Child MaltreatmentNCT02961010
Evaluating the Effectiveness of Keeping Safe - a School Based Intervention Aimed at Preventing Abuse
A study testing Keeping Safe in people with Child Maltreatment, run by National Society for the Prevention of Cruelty to Children at 1 site in United Kingdom.
Trial summary
This study evaluates the effectiveness of Keeping Safe, a whole school preventative education intervention in improving children's knowledge and understanding to keep safe in situations of abuse. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Maltreatment
- What is being tested?
- Keeping Safe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to 30 Jun 2018
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children 4-11 years attending mainstream sector primary school in Northern Ireland whose school has accepted the invitation to take part in the RCT and whose parents have provided consent for their participation.
Who cannot join
- children attending special sector primary schools in Northern Ireland.
- children 4-11 years attending mainstream sector primary school in Northern Ireland whose school has not been invited/ rejected the invitation to take part in the RCT
- children 4-11 years attending mainstream sector primary school in Northern Ireland whose school has accepted the invitation to take part in the RCT and whose parents have not provided consent for their participation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Society for the Prevention fo Cruelty to Children
Belfast, Northern Ireland, BT15 3HN
About this study
Official title: A Cluster Randomised Controlled Trial of Keeping Safe: Investigating the Effectiveness of a Whole School Preventative Education Programme in Improving Children's Knowledge and Understanding to Keep Safe in Situations of Abuse
This study evaluates the effectiveness of Keeping Safe, a whole school preventative education intervention in improving children's knowledge and understanding to keep safe in situations of abuse. The intervention
- Comprises three themes (1) Healthy Relationships; (2) My Body; and (3) Being Safe and includes content across the following keeping safe concepts; bullying, neglect, emotional, physical, domestic and sexual abuse, in online and offline contexts.
- Includes activities for the formal and informal school curricula - 63 lessons will be taught to children by their classroom teacher; 3 per term, 9 per year across 7 years from Primary 1 to primary 7 (age 4-11 years).
- Each lesson is accompanied by directed homework activities to involve and engage parents and enable them reinforce learning at home. A number of whole school, key stage and year group assemblies have also been prepared.
- At the beginning of each term school leaders will deliver a prepared assembly to introduce the theme for the term. Following this assembly each teacher will deliver 3 lessons tailored to the age group of their class and parents will assist with home works. The lessons use eBooks, character animations, stories, rhymes, and interactive whiteboard activities to engage children in their learning.
The intervention adopts a whole-school approach and seeks to build the capacity and skills of teachers and parents as key partners. Teachers will receive a comprehensive package of training, ongoing support and resource materials to equip them with the skills they need to effectively communicate sensitive keeping safe messages. Parents will also receive a package of resources to help them feel confident about communicating sensitive messages to their children.
Read the detailed description
Exploratory research, funded by the Department of Education and undertaken by the NSPCC in 2008, investigated the need for preventative education that aimed to equip pupils with the skills to recognise and respond appropriately to bullying, child abuse and domestic abuse in primary schools in Northern Ireland. Subsequently, an intervention was designed based on the findings from stakeholder consultations (NSPCC reports, 2011) and existing research in the field of school based prevention.
This study uses a cluster randomised controlled trial (RCT) design to evaluate the effectiveness of Keeping Safe, a whole school preventative education intervention in improving children's knowledge and understanding to keep safe in situations of abuse including sexual and domestic abuse.
Randomisation will take place at school level. Schools will be allocated either to the intervention group or a waitlist control group. Following randomisation, intervention schools will receive the package of training and support across a 3 month period. This comprises a blended package of continuing professional development training and support for teachers and school staff to enable them teach sensitive preventative education concepts through the formal statutory Personal Development curriculum, and all other informal opportunities that present in the daily life of the school. Intervention schools will then implement the Keeping Safe intervention in their school for 2 school years, between 2016 and 2018.
The Wait List Control group will continue with standard practice, teaching the Personal Development curriculum between 2016 and 2018. Both groups will participate in the evaluation between March 2016 and July 2018 and the wait list control group will receive the programme in Sept 2018.
This RCT will collect data at 3 timepoints: Baseline (March/ June 2016), Time One (May -June 2017) and Time Two (May- June 2018). Outcome data on children's knowledge and understanding will be collected at all 3 time points as will data on (1) teacher confidence and teaching practice, (2) parent confidence and practice, (3) school level administrative data (e.g. incidence of disclosure and referral out) and (4) school climate/organizational culture.
