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CompletedNCT01352468Updated Aug 1, 2017Results posted

Development of a Multi-faceted Cognitive Training Program for Children With Attention Deficit Hyperactivity Disorder (ADHD)

An interventional study of Multifaceted cognitive training in Attention Deficit Hyperactivity Disorder, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2017-08-01.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
7 Years to 12 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder

Keywords

  • ADHD
  • cognitive training
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 44 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Multifaceted Cognitive Training

    Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.

    Other: Multifaceted cognitive training

  • Sham comparator
    Sham Cognitive Training

    Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training

    Other: Multifaceted cognitive training

Interventions

  • OtherMultifaceted cognitive training

    Four computerized training tasks

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. 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

    Time frame: 8 weeks

  2. Proportion of Words Read Accurately Using the AIMSWEB

    Number of words read correctly divided by number of words read

    Time frame: 8 weeks

07

Results

Posted Aug 1, 2017

Participant flow

Participant flow — Overall Study
MilestoneMultifaceted Cognitive TrainingSham Cognitive Training
Started2222
Completed1718
Not completed54

Outcome measures

PrimaryTotal 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.

Time frame:
8 weeks
Reported as:
Mean · units on a scale
Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale
units on a scaleMultifaceted Cognitive TrainingSham Cognitive Training
Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale25.94 ± 8.9528.28 ± 8.21
Statistical analysis
  • Multifaceted Cognitive Training vs Sham Cognitive Training · ANCOVA · p = .35Controlling for baseline scores
SecondaryReaction Time Variability on go/No-go Task

Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task

Time frame:
8 weeks
Reported as:
Mean · milliseconds
Reaction Time Variability on go/No-go Task
millisecondsMultifaceted Cognitive TrainingSham Cognitive Training
Reaction Time Variability on go/No-go Task182.51 ± 96.12160.25 ± 95.82
Statistical analysis
  • Multifaceted Cognitive Training vs Sham Cognitive Training · ANCOVA · p = .68Controlling for baseline scores
SecondaryProportion of Words Read Accurately Using the AIMSWEB

Number of words read correctly divided by number of words read

Time frame:
8 weeks
Reported as:
Mean · proportion of words read accurately
Proportion of Words Read Accurately Using the AIMSWEB
proportion of words read accuratelyMultifaceted Cognitive TrainingSham Cognitive Training
Proportion of Words Read Accurately Using the AIMSWEB.98 ± .01.98 ± .02
Statistical analysis
  • Multifaceted Cognitive Training vs Sham Cognitive Training · ANCOVA · p = .57Controlling for baseline scores

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Multifaceted Cognitive Training—0/22 (0%)0/22 (0%)
Sham Cognitive Training—0/22 (0%)0/22 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Multifaceted Cognitive TrainingSham Cognitive TrainingTotal
<=18 years222244
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(years)Multifaceted Cognitive TrainingSham Cognitive TrainingTotal
Mean9.05 ± 1.739.22 ± 1.659.14 ± 1.68
Sex: Female, Male
Sex: Female, Male(Participants)Multifaceted Cognitive TrainingSham Cognitive TrainingTotal
Female6410
Male161834
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Multifaceted Cognitive TrainingSham Cognitive TrainingTotal
Hispanic or Latino011
Not Hispanic or Latino222143
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Multifaceted Cognitive TrainingSham Cognitive TrainingTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander101
Black or African American145
White201838
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Multifaceted Cognitive TrainingSham Cognitive TrainingTotal
United States222244
08

Study locations

1 site
  • Cincinnati Childrens Hospital Medical Center
    Cincinnati, Ohio 45229, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01352468
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
May 12, 2011
Start date
Apr 2011
Primary completion
Dec 2013
Completion
Jun 2016
Results posted
Aug 1, 2017
Last update
Aug 1, 2017

Study contacts

Jeffery N Epstein, Ph.D.
principal investigator · Cincinnati Childrens Hospital Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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