Protocol summary

Study aim
The Effect of Cognitive Therapy on Anxiety, Self-esteem, Social Behavioral Skills and Academic Self-Efficacy in Children with Learning Disorder
Design
This study was conducted as a pre-test and post-test clinical trial in two groups of control and experiment. A cognitive therapy game using the "Cat Cat" method will be performed in a 16-session program, 3 days a week, for 45 minutes. Test evaluation tools consist of Colorado Wilkat learning difficulties questionnaires, Jink & Morgan's self-efficacy questionnaire, Rater's Teacher's Inventory, Spence Anxiety Inventory, Cooper Smith's Self-Esteem Questionnaire, Gersham and Elliott Social Proficiency Questionnaire.
Settings and conduct
After receiving the ethics code from Semnan University of Medical Sciences and obtaining a referral letter for Rehabilitation Centers and Semnan Learning Disorders School, following the ethical point of view, the purpose of the study, the methods and conditions of the test, for all participants fully explained will be given. Questions and answers will be given to participants in order to resolve any ambiguity. Also, all written consent will be received from all participants. Two occupational therapists are participating in this study. One of them is a tester and a blind therapist and the other is a therapist and familiar with the treatment. Before the commencement of group cognitive therapy games sessions, participants attend a single session in a quiet room, away from any stimulus by the examiner using the study tools. Then therapeutic interventions "are conducted in a 16-session program of 3 days a week for 45 minutes for participants in a group, each with a total of 10-8 children. After completing the therapeutic sessions, the function of each The participants will be tested by the test, at all stages of the test, the same conditions will be followed for all samples. The therapist participated in the group meetings in equal shares in the treatment interventions and the principles of the treatment group for all subjects The participants in the school will be grouped together
Participants/Inclusion and exclusion criteria
The criteria for entering the study include: ages 12-8, children with reading disorder with psychiatrist's diagnosis, and exclusion criteria including other psychiatric disorders, lack of cooperation between the child and parents in treatment sessions, and evaluations before and after intervention will be.
Intervention groups
After receiving the ethics code from Semnan University of Medical Sciences and obtaining a referral letter for Rehabilitation Centers and Semnan Learning Disorders School, following the ethical point of view, the purpose of the study, the methods and conditions of the test, for all participants fully explained will be given. Questions and answers will be given to participants in order to resolve any ambiguity. All participants will also receive written informed consent. Before the commencement of group cognitive therapy games sessions, participants attend a single session in a quiet room, away from any stimulus by the examiner using the study tools. Then therapeutic interventions "are conducted in a 16-session program of 3 days a week for 45 minutes for participants in a group, each with a total of 10-8 children. The control group also received common therapeutic treatment After completing the attending sessions, the performance of each participant will be re-evaluated by the test, and at all stages of the test, the same conditions will be met for all samples. The therapist will also treat all samples equally in group meetings. Therapeutic interventions and the principles of group therapy will be respected for all.
Main outcome variables
1. Anxiety 2. Self-esteem 3. Social skills 4. Learning difficulties 5. Academic self-efficacy 6. Behavior

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171219037954N1
Registration date: 2018-01-08, 1396/10/18
Registration timing: registered_while_recruiting

Last update: 2018-01-08, 1396/10/18
Update count: 0
Registration date
2018-01-08, 1396/10/18
Registrant information
Name
Minasadat Mirshoja
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
msj5831@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-23, 1396/10/02
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cognitive Therapy on Anxiety, Self-esteem, Social Behavioral Skills and Academic Self-Efficacy in Children with Reading Disabilities
Public title
Cognitive Play Therapy on Anxiety in Children with Reading Learning Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ages 12-8 children with reading disorder with diagnosis of a psychiatrist
Exclusion criteria:
The presence of learning disorder with other psychiatric disorders
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Each of the schools in Semnan is given a number. Numbers are written on separate paper. Then the number of a school by lot is removed randomly. Each student with a valid entry criteria is also given a number. From one to fifteen in the intervention group and from sixteen to thirty in the control group. Then, each student number is randomly assigned to the lot by lot.
Blinding (investigator's opinion)
Not blinded
Blinding description
In this way, the task is planned in such a way that the participant does not understand which of the two control or test groups belong.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
IR.SEMUMS.REC
Street address
15 km Damghan Road- Semnan University of Medical Sciences- Faculty of Rehabilitation
City
semnan
Province
Semnan
Postal code
3514799442
Approval date
2017-12-12, 1396/09/21
Ethics committee reference number
IR.SEMUMS.REC.1396.166

