Methylphenidate and the Relations Between Emotional Processing and Social Functioning Among Children With ADHD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Bnai Zion Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT01278667
First received: January 16, 2011
Last updated: January 23, 2011
Last verified: January 2011
  Purpose

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.


Condition
Attention Deficit Hyperactivity Disorder

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Bnai Zion Medical Center:

Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   9 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • children with ADHD under treatment with methylphenidate

Exclusion Criteria:

  • non-cooperative children
  • children suffering from other neurological or mental conditions
  • children suffering from asthma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278667

Contacts
Contact: Tami Szwarc 972 4 8246342 miguel.swartz@b-zion.org.il
Contact: Miguel Schwartz, MD 972 4 8359266 miguel@netvision.net.il

Locations
Israel
Dep. of Neurology, Bnai Zion Medical Center Recruiting
Haifa, Israel
Contact: Tami Szwarc    972 4 8246342    miguel.swartz@b-zion.org.il   
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
Principal Investigator: Miguel Schwartz, MD Dep. of Neurology, Bnai Zion Medical Center, Haifa, Israel
  More Information

No publications provided

Responsible Party: Roni Geva, Dept of Psychology, Fac of Social Sciences, Bar Ilan University, Ramat Gan, Israel
ClinicalTrials.gov Identifier: NCT01278667     History of Changes
Other Study ID Numbers: 80-10-BNZ
Study First Received: January 16, 2011
Last Updated: January 23, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Bnai Zion Medical Center:
ADHD
Memory
Social
Emotion
Methylphenidate

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014