IRCT | Investigating the effect of the Teach-back method on Parents Knowledge and Performance in relation to the Safety Care of Children with Autism (Randomized Controlled Trials)

Protocol summary

Study aim: Determining the impact of feedback-based training on parents' knowledge and performance about the safety care of children with autism.
Design: Clinical trial with control group, parallel group, one blind strain, Random Allocation software randomization, Random Block software randomization list.
Settings and conduct: Implementation of the intervention in coordination with the officials of the centers and parents on certain days during 3 weeks, one day a week, and one-hour training sessions a day. Only the statistician will not be aware of the assignment of samples to the control and intervention groups, and therefore, blinding will be done only for the statistician.
Participants/Inclusion and exclusion criteria: Entry criteria for parents: being responsible for taking care of a child with autism; having a file of the child under their care in the welfare center; having a smartphone. Non entry criteria : parents suffering from psychological illness based on self-report; a child suffering from other chronic diseases.
Intervention groups: Before the start of the first session, they will be divided into 4 groups of 9 people, on the first day, the goals of the research plan will be explained to the parents, and if they have any questions beyond the goals, they will be referred to the psychologist of the center. At the end of all three sessions, the parents' understanding of the training provided By asking them to repeat the material, they will be measured and in case of incomplete or wrong understanding, the educational material will be repeated and reviewed again. To ensure the parents' understanding, scenarios will be presented for group discussion. For the control group, no training or action will be taken, and at the end, The study will be uploaded for this group's use of the content of the educational package.
Main outcome variables: Primary outcome awareness, secondary outcome performance.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20240510061727N1

Registration date: 2024-05-21, 1403/03/01

Registration timing: prospective

Last update: 2024-05-21, 1403/03/01

Update count: 0
Registration date: 2024-05-21, 1403/03/01

Registrant information: Name

Maryam Moradi

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 13 3355 3202

Email address

mrymrdi99@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2024-05-22, 1403/03/02
Expected recruitment end date: 2024-07-06, 1403/04/16
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Investigating the effect of the Teach-back method on Parents Knowledge and Performance in relation to the Safety Care of Children with Autism (Randomized Controlled Trials)

Public title: Investigating the effect of the Teach-back method on Parents Knowledge and Performance in relation to the Safety Care of Children with Autism
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

Parents should be willing to participate in the research. Parents are responsible for taking care of autistic children. The file of the child with autism is under the care of the parents in the welfare center of Rasht city. Parents should take care of a child with autism at home. Parents should have a smartphone. Parents should have access to the Internet and virtual networks. Parents should be able to use mobile phones and virtual networks.

Exclusion criteria:

Parents have a psychological illness based on self-report. The child is suffering from other chronic diseases (physical and psychological). Parents have participated in educational and support programs similar to the intervention in the last year.
Age: No age limit
Gender: Both

Phase

N/A

Groups that have been masked

Data analyser

Sample size

Target sample size: 72

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization of the samples will be used based on the Random Allocation software, in this study, according to the sample size, using the block randomization method, 9 blocks of 4 will be divided into intervention and control groups. To generate the randomization list, Random Block software will be selected and the sequence of entering the samples in the educational intervention and non-educational intervention groups will be selected based on the list of cases of children with autism in the centers covered by the Rasht Welfare Department. For concealment, the sequence list is kept in a sealed envelope with the supervisor (Dr. Yasman Yaghoubi), and after obtaining permission to conduct the research and the necessary coordination, the envelope is opened and read daily in the relevant centers.

Blinding (investigator's opinion)

Single blinded

Blinding description

Given that the researcher knows the characteristics of the control and intervention group participants, there is no possibility of blinding the researcher. On the other hand, the program is explained in the consent form that is given to the participants, and therefore the participants will be assigned to the control and intervention groups, so there will be no possibility of blinding the participants. Only the statistician will not be aware of the assignment of samples to the control and intervention groups, and therefore, blinding will be done only for the statistician.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committee of Guilan University of Medical Sciences

Street address

Namjo St., in front of Azodi Stadium.

City

Rasht

Province

Guilan

Postal code

41446-66949
Approval date: 2024-05-01, 1403/02/12
Ethics committee reference number: IR.GUMS.REC.1403.042

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: In this study, the awareness and performance of parents of children with autism are measured about preventive care; For this purpose, awareness is the primary outcome.
Timepoint: It will be done 2 times, before the start of the first training session and one month after the last training session.
Method of measurement: A researcher-made questionnaire in the field of parents' awareness about the safe care of children with autism, which questionnaires have been reviewed by 11 faculty members of Shahid Beheshti School of Nursing and Midwifery in Rasht, the content validity ratio in these two questionnaires has been acceptable, and the content validity index has been approved for The awareness questionnaire is 0.92. To determine the internal consistency of the awareness questionnaire, Richardson20 was used. The Richardson20 coefficient was obtained as 0.717 after removing question 17, so this tool with 24 questions has acceptable internal consistency. To determine the external consistency of the awareness questionnaire, the ICC coefficient and Test-Retest coefficient were used. became. The Test-Retest coefficient of the two knowledge questionnaires was 91.4% and the ICC coefficient was 0.952; Therefore, the awareness tool has acceptable reliability in terms of external stability.

