A clinical trial to comparison the effectiveness of choice theory on behavioral problems in attention deficit hyperactivity disorder (ADHD) with oppositional defiant disorder (ODD) patients
Objective: To comparison the effectiveness of choice theory on behavioral problems in attention deficit hyperactivity disorder (ADHD) with oppositional defiant disorder (ODD) patients.
Design: A single-blind block randomized clinical trial.
Study population: Attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) patients.
Inclusion criteria: Attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) patients base on DSM-V criteria; aged between 12 and 18 years; no signs of systemic diseases and other psychological diseases; history of normal IQ; have the standard drug treatment in the last of 3 to 12 months.
Exclusion criteria: Unwillingness to continue the study; incidence of systemic diseases and other psychological diseases.
Sample size: 32 cases.
Study intervention: The intervention group received the standard treatment for ADHD (1-10 mg/kg ritalin and 10 mg risperidone per day) and received five 120-minute sessions of training based on choice theory for five consecutive weeks. The control group received the standard treatment for ADHD (1-10 mg/kg ritalin and 10 mg risperidone per day) along with group sessions similar to the intervention group, but without any special theoretical basis.
Study outcome: Evaluation and comparison of the results obtained from SDQ and ODD questionnaires in the intervention and control groups before, as well as 1 and 4 weeks after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011431920N1
Registration date:2017-05-21, 1396/02/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-05-21, 1396/02/31
Registrant information
Name
Mahdieh Fatemi Naeri
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3847 0031
Email address
fateminm932@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to comparison the effectiveness of choice theory on behavioral problems in attention deficit hyperactivity disorder (ADHD) with oppositional defiant disorder (ODD) patients
Public title
The effects of choice theory on behavioral problems
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) patients base on DSM-V criteria; aged between 12 and 18 years; no signs of systemic diseases and other psychological diseases; history of normal IQ; have the standard drug treatment in the last of 3 to 12 months.
Exclusion criteria: Unwillingness to continue the study; incidence of systemic diseases and other psychological diseases.
Age
From 12 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
IR.FM.REC.1395.109
Health conditions studied
1
Description of health condition studied
Attention deficit hyperactivity disorder (ADHD)
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
2
Description of health condition studied
Oppositional defiant disorder (ODD)
ICD-10 code
F91.3
ICD-10 code description
Oppositional defiant disorder
Primary outcomes
1
Description
Strengths and difficulties
Timepoint
Before, 1 and 4 weeks after the intervention
Method of measurement
Strengths and Difficulties Questionnaire (SDQ)
2
Description
Oppositional defiant disorder
Timepoint
Before, 1 and 4 weeks after the intervention
Method of measurement
Oppositional Defiant Disorder (ODD) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Who received the standard treatment for ADHD (1-10 mg/kg ritalin and 10 mg risperidone per day) and received five 120-minute sessions of training based on choice theory for five consecutive weeks
Category
Treatment - Other
2
Description
Control group: Who received the standard treatment for ADHD (1-10 mg/kg ritalin and 10 mg risperidone per day) along with group sessions similar to the intervention group, but without any special theoretical basis.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebn'e Sina Hospital
Full name of responsible person
Mahdiea Fatemi Naeri
Street address
Side of Astan Quds Vehicles, Horr Ameli Boulevard
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdieh Fatemi Naeri
Position
Psychiatrist
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3711 2701
Fax
Email
mahdiehfatemi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdieh Fatemi Naeri
Position
Psychiatrist
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3711 2701
Fax
Email
mahdiehfatemi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdieh Fatemi Naeri
Position
Psychiatrist
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3711 2701
Fax
Email
mahdiehfatemi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)