Protocol summary

Study aim
Determination of the effect of altogether on the relationship between parent-child and perceived stress and the meaning of mothers with children with atherosclerosis referring to Pishgaman Omid center in 1396
Design
experimental- controlled group- randomized tria
Settings and conduct
Pishgaman Omid Center
Participants/Inclusion and exclusion criteria
1- Having a child with autism diagnosis by a registered psychiatrist in the case 2. Having a minimum third degree 3. Not having a physical or mental illness according to your mother's opinion
Intervention groups
Mothers with child autism from 3 to 15 years of age
Main outcome variables
Perceived stress, Parent-Child Relationship and Meaningfulness

General information

Reason for update
Acronym
Autism
IRCT registration information
IRCT registration number: IRCT20140212016564N11
Registration date: 2018-07-07, 1397/04/16
Registration timing: registered_while_recruiting

Last update: 2018-07-07, 1397/04/16
Update count: 0
Registration date
2018-07-07, 1397/04/16
Registrant information
Name
Molood Radfar
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1275 4961
Email address
radfar.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
none
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2019-02-23, 1397/12/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of logotherapy on Perceived stress, Parent-Child Relationship and Meaningfulness of Mothers of Children with Autism Disorder referred to the Pishgaman Omid Center in Urmia, 2017
Public title
The Effect of logotherapy on Perceived stress, Parent-Child Relationship and Meaningfulness of Mothers of Children with Autism Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Having a child with autism diagnosis by a psychiatrist 2.Having a third grade middle school 3. Not having a physical or mental illness
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
To ensure the random allocation: The method of assignment to groups was done in this way That:We put number cards in the envelope and will be placed in two groups.
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 Urmia University of Medical Sciences
Street address
UMSU Central Site: Orjhans Street, Resalat Blvd, Urmia , Iran (Postal Code:571478334)
City
urmia
Province
West Azarbaijan
Postal code
571478334
Approval date
2017-12-03, 1396/09/12
Ethics committee reference number
ir.umsu.rec.1396.282

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
Parent-child relationship and perceived stress and sensation of mothers with children with atherosclerosis
Timepoint
3 month after intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
This research is experimental with control and intervention groups. The researcher with a referral from Urmia University of Medical Sciences refer to Pishgaman Omid center in 2017 . If the mothers are willing and willing to participate in the study, they will be provided with a list of them and will be selected as simple random sampling and according to the sample size formula. At first, a demographic questionnaire and a personalized consent form will be provided to both groups. Data will be collected by three stressful questionnaires, mother and child relationship assessment, and the meaning of life. In addition to current programs, Logothrapy meetings will be held for the intervention group during 10 sessions (two sessions a week), but the group Control Received the current programs. After the completion of intervention and follow up, Logothrapy training will be provided to the control group in 5 (one-hour) meetings.The members of the intervention group (two groups of 10 person) will be present at the meetings. After three months, questionnaires will be completed .The Logothrapy will be performed for groups (2 groups and in each group is of 10 person) for 10 sessions and each session lasts for 90 minutes.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pishgaman Omid Center
Full name of responsible person
Dr.Solaimani
Street address
Sadi street, Boustan avenue, Pishgaman Omid Center, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
33746-57351
Phone
+98 44 3368 6177
Email
msoleymani21@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Soada mihandoust
Street address
Nazlou Road
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3275 4961
Fax
+98 44 3222 9059
Email
S.mihandoost@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
50
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
Oroumia University of Medical Sciences
Full name of responsible person
Soada Mihandoust
Position
PhD Candidate in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Nazlou, 11 km of Nazlou Road
City
Urmia
Province
West Azarbaijan
Postal code
98 44 322 290 59
Phone
+44 32754961
Fax
+98 44 3222 9059
Email
S.mihandoost@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Moloud Radfar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardis Nazlou, 11 km of Nazlou Road
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+44 32754961
Fax
+98 44 3222 9059
Email
mradfar1343@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Soada Mihandoust
Position
Ph.D. Candidate in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Nazlou, 11 km of Nazlou Road
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+44 32754961
Email
S.mihandoost@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I'm still in the analyzing data and the work not completed.
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
No - There is not 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
Loading...