Protocol summary

Study aim
Comparison between efficacy of reality therapy and mindfulness –based cognitive therapy on psychological well-being and cognitive emotion regulation and mother's attitude towards child's with autism spectrum disorders.
Design
three parallel group randomized trial. 45 participants, the study design in two therapy intervention group and one control group
Settings and conduct
The study population consisted of mothers of students with autism in the first to fifth grade of a special school in Mashhad. The purposeful sampling method was to select 45 mothers from the mothers and then randomly divided into two experimental groups and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: not having a mental disorder, Not participating in psychotherapy, do not take psychotropic drugs or drug abuse for the past six months, Completion of the informed consent form and attending the meetings. exclusion criteria Attending therapeutic sessions or psychotherapy training concurrently, Absence of more than two sessions, Not willing to continue attending meetings.
Intervention groups
One experimental group will receive reality therapy and the second experimental group will receive Mindfulness-Based Cognitive Therapy in 10 weeks and the control group will receive no treatment.
Main outcome variables
psychological well-being

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101130005280N30
Registration date: 2019-09-25, 1398/07/03
Registration timing: retrospective

Last update: 2019-09-25, 1398/07/03
Update count: 0
Registration date
2019-09-25, 1398/07/03
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion between efficacy of reality therapy and mindfulness –based cognitive therapy on psychological well-being and cognitive emotion regulation and mother's attitude towards child's with autism spectrum disorders.
Public title
Comparison between efficacy of reality therapy and mindfulness –based cognitive therapy mother's attitude towards child's with autism spectrum disorders.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
not having a mental disorder Not participating in psychotherapy do not take psychotropic drugs or drug abuse for the past six months Completion of the informed consent form and attending the meetings.
Exclusion criteria:
Attending therapeutic sessions or psychotherapy training concurrently Absence of more than two sessions Not willing to continue attending meetings
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization, randomly allocate a participant to a treatment group, while maintaining a balance across treatment groups. prepared a list of all permutations for the block size. selected one of them and based on arrangement allocated participants to a treatment and control groups with sealed envelope. Participants will be unaware of the type of intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
After obtaining informed consent, participants were classified into intervention groups and were not aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of Islamic Azad University Mshhhad Branch
Street address
Central building Ethics Committee of Islamic Azad University ,Emamyieh Street, Ghasem Abad, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Approval date
2019-06-12, 1398/03/22
Ethics committee reference number
IR.IAU.MSHD.REC.1398.047

Health conditions studied

1

Description of health condition studied
Autism Spectrum disorders
ICD-10 code
F84.0
ICD-10 code description
Childhood autism

Primary outcomes

1

Description
Psychological Wellbeing Scale
Timepoint
Before intervention and after intervention and 1 month after intervention
Method of measurement
REF Questionier

2

Description
Cognitive Emotion Regulation Questionnaire
Timepoint
Before intervention and after intervention and 1 month after intervention
Method of measurement
CERQ Questionnaire

3

Description
Mother's attitude towards child's
Timepoint
Before intervention and after intervention and 1 month after intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: reality therapy
Category
Treatment - Other

2

Description
Intervention group: mindfulness –based cognitive therapy
Category
Treatment - Other

3

Description
Control group:no treatment
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Exceptional children School
Full name of responsible person
Saeid Teymori
Street address
mashhad
City
Ghasem Abad, Mashhad.
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3525 1022
Email
Steimory28@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saeid Teymori
Street address
Central building Ethics Committee of Islamic Azad University ,Emamyieh Street, Ghasem Abad, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3525 1022
Email
Steimory28@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
Private
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
Saeid Teymori
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ostad Yusofi Street, Emamieh Boulevard ,GhasemAbad, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3525 1022
Email
Steimory28@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saeid Teymori
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ostad Yusofi Street, Emamieh Boulevard ,GhasemAbad, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3525 1022
Email
Steimory28@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ziba Emamdoust
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 57, Shadkam Street, Kohsangi Ave, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9174637167
Phone
+98 51 3525 1022
Email
zibaemamdoost@yahoo.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
No - There is not a plan to make this available
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