Protocol summary

Study aim
Determining the effect of mindfulness group training on anxiety, stress and depression of mothers with children with learning disabilities
Design
44 mothers of children with eligible learning disabilities, the samples were randomly divided into two groups of control and intervention using random blocking method. The size of each block will be equal to two, four or eight samples. After being assigned to the blocks, individuals will enter one of the two control and test groups. Therefore, by random selection, we will finally reach an equal volume of control and test, which is 22 people.
Settings and conduct
In the Center for Special Learning Disabilities, the statistical population of the study includes mothers of children with learning disabilities. The DASS-21 questionnaire will be completed in the intervention group in three stages, before the intervention, immediately after the sessions and 2 months after the training, and for the control group in the previous three stages, two and four months later.
Participants/Inclusion and exclusion criteria
Complete satisfaction from participating in the research Able to speak and understand Persian language Having at least one child with each type of learning disability Living with a child with a learning disability in a home
Intervention groups
Content of 8 sessions in 90-minute sessions twice a week based on Kabat Zain mindfulness training package in the form of lectures, group discussions and performing and practicing techniques. about 30 minutes are devoted to reviewing the summary of the previous session and doing homework and homework, and then will be accompanied by expressing new content and mindfulness techniques related to the same session. During the intervention for the experimental group, the control group benefits from the training and routine interventions.
Main outcome variables
Anxiety; Stress ; Depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201126049493N1
Registration date: 2021-02-13, 1399/11/25
Registration timing: prospective

Last update: 2021-02-13, 1399/11/25
Update count: 0
Registration date
2021-02-13, 1399/11/25
Registrant information
Name
Elham Hasannia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3378 8536
Email address
elhamhasannia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating The Effect of Mindfulness Group Training on Anxiety, Stress and Depression of mothers with children with learning disabilities
Public title
Evaluating The Effect of Mindfulness Group Training on Anxiety, Stress and Depression of mothers with children with learning disabilities
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Complete satisfaction from participating in the research Able to speak and understand Persian language Ability to participate in group intervention sessions Availability of mothers of children Having a diploma Have at least one child with each type of learning disability Living with a child with a learning disability in a home
Exclusion criteria:
The presence of parents of children with learning disabilities in a psychotherapy or other counseling process, at the same time as conducting research Existence of psychiatric disorder (parents' own report on having a history of psychiatric illness and hospitalization due to this) Taking psychotropic drugs The child has other medical and psychiatric disorders (based on the student's educational record and parents' self-declaration) Absence of more than two sessions of training sessions
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
A sequence of random numbers will be created using the agricolae package in R software.Samples are randomly divided into control and intervention groups using random blocking method. The size of each block will be equal to two, four or eight samples. People will receive one of the treatments by accident after being assigned to the blocks.
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 Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2021-02-11, 1399/11/23
Ethics committee reference number
IR.QUMS.REC.1399.473

Health conditions studied

1

Description of health condition studied
Learning disability
ICD-10 code
F81.9
ICD-10 code description
Developmental disorder of scholastic skills, unspecified

Primary outcomes

1

Description
stress
Timepoint
Stress, anxiety and depression variables in the intervention and test groups in three stages, before the intervention, immediately after the sessions and 2 months after the training.
Method of measurement
DASS-21 questionnaire

2

Description
anxiety
Timepoint
Stress, anxiety and depression variables in the intervention and test groups in three stages, before the intervention, immediately after the sessions and 2 months after the training.
Method of measurement
DASS-21 questionnaire

3

Description
depression
Timepoint
Stress, anxiety and depression variables in the intervention and test groups in three stages, before the intervention, immediately after the sessions and 2 months after the training.
Method of measurement
DASS-21 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The content of the sessions will be held in 8 sessions of 90 minutes twice a week based on the Kabat Zain mindfulness training package in the rehabilitation training center for special learning problems equipped with audio-visual facilities and with a suitable space. Sessions will be held in the form of lectures, questions and answers, group discussions and performing and practicing techniques, as well as using visual aids such as PowerPoint and pictures and in compliance with all health protocols. At the beginning of each session, about 30 minutes are devoted to reviewing the summary of the previous session and doing homework and homework, and then will be accompanied by expressing new content and mindfulness techniques related to the same session, and at the end of the session by delivering attachments Related to the topic of the same session and homework The session ends. DASS-21 questionnaire was completed in three stages in the experimental group, before the intervention, immediately after the sessions and 2 months after training (follow-up) and for the control group in three stages (before, two and four months after). Will be. The treatment protocol used in this study was taken from the practical handbook of cognitive therapy based on the presence of the mind.
Category
Other

2

Description
Control group: The control group benefits from the routine training and interventions of the center as in the past (they will not have any targeted training and intervention according to the research criteria). The instructor of the sessions is a master student of psychiatric nursing who has passed mindfulness courses. The DASS-21 questionnaire is in the experimental group in three stages, before the intervention, immediately after the sessions and 2 months after Training (follow-up) and for the control group will be completed in three stages (before, two and four months later).
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation Training Center for Special Learning Disabilities
Full name of responsible person
Fatemeh Parvandi
Street address
Rehabilitation Training Center for Special Learning Disabilities, Vali Asr intersection
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
Elhamhasannia@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. MohammadMahdi Emamjome
Street address
Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
memamjomeh@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Elham Hasannia
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
Elhamhasannia@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Elham Hasannia
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
Elhamhasannia@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Elham hasannia
Position
Master of Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
Elhamhasannia@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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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