Combined Cognitive Remediation and Behavioral Intervention for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
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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
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Tracking Information | ||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01137318 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | 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. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Treatment |
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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. |
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Study Arms |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Actual Enrollment ICMJE |
84 | |||
Original Estimated Enrollment ICMJE |
85 | |||
Estimated Study Completion Date | 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 |
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Sex/Gender |
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Ages | 7 Years to 11 Years (Child) | |||
Accepts Healthy Volunteers | 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 | Not Provided | |||
Responsible Party | Anil Chacko, Queens College, The City University of New York | |||
Study Sponsor ICMJE | Queens College, The City University of New York | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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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 |