Development of a family- based sensory diet program on attention deficit, hyperactivity and impulsivity in elementary school students with attention deficit hyperactivity disorder
Determining the effect of family-based sensory diet program on attention deficit, hyperactivity and impulsivity in elementary school students with attention deficit hyperactivity disorder
Design
The study population will include 30 children with Attention Deficit Hyperactivity Disorder in Tehran, 6-12 years old. Hasti Therapy Clinic will be selected during the WISC-IV Children's Wechsler Scale to measure children's intelligence and the Connors Parent Form Scale for Attention Deficit Hyperactivity Disorder and will be randomly divided into two groups of 15 intervention and control.The intervention group will use 12 sessions of family-centered sensory diet program, 3 sessions per week and each session for 45 minutes, which is based on the Wilberger Sensory Protocol.
Settings and conduct
.In the first session, with the aim of getting to know the family and the child, examining the child's sensory status, trainings on correcting environmental stimuli, the child's work environment, planning and scheduling the sensory regime will be done. In the next sessions of the intervention, parents will be given trainings to modulate sensory inputs and increase self-regulation, increase the level of consciousness, raise the level of attention using vestibular stimuli, profound sense, appropriate vision and controlled hearing. Each treatment session consisted of 5 to 6 exercises, and as the children progressed, the exercises became more difficult in the next sessions or other exercises will be used.
Participants/Inclusion and exclusion criteria
Having Attention Deficit Hyperactivity Disorder
Age range 6-12 years.
Intervention groups
The control group of occupational therapy services and the intervention group will receive sensory diet programs in addition to occupational therapy.
Main outcome variables
Changes in the symptoms of children with attention deficit hyperactivity disorder are expected
General information
Reason for update
Acronym
Attention Deficit Hyperactivity Disorder= ADHD
IRCT registration information
IRCT registration number:IRCT20220214054020N1
Registration date:2022-05-14, 1401/02/24
Registration timing:retrospective
Last update:2022-05-14, 1401/02/24
Update count:0
Registration date
2022-05-14, 1401/02/24
Registrant information
Name
Shila Shabdini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6690 1720
Email address
shila.shabdini@srbiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-25, 1400/12/06
Expected recruitment end date
2022-05-05, 1401/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development of a family- based sensory diet program on attention deficit, hyperactivity and impulsivity in elementary school students with attention deficit hyperactivity disorder
Public title
"Effect of sensory diet on attention deficit/ hyperactivity"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a diagnosis of inattention and hyperactivity.
Having a natural consciousness.
Health of the visual and auditory system.
Exclusion criteria:
Family reluctance to participate in the study
Lack of cooperation of the child to participate in the study
Age conditions of the child outside the age range of 6-12 years
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
For simple randomization at sealedenvelope.com, the Simple Randomization Services section enters the research information, including the intervention description, sample size, and the researcher's e-mail address, which is issued a password for the research. The names of the samples are entered in the patient's field to perform the research and a random request is made from the site, and the site randomly places the sample in group A or B and sends the result to the researcher's email.
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
, Islamic Azad University, Science and Research Branch, Tehran
Street address
No,92.,bagherkhan ST., satarkhan Ave
City
Tehran
Province
Tehran
Postal code
1441633571
Approval date
2021-06-24, 1400/04/03
Ethics committee reference number
IR.IAU.SRB.REC.1400.155
Health conditions studied
1
Description of health condition studied
Attention deficit/hyperactivity Disorder
ICD-10 code
F90
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Measuring the rate of change in attention deficit, hyperactivity and impulsivity scores
Timepoint
The intervention group will use 12 sessions of family-centered sensory diet program, 3 sessions per week and each session for 45 minutes, for one month from the beginning of the program.
Method of measurement
Conners Behavior Scale of Parent Form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Family-Based Sensory Diet: This program bases on the Wilberger (2018) treatment protocol and is a comprehensive sensory approach to treating sensory processing problems. This theory, officially known as the technique of deep pressure, deep sense and mouth touch, helps to organize the mind, brain and body and increases attention, participation in daily activities, reduces tactile defense and increases body self-regulation. This protocol consists of three components: pulling the sensory brush to the body, compressing the joints, and sensory diet. Sensory diet is a set of sensory activities and inputs to the body and nervous system to maintain a person's level of arousal.Activities are selected according to the needs of the person and are included in his daily plan and increase the level of consciousness, increase the body's awareness about himself, the environment and others, attend activities, improve learning, play, sleep, interact with Peers and increase the level of efficiency. The intervention group will use 12 sessions of family-centered sensory diet program, 3 sessions per week and each session for 45 minutes, which was taken from Wilburger Sensory protocol.
Category
Rehabilitation
2
Description
control group:Since the children will be selected from rehabilitation centers and receive an occupational therapy program one or two sessions per week, it will not be ethically possible to eliminate occupational therapy. Occupational therapy routine includes attention and concentration exercises and structural activity exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hasti center
Full name of responsible person
Shila shabdini
Street address
Satarkhan Allay-bagherkhan Allay-No92
City
Tehran
Province
Tehran
Postal code
1441633571
Phone
+98 21 6690 1720
Email
shilashabdini26@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mohammad Parsa Azizi
Street address
Islamic Azad University Science and Research Branch, University Square, Shohada Hesarak Blvd., End of Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Email
shila.shabdini@srbiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Independent by researchers
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Mohammadparsa Azizi
Position
Association professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Science and Research Branch, University Square, Shohada Hesarak Blvd., End of Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Email
mp.azizi@srbiau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Mohammadparsa Azizi
Position
Association professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Science and Research Branch, University Square, Shohada Hesarak Blvd., End of Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Email
mp.azizi@srbiau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shila Shabdini
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
No.92, Bagherkhan ST., Satarkhan Ave
City
Tehran
Province
Tehran
Postal code
1441633571
Phone
+98 21 6690 1720
Email
shila.shabdini@srbiau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The individual identity of children with the disorder will not be revealed
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Development of a family-based sensory diet program on attention deficit, hyperactivity and impulsivity in elementary school students with attention deficit hyperactivity disorder
When the data will become available and for how long
March 1400 to 6 months late
To whom data/document is available
Prior to publication, only researchers will be aware of the data
Under which criteria data/document could be used
Once published as an article, they will be available in reputable scientific journals
From where data/document is obtainable
researchers
What processes are involved for a request to access data/document
Request data from researchers, receive confirmation of data dissemination from other researchers participating in the research and make the data available to the applicant