Health conditions studied

1

Description of health condition studied
Specific developmental disorders of scholastic skills
ICD-10 code
F81.0
ICD-10 code description
Specific reading disorder

Primary outcomes

1

Description
Learning problems
Timepoint
10 to 15 minutes
Method of measurement
Colorado Wilkat Learning Problems Questionnaire

2

Description
anxiety
Timepoint
10 to 15 minutes
Method of measurement
Jink & Morgan Academic Self-Efficacy Inventory

3

Description
behavioral problems
Timepoint
10 to 15 minutes
Method of measurement
Rutter Behavioral Questionnaire Teacher Form

4

Description
Anxiety
Timepoint
10 to 15 minutes
Method of measurement
Spence Anxiety Inventory

5

Description
Self-Esteem
Timepoint
10 to 15 minutes
Method of measurement
Cooper Smith Self-Esteem Questionnaire

6

Description
Social skills problems
Timepoint
10 to 15 minutes
Method of measurement
Gersham and Elliot Social Skills Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Children with learning disabilities 8 to 12 years of age, in a 16-session program, 3 days a week for 45 minutes for participants in a group. Each group has 10-8 children. Therapeutic interventions designed for each treatment session: First session: Getting to know each other and explaining the principles of treating situations that disturb the child. Session 2: Review the previous session Helping the child to recognize different feelings and recognize the differentiation of anxiety Concerns about other feelings Child's recognition of body reactions to anxiety Start anxiety hierarchy designing - Session 3: Review the session Pre-recognition of the child's response Body Anxiety. Session Four: Encouraging Parents to Participate in a Therapeutic Plan and Creating Safe Children's Responses to Child and Parent's Questions. Session F: Reviewing the Anxiety Tip and Concerns in the Child. Familiarizing with the Methods of Attraction. Session Six: Explaining Thoughts. Negative Person and Their Impact on Anxiety Helps Identify Child's Insomnia During Anxiety Helps Positive / Relaxation Suggestions, Seventh Session: Self-Controversy and Problem-Solving Training, Eighth Session: Beginning A Practice in Tense Situations, Ninth Meeting: Second Meeting with Parents, Tenth Meeting: Facing the Child in Situations with Less Exposed Anxiety, Lesson 11: Exercise of the child in situations with less anxiety, Twelfth session: Facing the child in moderate anxiety situations, Thirteenth session: Exercise of the child in situations with moderate anxiety with tranquility, Session fourteen: Facing the child in 15th session of anxiety. Exercise of the child in situations with high anxiety with calm. Sixteenth session: generalize the skills learned to other environments
Category
Behavior

2

Description
Control group: Includes children with learning disabilities, aged 8-12 years, who benefit from routine and professional care services in rehabilitation centers.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Exceptional schools in Semnan city
Full name of responsible person
Mina sadat Mirshoja
Street address
Damghan Road, Semnan University of Medical Sciences, Faculty of Rehabilitation
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4180
Email
msj5831@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Scienes, Basij Blvd, Semnan
City
semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@gmail.com
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
Mina sadat Mirshoja
Position
faculty
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Damghan Road, Semnan University of Medical Sciences, Faculty of Rehabilitation
City
semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4180
Email
msj5831@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
mina sadat mirshoja
Position
faculty
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Damghan Road, Semnan University of Medical Sciences, Faculty of Rehabilitation
City
semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4180
Email
msj5831@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
mina sadat mirshoja
Position
faculty
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Damghan Road, Semnan University of Medical Sciences, Faculty of Rehabilitation
City
semnan
Province
Semnan
Postal code
5314799442
Phone
+98 23 3365 4180
Email
msj5831@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Yes - There is 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
Title and more details about the data/document
Reproductive in the field of rehabilitation and behavioral science
When the data will become available and for how long
One year
To whom data/document is available
researchers
Under which criteria data/document could be used
Behavioral sciences and its effects
From where data/document is obtainable
Semnan University of Medical Sciences
What processes are involved for a request to access data/document
Supervision of the Student Research Committee of Semnan University of Medical Sciences - fulfillment of main investigator's obligations
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