Evaluation of the Effect of Education based on Leventhal's Self-Regulation Model on The Psychological Distress of Parent’s of Children with Autism in Qazvin, 1397
Determining the Effect of Education Based on Leventhal's Pattern of Self-Regulatory Pattern on Psychological Distribution of Parents of Children with Autism in Qazvin, 1397
Design
Clinical trials with control group,Randomized
Settings and conduct
The research environment is Sina Autism Home located at Vali Asr Crossroads, Shahed Street, the only Autism Spectrum Dispensary Training and Rehabilitation Center, and Leventhal's training for the test group during 4 sessions of 75 minutes in person and in the community at Sina's Autism Home Qazvin will be done.
Participants/Inclusion and exclusion criteria
In this study, the parents of children with autism who are referred to the home of Autism Sina in Qazvin will be included in the research.
Inclusion criteria:
• Complete satisfaction of the company in the research
• Ability to speak and understand Persian language
• No psychiatric disorder
• Not receiving other educational interventions simultaneously with the plan
• The availability of children's parents
• Do not use Psychotropic drugs
• Having reading and writing skills
Having at least one child with autism
• Life with a child's autism in a home
Exclusion criteria:
• The presence of parents of autistic children in a psychotherapy or other counseling process, while conducting research
• The parents of children with autism are reluctant to continue to cooperate and withdraw from the research project
• Lack of more than one session of training sessions
Intervention groups
Parents using Random Allocation Rule (assigning couple or individual scores to selected files and then a simple draw) will be divided into two groups of control and test and the Leventhal pattern training for the test group during the four sessions of 75 minutes in face and group At home of Autism Sinai City of Qazvin will be held
Main outcome variables
Leventhal's self-regulation model ; Psychological Distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180721040549N1
Registration date:2018-10-17, 1397/07/25
Registration timing:registered_while_recruiting
Last update:2018-10-17, 1397/07/25
Update count:0
Registration date
2018-10-17, 1397/07/25
Registrant information
Name
Marzieh Hajikarimbaba
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3252 3405
Email address
m.hajikarimbaba@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-09, 1397/04/18
Expected recruitment end date
2018-11-09, 1397/08/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Education based on Leventhal's Self-Regulation Model on The Psychological Distress of Parent’s of Children with Autism in Qazvin, 1397
Public title
Evaluation of the Effect of Education based on Leventhal's Self-Regulation Model on The Psychological Distress of Parent’s of Children with Autism in Qazvin, 1397
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Complete satisfaction of the company in the research• • • • • • •
Ability to speak and understand Persian language
No psychiatric disorder (parental report of having a history of mental illness and hospitalization)
Not receiving other educational interventions simultaneously with the plan
The availability of children's parents
Do not use Psychotherapeutic drug
Having reading and writing skills
Having at least one child with autism
Life with a child's autism in a home
Exclusion criteria:
The presence of parents of autistic children in a psychotherapy or other counseling process, while conducting research (during the period of this project, do not receive training on the subject of research and psychological training)
The parents of children with autism are reluctant to continue to cooperate and withdraw from the research project
Lack of more than one session of training sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After entering 60 mothers of eligible children with autism, they are assigned to the control and test groups using a randomized four-way parents method. So by randomly selecting 15 blocks of 4 blocks of 6 blocks, we will eventually reach the equalization of the control and the test of 30 people.
After this stage, the parents will be divided into two groups of control and test using random allocation using the Random Allocation Rule method (assigning paired or individual scores to selected files and then simple drawings)It will be divided into two groups of control and test.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Valiasr Street, Shahed Street, Sinai Autism House
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Approval date
2018-04-30, 1397/02/10
Ethics committee reference number
IR.QUMS.REC.1397.021
Health conditions studied
1
Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Psychological Distress: Psychological distress is a state of emotional distress and pain that is defined by symptoms of depression (such as loss of interest, sadness and despair) and anxiety (such as restlessness and tension), and may be associated with physiological signs Such as insomnia, headache and lack of energy), and disturbance in social function and everyday life of individuals. In this study, the psychological distress is the mean scores that will be examined by the Kessler Psychological Distress Questionnaire.
Timepoint
Before intervention and every month up to 6 months after intervention
Method of measurement
Kessler Psychological Distress Scale (K10)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Training based on Leventhal's self-regulation model in the present study in four sessions of 75 minutes in group
Category
Other
2
Description
Control group: Do not attend these training sessions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Home Autism Sinai Qazvin
Full name of responsible person
Tayyaba Emami
Street address
Qazvin - Vali Asr Crossroad, Shahed Street No. 15 - Sinai Autism House
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3322 9675
Email
m.hajkarimbaba@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peimani
Street address
ِDept of research Qazvin University of Medical Sciences Shahid Beheshti,
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 3333 8034
Email
nursingpublicaffairs@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Marzieh Haji Karim Baba
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qazvin - Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3252 3405
Email
m.hajkarimbaba@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Marzieh Haji Karim Baba
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qazvin - Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 8034
Email
m.hajkarimbaba@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Marzieh Haji Karim Baba
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qazvin - Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 8034
Email
m.hajkarimbaba@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available