Plain English Summary
Background and study aims:
Child sexual abuse is a serious issue with serious consequences. Self-care education programs can improve children’s awareness, knowledge, and skills to defend themselves against sexual abuse. The aim of this study is to evaluate a psychological intervention program with a smart robot for sexual care in elementary school children.
Who can participate?
Children aged 8-12 (elementary school) in Ghaenat City, Iran in 2019
What does the study involve?
Children are randomly allocated to the test and control groups. First, all students fill in a questionnaire. The participants in the test group attend 10 45-minute sessions of psychological intervention (with robots) in 5 weeks (two sessions per week). At the beginning of each session, the researcher explains the session’s topic and then a robot teaches the content of the session via tools such as PowerPoints and movies. The material related to each session is emphasized after the training, and finally, the educational content of each session is reviewed and the possible questions and tasks of the previous session are answered. In the end, assignments are allocated to the participants to practice the skills learned during the session. On the other hand, no intervention is carried out for the participants in the control group. After the education process, both groups fill the questionnaire again. Three months after the intervention, all of the participants fill the questionnaire one more time as the follow-up stage. Educational sessions are held for the control group at the end of the study.
What are the possible benefits and risks of participating?
The benefits of this intervention are prevention and awareness of child sexual abuse. There is no risk to the participants.
Where is the study run from?
Private center, Khorasan, Ghaenat (Iran)
When is the study starting and how long is it expected to run for?
February 2019 to December 2019
Who is funding the study?
Investigator-initiated and funded
Who is the main contact?
Mohammad Tahan
t.mohammad2@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Mr Mohammad Tahan
ORCID ID
http://orcid.org/0000-0003-2175-4584
Contact details
no 4
Atar 7
Ghaenat
9761696116
Iran
+98 (0)9120252104
t.mohammad2@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Effectiveness of a robot-based psychological intervention program on sexual care in elementary-school children
Acronym
Study hypothesis
Does a robot psychological interventional program affect the sexual care of elementary school children?
Ethics approval
Approved 28/07/2019, Iran National Committee for Ethics in Biomedical Research (Islamic Azad University, Bojnourd Branch - Research Ethics Committee, Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran; +98 (0)21 81455618; ethics@behdasht.gov.ir), ref: IR.IAU.BOJNOURD.REC.1398.004
Study design
Quasi-experimental research with a pretest-posttest design and a control group
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Sexual care of elementary school children
Intervention
After receiving a license from the vice-chancellor for research and technology of Islamic Azad University, Birjand Branch, ethical code in research, and permission from the head of education in Qaen and communicating with elementary schools of the city, parents suggested by teachers are invited to participate in a briefing meeting to explain research objectives and implementation stages. Written informed consent is obtained from all parents and they are ensured of the confidentiality terms regarding their personal information. In a meeting, 80 children are selected and allocated to two test and control groups. First, all students fill the questionnaire and the scores obtained are considered as a pretest. The participants in the test group attend 10 45-minute sessions of psychological intervention (with robots) in 5 weeks (two sessions per week). The first session is held in Payam Salamat Clinic. At the beginning of each session, the researcher explains the session’s topic and then a robot teaches the content of the session via tools such as PowerPoints and movies. The material related to each session is emphasized after the training, and finally, the educational content of each session is reviewed and the possible questions and tasks of the previous session are answered. In the end, assignments are allocated to the participants to practice the skills learned during the session. On the other hand, no intervention is carried out for the participants in the control group. After the education process, both groups fill the questionnaire again and the scores are considered as a posttest. Three months after the intervention, all of the participants fill the questionnaire one more time as the follow-up stage. In order to adhere to research principles, educational sessions are held for the control group at the end of the study. A summary of the content of each session is presented in:
1. Training program -Introduction to robots
2. Introducing, familiarizing and informing about body parts
3. Identifying, informing and becoming acquainted with important and private body parts
4. Learning to recognize people (distinguishing family members, acquaintances and strangers)
5. Learning how to connect with family members, acquaintances and strangers
6. Identifying dangerous and harmful situations and moments
7. Identifying and introducing dangerous and harmful situations and moments and how to deal with them (family)
8. Identifying and introducing dangerous and harmful situations and moments and how to deal with them (acquaintances)
9. Identifying and introducing dangerous and harmful situations and moments and how to deal with them (strangers)
10. Overviewing past topics and reviewing all items considered
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Children's knowledge and awareness of sexual abuse measured using Questionnaire of Children's Knowledge and Awareness of Sexual Abuse at 6 months
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
27/02/2019
Overall trial end date
20/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Willingness to participate in the study
2. Aged 8-12 years
3. No history of acute psychological and physical diseases (based on interviewing and health checklist of students)
4. Consent form completed by parents
Participant type
Other
Age group
Child
Gender
Both
Target number of participants
80 participants (40 female and 40 male)
Total final enrolment
80
Participant exclusion criteria
1. Absence from one educational session
2. Taking specific drugs
3. Simultaneous participation in a similar educational intervention
4. Unwillingness to participate in the research
Recruitment start date
01/08/2019
Recruitment end date
20/12/2019
Locations
Countries of recruitment
Iran
Trial participating centre
Private center
Khorasan
Ghaenat
97616
Iran
Sponsor information
Organisation
Islamic Azad University of Birjand
Sponsor details
Ghaffari Avenue
Birjand
9717711111
Iran
+5631310
info@iaubir.ac.ir
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in high-impact peer-reviewed journal.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.
Intention to publish date
30/07/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list