Attention Deficit Disorder With HyperactivityNCT00381407
Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder
A study testing Organizational Skills Training and Contingency management (CM) in people with Attention Deficit Disorder With Hyperactivity, run by NYU Langone Health at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Organizational Skills Training and Contingency management (CM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University
Durham, North Carolina, 27708
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Organizational Skills Treatment for ADHD Children
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.
Read the 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.
- Being tested
- Organizational Skills Training, Contingency management (CM)
- Keywords
- ADHD, Organizational Skills, Contingency Management
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organizational Skills TrainingBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive organizational skills training program Receives: Behavioral: Organizational Skills Training |
| 2 | Experimental | Participants will receive contingency management program Receives: Behavioral: Contingency management (CM) |
| 3 | No intervention | Participants will receive wait list condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Organizational Skills Scale (COSS)
Measured: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
Academic Performance Rating Scale (APRS)
Measured: 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: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
Family Environment Scale
Measured: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
Behavior Assessment System for Children
Measured: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Howard Abikoff, NYU Langone Health
- Investigators
- Howard B. Abikoff, PhD, Principal investigator, New York University Child Study CenterKaren Wells, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381407
- Sponsor's protocol ID
- R01MH074013
- Other IDs
- R01MH074013, DDTR B2-NDH
- Status last verified
- Apr 2013
- First submitted
- 25 Sep 2006
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organizational Skills Treatment for ADHD Children
- ClinicalTrials.gov ID
- NCT00381407
- Acronym / sponsor ID
- R01MH074013
- Keywords
- ADHD, Organizational Skills, Contingency Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2006
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 27 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Organizational Skills TrainingParticipants will receive organizational skills training program |
| 2 | Experimental | Behavioral: Contingency management (CM)Participants will receive contingency management program |
| 3 | No intervention | –Participants will receive wait list condition |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organizational Skills TrainingParticipants 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. | Behavioural | 1 |
| 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. | Behavioural | 2 |
Primary outcome
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
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
3 secondary outcomes
Homework Problems Checklist
Time frame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
Family Environment Scale
Time frame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
- Click here for the NYU Child Study Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard B. Abikoff, PhD principal investigator
New York University Child Study Center
Karen Wells, PhD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organizational Skills Training and Contingency management (CM) in people with Attention Deficit Disorder With Hyperactivity, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2013.