Protocol summary

Summary
Objective: To comparison, the effectiveness of parenting education based on choice theory in attention deficit hyperactivity disorder (ADHD) with oppositional defiant disorder (ODD) patients. Design: A single-blind non-randomized clinical trial. Inclusion 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. Study population: Attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) patients. Sample size: 32 cases. Study intervention: Groups of studies, the effectiveness of parenting education is examining based on choice theory comparison with SDQ and ODD questionnaire. Study outcome: Evaluation and comparison of SDQ and ODD questionnaire outcomes and evaluation of depression, anxiety and stress of parents by DASS-21 questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017012932268N1
Registration date: 2017-03-27, 1396/01/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-27, 1396/01/07
Registrant information
Name
Arash Askari Noghabi
Name of organization / entity
University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 3007
Email address
askariaa21@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To comparison the effectiveness of parenting education based on choice theory in attention deficit hyperactivity disorder (ADHD) with oppositional defiant disorder (ODD) patients.
Public title
Parenting education based on choice theory.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion 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)
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 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
2016-11-16, 1395/08/26
Ethics committee reference number
IR.MUMS.REC.1393.381

Health conditions studied

1

Description of health condition studied
Attention deficit hyperactivity disorder (ADHD)
ICD-10 code
F98.8
ICD-10 code description
Other specified behavioural and emotional disorders with onset usually occurring in childhood and adolescence

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
3 and 12 months after treatment
Method of measurement
Strengths and Difficulties Questionnaire (SDQ)

2

Description
oppositional defiant disorder
Timepoint
3 and 12 months after treatment
Method of measurement
Oppositional Defiant Disorder (ODD) questionnaire

Secondary outcomes

1

Description
depression, anxiety and stress of parents
Timepoint
After inclusion
Method of measurement
DASS-21 test

Intervention groups

1

Description
parenting education based on choice theory
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ebn'e Sina Hospital
Full name of responsible person
Arash Askari Noghabi
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
Arash Askari Noghabi
Position
Psychiatrist
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3728 1401
Fax
Email
Askaria921@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atefe Soltanifar
Position
Psychiatrist
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3728 1401
Fax
Email
soltanifara@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arash Askari Noghabi
Position
Psychiatrist
Other areas of specialty/work
Street address
Ghoreyshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3728 1401
Fax
Email
Askaria921@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...