Efficacy of methylphenidate on ability of theory of mind in children with ADHD
Design
Patients will randomly be selected from 30 patients referred to the ADHD clinic and studied.
Settings and conduct
This is a clinical trial study performed at Imam Hossein Hospital in Tehran. Thirty patients with ADHD who meet the inclusion criteria will be pre-tested with the Hutchin`s Theory of mind Questionnaire (for parents) and the children's TOM test. Diagnosis is based on parental history and then clinical interview and K-SADS. The severity of the disorder is calculated with the ADHD-RS followed by the Hutchin`s and TOM tests.
Participants/Inclusion and exclusion criteria
Ages 7 to 9 years old
Having DSM-4 criteria for the diagnosis of ADHD based on K-SADS
Having parental consent to participate in the research
No history of medication for the disorder
Intervention groups
Children with ADHD will be treated with slow-release methylphenidate for 4 weeks. Questionnaires will be completed before and after one month of treatment.
Main outcome variables
The potential effects of current ADHD therapies on theory of mind have not been adequately explored. Given the prevalence of ADHD and the development of psychosocial complications at different stages of development, the association of the disorder with the theory of the mind and the inability to communicate socially and express emotion empathy with others, This study aimed to determine the effect of methylphenidate on the ability of the theory of mind in children aged 7 to 9 years with attention deficit hyperactivity disorder.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190827044633N1
Registration date:2020-04-22, 1399/02/03
Registration timing:retrospective
Last update:2020-04-22, 1399/02/03
Update count:0
Registration date
2020-04-22, 1399/02/03
Registrant information
Name
Ghadir Mohammad Hoseiny Biareh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 3457
Email address
ghmhoseiny@mail.sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: efficacy of extended- release methylphenidate on theory of mind ability of 7-9year old children with attention-deficit hyperactivity disorder.
Public title
efficacy of extended- release methylphenidate on theory of mind ability of 7-9year old children with attention-deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 7 and 9 years old - - -
Diagnostic and Statistical Manual-4 criteria for diagnosis of attention-deficit hyperactivity disorder
Parental consent to participate in research
Lack of history of medication for the disorder
Exclusion criteria:
Wechsler's IQ of less than 91 based on Wechsler's test - -
other major psychiatric illnesses including ASD
any physical defects that prevent tests, including severe visual and hearing impairment
Age
From 7 years old to 9 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
3rd floor,Collage of medicine,Next to Taleghani hospital,Evin,Chamran highway,Tehran
City
Tehran
Province
Tehran
Postal code
1651976341
Approval date
2019-12-29, 1398/10/08
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.495
Health conditions studied
1
Description of health condition studied
Attention Deficit/ Hyperactivity Disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attentionAttention deficit:disorder with hyperactivityhyperactivity disordersyndrome with hyperactivityExcl.:hyperkinetic disorder associated with conduct disorder (F90.1)
Primary outcomes
1
Description
Score in the Hutchin's Theory of Mind Questionnaire
Timepoint
At baseline and one month after treatment with long-acting methylphenidate.
Method of measurement
Hutchin`s Theory of Mind Questionnaire
2
Description
Score in the TOM(Theory of Mind) test
Timepoint
At baseline and one month after treatment with long-acting methylphenidate.
Method of measurement
TOM(Theory of Mind) test
3
Description
score in Attention Deficit Hyperactivity Disorder Rating scale
Timepoint
At baseline and one month after treatment with long-acting methylphenidate.
Intervention group: Patients with Attention Deficit Hyperactivity Disorder receive long-acting methylphenidate 18 mg tablets, manufactured by Sandoz, at a dose of 0.6-1.2 mg / kg, orally, once daily for one month.