Determining the effect of mother empowerment on children aggression aged 6-12 years with autism
Design
A randomized clinical trial, without blinding (Only data collector will blind), on 60 mothers of children with Autism in autism centers
Settings and conduct
Mothers of eligible children are selected by available methods and then the centers are divided randomly so that one of them would be the intervention group and the other would be the control group.
single-blind (participants and care providers)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers who agree with participation in the study; their children have one of the types of autism; children age between 6 to 12 years; the autistic child should not be diagnosed with other mental illnesses.
Exclusion criteria: Mothers who participated in other similar activities.
Intervention groups
Intervention group: based on need assessment and includes the implementation of the family-center empowerment model. Control group: receive routine care from the center.
Main outcome variables
Aggression score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210602051482N1
Registration date:2021-09-26, 1400/07/04
Registration timing:prospective
Last update:2021-09-26, 1400/07/04
Update count:0
Registration date
2021-09-26, 1400/07/04
Registrant information
Name
Mohanad Dawood
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3854 2022
Email address
abassmohanad2018@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2021-12-16, 1400/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of Mothers Empowerment on Aggression score of 6 – 12 Years Old Children with Autism in Al- Nasiriya City at 2021
Public title
Impact of Mothers Empowerment on Aggression of Children with Autism
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Their child has one of the types of autism,
Children age between 6 to 12 years.
Lack of experience of a stressful event in the last six months.
Parents agreed with participation in the study.
The autistic child should not be diagnosed with other mental illnesses.
Exclusion criteria:
Parents who have participated in other similar activities.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method (entry of research participants from the community to the sample) will be non-random (convenient sampling). Mothers of children with autism in the Iraqi city of Nasiriyah are selected from special care centers for children with autism. The Iraqi city of Nasiriyah has two autistic children's centers. With a simple randomization method, lottery, one center will be assigned to the intervention group and another center to the control group. Then, for each of the intervention and control groups, 30 people from each center will be selected by lot.
Blinding (investigator's opinion)
Single blinded
Blinding description
All the goals and methods of the study will be explained to the participants in the study when obtaining informed consent. Interventions and evaluations will also be performed by the researcher. Therefore, in this study, only the person responsible for data analysis can be blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad, Ph.D. Crossroads, Mashhad School of Nursing and Midwifery, Ethics Committee
City
Mashahd
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-07-27, 1400/05/05
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.042
Health conditions studied
1
Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
aggressive behavior score towards oneself.aggressive behavior score towards others.aggressive behavior score towards property.
Timepoint
before intervention and 4 weeks after intervention
Method of measurement
demographic data questionnaire and aggression questionnaire. This questionnaire would be an assessment tool for aggression of the children aged 6-12 years and consists of 40 questions that measure the dimensions of aggression, including aggression towards oneself, towards others and towards properties.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: empowerment model in 4 stages Content: threat perception (1) To increasing knowledge and awareness in association with the disease. In first session introduce with mothers and assessment problems with child’s autism. The researcher guides mothers to identify effective thoughts and feelings in stressful and aggressive situations for children. Problem solving (2) to increase participation in order to increase self-esteem and self-efficacy of the individual in coping with problems. Create a group discussion among the participants to exchange experiences (with the researcher's assistance) to solve problems. Educational participation (3) Participate the mothers in care giving. The researcher mothers the stressful conditions and the resulting changes in children with autism. The researcher teaches people to make positive mental changes. The researcher presents relaxation patterns in stressful and aggressive situations for children. Teaching stress management skills and how to deal with aggressive and stubbornness situations in children. The researcher teaches attention and focus techniques for autistic children. Training on the use of movement activities (such as playing a small ball, zigzag walking between cones) for children to direct the behavior towards a specific task and move from a random state to a purposeful state of behavior (Discharging the excess energy and random movements and employing them in purposeful, organized and positive activities). It reinforces and supports the desired behaviors of the aggressive child. Training skills on the acquired skills and the need to apply these skills when dealing with aggressive situations for autistic children provided presentations in the previous sessions were given to the mothers as CD-face-to-face training educational pamphlets. Evaluation (4) to determine learning rate and participation of the individuals. An evaluation at the end of each session and an evaluation also which will done finally.
Category
Other
2
Description
Control group: For children in the control group in autistic children's centers in Nasiriyah, a series of pamphlets are delivered to parents that contain trainings such as the behaviors of these children and how to deal with it. They usually do not have classes and face-to-face meetings with their parents. These pamphlets will also be provided to the participants of the intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Nasiriyah autism center
Full name of responsible person
Dr. Naama Al-Tamimi
Street address
Nasiriyah City , Al Shaibani Street
City
Nasiriyah
Postal code
IR.MUMS.NURSE.REC.14
Phone
+964 21 032 3880
Email
ma19951993am@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ms. Dr. Latif Nejad
Street address
Faculty of Nursing and Midwifery, Mashhad, Daneshgah St., Ibn Sina Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3854 2022
Email
MansouriF1@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Behnam vashani
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Mashhad, Daneshgah St., Ibn Sina Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3854 2022
Email
behnamhr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tahereh Sadeghi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
Mashhad, Daneshgah St., Ibn Sina Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3854 2022
Email
sadeghit@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohanad Dawood
Position
Master of pediatric nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
No.33,Pirozi,Razavi Khorasan,Mashhad,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3854 2022
Fax
Email
abassmohanaa2018@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
Investigating the Impact of Mothers Empowerment on Aggression score of 6 – 12 Years Old Children with Autism in Al- Nasiriya City at 2021.
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
e.g., starting 6 months after publication
To whom data/document is available
is this only available for people working in academic institutions
Under which criteria data/document could be used
This should be within the scope of the researcher's work for scientific purposes.
The conditions that Mashhad University of Medical Sciences pursues in the field of acquiring medical knowledge
From where data/document is obtainable
abddavoudm982@mums.ac.ir
What processes are involved for a request to access data/document
Every week, applications are reviewed by the above-mentioned e-mail. Respond to them and send the required information as possible.