Primary outcomes (childrens)
- If exposure to the Keeping Safe programme:
- Impacts/changes children's self-reported knowledge and understanding of the following keeping safe concepts; bullying, neglect, physical, emotional, domestic and sexual abuse and in what ways?
- Impacts/changes children's self-reported self-efficacy to keep safe in situations of bullying, neglect, physical, emotional, domestic and sexual abuse and in what ways?
- If children's self-reported knowledge and understanding in relation to the above keeping safe concepts changes over the 2 year period that the programme is being implemented and in what ways?
- If changes in children's knowledge and understanding vary for different groups of children, and in what ways?
Secondary Outcomes (teachers and parents)
- If engagement with the Keeping Safe programme:
- Impacts/changes teachers' self-reported knowledge in teaching keeping safe messages and in what ways?
- Impacts/changes teachers' self-reported confidence and comfort in their own skills to manage sensitive issues in relation to Keeping Safe in the classroom and in what ways?
- How school context factors such as size, sector and management type, and professional experience factors (length of teaching service, nature of role in school) impact on teacher knowledge, comfort and confidence in teaching Keeping Safe messages.
- If the continuing professional development training and resources specifically designed for the Keeping Safe programme impact on teachers' teacher knowledge, comfort and confidence in teaching keeping safe messages.
- If implementing the Keeping Safe programme leads to change in school ethos/climate, and if this differs across schools and in what ways?
- If engagement with the Keeping Safe programme (parent resources and directed homework activities):
- Impacts/changes parents' self-reported knowledge of and confidence to communicate with their child about keeping safe messages and in what ways?
- Impacts/changes parents' self-reported current and future confidence to communicate with their child about keeping safe messages and in what ways?
- If reported changes in parents' knowledge and confidence vary for different groups of parents and in what ways?
- How personal (gender) parenting profile (age of children, no of children, relationship to child) and home context (postcode and household income) factors impact on parents' knowledge and confidence in relation to keeping safe messages.
- How parents' knowledge and confidence change over the 2 year period that the programme is being implemented and in what ways?
Data will be collected from children using a questionnaire designed to assess their knowledge and understanding of a range of keeping safe concepts and their self-reported self-efficacy to keep safe in unsafe situations. The questionnaire is a composite measure comprising existing and adapted standardised measures across a range of keeping safe concepts.
The content and administration of the questionnaire (online and paper versions available) have been tailored to ensure age and developmental appropriateness (a number of different versions will be used with varying age groups).
All classroom teachers will be invited to complete a self-report questionnaire (online or paper versions available) measuring their confidence, comfort and teaching practices with regards the programme. Fidelity data with regard to completion of continuing professional learning will be collated from the analytics function on the e-learning programme. Self-reported fidelity to programme implementation in the classroom will be collated using a fidelity monitoring form.
Information on school context (size, sector, management type) and professional experience (length of teaching service, nature of role in school) will also be collected to identify if these impact on teacher knowledge and confidence in teaching keeping safe messages.
All parents will be invited to complete a self-report questionnaire (online and paper) to assess their knowledge and confidence to talk to their children about sensitive keeping safe messages.
Information will also be collected on parents' personal profile (gender) parenting profile (age of children, no of children, relationship to child) home context (Postcode and household income) to identify if these make a difference to parent knowledge and confidence in communicating with their child(ren) about keeping safe messages
Additional school-level administrative data will be collected on Free School Meals/ newcomer children, level of Social Service engagement with school (referrals out etc) to see if these types of experience impact on teacher knowledge and confidence in teaching keeping safe messages, and to examine any difference between intervention and wait-list control schools.
- Conditions
- Child Maltreatment
- Being tested
- Keeping Safe
- Keywords
- school based prevention, child sexual and domestic abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keeping SafeBehavioural
A whole school Preventative Education programme
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive the Keeping Safe programme between 2016 and 2018. This comprises a blended package of continuing professional development training and support (plus resource materials) for teachers and school staff to enable them teach sensitive preventative education concepts through the formal statutory Personal Development curriculum, and all other informal opportunities that present in the daily life of the school. Following randomisation, intervention schools will receive the package of training and support across a 3 month period and will then implement/teach in their school across 2 school years. The intervention group will collect outcome data for the evaluation between March 2016 and June 2018. Receives: Behavioral: Keeping Safe |
| Wait-list Control Group | No intervention | The Wait List Control group will continue with standard practice of teaching the statutory Personal Development curriculum between 2016 and 2018. They will not receive the Keeping Safe intervention until Sept 2018 following completion of the evaluation. The Waitlist control intervention group will collect outcome data for the evaluation between March 2016 and June 2018. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Knowledge of Abuse Questionnaire (CKAQ) (Tutty, 1995)
a 33-item self-report measure used to assess children's knowledge of sexual abuse.
