Attention Deficit Hyperactivity DisorderNCT01278667
Methylphenidate and the Relations Between Emotional Processing and Social Functioning Among Children With ADHD
An observational study of Attention Deficit Hyperactivity Disorder, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
Children with ADHD are in high risk to develope social difficulties. The present study will examine the emotional processing in those children. The main purpose is to investigate the connection between memory and recognition of facial expressions, how those abilities influence social functioning and if Methylphenidate… Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jun 2012
- Phase
- Observational
- 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with ADHD are in high risk to develope social difficulties. The present study will examine the emotional processing in those children. The main purpose is to investigate the connection between memory and recognition of facial expressions, how those abilities influence social functioning and if Methylphenidate influence the emotional processing. The study will include 80 children in ages 9-12 years, recruited from a community sample include schools in Haifa. They will devided in 2 groups; children with ADHD treated with Methylphenidate, and healthy children without ADHD. The children will do computerized tasks that examine recognition and memory of facial expressions. Social function will be examined by questionnaires filled by parents and teachers.
Who may be able to join
- children with ADHD under treatment with methylphenidate
Who cannot join
- non-cooperative children
- children suffering from other neurological or mental conditions
- children suffering from asthma
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Dep. of Neurology, Bnai Zion Medical Center
Haifa
Tami Szwarc, 972 4 8246342, miguel.swartz@b-zion.org.il
About this study
Official title: Difficulties in Emotional Processing, the Influence of Methylphenidate on This Processing and the Relations Between Emotional Processing and Social Functioning Among Children With ADHD
Children with ADHD are in high risk to develope social difficulties. The present study will examine the emotional processing in those children. The main purpose is to investigate the connection between memory and recognition of facial expressions, how those abilities influence social functioning and if Methylphenidate influence the emotional processing.
The study will include 80 children in ages 9-12 years, devided in 2 groups; children with ADHD treated with Methylphenidate, and healthy children without ADHD. The children will do computerized tasks that examine recognition and memory of facial expressions. Social function will be examined by questionnaires filled by parents and teachers.
Read the detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is characterized by short attention and concentration, impulsive and hyperactive behavior. Children with ADHD are in high risk to develop difficulties in social adjustment. The social difficulties challenge the support that those children get from their environment through their lives.
Last years studies on the causes that influence ADHD's social difficulties, suggests that they derive from problems in emotional information processing. Some research focus on recognition deficits of emotion and facial expressions, but their results are inconsistent. Moreover, there is a disagreement about the problems in the emotional processing that influence the social behavior of children with ADHD.
In the present study we will further examine the emotional information processing in children with ADHD. We will focus on recognition and memory of facial expressions. The main purpose of the current study is to investigate the connection between memory and recognition of facial expressions, and how those abilities influence social functioning. Another purpose is to investigate the assumption that beyond impulsivity and inattention, the difficulty in emotional processing is caused by specific deficits in the capacity to recognize and recall facial expressions. In order to test this assumption we will compare between the ability to recognize and recall facial expressions and the ability to recognize and recall objects.
ADHD is positively influenced by arousing drugs. Methylphenidate is the most prescribed and investigated drug in Israel. This drug improves attention, social and cognitive functions, and reduces hyperactive and impulsive behavior. However, its influence on emotional processing was not studied enough. Another purpose of this study is to test the efficiency of this drug on emotional processing.
