Cognitive Training Trial

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.

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 Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: Computerized Progressive Attention Training; Other: Sham Comparator Cognitive Training

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Center for ADHD, Cincinnati Childrens Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Training; Computerized Progressive Attention Training	Other: Computerized Progressive Attention Training; 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: Non-progressive cognitive training; 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.	Other: Sham Comparator Cognitive Training; Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	2 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 17, 2010
• First Submitted That Met QC Criteria: May 27, 2010
• First Posted (Estimate): May 28, 2010

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: K24MH064478 (U.S. NIH Grant/Contract)