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

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT01352468
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 44
• Location: 1
• Arms: 2
• Duration (Months): 62
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Other: Multifaceted cognitive training	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Development of a Multi-faceted Cognitive Training Program for Children With ADHD
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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; Four computerized training tasks
Sham Comparator: Sham Cognitive Training Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training	Other: Multifaceted cognitive training; Four computerized training tasks

Outcome Measures

Primary Outcome Measures

1. Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale [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.

Secondary Outcome Measures

1. Reaction Time Variability on go/No-go Task [8 weeks]

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

2. Proportion of Words Read Accurately Using the AIMSWEB [8 weeks]

   Number of words read correctly divided by number of words read

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 12 Years
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Jeffery N Epstein, Ph.D., Cincinnati Childrens Hospital Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT01352468
• Other Study ID Numbers: R33MH085842; R21MH085842
• First Posted: May 12, 2011
• Last Update Posted: Aug 1, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by Children's Hospital Medical Center, Cincinnati: ADHD; cognitive training
• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity

Study Results

Participant Flow

Arm/Group Title	Multifaceted Cognitive Training	Sham Cognitive Training
Arm/Group Description	Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency. Multifaceted cognitive training: Four computerized training tasks	Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training Multifaceted cognitive training: Four computerized training tasks
Period Title: Overall Study
STARTED	22	22
COMPLETED	17	18
NOT COMPLETED	5	4

Baseline Characteristics

Arm/Group Title	Multifaceted Cognitive Training	Sham Cognitive Training	Total
Arm/Group Description	Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency. Multifaceted cognitive training: Four computerized training tasks	Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training Multifaceted cognitive training: Four computerized training tasks	Total of all reporting groups
Overall Participants	22	22	44
Age (Count of Participants)
<=18 years	22 100%	22 100%	44 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	9.05 (1.73)	9.22 (1.65)	9.14 (1.68)
Sex: Female, Male (Count of Participants)
Female	6 27.3%	4 18.2%	10 22.7%
Male	16 72.7%	18 81.8%	34 77.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 4.5%	1 2.3%
Not Hispanic or Latino	22 100%	21 95.5%	43 97.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	1 4.5%	0 0%	1 2.3%
Black or African American	1 4.5%	4 18.2%	5 11.4%
White	20 90.9%	18 81.8%	38 86.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	22 100%	22 100%	44 100%

Outcome Measures

1. Primary Outcome

Title	Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Multifaceted Cognitive Training	Sham Cognitive Training
Arm/Group Description	Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency. Multifaceted cognitive training: Four computerized training tasks	Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training Multifaceted cognitive training: Four computerized training tasks
Measure Participants	17	18
Mean (Standard Deviation) [units on a scale]	25.94 (8.95)	28.28 (8.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Multifaceted Cognitive Training, Sham Cognitive Training
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.35
	Comments
	Method	ANCOVA
	Comments	Controlling for baseline scores

2. Secondary Outcome

Title	Reaction Time Variability on go/No-go Task
Description	Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Multifaceted Cognitive Training	Sham Cognitive Training
Arm/Group Description	Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency. Multifaceted cognitive training: Four computerized training tasks	Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training Multifaceted cognitive training: Four computerized training tasks
Measure Participants	17	17
Mean (Standard Deviation) [milliseconds]	182.51 (96.12)	160.25 (95.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Multifaceted Cognitive Training, Sham Cognitive Training
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.68
	Comments
	Method	ANCOVA
	Comments	Controlling for baseline scores

3. Secondary Outcome

Title	Proportion of Words Read Accurately Using the AIMSWEB
Description	Number of words read correctly divided by number of words read
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Multifaceted Cognitive Training	Sham Cognitive Training
Arm/Group Description	Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency. Multifaceted cognitive training: Four computerized training tasks	Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training Multifaceted cognitive training: Four computerized training tasks
Measure Participants	17	18
Mean (Standard Deviation) [proportion of words read accurately]	.98 (.01)	.98 (.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Multifaceted Cognitive Training, Sham Cognitive Training
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.57
	Comments
	Method	ANCOVA
	Comments	Controlling for baseline scores

Adverse Events

Arm/Group Title	Multifaceted Cognitive Training		Sham Cognitive Training
Arm/Group Description	Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency. Multifaceted cognitive training: Four computerized training tasks		Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training Multifaceted cognitive training: Four computerized training tasks
All Cause Mortality
	Multifaceted Cognitive Training		Sham Cognitive Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Multifaceted Cognitive Training		Sham Cognitive Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Multifaceted Cognitive Training		Sham Cognitive Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.