The present study will include 80 children in ages 9-12 years, divided in 2 groups; 40 children with ADHD treated with Methylphenidate, and 40 healthy children without ADHD. The ADHD group will be tested in 2 sessions; one under drug treatment and one without drug treatment. The healthy children will be tested in 1 session. The children will do computerized tasks (Complex Reaction Time, Modified Day-Night and Attention Network Test) that examine recognition and memory of facial expressions. In order to examine their social function, their parents and teachers will fill questionnaires (BRIEF, CBCL/6-18 and TRF/6-18).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Memory, Social, Emotion, Methylphenidate
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 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.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Investigators
- Miguel Schwartz, MD, Principal investigator, Dep. of Neurology, Bnai Zion Medical Center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278667
- Sponsor's protocol ID
- 80-10-BNZ
- Status last verified
- Jan 2011
- First submitted
- 16 Jan 2011
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difficulties in Emotional Processing, the Influence of Methylphenidate on This Processing and the Relations Between Emotional Processing and Social Functioning Among Children With ADHD
- ClinicalTrials.gov ID
- NCT01278667
- Acronym / sponsor ID
- 80-10-BNZ
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Memory, Social, Emotion, Methylphenidate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 19 Jan 2011 (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 ADHD are in high risk to develope social difficulties. The present study will examine the emotional processing in those children. The main purpose is to investigate the connection between memory and recognition of facial expressions, how those abilities influence social functioning and if Methylphenidate influence the emotional processing.
The study will include 80 children in ages 9-12 years, devided in 2 groups; children with ADHD treated with Methylphenidate, and healthy children without ADHD. The children will do computerized tasks that examine recognition and memory of facial expressions. Social function will be examined by questionnaires filled by parents and teachers.
Detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is characterized by short attention and concentration, impulsive and hyperactive behavior. Children with ADHD are in high risk to develop difficulties in social adjustment. The social difficulties challenge the support that those children get from their environment through their lives.
Last years studies on the causes that influence ADHD's social difficulties, suggests that they derive from problems in emotional information processing. Some research focus on recognition deficits of emotion and facial expressions, but their results are inconsistent. Moreover, there is a disagreement about the problems in the emotional processing that influence the social behavior of children with ADHD.
In the present study we will further examine the emotional information processing in children with ADHD. We will focus on recognition and memory of facial expressions. The main purpose of the current study is to investigate the connection between memory and recognition of facial expressions, and how those abilities influence social functioning. Another purpose is to investigate the assumption that beyond impulsivity and inattention, the difficulty in emotional processing is caused by specific deficits in the capacity to recognize and recall facial expressions. In order to test this assumption we will compare between the ability to recognize and recall facial expressions and the ability to recognize and recall objects.
ADHD is positively influenced by arousing drugs. Methylphenidate is the most prescribed and investigated drug in Israel. This drug improves attention, social and cognitive functions, and reduces hyperactive and impulsive behavior. However, its influence on emotional processing was not studied enough. Another purpose of this study is to test the efficiency of this drug on emotional processing.
The present study will include 80 children in ages 9-12 years, divided in 2 groups; 40 children with ADHD treated with Methylphenidate, and 40 healthy children without ADHD. The ADHD group will be tested in 2 sessions; one under drug treatment and one without drug treatment. The healthy children will be tested in 1 session. The children will do computerized tasks (Complex Reaction Time, Modified Day-Night and Attention Network Test) that examine recognition and memory of facial expressions. In order to examine their social function, their parents and teachers will fill questionnaires (BRIEF, CBCL/6-18 and TRF/6-18).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with ADHD are in high risk to develope social difficulties. The present study will examine the emotional processing in those children. The main purpose is to investigate the connection between memory and recognition of facial expressions, how those abilities influence social functioning and if Methylphenidate influence the emotional processing. The study will include 80 children in ages 9-12 years, recruited from a community sample include schools in Haifa. They will devided in 2 groups; children with ADHD treated with Methylphenidate, and healthy children without ADHD. The children will do computerized tasks that examine recognition and memory of facial expressions. Social function will be examined by questionnaires filled by parents and teachers.
Key inclusion criteria (1 listed)
- children with ADHD under treatment with methylphenidate
Key exclusion criteria (3 listed)
- non-cooperative children
- children suffering from other neurological or mental conditions
- children suffering from asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2011.
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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.
Miguel Schwartz, MD principal investigator
Dep. of Neurology, Bnai Zion Medical Center, Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder, run by Bnai Zion Medical Center at 1 site in Israel.
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 1 inclusion and 3 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 25 Jan 2011. 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 Israel. 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 Tami Szwarc (972 4 8246342, miguel.swartz@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 25 Jan 2011.