Investigating the effect of computer learning and diary on the self-regulation and emotional adjustment in teenagers with attention deficit hyperactivity disorder
Determining the level of self-regulation and emotional adaptation in adolescents with attention deficit hyperactivity disorder using computer learning and diary methods
Design
The upcoming clinical trial has a randomized control group with one-way blinded factorial groups, which was used for randomization usingGPower's Random Allocation software.
Settings and conduct
After the sampling, the participants will go to the neurofeedback department of Ibn Sina Psychiatric Hospital and will be trained with RihaCam cognitive rehabilitation software in the presence of a psychologist and a doctor, and they will receive a semi-structured diary. It should be noted that the pre-test and post-test will also be conducted.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Adolescents from the age of 11 to 19 years with ADHD diagnosed by a specialist in child and adolescent psychiatry
Ability to read and write
Not having vision, hearing, muscle and physical problems
Not suffering from known concomitant diseases such as schizophrenia, autism, low IQ
Not using drugs according to the information received from parents
Family and patient satisfaction
Exclusion criteria
Lack of physical and mental ability to continue treatment
Drug use during the intervention
Not participating in more than two intervention sessions
Intervention groups
In the intervention group, the computer learning method will be used using Rihacom software and the self-management tool of the diary, and after the end of the intervention, emotion regulation training sessions will be provided for the control group.
Main outcome variables
Evaluation of changes in self-regulation and emotional adjustment of participants
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231019059769N1
Registration date:2023-12-07, 1402/09/16
Registration timing:prospective
Last update:2023-12-07, 1402/09/16
Update count:0
Registration date
2023-12-07, 1402/09/16
Registrant information
Name
Fatemeh zahra Janbabanezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3572 5164
Email address
roya.jbn3910@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-21, 1402/09/30
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of computer learning and diary on the self-regulation and emotional adjustment in teenagers with attention deficit hyperactivity disorder
Public title
Investigating the effect of computer learning and diary on the self-regulation and emotional adjustment in teenagers with attention deficit hyperactivity disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents from the age of 11 to 19 years with ADHD diagnosed by a specialist
Ability to read and write
Not having vision, hearing, muscle and physical problems
Not suffering from known concomitant diseases such as schizophrenia, autism, low IQ
Not using drugs according to the information received from parents
Family and patient satisfaction
Exclusion criteria:
Inability to read and write
Substance use
Having bipolar schizophrenia and autism
Age
From 11 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation of replacement blocks will be allocated in 6 blocks of 6 with the Random Allocation software according to the attached list. Thus, with the available sampling method, the patients who refer to Ibn Sina Hospital will be included in the study according to the entry criteria and according to the attached table. which is explained by G power, the first patient enters the intervention group according to the block of 6, the next 3 patients enter the control group, and the last two patients also enter the intervention group
It should be mentioned that the allocation is considered in the form of 6 blocks, in each block 3 patients will be in the intervention group and 3 patients will be in the control group, and it will continue up to 36 people, which will actually be 6 blocks of 6.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is one-sided blind, the person analyzing the information does not have access to the separation of the control and intervention groups when checking the results of the pre- and post-questionnaires, so they do not know which group the results of the analysis belong to, but the researcher and the participant He knows that the intervention has been done for him. Therefore, in this way, the bias will be as much as possible.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Nursing and Midwifery Faculties, Management and Medical Information - Shiraz Uni
Street address
Shiraz town, Shiraz University of Medical Sciences Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2023-10-28, 1402/08/06
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.095
Health conditions studied
1
Description of health condition studied
Attention deficit hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Attention-deficit hyperactivity disorder, predominantly inattentive type
Primary outcomes
1
Description
Self regulation
Timepoint
The effect of computer learning and diary on self-regulation and emotional adjustment before immediately and 1 month after the intervention
Method of measurement
Miler-brown self regulation Questionnaire
Secondary outcomes
1
Description
Emotional adjustment
Timepoint
Effect of computerised learning and time diary on emotional adjustment before immediate and 1month after intervention
Method of measurement
Rabio Emotional adjustment Questionnaire
Intervention groups
1
Description
In addition to routine treatment, the intervention group will receive RIHACOM cognitive-rehabilitation interventions and event recording. Interventions will be carried out for patients using Rihakam cognitive-rehabilitation software for 10 sessions of 45 minutes for 5 weeks. During the first session, how to use the diary book and complete it, how to perform rehabilitation exercises will be taught. In these interventions, the response control module of Rihakam software will be used, which includes four stages: training warm-up, main test and cooling down. The first and second stages last 1 minute each, which is a response exercise based on the patient's attention. 90 seconds later, the main test begins. This test is based on mental performance and automatic adaptation of the software so that based on the reaction time, immediately after seeing the command variable of the software, the participant must click on the running exercise which is in Farsi language. Exercises are graded from 0 to 130 based on performance, so a higher score indicates better performance. In each session, the performance of the participant is saved in the software, and based on that training level, the next session begins. In the second and subsequent sessions, based on the person's performance in the previous session with the automatic evaluation of the device, the next steps are performed with different degrees of difficulty for the person. This work continues up to 10 sessions. During these 10 sessions and up to one month after the end of the intervention, the participants will be asked to express their emotional performance during the day in the form of a daily diary, including guidelines for use, goals, introduction of emotion, behavior and impulsive behavior. that these booklets will be collected and analyzed weekly. The main content of the booklet is in the form of tables, including columns such as days of the week, time and place of the event, and rows containing emotion-oriented behaviors such as verbal violence, behavioral violence, delaying the response to the stimulus, impulsive behavior, the will to complete the work, motivation. Starting work, smoking, using virtual space, etc. After the end of the interventions, these booklets will be completed and then collected by the participant as a follow-up tool for the patient.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebn Sina Hospital
Full name of responsible person
Dr Sarah Dehbozorgi
Street address
Shiraz Town, Hafez Blvd, 8Ave
City
Shiraz
Province
Fars
Postal code
7144676541
Phone
+98 71 3228 9604
Fax
+98 71 3228 0236
Email
dehbozorgi.sa@gmail.com
Web page address
http://ebnesina.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hashem Hashempour
Street address
Shiraz town , Blvd Zand, Namazi square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹-۷۱۹۳۶
Phone
+98 71 3647 4254
Email
nurs_midwif@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr Ladan Zarshenas
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Zand Blvd Namazi square Nursing faculty
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹-۷۱۹۳۶
Phone
+98 917 308 8285
Email
zarshenas@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Ladan Zarshenas
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zand Blvd, Namazi Square, Nursing Faculty
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹-۷۱۹۳۶
Phone
+98 917 308 8285
Email
zarshenas@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Ladan Zarshenas
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zand Blvd Namazi Square Nursing Faculty
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹-۷۱۹۳۶
Phone
+98 917 308 8285
Email
zarshenas@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
clinical report
When the data will become available and for how long
4month
To whom data/document is available
Research team
Under which criteria data/document could be used
__
From where data/document is obtainable
Conductor of the research project
What processes are involved for a request to access data/document