NCT00381407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

April 19, 2013

Status Verified

April 1, 2013

Enrollment Period

4.4 years

First QC Date

September 25, 2006

Last Update Submit

April 17, 2013

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHDOrganizational SkillsContingency Management

Outcome Measures

Primary Outcomes (2)

  • Children's Organizational Skills Scale (COSS)

    Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year

  • Academic Performance Rating Scale (APRS)

    Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year

Secondary Outcomes (3)

  • Homework Problems Checklist

    Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year

  • Family Environment Scale

    Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year

  • Behavior Assessment System for Children

    Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year

Study Arms (3)

1

EXPERIMENTAL

Participants will receive organizational skills training program

Behavioral: Organizational Skills Training

2

EXPERIMENTAL

Participants will receive contingency management program

Behavioral: Contingency management (CM)

3

NO INTERVENTION

Participants will receive wait list condition

Interventions

Organizational Skills TrainingBEHAVIORAL

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.

1
Contingency management (CM)BEHAVIORAL

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.

2

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New York University School of Medicine

New York, New York, 10016, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Howard B. Abikoff, PhD

    New York University Child Study Center

    PRINCIPAL INVESTIGATOR

  • Karen Wells, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Institute for Attention Deficit Hyperactivity and Behavior Disorders

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 27, 2006

Study Start

September 1, 2006

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

April 19, 2013

Record last verified: 2013-04

Locations

US(2)