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Combined Cognitive Remediation and Behavioral Intervention for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01137318
Recruitment Status : Unknown
Verified November 2012 by Anil Chacko, Queens College, The City University of New York.
Recruitment status was:  Active, not recruiting
First Posted : June 4, 2010
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):
Anil Chacko, Queens College, The City University of New York

Tracking Information
First Submitted Date  ICMJE February 24, 2010
First Posted Date  ICMJE June 4, 2010
Last Update Posted Date November 14, 2012
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2010)
  • ADHD Symptoms [ Time Frame: 3 month follow up ]
    Disruptive Behavior Disorder Rating Scale: ADHD symptoms will be measured using the Disruptive Behavior Disorders rating scale (DBD) administered to the child's parent and teacher. The DBD is a 45-item measure that asks parents to rate the DSM symptoms of ADHD, ODD, and CD on a four point Likert scale (i.e., Not at all, Just a little, Pretty Much, or Very Much). For this study, the average scores for DSM-IV Inattentive symptoms, DSM-IV Hyperactive-Impulsive symptoms, DSM-IV ODD symptoms, and DSM-IV CD symptoms will be used.
  • Impairment [ Time Frame: 3 month follow up ]
    Parent and teacher ratings of problem severity and need for treatment in important functional domains will be measured using the Impairment Rating Scale (IRS). The IRS measures impairment across domains of functioning as well as overall need for treatment. Parents and teachers place an "x" on a seven-point visual analogue scale to signify their child's functioning along a continuum of impairment that ranges from zero (Not a problem at all. Definitely does not need treatment or special services.) to six (Extreme problem. Definitely needs treatment and special services).
  • Academic Achievement [ Time Frame: 3 month follow up ]
    Wide Range Achievement Test 4 Progress Monitoring Version [WRAT4-PMV]is an adaptation of the WRAT4 and is specifically designed to be a reliable and efficient tool for monitoring the academic progress of students in Grades K-12 and college. A series of brief 15-item tests are offered in 4 areas of basic skills: word reading, sentence comprehension, spelling, and mathematics computation.
  • ODD symptoms [ Time Frame: 3 month follow up ]
    Disruptive Behavior Disorder Rating Scale: ODD symptoms will be measured using the Disruptive Behavior Disorders rating scale (DBD) administered to the child's parent and teacher. The DBD is a 45-item measure that asks parents to rate the DSM symptoms of ADHD, ODD, and CD on a four point Likert scale (i.e., Not at all, Just a little, Pretty Much, or Very Much). For this study, the average scores for DSM-IV Inattentive symptoms, DSM-IV Hyperactive-Impulsive symptoms, DSM-IV ODD symptoms, and DSM-IV CD symptoms will be used.
  • CD symptoms [ Time Frame: 3 month follow up ]
    Disruptive Behavior Disorder Rating Scale:CD symptoms will be measured using the Disruptive Behavior Disorders rating scale (DBD) administered to the child's parent and teacher. The DBD is a 45-item measure that asks parents to rate the DSM symptoms of ADHD, ODD, and CD on a four point Likert scale (i.e., Not at all, Just a little, Pretty Much, or Very Much). For this study, the average scores for DSM-IV Inattentive symptoms, DSM-IV Hyperactive-Impulsive symptoms, DSM-IV ODD symptoms, and DSM-IV CD symptoms will be used.
  • Motor Activity [ Time Frame: 3 month follow up ]
    Solid-state actigraph: Motor activity will be recorded throughout the assessment using two solid-state actigraphs that store data on the number of movements per unit time. Actigraphs will be worn on the waist and non-dominant ankle. Assessments of activity level taken during structured test-sessions in children are reliable and yield measures that are correlated with parent and teacher ratings of hyperactivity
  • Inattention [ Time Frame: 3 month follow up ]
    A-X Continuous Performance Test CPT214: This CPT runs on a computer and generates objective measures of inattention and impulsivity. Letters are presented individually for 200 msec., with a 1.5 sec. interstimulus interval. The child responds when he sees an "A" followed by an "X". A total of 400 letters are presented and the entire task lasts approximately 12 minutes.
  • Impulsivity [ Time Frame: 3 month follow up ]
    A-X Continuous Performance Test CPT214: This CPT runs on a computer and generates objective measures of inattention and impulsivity. Letters are presented individually for 200 msec., with a 1.5 sec. interstimulus interval. The child responds when he sees an "A" followed by an "X". A total of 400 letters are presented and the entire task lasts approximately 12 minutes.
  • Parenting Behavior [ Time Frame: 3 month follow up ]
    Alabama Parenting Questionnaire: The Alabama Parenting Questionnaire (APQ) is a 42-item measure of parenting that asks parents to rate different domains of parenting on a five-point scale ranging from one (never) to five (always). The APQ can be divided into six scales: Involvement, Positive Parenting, Poor Monitoring/Supervision, Inconsistent Discipline, Corporal Punishment, and an Other Discipline Practices Scale.
  • Parenting Stress [ Time Frame: 3 month follow up ]
    Parenting Stress Index-Short Form (PSI-SF). To gather information concerning the degree of and types of stress attributed to parenting, each parent will complete the PSI-SF. The PSI-SF is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. It yields a Total Stress score from 3 scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Cognitive Remediation and Behavioral Intervention for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
Official Title  ICMJE Combined Cognitive Remediation and Behavioral Intervention for Treatment of ADHD
Brief Summary