Secondary outcomes

1

Description: The secondary outcome is performance.
Timepoint: It will be done 2 times, before the start of the first training session and one month after the last training session.
Method of measurement: A researcher-made questionnaire in the field of parents' performance in connection with the safe care of children with autism, the questionnaires have been reviewed by 11 faculty members of the Shahid Beheshti College of Nursing and Midwifery in Rasht, the content validity ratio has been acceptable and the content validity index has been approved for the questionnaire. The performance is 0.94. Alpha Cronbach's coefficient was used to check the internal consistency of the performance questionnaire, and the alpha Cronbach's coefficient was 0.901, so this instrument has acceptable internal consistency with 25 questions. Also, the ICC coefficient and Test-Retest coefficient were used to determine the external stability of the performance tool. The test-retest coefficient of two performance questionnaires was 99.2% and the ICC coefficient was 0.981; Therefore, the performance tool has acceptable reliability in terms of external stability.

Intervention groups

1

Description: Intervention group: Before the start of the first training session, the questionnaires will be sent privately to the intervention group through the Ita and Baleh messenger, in coordination with the center officials and parents, the training will be carried out on specific days in the respective centers, before the start of the first training session of the group participants. intervention, they will be divided into 4 groups of 9 people, on the first day, the goals of the research project will be explained to the parents again, the main goal of the research will be education about safety care, and if they have any questions outside of the goals, they will be referred to the psychologist of the center. According to the program, during 3 weeks, one day per week and one hour per day, educational sessions will be held, so that in the first session, the prepared educational content will be presented through interactive lectures to the participants who are present in the groups. At the end of the first session, the participants are asked to write down the topics that are unclear to them or need more training on a sheet and provide them to the researcher. In the second session, the educational content according to the course plan, and then based on the needs assessment of each group, vague topics will be prepared separately and presented in an interactive lecture style in different groups, at the end of the second session, a survey of the participants regarding the proposal for improvement The solution will be implemented to help awareness and practice in connection with the safety care of children with autism. In the third session, the educational content will be prepared and presented according to the course plan and then based on the results of the survey in the second session. At the end of all three sessions, the parent's understanding of the given education will be measured by asking them to repeat the content. In case of incomplete or wrong understanding, the educational materials will be repeated and reviewed, and scenarios will be presented for group discussion to ensure parents' understanding. After one month from the last training session, the questionnaires of parents' awareness and performance regarding the safety care of children with autism will be provided to the learners through the messenger Ita and Baleh , to measure the level of awareness and performance of parents of children with autism.
Category: Lifestyle

2

Description: Control group: No training or action will be taken for the control group, before the start of the first training session in the intervention group, the questionnaires will be sent privately to the control group through the Ita and Baleh messenger, and again one month after the last training session in the intervention group, the questionnaires will be sent through It will be sent to the control group. After receiving the questionnaires, following the response of the control group, to use the educational content for the parents of this group, the educational package will be uploaded at the end of the study.
Category: N/A

Recruitment centers

1

Recruitment center: Name of recruitment center

Rasht Welfare Department

Full name of responsible person

Mozhgan Akhavan Zia

Street address

Nurse Street

City

Rasht

Province

Guilan

Postal code

4193713413

Phone

+98 13 3336 8900

Fax

+98 13 3336 8725

Email

info@ Behzisty-Guilan.ir

Web page address

http://www.behzisty-guilan.ir/

1

Sponsor: Name of organization / entity

Rasht University of Medical Sciences

Full name of responsible person

Dr. Pirouz Samidoust

Street address

Namjo St., Shahid Siyadati St., in front of 17 Shahrivar Hospital.

City

Rasht

Province

Guilan

Postal code

41446-66949

Phone

+98 13 3333 6394

Fax

+98 13 3333 6395

Email

research@gums.ac.ir

Web page address

https://gums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Rasht 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

Rasht University of Medical Sciences

Full name of responsible person

Maryam Moradi

Position

Master student

Latest degree

Bachelor

Other areas of specialty/work

Nursery

Street address

Shahid Beheshti Highway - Student Street

City

Rasht

Province

Guilan

Postal code

41469-39814

Phone

+98 13 3355 3202

Fax

+98 13 3355 0097

Email

Mrymrdi99@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Rasht University of Medical Sciences

Full name of responsible person

Yasaman Yaghobi

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

Nursery

Street address

Shahid Beheshti Highway - Student Street

City

Rasht

Province

Guilan

Postal code

41469-39814

Phone

+98 13 3355 3202

Fax

+98 13 3355 0097

Email

Yaghobiyasaman@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Rasht University of Medical Sciences

Full name of responsible person

Maryam Moradi

Position

Master student

Latest degree

Bachelor

Other areas of specialty/work

Nursery

Street address

Shahid Beheshti Highway - Student Street

City

Rasht

Province

Guilan

Postal code

41469-39814

Phone

+98 13 3355 3202

Fax

+98 13 3355 0097

Email

Mrymrdi99@gmail.com

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: Undecided - It is not yet known if there will be 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: 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: Part of individual data in demographic questionnaire. Total awareness and performance data.
When the data will become available and for how long: The access period starts one year after the results are published.
To whom data/document is available: All researchers in academic institutions and businesses.
Under which criteria data/document could be used: No decision has been made yet.
From where data/document is obtainable: Dr. Yasman Yagoubi, assistant professor of Rasht University of Medical Sciences, email address yaghobiyasaman@yahoo.com Maryam Moradi, Master student of Rasht University of Medical Sciences, email address mrymrdi99@gmail.com
What processes are involved for a request to access data/document: It will be sent as soon as possible after the checks done by the researcher.
Comments

Investigating the effect of the Teach-back method on Parents Knowledge and Performance in relation to the Safety Care of Children with Autism (Randomized Controlled Trials)