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

Primary Purpose

ADHD

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive remediation and Parent Training
Sponsored by
Queens College, The City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, Impairment, Treatment, Cognitive Remediation, Behavioral Parent Training

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

- Pervasive Developmental Disorder IQ< 80

Sites / Locations

  • Queens College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cognitive remediation and Behavioral Intervention

Low Level Cognitive Remediation and Behavioral Parent Traning

Arm Description

Outcomes

Primary Outcome Measures

ADHD Symptoms
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
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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
February 24, 2010
Last Updated
November 10, 2012
Sponsor
Queens College, The City University of New York
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1. Study Identification

Unique Protocol Identification Number
NCT01137318
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queens College, The City University of New York

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, Impairment, Treatment, Cognitive Remediation, Behavioral Parent Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive remediation and Behavioral Intervention
Arm Type
Experimental
Arm Title
Low Level Cognitive Remediation and Behavioral Parent Traning
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation and Parent Training
Intervention 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.
Primary Outcome Measure Information:
Title
ADHD Symptoms
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 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.
Time Frame
3 month follow up
Title
Impairment
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 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).
Time Frame
3 month follow up
Title
Academic Achievement
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 brief 15-item tests are offered in 4 areas of basic skills: word reading, sentence comprehension, spelling, and mathematics computation.
Time Frame
3 month follow up
Title
ODD symptoms
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 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.
Time Frame
3 month follow up
Title
CD symptoms
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 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.
Time Frame
3 month follow up
Title
Motor Activity
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 activity level taken during structured test-sessions in children are reliable and yield measures that are correlated with parent and teacher ratings of hyperactivity
Time Frame
3 month follow up
Title
Inattention
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 an "A" followed by an "X". A total of 400 letters are presented and the entire task lasts approximately 12 minutes.
Time Frame
3 month follow up
Title
Impulsivity
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 an "A" followed by an "X". A total of 400 letters are presented and the entire task lasts approximately 12 minutes.
Time Frame
3 month follow up
Title
Parenting Behavior
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 into six scales: Involvement, Positive Parenting, Poor Monitoring/Supervision, Inconsistent Discipline, Corporal Punishment, and an Other Discipline Practices Scale.
Time Frame
3 month follow up
Title
Parenting Stress
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-item self-scoring questionnaire/profile. It yields a Total Stress score from 3 scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child
Time Frame
3 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Diagnosis of ADHD Children 7-11 year olds English Speaking Exclusion Criteria: - Pervasive Developmental Disorder IQ< 80
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Chacko, PhD
Organizational Affiliation
Queens College, The City University of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queens College
City
Flushing
State/Province
New York
ZIP/Postal Code
11367
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24117656
Citation
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.
Results Reference
derived
Links:
URL
http://www.chipslab.org/news/RAMP/
Description
Refining Attention Memory and Parenting Study for Youth with ADHD

Learn more about this trial

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

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