Clinical trial NCT00381407: Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder
Official title: Organizational Skills Treatment for ADHD Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
Organizational Skills
Contingency Management
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-09-27
Enrollment: 157
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Children's Organizational Skills Scale (COSS)
timeFrame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
measure: Academic Performance Rating Scale (APRS)
timeFrame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
Secondary outcomes:
measure: Homework Problems Checklist
timeFrame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
measure: Family Environment Scale
timeFrame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
measure: Behavior Assessment System for Children
timeFrame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: New York University Child Study Center
name: Howard B. Abikoff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Karen Wells, PhD
role: PRINCIPAL_INVESTIGATOR
References: