Attention Deficit Hyperactivity DisorderNCT01133418
Cognitive Training Trial
A study testing Computerized Progressive Attention Training in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Currently, only two treatment modalities for pediatric attention deficit hyperactivity disorder (ADHD) are considered evidence-based: (1) pharmacological and (2) behavioral treatment. Recently, several studies have shown promising results suggesting efficacy for cognitive training interventions for children with ADHD. 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?
- Computerized Progressive Attention Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 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 Abbreviated Scale of Intelligence.
- Learning Disability: Children must score above 75 on all three of the Wechsler Individual Achievement Test (WIAT) subtests (Reading, Spelling, Numerical Operations).
- School: Children must be enrolled in a school setting from which teacher ratings can be obtained.
Who cannot join
- Understanding Level. The patient and parent cannot understand or follow instructions given in the study.
- History of Psychiatric Medications: Children must not have taken psychiatric medications within the past month. In addition, the family must indicate that they do not plan on placing their child on medication for any psychiatric condition during the course of 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. A pervasive developmental delay will be defined as a T score above 65 on the Autism Composite Scale of the PDD Behavior Inventory.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for ADHD, Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Efficacy of a Cognitive Training Intervention for Children With ADHD
Currently, only two treatment modalities for pediatric attention deficit hyperactivity disorder (ADHD) are considered evidence-based: (1) pharmacological and (2) behavioral treatment. Recently, several studies have shown promising results suggesting efficacy for cognitive training interventions for children with ADHD. These interventions directly train cognitive function (i.e., attention, working memory) by having children practice cognitive skills using computerized tasks. In these studies, improvements related to the cognitive training intervention have been documented on neuropsychological tests, academic tasks, and parent ratings of children's ADHD behavior. Given the ubiquitous finding of increased reaction time (RT) variability among children with ADHD, the candidate worked with a group of developers to modify a cognitive training intervention to target RT variability. That is, train the children to be less variable in their responding. Initial clinical data from this intervention suggest that intervention exposure improves behavioral outcomes. However, an appropriate powered randomized clinical trial is necessary to experimentally demonstrate intervention efficacy.Sixty-four (64) children diagnosed with ADHD (either Predominantly Inattentive Type or Combined Type) will be randomly assigned to intervention or control conditions. Children in the intervention group will receive 8 weeks of the Computerized Progressive Attention Training (CPAT) intervention. Children in the control group will receive the CPAT intervention but there will be no progression in difficulty based on performance as in the intervention group. Children in both groups will be assessed pre-intervention and immediately after the 8-week training on neuropsychological, behavioral, and academic outcome measures. Hypothesis-driven data analyses will assess intervention efficacy.
Hypothesis #1: Children in the experimental group exposed to the CPAT intervention will show greater improvement from pre- to post-intervention on neuropsychological tests compared to children in the control group.
Read more
Hypothesis #2: Children in the experimental group exposed to the CPAT intervention will show greater improvement from pre- to post-intervention on parent and teacher behavioral ratings of ADHD behavior compared to children in the control group.
Hypothesis #3: Children in the experimental group exposed to the CPAT intervention will show greater improvement from pre- to post-intervention on academic outcomes compared to children in the control group.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Computerized Progressive Attention Training, Sham Comparator 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.
Computerized Progressive Attention TrainingOther
Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability
Sham Comparator Cognitive TrainingOther
Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Computerized Progressive Attention Training Receives: Other: Computerized Progressive Attention Training |
| Non-progressive cognitive training | Sham comparator | Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance. Receives: Other: Sham Comparator 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: 2 months
Clinical Global Impression - Improvement
Blinded ratings of clinical global impression - Improvement. Scale = 1 (Very Much Improved) - 7 (Very Much Worse) Lower scores represent more improvement.