Measured: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
Knowledge/Attitudes to Woman Abuse' sub-scale of the 'Child/Teen Witness to Woman Abuse questionnaire (Sudermann et al., 2000)
a 10-item sub-scale used to assess children's knowledge of Domestic Abuse
Measured: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
Self-Efficacy Sub-scale (Dake et al., 2003)
a 5-item sub-scale used to assess children's perceived self-efficacy to keep safe in situations of abuse. An additional 4 items were added to this measure concerning online abuse, cyberbullying, and neglect
Measured: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
The What-If Situations Test (WIST) (Saslawsky & Wurtele, 1986)
a 6-item scenario-based measure designed to assess children's (aged 5-12) ability to recognise and respond to hypothetical situations of abuse. An additional 5 scenarios concerning non-contact, online, and peer-to-peer abuse
Measured: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
two Global Items from the Olweus (1996) bullying questionnaire
used to assess frequency of bullying perpetration/victimization.
Measured: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
Adaptation of the Multidimensional Neglectful Behaviour Scale (Kantor et al., 2004)
This 38-item measure is used as a screening tool for neglect. This measure has been adapted to be used as knowledge measure. 10 items across a range of neglect concepts will be used and presented as true/false questions.
Measured: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
Administrative school level data on children's behaviour
to be collated as a proxy measure of skills in recognising, telling and reporting abusive behaviour. This includes child in need/ child at risk disclosures, concerns raised, support received from external agencies.
Measured: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
Revised Children's Manifest Anxiety Scale (RCMAS 2) short 10 item (Reynold and Paget (1981)
a 10 item short version of the RCMAS - 'What I Think and Feel' used to assess children's self-reported anxiety
Measured: twice across 2 years; time 1 May/June 2017, time 2 May/June 2018
Secondary outcomes (6)
Survey on Perceived Confidence in, and Attitudes towards approaches to Teaching and Learning about Sensitive Issues in Health & Personal Development (Lynagh et al., 2010)
is 26-item survey designed to assess teachers' confidence in teaching and managing sensitive issues in the Health \& Personal Development syllabus. Part 2 of this measure will be used to assess teachers' confidence in managing sensitive issues. It has been adapted to focus on the classroom management issues that pertain to the Keeping Safe intervention
Measured: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
Subscale of the Teacher Willingness to Teach Sexual Health Education Questionnaire (Cohen et al., 2012)
includes a teacher comfort subscale comprising 26-items. This subscale has been adapted to include topics specific to the Keeping Safe programme.
Measured: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
The School Level Environment Survey (SLEQ) (Rentoul & Fraser, 1983; Aldridge et al., 2006)
a 24 item measure that assesses school culture from the perspective of the teacher. This will be adapted to ensure it is culturally appropriate.
Measured: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
Teacher fidelity measure
to completion of the CPD training programme and implementation /teaching of keeping safe programme
Measured: 3 times across 2 years; time 0 November/December 2016, time 1 May/June 2017, time 2 May/June 2018
Adaptation of 2 scales from the Parenting and Child Sexuality Questionnaire (Morawska et al., 2015)
adapted to include topics specific to the Keeping Safe Programme. This measure will be used to assess parent's knowledge and confidence to talk to their children about sensitive keeping safe issues
Measured: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
Parents' current and future confidence measure (Walsh et al., 2012).
2 questions adapted to assess parents' current and future confidence to talk to their children about keeping safe
Measured: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study startJun 2015
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Child MaltreatmentStudies 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
- Masking
- None (open label)
- Enrolment
- 6,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Society for the Prevention of Cruelty to Children
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Education Northern Ireland
- Responsible party
- Sponsor
- Investigators
- Aisling M McElearney, PhD, Principal investigator, National Society for the Prevention of Cruelty to Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961010
- Sponsor's protocol ID
- NIKS001
- Status last verified
- Jun 2019
- First submitted
- 8 Nov 2016
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dake JA, Price JH, Murnan J. Evaluation of a child abuse prevention curriculum for third-grade students: assessment of knowledge and efficacy expectations. J Sch Health. 2003 Feb;73(2):76-82. doi: 10.1111/j.1746-1561.2003.tb03576.x.
