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Effectiveness of self-differentiation psycho education based on systemic theory on family function, parental stress, marital satisfaction and adjustment and resilience in mothers of children with Autism Spectrum Disorder

Protocol summary

Study aim
Evaluation of the effectiveness of systems theory-based self-differentiation psycho education in increasing the self-differentiation , increasing family Function,reducing parenting stress, Increasing the Marital Adjustment,Increasing the Marital Satisfaction,Increasing the Resilience of Mothers of Children with Autism Spectrum
Design
Randomized controlled trial, available sampling,Parallel groups, not blinded, randomized placement in intervention and control group, sample size 36,pretest post test and follow up, one month follow up
Settings and conduct
available Sampling at the Mita Charity.Volunteers randomly assigned into two groups, one experimental and one control group. The sampling process was carried out in 5 stages. Patient selection, pre-test, intervention, post-test, and one-month follow-up.
Participants/Inclusion and exclusion criteria
Entry Criteria: Couples living together, having at least one child with autism diagnosis, low score on differentiation scale. Having minimum guidance education Exit criterion: Simultaneous participation in other psychological therapies, diagnosis of severe psychiatric disorders such as psychotic disorders and acute personality disorders of any drug use, unwillingness to cooperate
Intervention groups
Intervention in the form of self-differentiation Psycho education is carried out in 10 sessions according to the Young and Long protocol (2006). The control group received no intervention in this study
Main outcome variables
family function,parental stress, marital satisfaction and adjustment and resilience

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181126041764N1
Registration date: 2019-11-02, 1398/08/11
Registration timing: retrospective

Last update: 2019-11-02, 1398/08/11
Update count: 0
Registration date
2019-11-02, 1398/08/11
Registrant information
Name
fatemeh jokar bezein
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7742 1963
Email address
f.jokar91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-27, 1398/05/05
Expected recruitment end date
2019-08-17, 1398/05/26
Actual recruitment start date
2019-07-27, 1398/05/05
Actual recruitment end date
2019-08-21, 1398/05/30
Trial completion date
2019-10-21, 1398/07/29
Scientific title
Effectiveness of self-differentiation psycho education based on systemic theory on family function, parental stress, marital satisfaction and adjustment and resilience in mothers of children with Autism Spectrum Disorder
Public title
Effectiveness of self-differentiation psycho education in mothers of children with Autism Spectrum Disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a marital relationship Having at least one child diagnosed with autism Gaining a low score on the scale of differentiation Having a minimum education degree
Exclusion criteria:
diagnosed of severe psychiatric disorders such as psychotic disorders and acute personality disorders Taking any drugs Disclaimer of cooperation in the project
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Actual sample size reached: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done through available sampling until the completion of the sample, in which the mothers who volunteered to participate in the research will be recruited based on the inclusion and exclusion criteria of the registrant; Random number tables are used in the experimental and control groups.
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 social welfare and rehabilitation sciences University
Street address
Kodakyar Ave., daneshjo blvd., Evin
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۷۱
Approval date
2018-12-16, 1397/09/25
Ethics committee reference number
IR.USWR.REC.1397.111

Health conditions studied

1

Description of health condition studied
self-differentiation,family function, parental stress, marital satisfaction marital adjustment, resilience
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
family function
Timepoint
before the first sessions of psycho education, the last session of intervention and a month later of the last session of intervention
Method of measurement
Family Functioning Assessment Scale (FAD)

2

Description
parental stress
Timepoint
before the first sessions of psycho education, the last session of intervention and a month later of the last session of intervention
Method of measurement
Parenting Stress Questionnaire (PSI-SF)

3

Description
marital satisfaction
Timepoint
before the first sessions of psycho education, the last session of intervention and a month later of the last session of intervention
Method of measurement
Enrich marital satisfaction

4

Description
marital adjustment
Timepoint
before the first sessions of psycho education, the last session of intervention and a month later of the last session of intervention
Method of measurement
Marital Adjustment Questionnaire (DAS),

5

Description
resilience
Timepoint
before the first sessions of psycho education, the last session of intervention and a month later of the last session of intervention
Method of measurement
Conner & Davidson Resilience Questionnaire (CD-RISC)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention with self-differentiation Psycho education according to Young and Long protocol (2006) was performed in ten sessions in experimental group and control group received no intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Autism Aid Mothers Charity (MITA)
Full name of responsible person
kiandokht salehi
Street address
2 deadend, Behafarin ave, Valiasr Square
City
Tehran
Province
Tehran
Postal code
1737843994
Phone
+98 21 8894 5982
Email
F.jokar91@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Khankeh Hamid
Street address
Kodakyar Ave., daneshjo blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0081
Fax
+98 21 2218 0121
Email
hamid.khankeh@ki.se
Web page address
https://uswr.ac.ir/page/%D9%85%D8%B9%D8%A7%D9%88%D9%86+%D8%AA%D8%AD%D9%82%DB%8C%D9%82%D8%A7%D8%AA+%D9%88+%D9%81%D9%86+%D8%A2%D9%88%D8%B1%DB%8C
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Khankeh Hamid
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0008
Fax
+98 21 2218 0160
Email
hamid.khankeh@ki.se
Web page address
https://uswr.ac.ir/page/%D9%85%D8%B9%D8%A7%D9%88%D9%86+%D8%AA%D8%AD%D9%82%DB%8C%D9%82%D8%A7%D8%AA+%D9%88+%D9%81%D9%86+%D8%A2%D9%88%D8%B1%DB%8C

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Fatemeh Jokar bezein
Position
MA student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 15, 2/30 Alley,2th Niroohavayi Ave, Piroozi Ave
City
Tehran
Province
Tehran
Postal code
1737843994
Phone
+98 21 7742 1963
Fax
Email
f.jokar91@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Fatemeh Jokar bezein
Position
MA student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 15, 2/30 Alley,2th Niroohavayi Ave, Piroozi Ave
City
Tehran
Province
Tehran
Postal code
1737843994
Phone
+98 21 7742 1963
Fax
Email
f.jokar91@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
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