Skip to content

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

Development of a Multi-faceted Cognitive Training Program for Children With ADHD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01352468
Enrollment
44
Registered
2011-05-12
Start date
2011-04-30
Completion date
2016-06-30
Last updated
2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD, cognitive training

Brief 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.

Interventions

OTHERMultifaceted cognitive training

Four computerized training tasks

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale8 weeksTotal 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.

Secondary

MeasureTime frameDescription
Reaction Time Variability on go/No-go Task8 weeksStandard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task
Proportion of Words Read Accurately Using the AIMSWEB8 weeksNumber of words read correctly divided by number of words read

Countries

United States

Participant flow

Participants by arm

ArmCount
Multifaceted Cognitive Training
Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency. Multifaceted cognitive training: Four computerized training tasks
22
Sham Cognitive Training
Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training Multifaceted cognitive training: Four computerized training tasks
22
Total44

Baseline characteristics

CharacteristicMultifaceted Cognitive TrainingSham Cognitive TrainingTotal
Age, Categorical
<=18 years
22 Participants22 Participants44 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous9.05 years
STANDARD_DEVIATION 1.73
9.22 years
STANDARD_DEVIATION 1.65
9.14 years
STANDARD_DEVIATION 1.68
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
22 Participants21 Participants43 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants4 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
20 Participants18 Participants38 Participants
Region of Enrollment
United States
22 participants22 participants44 participants
Sex: Female, Male
Female
6 Participants4 Participants10 Participants
Sex: Female, Male
Male
16 Participants18 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 220 / 22
serious
Total, serious adverse events
0 / 220 / 22

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Multifaceted Cognitive TrainingTotal ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale25.94 units on a scaleStandard Deviation 8.95
Sham Cognitive TrainingTotal ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale28.28 units on a scaleStandard Deviation 8.21
p-value: 0.35ANCOVA
Secondary

Proportion of Words Read Accurately Using the AIMSWEB

Number of words read correctly divided by number of words read

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
Multifaceted Cognitive TrainingProportion of Words Read Accurately Using the AIMSWEB.98 proportion of words read accuratelyStandard Deviation 0.01
Sham Cognitive TrainingProportion of Words Read Accurately Using the AIMSWEB.98 proportion of words read accuratelyStandard Deviation 0.02
p-value: 0.57ANCOVA
Secondary

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

Population: Go/No-Go task data was not available for one participant in the Sham Cognitive Training condition

ArmMeasureValue (MEAN)Dispersion
Multifaceted Cognitive TrainingReaction Time Variability on go/No-go Task182.51 millisecondsStandard Deviation 96.12
Sham Cognitive TrainingReaction Time Variability on go/No-go Task160.25 millisecondsStandard Deviation 95.82
p-value: 0.68ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026