Child AbuseinterventionNCT03956628
Evaluation of Preventive (Stay Safe) Training Program of Child Abuse for Teachers and Children
A study testing stay safe program in people with Child Abuse, run by Bahauddin Zakariya University at 1 site in Pakistan.
Trial summary
The current study aims to elaborate the effectiveness of stay safe programme which is a child abuse prevention programme for children, this study examine the effectiveness of this programme on children and teachers of Multan city schools. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Abuse
- What is being tested?
- stay safe program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2018to 15 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- students enrolled in class 1-2
- age range between 5-9
- students allowed by their parents to participate in the study.
Who cannot join
- students not enrolled in class 1 or 2
- students not within age range.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Preventive (Stay Safe) Training Program of Child Abuse for Teachers and Children: A Randomized Controlled Trial From Multan City
The current study aims to elaborate the effectiveness of stay safe programme which is a child abuse prevention programme for children, this study examine the effectiveness of this programme on children and teachers of Multan city schools. Mainly, this study enhance the understanding of teachers and children to provide protection and confidence by following programme.
Read the detailed description
The study examine the stay safe programme effectiveness among school teachers and children, as Pakistan is today badly indulge in this issue; In this circumstances this type of study provide essential role in society. some schools from Multan city are included, the quasi experimental study is used, where the participants are randomly divided into two groups (control and experimental). school based sampling method is used where different campuses of one school is included, through random number generator, six schools are selected for participation where 3 schools are included in control group and 3 are in experimental group. the participants consist of school teachers and children, where each group (children \& teachers) is further divided into control and experimental group. children and teachers of class 1 and 2 are included. scales used in the study are Battle self-esteem inventory and children knowledge and skills questionnaire for children while teachers knowledge and skills questionnaire for teachers is used in study. 1 week time gap is also considered between pre and post testing for better examination of change. stay safe programme is very powerful tool as it cover different sensitive issues and provide confidence or safety skills to children.it also provide teachers with the strategies that they should use to make classroom environment healthy or encourage children to speak up and also provide guidance to deal with issues safely and listen every child carefully. Different videos, worksheets, basic knowledge that cover 5 major topics like feeling safe and unsafe, wanted and unwanted touch, bullying, tell adults about negative interaction with bullies and victimizers, strangers and dealing with strangers are all include in the stay safe programme. The lessons that include in this programme are so healthy and best for the protection of child, it also boost their self-esteem and make them worthy and active cognitively. informed consent is provided to participants for initiating the study properly, as it is ethical. every participant data would be confidential or the theme of study would be debrief to the control group after study.
- Conditions
- Child Abuse
- Being tested
- stay safe program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stay safe programBehavioural
Prevention consist of 5-6 lessons having topics about learning safety skills which includes identifying touch, safe and unsafe environment/events, bullying, the good or bad secrets and strangers.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | participants in experimental group receive intervention and experimental group consists of two sub groups, teachers and students. Receives: Behavioral: stay safe program |
| control group | No intervention | participants in control group does not receive intervention and control group consists of two sub groups, teachers and students. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children Safety Knowledge and Skills Questionnaire (SKSQ)
the scale consist of 18 items. it is an open ended questionnaire which consist of the scoring key is 4- someone you don't know, 3- man/woman you don't know, 2- no response or don't know and 1- misconception.It measure the knowledge of children about strangers, bullying, touch, secrets, lost, disclosure and bribes. these are the sub scales and sub scales sum up to make a total score for each child. the items of scale deal with different knowledge and skills of children related to self-protection. The range of scoring is from 18 to 80 for complete questionnaire.maximum value is 80 and minimum is 18. Internal consistency reliability coefficient in regards to the stay safe programme (alpha = .79). if a child get 18 scores that means his safety knowledge is low while 80 means knowledge is high. this score obtains after sum up or average of the total sub scales.
Measured: 2 months
Teachers' Knowledge/Attitudes Questionnaire (TKAQ)
A 38 item questionnaire which assessed knowledge of prevalence, causes and indicators of child sexual abuse as well as characteristics of victims and offenders. In addition it examined parents' self-reports of the likelihood of them believing a child's disclosure of abuse, attributions of responsibility for sexual victimisation attitudes towards prevention, knowledge of and attitudes towards services and confidence/anxieties relating to sexual abuse.
Parents responded to each item on a five point Likert scale ranging from "strongly agree" to "strongly disagree". For 22 items "strongly agree" is the correct response and for 16 items "strongly disagree" is correct. Each item is scored from 1 to 5 and the potential range for total scores is from 38 to 190. The alpha co-efficient for the total questionnaire was .80, indicating good internal consistency reliability.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start15 Sep 2018
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups, experimental and control group. Experimental group will be provided with psycho education about safety skills related to child abuse. Control group will not be given any intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahauddin Zakariya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab noor Hussain, Bahauddin Zakariya University
- Investigators
- Rizwana Amin, PhD, Principal investigator, Bahauddin Zakariya University Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956628
- Sponsor's protocol ID
- MPP-17-07
- Acronym
- intervention
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
MacIntyre D, Carr A. Evaluation of the effectiveness of the stay safe primary prevention programme for child sexual abuse. Child Abuse Negl. 1999 Dec;23(12):1307-25. doi: 10.1016/s0145-2134(99)00092-7.