The objective of this study is to evaluate a novel sequenced combination of a promising, computerized cognitive training program targeting working memory (WM) deficits in children with attention-deficit/hyperactivity disorder (ADHD) in combination with behavioral parent training, a well-established, evidence-based intervention for ADHD.

The combined active intervention, compared to the combined control intervention will result in improvement in primary psychosocial (i.e., parent/teacher reported child impairment; parental stress; parenting behavior; and observed child academic achievement) and psychiatric (parent/teacher rated ADHD, ODD, and CD symptoms; observed activity level and attention) outcomes at post-treatment and follow up assessment, with the combined active intervention resulting in greater improvements in these outcomes.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE ADHD
Intervention  ICMJE Behavioral: Cognitive remediation and Parent Training
Cognitive Intervention is CogMed Working Memory Training program, which is a 5-week, 5days/week computerized training program completed at home. The Parent Training is a 2.0 hour, weekly, group sessions that focus on behavioral management procedures.
Study Arms  ICMJE
  • Experimental: Cognitive remediation and Behavioral Intervention
    Intervention: Behavioral: Cognitive remediation and Parent Training
  • Placebo Comparator: Low Level Cognitive Remediation and Behavioral Parent Traning
    Intervention: Behavioral: Cognitive remediation and Parent Training
Publications * Chacko A, Bedard AC, Marks DJ, Feirsen N, Uderman JZ, Chimiklis A, Rajwan E, Cornwell M, Anderson L, Zwilling A, Ramon M. A randomized clinical trial of Cogmed Working Memory Training in school-age children with ADHD: a replication in a diverse sample using a control condition. J Child Psychol Psychiatry. 2014 Mar;55(3):247-55. doi: 10.1111/jcpp.12146. Epub 2013 Oct 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: November 10, 2012)
84
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2010)
85
Estimated Study Completion Date  ICMJE July 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Diagnosis of ADHD Children 7-11 year olds English Speaking

Exclusion Criteria:

- Pervasive Developmental Disorder IQ< 80

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01137318
Other Study ID Numbers  ICMJE 1R34MH088845-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Anil Chacko, Queens College, The City University of New York
Original Responsible Party Anil Chacko, PhD, Queens College, City University of New York
Current Study Sponsor  ICMJE Queens College, The City University of New York
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anil Chacko, PhD Queens College, The City University of New York
PRS Account Queens College, The City University of New York
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP