Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Organizational Skills Treatment for ADHD Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381407
• Other study ID #: R01MH074013
• Secondary ID: R01MH074013DDTR
• Status: Completed
• Phase: N/A
• First received: September 25, 2006
• Last updated: April 17, 2013
• Start date: September 2006
• Est. completion date: February 2011

Study information

• Verified date: April 2013
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Organizational Skills Scale (COSS)		Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year	No
Primary	Academic Performance Rating Scale (APRS)		Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year	No
Secondary	Homework Problems Checklist		Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year	No
Secondary	Family Environment Scale		Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year	No
Secondary	Behavior Assessment System for Children		Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year	No

External Links

•   Click here for the NYU Child Study Center website