Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00381407

Purpose

This study will evaluate the effectiveness of organizational skills training in improving organizational, time management, and planning difficulties in children with attention deficit hyperactivity disorder.

Condition	Intervention
Attention Deficit Disorder With Hyperactivity	Behavioral: Organizational Skills Training Behavioral: Contingency management (CM)

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Organizational Skills Treatment for ADHD Children

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Children's Organizational Skills Scale (COSS) [ Time Frame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year ] [ Designated as safety issue: No ]
Academic Performance Rating Scale (APRS) [ Time Frame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Homework Problems Checklist [ Time Frame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year ] [ Designated as safety issue: No ]
Family Environment Scale [ Time Frame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year ] [ Designated as safety issue: No ]
Behavior Assessment System for Children [ Time Frame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	September 2006
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive organizational skills training program	Behavioral: Organizational Skills Training Participants in the OST group attend twenty 1-hour sessions over 10 weeks. OST trains children to use a variety of techniques for improving their organizational skills. Both children and their parents attend every OST session.
2: Experimental Participants will receive contingency management program	Behavioral: Contingency management (CM) Participants in the CM group will attend twenty 1-hour sessions over 10 weeks. CM trains parents and teachers to identify desired "end" behaviors and to increase the frequency of these behaviors through the use of a structured reward system. Both children and their parents attend every CM session, but the children's participation will be minimal.
3: No Intervention Participants will receive wait list condition

Detailed Description:

Attention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders among children. Children with ADHD frequently lack organizational, time management, and planning skills. These deficits can cause impaired functioning in multiple settings, including home, school, and peer relationships. Advancements in treatment options for these deficits, however, have been minimal. Previous research has indicated that organizational skills training (OST) is an effective intervention for improving organizational skills in children with ADHD. Its effectiveness relative to other available treatments is unknown. This study will compare the effectiveness of OST with that of contingency management (CM) and a waitlist condition in improving organizational, time management, and planning skills deficits in children with ADHD.

Participants in this study are randomly assigned to OST, CM, or Wait-List (WL). Participants in the OST and CM groups attend 20 1-hour sessions over 10 weeks. OST trains children to use a variety of techniques for improving their organizational skills. Both children and their parents attend every OST session. CM does not involve skills training. Rather, CM trains parents and teachers to identify desired "end" behaviors and to increase the frequency of these behaviors through the use of a structured reward system. Both children and their parents attend every CM session, but the children's participation will be minimal. Participants assigned to the waitlist condition will have the opportunity to receive their choice of either OST or CM once they have completed the study. All participants attend follow-up visits 1 month post-treatment. Participants assigned to OST and CM attend follow-up visits after 1 and 4 months into their next school grade. School performance, feelings about school, ADHD symptoms, organizational skills, family environment, medication or services received, and use of treatment strategies will be assessed at each follow-up visit.

Eligibility

Ages Eligible for Study:	8 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Between grades 3 and 5 in school
Meets criteria for ADHD, any subtype (a formal diagnosis prior to study entry is not necessary)
Meets minimum score requirements on either Conners Parent or Conners Teacher Rating Scales
Meets minimum criteria for organizational, time management, and planning deficits, as reported by parent or teacher
Estimated IQ is greater than 85, as determined by the Wechsler Abbreviated Scale of Intelligence
Has a teacher that is willing to participate
Parents' schedule will allow attendance at study visits

Exclusion Criteria:

Attends an all-day special education classroom or works with a para-professional in school
Diagnosis of pervasive developmental disorder (PDD), psychosis, bipolar disorder, or post-traumatic stress disorder (PTSD)
Current history of significant suicidality or sexual or physical abuse
Any other comorbid psychiatric diagnosis or medical condition with significant symptoms that may interfere with study participation (e.g., severe depression, obsessive-compulsive disorder [OCD], or cystic fibrosis)
Child's teacher has previously participated in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381407

Contacts

Contact: Robyn Stotter, BA	212-263-2734	robyn.stotter@med.nyu.edu
Contact: Elizabeth Steinberg, BA	212-263-2738	elizabeth.steinberg@med.nyu.edu

Locations

United States, New York
New York University Child Study Center	Recruiting
New York, New York, United States, 10016
Contact: Robyn Stotter, BA 212-263-2734 robyn.stotter@med.nyu.edu
Contact: Elizabeth Steinberg, BA 212-263-2738 elizabeth.steinberg@med.nyu.edu
Sub-Investigator: Richard Gallagher, PhD
United States, North Carolina
Duke University	Recruiting
Durham, North Carolina, United States, 27708
Contact: Desiree Murray, PhD 919-416-2082 murra038@mc.duke.edu
Contact: Kristen Newitt 919-286-5262 kristen.newitt@duke.edu

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Howard B. Abikoff, PhD	New York University Child Study Center
Principal Investigator:	Karen Wells, PhD	Duke University

More Information

Click here for the NYU Child Study Center website This link exits the ClinicalTrials.gov site

Responsible Party:	New York University Child Study Center ( Howard Abikoff, PhD / Director, Institute for Attention Deficit Hyperactivity and Behavior Disorders )
Study ID Numbers:	R01 MH74013, DDTR B2-NDH
Study First Received:	September 25, 2006
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00381407
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

ADHD
Organizational Skills
Contingency Management

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009