Clinical trial of effect of multimedia parent management training vs face to face method and non method acting on parents of 3-10 years old children with oppositional defiant disorder on the rate of Oppositional Defiant Disorder such as conduct Problems، hyperactivity and anxiety
This study intended to determine the efficacy of Multimedia-Parent Management Training (M-PMT) for treatment of children with Oppositional Defiant Disorder (ODD). For this random controlled trial, 45 mothers of 3-10 years old children with ODD who refereed to Doctor Shaikh and Ibn-e Sina Hospitals, Mashhad, Iran will be assessed. They will be divided by simple random allocation into three groups. Inclusion criteria for participants are: ability and interest in participating in training sessions and it is necessary that mothers have at least high diploma and exclusion criteria includes: literacy under high school diploma; having psychological disorders; having children with co-morbid disorders such as medical or neuropsychiatric problems. We will provide parent management training via face to face method (PMT) for the first group and multimedia parent management training (M-PMT) for the second group,the third group will be given no treatment. Training program will run during 8 sessions each last one hour. Intervention is cognitive-behavioral therapy. Primary outcome measures is consisted of assessment of parent management, behavioral problems, hyperactivity, impulsive behaviors, anxiety and level of learning in children. Data will be assessed with Bamerind and Conner's parents’ questionnaires before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202299175N1
Registration date:2013-01-23, 1391/11/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-23, 1391/11/04
Registrant information
Name
Lida Jarahi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 9262
Email address
jarahil@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of effect of multimedia parent management training vs face to face method and non method acting on parents of 3-10 years old children with oppositional defiant disorder on the rate of Oppositional Defiant Disorder such as conduct Problems، hyperactivity and anxiety
Public title
Effectiveness of multimedia-Parent Management Training
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: mothers with ability and interest in participating training sessions, having diploma at least
Exclusion criteria:Literacy under diploma; mothers or children with Neuropsychiatric problems
Age
From 3 years old to 10 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Parents with 3-10 years old children with oppositional defiant disorder who referred to Ibne Sina and DR Shaikh Hospitals will split into three groups of control، multimedia training،face to face learning respectively
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Mashhad University of Medical Sciences
Street address
Pardis of university, Azadi square, Mashhad, Iran
City
Mashhad
Postal code
9177948974
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
88630
Health conditions studied
1
Description of health condition studied
Oppositional defiant disorder
ICD-10 code
f91.3
ICD-10 code description
Oppositional defiant disorder
Primary outcomes
1
Description
hyperactivity
Timepoint
Before intervention and 2 months later
Method of measurement
Conner's parent questionnaire in hyperactivity
2
Description
parent management
Timepoint
Before intervention and 2 months later
Method of measurement
Bamerind parents questionnaire
3
Description
behavioral problems
Timepoint
Before intervention and 2 months later
Method of measurement
Conner's parents questionnaire in behavioral problems
Secondary outcomes
empty
Intervention groups
1
Description
Intervention method in second experimental group is multimedia software of parental management training shown to the subjects during 8 weekly sessions each last 1 hour.
Category
Behavior
2
Description
Intervention method in first experimental group is parental management training via face to face method during 8 weekly sessions each last 1 hour.
Category
Behavior
3
Description
The control group will not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Shaikh Hospital
Full name of responsible person
Dr Hamid Ebadi
Street address
Taheri Street, Touhid Square, Mashhad
City
Mashhad
2
Recruitment center
Name of recruitment center
Ibne Sina Hospital
Full name of responsible person
Dr Maryam Tavakoli
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue,boo Ali square Mashhad
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
Dr Mohsen Tafaghodi
Street address
Department of pharmaceutics,School of pharmacy, Pardis of University, Azadi Square, Mashhad,
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
Lida Jarahi
Position
Specialist of community medicine
Other areas of specialty/work
Street address
Pardis of university, Mashhad University of Medical Sciences, Mashhad
City
Mashhad
Postal code
8564-917794
Phone
+98 51 1882 9386
Fax
Email
jarahil@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
Dr Peiman Hashemian
Position
Child and Adolescent Psychiatrist,
Other areas of specialty/work
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue,boo Ali square, Mashhad
City
Mashhad
Postal code
91959
Phone
+98 51188829262
Fax
Email
hashemianp@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
Lida Jarahi
Position
Specialist of community medicine
Other areas of specialty/work
Street address
Pardis of university, Mashhad University of Medical Sciences, Mashhad
City
Mashhad
Postal code
9177948974
Phone
Fax
+98 51 1876 3342
Email
jarahil@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)