Expired Study
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Flushing, New York 11367


Purpose:

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.


Criteria:

Inclusion Criteria: - Diagnosis of ADHD Children 7-11 year olds English Speaking Exclusion Criteria: - Pervasive Developmental Disorder IQ< 80


Study is Available At:


Original ID:

1R34MH088845-01


NCT ID:

NCT01137318


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Combined Cognitive Remediation and Behavioral Intervention for Treatment of ADHD


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

7 Years


Maximum Age:

11 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Queens College, The City University of New York


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

84


Enrollment Type:

Actual


Overall Contact Information

Official Name:Anil Chacko, PhD
Principal Investigator
Queens College, The City University of New York

Study Dates

Start Date:September 2009
Completion Date:July 2013
Completion Type:Anticipated
Primary Completion Date:December 2012
Primary Completion Type:Anticipated
Verification Date:November 2012
Last Changed Date:November 10, 2012
First Received Date:February 24, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:ADHD Symptoms
Time Frame:3 month follow up
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Impairment
Time Frame:3 month follow up
Safety Issues:False
Description: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 treatmen
Outcome Type:Primary Outcome
Measure:Academic Achievement
Time Frame:3 month follow up
Safety Issues:False
Description: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 br
Outcome Type:Primary Outcome
Measure:ODD symptoms
Time Frame:3 month follow up
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:CD symptoms
Time Frame:3 month follow up
Safety Issues:False
Description: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 AD
Outcome Type:Primary Outcome
Measure:Motor Activity
Time Frame:3 month follow up
Safety Issues:False
Description: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 activit
Outcome Type:Primary Outcome
Measure:Inattention
Time Frame:3 month follow up
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Impulsivity
Time Frame:3 month follow up
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Parenting Behavior
Time Frame:3 month follow up
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Parenting Stress
Time Frame:3 month follow up
Safety Issues:False
Description: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-it

Study Interventions

Intervention Type:Behavioral
Name:Cognitive remediation and Parent Training
Description: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.
Arm Name:Cognitive remediation and Behavioral Intervention

Study Arms

Study Arm Type:Experimental
Arm Name:Cognitive remediation and Behavioral Intervention
Study Arm Type:Placebo Comparator
Arm Name:Low Level Cognitive Remediation and Behavioral Parent Traning

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Queens College, The City University of New York

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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