Protocol summary

Study aim
Determining the effectiveness of reality therapy on psychological capital, emotional self-regulation and anxiety sensitivity in children mothers with autism
Design
Clinical trial with control group (15 participants) and experimental group (15 participants), community-based, pragmatic, parallel groups, randomised controlled
Settings and conduct
Thirty mothers referred from the Autism Spectrum Association of Rasht city,will be selected by available sampling method and will be randomly divided into two experimental and control groups. After performing the pre-test for all participants, the virtual reality therapy group training course in a virtual training channel with voice and image and presenting written summaries with interaction and receiving feedback in the experimental group for For 8 sessions, 90 minutes will be held in 4 weeks. There will be no intervention in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers between 25 and 35 years old, Children with autism 3-10 years old, Severity of high-functioning autism according to psychiatrist; Exclusion criteria: Psychiatric problems.
Intervention groups
The intervention group consisted of 15 mothers referred from the Autism Spectrum Association who were randomly placed in the experimental group with the inclusion criteria. No intervention was performed for the control group that will refere from autism Spectrum Association.
Main outcome variables
Psychological Capital; Emotional Self-Regulation; Anxiety Sensitivity

General information

Reason for update
Acronym
RT
IRCT registration information
IRCT registration number: IRCT20210619051622N1
Registration date: 2021-08-10, 1400/05/19
Registration timing: prospective

Last update: 2021-08-10, 1400/05/19
Update count: 0
Registration date
2021-08-10, 1400/05/19
Registrant information
Name
Seyedeh Masoumeh Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3213 3959
Email address
sami.bagheri78@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-11, 1400/05/20
Expected recruitment end date
2021-09-11, 1400/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Reality Therapy on Psychological Capital, Emotional Self-Regulation and Anxiety Sensitivity in Mothers of Children With Autism
Public title
The effectiveness of reality therapy on psychological variables in mothers with children with autism spectrum disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers' consent to participate in the study Age of mothers between 25 and 40 years, Age of child with autism 3-10 years, Severity of high-functioning autism according to psychiatrist.
Exclusion criteria:
History of psychiatric problems, Distortion of questionnaires, Lack of entrance criteria.
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method in this research, in terms of selecting the sample to enter the research, it is done by sampling and being in the intervention and control group is a simple random and by lottery.
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 Islamic Azad University - Lahijan Branch
Street address
No. 4, Eskan Building, First Alley, Taleghani Alley, Moallem Blvd, Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
4157933809
Approval date
2021-05-26, 1400/03/05
Ethics committee reference number
IR.IAU.LIAU.REC.1400.022

Health conditions studied

1

Description of health condition studied
Mothers of children with autism spectrum disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Miller and Brown's self-regulation scale (SRQ)
Timepoint
Assessment will be done once at the beginning of the study and once after the intervention.
Method of measurement
Miller and Brown's self-regulation scale (SRQ)

2

Description
Anxiety Sensitivity Index (ASI)
Timepoint
Assessment will be done once at the beginning of the study and once after the intervention.
Method of measurement
Anxiety Sensitivity Index (ASI)

3

Description
Luthans Psychological Capital Questionnaires (PCQ)
Timepoint
Assessment will be done once at the beginning of the study and once after the intervention.
Method of measurement
Luthans Psychological Capital Questionnaires (PCQ)

Secondary outcomes

empty

Intervention groups

1

Description
This research consists of two control groups and an experimental group. In each group, 15 people participate. First, a questionnaire is given to both groups. After separating the groups, the reality therapy training intervention was used for the experimental group. Reality therapy has been based on choice theory. Workshops for the experimental group consisted of 8 sessions for one month in which participants received training twice a week for 90 minutes by presenting videos, booklets, flashcards, audio and video content. Then, in order to evaluate the effectiveness of the intervention, a questionnaire was given to both groups again to compare the changes obtained from training in the training group with the control group. It should be noted that no drug treatment was used in this
Category
Behavior

2

Description
There was no intervention on the control group and this group completed the study questionnaires in only two stages.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Besharat Exceptional School
Full name of responsible person
Kobra Alijanpour
Street address
Besharat Exceptional School, Gilan Boulevard, Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
4164615555
Phone
+98 13 3377 2838
Email
Kobraalijanpour@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Gholamreza Vaghar
Street address
Islamic Azad University., Lahijan
City
Rasht
Province
Guilan
Postal code
1616
Phone
+98 13 4222 9081
Email
gholamreza.vaghar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Seyedeh Masoumeh Bagheri
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 4, Eskan Building, First Alley, Taleghani Alley, Moallem Blvd, Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
4157933809
Phone
+98 13 3213 3959
Email
sami.bagheri78@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedeh Masoumeh Bagheri
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 4, Eskan Building, First Alley, Taleghani Alley, Moallem Blvd, Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
4157933809
Phone
+98 13 3213 3959
Email
sami.bagheri78@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedeh Masoumeh Bagheri
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 4, Eskan Building, First Alley, Taleghani Alley, Moallem Blvd, Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
4157933809
Phone
+98 13 3213 3959
Email
sami.bagheri78@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
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
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