Measured: 2 months
Secondary outcomes (2)
Intra-individual Variability on Go/No-Go Task
Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task
Measured: 2 months
Academic Improvement Measurement System - Web-based (AIMSWEB) Reading Score (Proportion Accurate)
Number of words read correctly divided by number of words read (range = 0-1.0) Higher values represent better reading accuracy
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2014
- 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Jeff Epstein, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133418
- Sponsor's protocol ID
- K24MH064478
- Status last verified
- Apr 2017
- First submitted
- 17 May 2010
- Last updated
- 30 May 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 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Cognitive Training Intervention for Children With ADHD
- ClinicalTrials.gov ID
- NCT01133418
- Acronym / sponsor ID
- K24MH064478
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Posted 1 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, only two treatment modalities for pediatric attention deficit hyperactivity disorder (ADHD) are considered evidence-based: (1) pharmacological and (2) behavioral treatment. Recently, several studies have shown promising results suggesting efficacy for cognitive training interventions for children with ADHD. These interventions directly train cognitive function (i.e., attention, working memory) by having children practice cognitive skills using computerized tasks. In these studies, improvements related to the cognitive training intervention have been documented on neuropsychological tests, academic tasks, and parent ratings of children's ADHD behavior. Given the ubiquitous finding of increased reaction time (RT) variability among children with ADHD, the candidate worked with a group of developers to modify a cognitive training intervention to target RT variability. That is, train the children to be less variable in their responding. Initial clinical data from this intervention suggest that intervention exposure improves behavioral outcomes. However, an appropriate powered randomized clinical trial is necessary to experimentally demonstrate intervention efficacy.Sixty-four (64) children diagnosed with ADHD (either Predominantly Inattentive Type or Combined Type) will be randomly assigned to intervention or control conditions. Children in the intervention group will receive 8 weeks of the Computerized Progressive Attention Training (CPAT) intervention. Children in the control group will receive the CPAT intervention but there will be no progression in difficulty based on performance as in the intervention group. Children in both groups will be assessed pre-intervention and immediately after the 8-week training on neuropsychological, behavioral, and academic outcome measures. Hypothesis-driven data analyses will assess intervention efficacy.
Hypothesis #1: Children in the experimental group exposed to the CPAT intervention will show greater improvement from pre- to post-intervention on neuropsychological tests compared to children in the control group.
Hypothesis #2: Children in the experimental group exposed to the CPAT intervention will show greater improvement from pre- to post-intervention on parent and teacher behavioral ratings of ADHD behavior compared to children in the control group.
Hypothesis #3: Children in the experimental group exposed to the CPAT intervention will show greater improvement from pre- to post-intervention on academic outcomes compared to children in the control group.
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 |
|---|---|---|
| Cognitive Training | Experimental | Other: Computerized Progressive Attention TrainingComputerized Progressive Attention Training |
| Non-progressive cognitive training | Sham comparator | Other: Sham Comparator Cognitive TrainingChildren in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 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 Abbreviated Scale of Intelligence.
Key exclusion criteria (4 listed)
- Understanding Level. The patient and parent cannot understand or follow instructions given in the study.
- History of Psychiatric Medications: Children must not have taken psychiatric medications within the past month. In addition, the family must indicate that they do not plan on placing their child on medication for any psychiatric condition during the course of 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. A pervasive developmental delay will be defined as a T score above 65 on the Autism Composite Scale of the PDD Behavior Inventory.
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 |
|---|---|---|
| Computerized Progressive Attention TrainingFour comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability | Other | Cognitive Training |
| Sham Comparator Cognitive TrainingSame tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty | Other | Non-progressive cognitive training |
Primary outcome
Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale
Time frame: 2 months
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.
Clinical Global Impression - Improvement
Time frame: 2 months
Blinded ratings of clinical global impression - Improvement. Scale = 1 (Very Much Improved) - 7 (Very Much Worse) Lower scores represent more improvement.
2 secondary outcomes
Intra-individual Variability on Go/No-Go Task
Time frame: 2 months
Academic Improvement Measurement System - Web-based (AIMSWEB) Reading Score (Proportion Accurate)
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Progressive Attention 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 7 inclusion and 4 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 30 May 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 May 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: 2 months). The study lists 2 primary outcomes in all. 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 30 May 2017.