Condition category
Mental and Behavioural Disorders
Date applied
19/06/2020
Date assigned
15/07/2020
Last edited
15/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://iaubir.ac.ir

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

Publication citations

Additional files

Editorial Notes

15/07/2020: Trial's existence confirmed by Iran National Committee for Ethics in Biomedical Research.