PubMed 12643023Sudermann M, Marshall L. and Loosely S. Evaluation of the London (Ontario) community group treatment programme for children who have witnessed woman abuse. Journal of Aggression, Maltreatment and Trauma 3(1): 127-146, 2000.
Tutty L. The revised Children's Knowledge of Abuse Questionnaire: development of a measure of children's understanding of sexual abuse prevention concepts. Social Work Research 19(2): 112-120, 1995.
Lynagh M.Gilligan G. and Handley T. Teaching about, and dealing with, sensitive issues in schools: How confident are pre-service teachers? Asia-Pacific Journal of Health, Sport and Physical Education 1 (3/4) 2010
Olweus D. The revised Olweus Bully/Victim Questionnaire for Students. Bergen, Norway: University of Bergen.1996
Cohen JN. Byers SE. and Sears HA. Factors Affecting Canadian Teachers' Willingness to Teach Sexual Health Education. Sex Education: Sexuality, Society and Learning, 12 (3): 299-316, 2012.
Kantor GK, Holt MK, Mebert CJ, Straus MA, Drach KM, Ricci LR, MacAllum CA, Brown W. Development and preliminary psychometric properties of the multidimensional neglectful behavior scale-child report. Child Maltreat. 2004 Nov;9(4):409-28. doi: 10.1177/1077559504269530.
PubMed 15538039Aldridge JM. Laugksch RC and Fraser BJ School -level environment and outcomes - based education in South Africa. Learning Environment Research 9: 123-147. 2006
Walsh K, Brandon L, Chirio L. Mother-child communication about sexual abuse prevention. J Child Sex Abus. 2012;21(4):399-421. doi: 10.1080/10538712.2012.675424.
PubMed 22809046Saslawsky DA, Wurtele SK. Educating children about sexual abuse: implications for pediatric intervention and possible prevention. J Pediatr Psychol. 1986 Jun;11(2):235-45. doi: 10.1093/jpepsy/11.2.235. No abstract available.
PubMed 3723285Morawska A, Walsh A, Grabski M, Fletcher R. Parental confidence and preferences for communicating with their child about sexuality. Sex Education 15(3): 235-48, 2015.
McElearney A, Scott J, Adamson G, Turtle K, McBride O, Stephenson P. Keeping safe: establishing the need to teach 'keeping safe' messages in primary schools in Northern Ireland: what do children currently know and understand? London: NSPCC, 2011.
Stephenson P, McElearney A, Stead J. The development of effective preventative education in primary schools in Northern Ireland: summary report. London: NSPCC, 2011.
McElearney A, Stephenson P, Adamson G. The development of effective preventative education in primary schools in Northern Ireland: exploring practice, policy and research implications. London: NSPCC, 2011.
McElearney A, Scott J, Stephenson P, Tracey A, Corry D. The views of principals, teachers and other school staff in relation to teaching "keeping safe" messages in primary schools in Northern Ireland. London: NSPCC, 2011.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomised Controlled Trial of Keeping Safe: Investigating the Effectiveness of a Whole School Preventative Education Programme in Improving Children's Knowledge and Understanding to Keep Safe in Situations of Abuse
- ClinicalTrials.gov ID
- NCT02961010
- Acronym / sponsor ID
- NIKS001
- Conditions
- Child Maltreatment
- Keywords
- school based prevention, child sexual and domestic abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,300 participants (actual)
- Lead sponsor
- National Society for the Prevention of Cruelty to ChildrenUniversity, hospital or other
- Collaborators
- Department of Education Northern Ireland
- Study start
- Jun 2015
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 10 Nov 2016 (estimated)
- 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.
This study evaluates the effectiveness of Keeping Safe, a whole school preventative education intervention in improving children's knowledge and understanding to keep safe in situations of abuse. The intervention
- Comprises three themes (1) Healthy Relationships; (2) My Body; and (3) Being Safe and includes content across the following keeping safe concepts; bullying, neglect, emotional, physical, domestic and sexual abuse, in online and offline contexts.
- Includes activities for the formal and informal school curricula - 63 lessons will be taught to children by their classroom teacher; 3 per term, 9 per year across 7 years from Primary 1 to primary 7 (age 4-11 years).
