Attention Deficit Hyperactivity DisorderNCT01133028
Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Behavioral contingency management and Tolerance training in people with Attention Deficit Hyperactivity Disorder, run by University of Virginia at 1 site in United States.
Trial summary
Children with Attention-Deficit/Hyperactivity Disorder (ADHD) comprise about 5-10% of the elementary school-age population. One place where children with ADHD have great difficulty is in being accepted by peers and in making friends. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Behavioral contingency management and Tolerance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jun 2012
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children ages 6-8
- Primary diagnosis of ADHD
Who cannot join
- Pervasive Developmental Disorder
- Verbal IQ below 75
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22904
Amori Y Mikami, PhD, 434-243-2327, mikami@virginia.edu
Amori Y Mikami, PhD
About this study
Official title: Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Children with Attention-Deficit/Hyperactivity Disorder (ADHD) comprise about 5-10% of the elementary school-age population. One place where children with ADHD have great difficulty is in being accepted by peers and in making friends. It has unfortunately been very difficult for the field to find good treatments for peer relationship problems for this population. Even when children with ADHD do improve their behavior, it is common that peers do not seem to like the child with ADHD any better. This may happen because children often have negative reputations with their classmates that are hard to change. That is, once a class of children get the impression that one child is disliked or the social outcast, even if that child's ADHD symptoms get better, the peer group may not notice any of these improvements. It is hypothesized that the elementary school teacher may be able to help peers notice positive behavior changes in children with ADHD when they do occur. This clinical trial will design and pilot-test an intervention that would train teachers in classroom practices to reduce the peer rejection of students with ADHD. The pilot test will be conducted in a summer program created to be similar to a regular school classroom in structure. If the treatment seems to succeed in the summer program, then it will be tried in regular classrooms in a future study.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Behavioral contingency management, Tolerance training
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD)
- 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.
Behavioral contingency managementBehavioural
Teachers will learn to use reinforcements and response cost procedures to encourage children's display of prosocial behaviors.
Tolerance trainingBehavioural
Teachers will be instructed in procedures to encourage the peer group to be accepting of children with ADHD.
| Study group | Role | What they receive |
|---|---|---|
| Combined | Experimental | This represents a combination of the tolerance training and behavioral management interventions together. Receives: Behavioral: Behavioral contingency management; Behavioral: Tolerance training |
| Behavioral management | Active comparator | This represents the behavioral contingency management intervention only. Receives: Behavioral: Behavioral contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Peer Relationships
This is collected in the summer program in which the intervention will be adminstered. On the first day of the program (before treatment begins), pre-test measures will be taken. They will be re-taken on the last day of the program two weeks later (on the last day of treatment). Peer relationships will be assessed by peer sociometric interviews. Proportion scores of peer acceptance, reciprocated friendship, and inclusion in social networks will be calculated, and changes in these outcomes over the summer prorgam will be considered as evidence to evaluate the treatment.
Measured: The first day of the treatment and the last day of the treatment (two weeks later)
Secondary outcomes (1)
Child Behavior Problems
This measure will be collected on the same time frame as is the primary outcome measure. Children's behavior problems (aggression, inattention, hyperactivity/impulsivity, social withdrawal) will be assessed by teacher report and by observation. Changes in behavior problems during this period will be considered as evidence for the efficacy of the treatment.
Measured: The first day of the treatment and the last day of the treatment (two weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startJan 2011
- Primary completionSep 2011 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Amori Y Mikami, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133028
- Sponsor's protocol ID
- 2010-0066-00
- Status last verified
- May 2010
- First submitted
- 10 May 2010
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01133028
- Acronym / sponsor ID
- 2010-0066-00
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 28 May 2010 (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.
Children with Attention-Deficit/Hyperactivity Disorder (ADHD) comprise about 5-10% of the elementary school-age population. One place where children with ADHD have great difficulty is in being accepted by peers and in making friends. It has unfortunately been very difficult for the field to find good treatments for peer relationship problems for this population. Even when children with ADHD do improve their behavior, it is common that peers do not seem to like the child with ADHD any better. This may happen because children often have negative reputations with their classmates that are hard to change. That is, once a class of children get the impression that one child is disliked or the social outcast, even if that child's ADHD symptoms get better, the peer group may not notice any of these improvements. It is hypothesized that the elementary school teacher may be able to help peers notice positive behavior changes in children with ADHD when they do occur. This clinical trial will design and pilot-test an intervention that would train teachers in classroom practices to reduce the peer rejection of students with ADHD. The pilot test will be conducted in a summer program created to be similar to a regular school classroom in structure. If the treatment seems to succeed in the summer program, then it will be tried in regular classrooms in a future study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined | Experimental | Behavioral: Behavioral contingency management, Behavioral: Tolerance trainingThis represents a combination of the tolerance training and behavioral management interventions together. |
| Behavioral management | Active comparator | Behavioral: Behavioral contingency managementThis represents the behavioral contingency management intervention only. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children ages 6-8
- Primary diagnosis of ADHD
Key exclusion criteria (2 listed)
- Pervasive Developmental Disorder
- Verbal IQ below 75
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 |
|---|---|---|
| Behavioral contingency managementTeachers will learn to use reinforcements and response cost procedures to encourage children's display of prosocial behaviors. | Behavioural | Behavioral management, Combined |
| Tolerance trainingTeachers will be instructed in procedures to encourage the peer group to be accepting of children with ADHD. | Behavioural | Combined |
Primary outcome
Child Peer Relationships
Time frame: The first day of the treatment and the last day of the treatment (two weeks later)
This is collected in the summer program in which the intervention will be adminstered. On the first day of the program (before treatment begins), pre-test measures will be taken. They will be re-taken on the last day of the program two weeks later (on the last day of treatment). Peer relationships will be assessed by peer sociometric interviews. Proportion scores of peer acceptance, reciprocated friendship, and inclusion in social networks will be calculated, and changes in these outcomes over the summer prorgam will be considered as evidence to evaluate the treatment.
1 secondary outcome
Child Behavior Problems
Time frame: The first day of the treatment and the last day of the treatment (two weeks later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
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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.
Amori Y Mikami, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral contingency management and Tolerance training in people with Attention Deficit Hyperactivity Disorder, run by University of Virginia at 1 site 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amori Y Mikami, PhD (4342432327, mikami@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Peer Relationships (time frame: The first day of the treatment and the last day of the treatment (two weeks later)). 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 28 May 2010.