PubMed 10626613MacIntyre D, Carr A. Helping children to the other side of silence: a study of the impact of the stay safe programme on Irish children's disclosures of sexual victimization. Child Abuse Negl. 1999 Dec;23(12):1327-40. doi: 10.1016/s0145-2134(99)00097-6.
PubMed 10626614
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Preventive (Stay Safe) Training Program of Child Abuse for Teachers and Children: A Randomized Controlled Trial From Multan City
- ClinicalTrials.gov ID
- NCT03956628
- Acronym / sponsor ID
- intervention / MPP-17-07
- Conditions
- Child Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Bahauddin Zakariya UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study aims to elaborate the effectiveness of stay safe programme which is a child abuse prevention programme for children, this study examine the effectiveness of this programme on children and teachers of Multan city schools. Mainly, this study enhance the understanding of teachers and children to provide protection and confidence by following programme.
Detailed description
The study examine the stay safe programme effectiveness among school teachers and children, as Pakistan is today badly indulge in this issue; In this circumstances this type of study provide essential role in society. some schools from Multan city are included, the quasi experimental study is used, where the participants are randomly divided into two groups (control and experimental). school based sampling method is used where different campuses of one school is included, through random number generator, six schools are selected for participation where 3 schools are included in control group and 3 are in experimental group. the participants consist of school teachers and children, where each group (children \& teachers) is further divided into control and experimental group. children and teachers of class 1 and 2 are included. scales used in the study are Battle self-esteem inventory and children knowledge and skills questionnaire for children while teachers knowledge and skills questionnaire for teachers is used in study. 1 week time gap is also considered between pre and post testing for better examination of change. stay safe programme is very powerful tool as it cover different sensitive issues and provide confidence or safety skills to children.it also provide teachers with the strategies that they should use to make classroom environment healthy or encourage children to speak up and also provide guidance to deal with issues safely and listen every child carefully. Different videos, worksheets, basic knowledge that cover 5 major topics like feeling safe and unsafe, wanted and unwanted touch, bullying, tell adults about negative interaction with bullies and victimizers, strangers and dealing with strangers are all include in the stay safe programme. The lessons that include in this programme are so healthy and best for the protection of child, it also boost their self-esteem and make them worthy and active cognitively. informed consent is provided to participants for initiating the study properly, as it is ethical. every participant data would be confidential or the theme of study would be debrief to the control group after study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There are two groups, experimental and control group. Experimental group will be provided with psycho education about safety skills related to child abuse. Control group will not be given any intervention.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: stay safe programparticipants in experimental group receive intervention and experimental group consists of two sub groups, teachers and students. |
| control group | No intervention | –participants in control group does not receive intervention and control group consists of two sub groups, teachers and students. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- students enrolled in class 1-2
- age range between 5-9
- students allowed by their parents to participate in the study.
Key exclusion criteria (2 listed)
- students not enrolled in class 1 or 2
- students not within age range.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stay safe programPrevention consist of 5-6 lessons having topics about learning safety skills which includes identifying touch, safe and unsafe environment/events, bullying, the good or bad secrets and strangers. | Behavioural | experimental group |
Primary outcome
Children Safety Knowledge and Skills Questionnaire (SKSQ)
Time frame: 2 months
the scale consist of 18 items. it is an open ended questionnaire which consist of the scoring key is 4- someone you don't know, 3- man/woman you don't know, 2- no response or don't know and 1- misconception.It measure the knowledge of children about strangers, bullying, touch, secrets, lost, disclosure and bribes. these are the sub scales and sub scales sum up to make a total score for each child. the items of scale deal with different knowledge and skills of children related to self-protection. The range of scoring is from 18 to 80 for complete questionnaire.maximum value is 80 and minimum is 18. Internal consistency reliability coefficient in regards to the stay safe programme (alpha = .79). if a child get 18 scores that means his safety knowledge is low while 80 means knowledge is high. this score obtains after sum up or average of the total sub scales.
Teachers' Knowledge/Attitudes Questionnaire (TKAQ)
Time frame: 2 months
A 38 item questionnaire which assessed knowledge of prevalence, causes and indicators of child sexual abuse as well as characteristics of victims and offenders. In addition it examined parents' self-reports of the likelihood of them believing a child's disclosure of abuse, attributions of responsibility for sexual victimisation attitudes towards prevention, knowledge of and attitudes towards services and confidence/anxieties relating to sexual abuse. Parents responded to each item on a five point Likert scale ranging from "strongly agree" to "strongly disagree". For 22 items "strongly agree" is the correct response and for 16 items "strongly disagree" is correct. Each item is scored from 1 to 5 and the potential range for total scores is from 38 to 190. The alpha co-efficient for the total questionnaire was .80, indicating good internal consistency reliability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Results publication: PubMed 10626613MacIntyre D, Carr A. Evaluation of the effectiveness of the stay safe primary prevention programme for child sexual abuse. Child Abuse Negl. 1999 Dec;23(12):1307-25. doi: 10.1016/s0145-2134(99)00092-7.
- Results publication: PubMed 10626614MacIntyre D, Carr A. Helping children to the other side of silence: a study of the impact of the stay safe programme on Irish children's disclosures of sexual victimization. Child Abuse Negl. 1999 Dec;23(12):1327-40. doi: 10.1016/s0145-2134(99)00097-6.
- this article was cited in the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rizwana Amin, PhD principal investigator
Bahauddin Zakariya University Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stay safe program in people with Child Abuse, run by Bahauddin Zakariya University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children Safety Knowledge and Skills Questionnaire (SKSQ) (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03956628, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.