consent by parents or legal guardians.
- Age at time of Screening: 7 to 12 years of age, inclusive.
- Gender: includes male and female children.
- ADHD Diagnostic Status: ADHD patients must meet DSM-IV criteria for ADHD-PIT or ADHD-CT subtype. Section D.4 below describes in detail the diagnostic process for arriving at diagnosis.
- Cognitive Functioning: IQ of greater than 80 as estimated by the Wechsler Intelligence Scale for Children Fourth Edition.
Key exclusion criteria (3 listed)
- Understanding Level. The patient and parent cannot understand or follow instructions given in the study.
- Exclusionary Psychiatric Conditions: Children who meet diagnostic criteria on the K-SADS for OCD, any psychotic disorder, major depressive disorder or bipolar disorder will be excluded from participation.
- Developmental Disabilities. Patients will be excluded if they are deemed to be significantly developmentally delayed or have a pervasive developmental disorder. Developmental delay will be operationally defined as an IQ score below 80. Children scoring 80 or above will be included. A semi-structured interview, the CAARTE, will be used to screen for autism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifaceted cognitive trainingFour computerized training tasks | Other | Multifaceted Cognitive Training, Sham Cognitive Training |
Primary outcome
Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale
Time frame: 8 weeks
Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0="Never"; 1="Occasionally"; 2="Often"; 3="Very often"); higher scores indicate higher severity of ADHD symptoms.
2 secondary outcomes
Reaction Time Variability on go/No-go Task
Time frame: 8 weeks
Proportion of Words Read Accurately Using the AIMSWEB
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Attention Deficit Hyperactivity Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffery N Epstein, Ph.D. principal investigator
Cincinnati Childrens Hospital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted cognitive training in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.