Protocol summary

Study aim
The purpose of the present study was assessing the effect of acceptance and commitment therapy on reducing parental stress (parental disturbances, dysfunction parent-child relationship, and parent's perception of difficult children), and increasing family empowerment
Design
The two rehab clinics are going to be selected randomly, and the participants will be assigned to the test and control groups based on the draw
Settings and conduct
The treatment and completion of the questionnaires will be carried out in the clinic, and each session will be hold once a week.
Participants/Inclusion and exclusion criteria
Entry requirements include the tendency to participating in the group, at least 6 months have passed since childhood autism was diagnosed, and having at least middle school certificate Non-entry requirements include receiving psychological treatment over the past year and in parallel and having other psychiatric disorders
Intervention groups
Acceptance and commitment group therapy are going to carry out for the experimental group in 8 sessions. Before and after the sessions, pretest and post-test are going to be completed. In control group, questionnaires will be completed in two stages: pre-test and post-test
Main outcome variables
Decreasing parental stress and increasing family empowerment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190727044346N1
Registration date: 2019-08-04, 1398/05/13
Registration timing: registered_while_recruiting

Last update: 2019-08-04, 1398/05/13
Update count: 0
Registration date
2019-08-04, 1398/05/13
Registrant information
Name
Niloofar Goharbakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3445 2586
Email address
niloofar.goharbakhsh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-01, 1398/05/10
Expected recruitment end date
2019-08-11, 1398/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of acceptance and commitment therapy ob parental stress and family empowerment for parents of children with autism
Public title
Effectiveness of acceptance and commitment therapy for parents of children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Tendency for participating in the group Aged range from 20 to 55 At least 6 months have passed since childhood autism was diagnosed Having at least middle school certificate
Exclusion criteria:
Receiving psychological treatment over the past year and in parallel Having other psychological disorder
Age
From 22 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized method was used, and clinics and participants ere selected by using a simple random sampling method based on draw
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Science
Street address
No. 48, Nastaran alley, Bostan street, Shahid Beheshti street, Alborz town
City
Alborz
Province
Alborz
Postal code
3145646646
Approval date
2019-02-19, 1397/11/30
Ethics committee reference number
IR.SEMUMS.REC.1397.274

Health conditions studied

1

Description of health condition studied
Autism and acceptance and commitment therapy
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder

Primary outcomes

1

Description
The primary outcome of variable is parental stress and the degree of effectiveness of treatment will be assessed by that
Timepoint
The measurement time is before starting treatment and after treatment
Method of measurement
Short form of parental stress questionnaire from Abidin

Secondary outcomes

1

Description
Family empowerment and the degree of effectiveness of treatment will be assessed by that
Timepoint
The measurement time is before starting treatment and after treatment
Method of measurement
Family empowerment questuonnaire from Koren, DeChillo and Friesen

Intervention groups

1

Description
Intervention group: acceptance and commitment group therapy will be done for 8 sessions. The sessions will be hold once in every week, and key factors consist of defusion, self as context, contact with the present moment, values, committed action and acceptance. The goal of this study is increasing flexibility of client
Category
N/A

2

Description
Control group:This group does not receive any intervention, and they are assessed by pre-test and post-test
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Behpooyan rehabilitation clinic
Full name of responsible person
Negar Kalami
Street address
No. 473, Nasim alley, Taleghani street, Alborz town
City
Alborz
Province
Alborz
Postal code
6687698344
Phone
+98 26 3322 0189
Email
niloofar.goharbakhsh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mahmood Njafy
Street address
Faculty of psychology of Semnan university, Mehdishahr town, Semnan city
City
Mehdishahr
Province
Semnan
Postal code
1911135131
Phone
+98 23 3362 3300
Email
m_najafi@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mahmood Najafi
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Psychology faculty of Semnan university, Mehdishahr city, Semnan province
City
Mehdishahr
Province
Semnan
Postal code
3145646646
Phone
+98 23 3362 4250
Fax
Email
m_najafi@semnan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Niloofar Goharbakhsh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 48, Golestan alley., Bostan street., Shahid Beheshti street., Alborz town
City
Alborz
Province
Alborz
Postal code
3145646646
Phone
+98 26 3445 2586
Fax
Email
niloofar.goharbakhsh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Niloofar Goharbakhsh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 48, Golestan alley., Bostan street., Shahid Beheshti street., Alborz town
City
Alborz
Province
Alborz
Postal code
3145646646
Phone
+98 26 3445 2586
Fax
Email
niloofar.goharbakhsh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Pre-test and post-test questionnaires of participants and treatment protocol
When the data will become available and for how long
There have not considered any specific time period
To whom data/document is available
Other scholars who intend to do research on this subject
Under which criteria data/document could be used
To get familiar with the research process and facilitate the treatment process
From where data/document is obtainable
Semnan University Library
What processes are involved for a request to access data/document
First, you should email the responsible author, and then go to Semnan University for receiving documentation
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