Overview

This trial is active, not recruiting.

Condition adhd
Treatment cognitive remediation and parent training
Phase phase 2
Sponsor Queens College, The City University of New York
Start date September 2009
End date December 2012
Trial size 84 participants
Trial identifier NCT01137318, 1R34MH088845-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Experimental)
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)
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.

Primary Outcomes

Measure
ADHD Symptoms
time frame: 3 month follow up
Impairment
time frame: 3 month follow up
Academic Achievement
time frame: 3 month follow up
ODD symptoms
time frame: 3 month follow up
CD symptoms
time frame: 3 month follow up
Motor Activity
time frame: 3 month follow up
Inattention
time frame: 3 month follow up
Impulsivity
time frame: 3 month follow up
Parenting Behavior
time frame: 3 month follow up
Parenting Stress
time frame: 3 month follow up

Eligibility Criteria

Male or female participants from 7 years up to 11 years old.

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

Additional Information

Official title Combined Cognitive Remediation and Behavioral Intervention for Treatment of ADHD
Principal investigator Anil Chacko, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Queens College, The City University of New York.