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

NCT01137318 | Unknown Phase 2

• 1 other identifier: 1R34MH088845-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD; Impairment; Treatment; Cognitive Remediation; Behavioral Parent Training

Outcome Measures

Primary Outcomes (10)

• 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.

  3 month follow up

• 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).

  3 month follow up

• 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.

  3 month follow up

• 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.

  3 month follow up

• 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.

  3 month follow up

• 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

  3 month follow up

• 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.

  3 month follow up

• 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.

  3 month follow up

• 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.

  3 month follow up

• 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

  3 month follow up

Study Arms (2)

Cognitive remediation and Behavioral Intervention

EXPERIMENTAL

Behavioral: Cognitive remediation and Parent Training

Low Level Cognitive Remediation and Behavioral Parent Traning

PLACEBO COMPARATOR

Behavioral: Cognitive remediation and Parent Training

Interventions

Cognitive remediation and Parent Training BEHAVIORAL

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.

Cognitive remediation and Behavioral Intervention; Low Level Cognitive Remediation and Behavioral Parent Traning

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \- Pervasive Developmental Disorder IQ\< 80

Sponsors & Collaborators

• Queens College, The City University of New York: lead

Study Sites (1)

Queens College

Flushing, New York, 11367, United States

Location

Related Publications (1)

• 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.

  PMID: 24117656 DERIVED

Related Links

• Refining Attention Memory and Parenting Study for Youth with ADHD

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anil Chacko, PhD

  Queens College, The City University of New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: June 4, 2010
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2013
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

US (1)