- Each lesson is accompanied by directed homework activities to involve and engage parents and enable them reinforce learning at home. A number of whole school, key stage and year group assemblies have also been prepared.
- At the beginning of each term school leaders will deliver a prepared assembly to introduce the theme for the term. Following this assembly each teacher will deliver 3 lessons tailored to the age group of their class and parents will assist with home works. The lessons use eBooks, character animations, stories, rhymes, and interactive whiteboard activities to engage children in their learning.
The intervention adopts a whole-school approach and seeks to build the capacity and skills of teachers and parents as key partners. Teachers will receive a comprehensive package of training, ongoing support and resource materials to equip them with the skills they need to effectively communicate sensitive keeping safe messages. Parents will also receive a package of resources to help them feel confident about communicating sensitive messages to their children.
Detailed description
Exploratory research, funded by the Department of Education and undertaken by the NSPCC in 2008, investigated the need for preventative education that aimed to equip pupils with the skills to recognise and respond appropriately to bullying, child abuse and domestic abuse in primary schools in Northern Ireland. Subsequently, an intervention was designed based on the findings from stakeholder consultations (NSPCC reports, 2011) and existing research in the field of school based prevention.
This study uses a cluster randomised controlled trial (RCT) design to evaluate the effectiveness of Keeping Safe, a whole school preventative education intervention in improving children's knowledge and understanding to keep safe in situations of abuse including sexual and domestic abuse.
Randomisation will take place at school level. Schools will be allocated either to the intervention group or a waitlist control group. Following randomisation, intervention schools will receive the package of training and support across a 3 month period. This comprises a blended package of continuing professional development training and support for teachers and school staff to enable them teach sensitive preventative education concepts through the formal statutory Personal Development curriculum, and all other informal opportunities that present in the daily life of the school. Intervention schools will then implement the Keeping Safe intervention in their school for 2 school years, between 2016 and 2018.
The Wait List Control group will continue with standard practice, teaching the Personal Development curriculum between 2016 and 2018. Both groups will participate in the evaluation between March 2016 and July 2018 and the wait list control group will receive the programme in Sept 2018.
This RCT will collect data at 3 timepoints: Baseline (March/ June 2016), Time One (May -June 2017) and Time Two (May- June 2018). Outcome data on children's knowledge and understanding will be collected at all 3 time points as will data on (1) teacher confidence and teaching practice, (2) parent confidence and practice, (3) school level administrative data (e.g. incidence of disclosure and referral out) and (4) school climate/organizational culture.
Primary outcomes (childrens)
- If exposure to the Keeping Safe programme:
- Impacts/changes children's self-reported knowledge and understanding of the following keeping safe concepts; bullying, neglect, physical, emotional, domestic and sexual abuse and in what ways?
- Impacts/changes children's self-reported self-efficacy to keep safe in situations of bullying, neglect, physical, emotional, domestic and sexual abuse and in what ways?
- If children's self-reported knowledge and understanding in relation to the above keeping safe concepts changes over the 2 year period that the programme is being implemented and in what ways?
- If changes in children's knowledge and understanding vary for different groups of children, and in what ways?
Secondary Outcomes (teachers and parents)
- If engagement with the Keeping Safe programme:
- Impacts/changes teachers' self-reported knowledge in teaching keeping safe messages and in what ways?
- Impacts/changes teachers' self-reported confidence and comfort in their own skills to manage sensitive issues in relation to Keeping Safe in the classroom and in what ways?
- How school context factors such as size, sector and management type, and professional experience factors (length of teaching service, nature of role in school) impact on teacher knowledge, comfort and confidence in teaching Keeping Safe messages.
- If the continuing professional development training and resources specifically designed for the Keeping Safe programme impact on teachers' teacher knowledge, comfort and confidence in teaching keeping safe messages.
- If implementing the Keeping Safe programme leads to change in school ethos/climate, and if this differs across schools and in what ways?
- If engagement with the Keeping Safe programme (parent resources and directed homework activities):
- Impacts/changes parents' self-reported knowledge of and confidence to communicate with their child about keeping safe messages and in what ways?
- Impacts/changes parents' self-reported current and future confidence to communicate with their child about keeping safe messages and in what ways?
- If reported changes in parents' knowledge and confidence vary for different groups of parents and in what ways?
