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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anil Chacko, Queens College, The City University of New York
ClinicalTrials.gov Identifier:
NCT01137318
First received: February 24, 2010
Last updated: November 10, 2012
Last verified: November 2012
  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.


Condition Intervention Phase
ADHD
Behavioral: Cognitive remediation and Parent Training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Combined Cognitive Remediation and Behavioral Intervention for Treatment of ADHD

Resource links provided by NLM:


Further study details as provided by Queens College, The City University of New York:

Primary Outcome Measures:
  • ADHD Symptoms [ Time Frame: 3 month follow up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Enrollment: 84
Study Start Date: September 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive remediation and Behavioral Intervention 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.
Placebo Comparator: Low Level Cognitive Remediation and Behavioral Parent Traning 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.

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Pervasive Developmental Disorder IQ< 80

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137318

Locations
United States, New York
Queens College
Flushing, New York, United States, 11367
Sponsors and Collaborators
Queens College, The City University of New York
Investigators
Principal Investigator: Anil Chacko, PhD Queens College, The City University of New York
  More Information

Additional Information:
No publications provided

Responsible Party: Anil Chacko, Assistant Professor, Queens College, The City University of New York
ClinicalTrials.gov Identifier: NCT01137318     History of Changes
Other Study ID Numbers: 1R34MH088845-01
Study First Received: February 24, 2010
Last Updated: November 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Queens College, The City University of New York:
ADHD
Impairment
Treatment
Cognitive Remediation
Behavioral Parent Training

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 15, 2014