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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeff Epstein, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01352468
First received: March 24, 2011
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
Other: Multifaceted cognitive training
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of a Multi-faceted Cognitive Training Program for Children With ADHD

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • ADHD ratings [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    parent and teacher ratings of ADHD symptoms


Secondary Outcome Measures:
  • Academic performance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Teacher rating of academic performance on the Academic Peformance Rating Scale

  • Stop Signal Reaction Time [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Stop signal reaction time on Stop Signal Test

  • Reaction time variability on go/no-go task [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Total score on Total Score on K-KEFS Color-Word Interference Test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • TEA-Ch Sky Search Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • TEA-CH Sky Search Dual Task Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Reaction Time variability on Child Attentional Network Task [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Working Memory Test Block Recall Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Reaction Time variability on Choice Discrimination Task [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Total score on Weschler Intelligence Scale for Children Digit Span task [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Raven's Progressive Matrices Total Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • AIMSWEB math score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • AIMSWEB reading score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: April 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352468

Locations
United States, Ohio
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Jeffery N Epstein, Ph.D. Cincinnati Childrens Hospital Medical Center
  More Information

No publications provided

Responsible Party: Jeff Epstein, Principal Investigator, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01352468     History of Changes
Other Study ID Numbers: R33MH085842, R21MH085842
Study First Received: March 24, 2011
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Children's Hospital Medical Center, Cincinnati:
ADHD
cognitive training

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014