Protocol summary

Study aim
The aim of this study was to Comparison of the Effectiveness Floor Time Play and Cognitive-Behavioral Play Therapy on Emotion Management, Self-Control, and Executive Functions in Students with Attention Deficit Hyperactivity Disorder and Mathematics Disorder.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized
Settings and conduct
The experimental groups of this study were trained in Omid Arak Counseling Center. The method was group work, blinding was not performed in this study. The interventions were performed by psychiatrists in experimental groups.
Participants/Inclusion and exclusion criteria
The criteria for entering the subjects are: Intermediate and Intermediate Intelligence (Lack of Mental Retardation), 4th, 5th and 6th Grade Elementary School Lack of mental disorders and no acute illness The criteria for leaving the subjects are: Taking psychiatric medications
Intervention groups
Floor Time Play (based on the theoretical foundations of fluoride in the form of 10 weekly therapy sessions) Cognitive-Behavioral Play Therapy (Based on Theoretical Foundations of Behavioral Cognitive Therapy in the form of 10 weekly therapy sessions) control group
Main outcome variables
Executive functions, self-control, emotion management.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200405046962N2
Registration date: 2020-05-07, 1399/02/18
Registration timing: retrospective

Last update: 2020-05-07, 1399/02/18
Update count: 0
Registration date
2020-05-07, 1399/02/18
Registrant information
Name
Farshid alipour
Name of organization / entity
Kharazmi University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 81 3421 0573
Email address
alipoorfarshid@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-02, 1398/07/10
Expected recruitment end date
2019-10-12, 1398/07/20
Actual recruitment start date
2019-10-12, 1398/07/20
Actual recruitment end date
2020-01-20, 1398/10/30
Trial completion date
2020-02-01, 1398/11/12
Scientific title
Comparison of the Effectiveness Floor Time Play and Cognitive-Behavioral Play Therapy on Emotion Management, Self-Control, and Executive Functions in Students with Attention Deficit Hyperactivity Disorder and Mathematics Disorder
Public title
Psychological intervention on improving the condition of children with attention deficit hyperactivity disorder and mathematical learning disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Intermediate and Intermediate Intelligence (Lack of Mental Retardation) Fourth, fifth and sixth grade of elementary school Lack of mental disorders and no acute illness
Exclusion criteria:
Lack of cooperation between the child or the family at each stage of the research Child restlessness and intolerance to research conditions
Age
From 9 years old to 13 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 45
Actual sample size reached: 36
Randomization (investigator's opinion)
Randomized
Randomization description
An random assignment was made in which all the subjects name were poured into a container and a name was randomly removed from the container. Then, to determine this person's intervention method, the name of the intervention method (dialectical, attachment and control) was randomly removed from another container.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization of subjects in the research groups was done by random assignment using lottery, so that the subjects did not know the type of group to which they would be members, the subjects were unaware that other people belong to the type of group. Also, group membership was done by lottery, so that after random selection of the subject, one of the groups was selected by lot. Also, the statistical analyst did not know the type of research groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University, arak Branch
Street address
No12, Building 1, Quarter Amirkabir University, Blv Imam Khomeini, Sq Imam Khomeini, Arak. Iran.
City
Arak
Province
Markazi
Postal code
91311-38361
Approval date
2019-11-02, 1398/08/11
Ethics committee reference number
IR.IAU.ARAK.REC.1399.002

Health conditions studied

1

Description of health condition studied
Attention Deficit Hyperactivity Disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders

2

Description of health condition studied
Mathematics Disorder
ICD-10 code
F81.2
ICD-10 code description
Mathematics disorder

Primary outcomes

1

Description
Executive Functions
Timepoint
Before the start of the intervention, after the end of the intervention, two months after the end of the intervention
Method of measurement
Executive Functions scale

Secondary outcomes

1

Description
Self-Control
Timepoint
Before the start of the intervention, after the end of the intervention, two months after the end of the intervention
Method of measurement
Self-Control scale

2

Description
emotion management
Timepoint
Before the start of the intervention, after the end of the intervention, two months after the end of the intervention
Method of measurement
emotion management scale

Intervention groups

1

Description
Intervention group 1 : Floor Time Play 1- Teaching and introducing emotions and how to identify the feelings of the child and parents and raising emotional awareness in general. Give it anger. 3- Paying attention to the negative and positive emotions of the child and those around him and the situations that arouse these emotions, because the emotions of the child and those around him affect the emotions of the parents. Be. 4. Emphasize that awareness of emotions and the ability to deal with them is important for dealing with them and for healthy functioning, and repression and disorder can lead to helplessness, frustration, and mental rumination. 5- Separating adaptive emotions from adaptive emotions. If the feeling is healthy, it should be used as a practical guide, and if it is unhealthy, it should be changed.
Category
Behavior

2

Description
Intervention group 2 : Cognitive-Behavioral Play Therapy The first session: Introducing the researcher and the children to each other, stating the purpose and rules of the group, teaching problem solving using allegory and story, chair games.Session 2: Psychological training includes recognizing and expressing thoughts and feelings, using painting, group games such as playing the wheel of emotion, playing cards of emotional situations, and playing balloons of anger.Session 3: Psychological education includes recognizing the dimensions of emotions using the story, and identifying the types of cognitions and emotions of the characters in the story, using the game of wolves and herds, and painting the faces of different emotions.Session 4: Cognitive Reconstruction, including Identifying and Challenging Challenges, Identifying Emotional Stimuli Using Role Play, Using Practical Drawings, Thinking Bubbles, or Playing Like Dolls with Different Behavioral Styles, Challenging Challenging Cognitive Distortions by Performing Play scale to feel angry and play thinking loudly.Session 5: Relaxation, and a variety of games such as bubble games, breathing trips, fantasy games, ice games and identifying relaxing activities by performing the magic rug game.Session 6: Stop Thought Techniques, Identify Disturbing Thoughts: Stop playing role-playing games, stop annoying thoughts, remotely control thoughts, and play the alarm clock game.Session 7: Learning to deal with problems, with stories and gamesSession 8: Positive self-talk and mindfulness training using role-playing.Session 9: Teaching social skills, recognizing and expressing emotions, communicating with others, using to show good social behaviors to children.Session 10: Discuss the general group on educational materials and the methods learned and review the games. Express the opinions of group members and post-test implementation.
Category
Behavior

3

Description
Control group: Control group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Counseling Center
Full name of responsible person
mazaher bodaghi
Street address
NO 1, St Malek, Arak, Iran.
City
Arak
Province
Markazi
Postal code
3818978695
Phone
+98 86 3222 0198
Email
psychology.book12@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahab Khaghani
Street address
No12, Building 1, Quarter Amirkabir University, Blv Imam Khomeini, Sq Imam Khomeini, Arak. Iran.
City
Arak
Province
Markazi
Postal code
۹۱۳۱۱-۳۸۳۶۱
Phone
+98 86 4313 2451
Email
amfa@iau-arak.ac.ir
Web page address
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
Mazaher Bodaghi
Position
psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
NO 1, St Malek, Arak, Iran.
City
arak
Province
Markazi
Postal code
3818978695
Phone
+98 86 3222 0197
Email
psychology.book12@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mazaher Bodaghi
Position
psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
NO 1, St Malek, Arak, Iran.
City
Arak
Province
Markazi
Postal code
3818978695
Phone
+98 86 3222 0197
Email
psychology.book12@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mazaher Bodaghi
Position
psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
NO 1, St Malek, Arak, Iran.
City
Arak
Province
Markazi
Postal code
3818978695
Phone
+98 86 3222 0197
Email
psychology.book12@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
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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