- How personal (gender) parenting profile (age of children, no of children, relationship to child) and home context (postcode and household income) factors impact on parents' knowledge and confidence in relation to keeping safe messages.
- How parents' knowledge and confidence change over the 2 year period that the programme is being implemented and in what ways?
Data will be collected from children using a questionnaire designed to assess their knowledge and understanding of a range of keeping safe concepts and their self-reported self-efficacy to keep safe in unsafe situations. The questionnaire is a composite measure comprising existing and adapted standardised measures across a range of keeping safe concepts.
The content and administration of the questionnaire (online and paper versions available) have been tailored to ensure age and developmental appropriateness (a number of different versions will be used with varying age groups).
All classroom teachers will be invited to complete a self-report questionnaire (online or paper versions available) measuring their confidence, comfort and teaching practices with regards the programme. Fidelity data with regard to completion of continuing professional learning will be collated from the analytics function on the e-learning programme. Self-reported fidelity to programme implementation in the classroom will be collated using a fidelity monitoring form.
Information on school context (size, sector, management type) and professional experience (length of teaching service, nature of role in school) will also be collected to identify if these impact on teacher knowledge and confidence in teaching keeping safe messages.
All parents will be invited to complete a self-report questionnaire (online and paper) to assess their knowledge and confidence to talk to their children about sensitive keeping safe messages.
Information will also be collected on parents' personal profile (gender) parenting profile (age of children, no of children, relationship to child) home context (Postcode and household income) to identify if these make a difference to parent knowledge and confidence in communicating with their child(ren) about keeping safe messages
Additional school-level administrative data will be collected on Free School Meals/ newcomer children, level of Social Service engagement with school (referrals out etc) to see if these types of experience impact on teacher knowledge and confidence in teaching keeping safe messages, and to examine any difference between intervention and wait-list control schools.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Keeping SafeThe intervention group will receive the Keeping Safe programme between 2016 and 2018. This comprises a blended package of continuing professional development training and support (plus resource materials) for teachers and school staff to enable them teach sensitive preventative education concepts through the formal statutory Personal Development curriculum, and all other informal opportunities that present in the daily life of the school. Following randomisation, intervention schools will receive the package of training and support across a 3 month period and will then implement/teach in their school across 2 school years. The intervention group will collect outcome data for the evaluation between March 2016 and June 2018. |
| Wait-list Control Group | No intervention | –The Wait List Control group will continue with standard practice of teaching the statutory Personal Development curriculum between 2016 and 2018. They will not receive the Keeping Safe intervention until Sept 2018 following completion of the evaluation. The Waitlist control intervention group will collect outcome data for the evaluation between March 2016 and June 2018. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children 4-11 years attending mainstream sector primary school in Northern Ireland whose school has accepted the invitation to take part in the RCT and whose parents have provided consent for their participation.
Key exclusion criteria (3 listed)
- children attending special sector primary schools in Northern Ireland.
- children 4-11 years attending mainstream sector primary school in Northern Ireland whose school has not been invited/ rejected the invitation to take part in the RCT
- children 4-11 years attending mainstream sector primary school in Northern Ireland whose school has accepted the invitation to take part in the RCT and whose parents have not provided consent for their participation.
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 |
|---|---|---|
| Keeping SafeA whole school Preventative Education programme | Behavioural | Intervention Group |
Primary outcome
Children's Knowledge of Abuse Questionnaire (CKAQ) (Tutty, 1995)
Time frame: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
a 33-item self-report measure used to assess children's knowledge of sexual abuse.
Knowledge/Attitudes to Woman Abuse' sub-scale of the 'Child/Teen Witness to Woman Abuse questionnaire (Sudermann et al., 2000)
Time frame: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
a 10-item sub-scale used to assess children's knowledge of Domestic Abuse
Self-Efficacy Sub-scale (Dake et al., 2003)
Time frame: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
a 5-item sub-scale used to assess children's perceived self-efficacy to keep safe in situations of abuse. An additional 4 items were added to this measure concerning online abuse, cyberbullying, and neglect
The What-If Situations Test (WIST) (Saslawsky & Wurtele, 1986)
Time frame: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
a 6-item scenario-based measure designed to assess children's (aged 5-12) ability to recognise and respond to hypothetical situations of abuse. An additional 5 scenarios concerning non-contact, online, and peer-to-peer abuse
two Global Items from the Olweus (1996) bullying questionnaire
Time frame: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
used to assess frequency of bullying perpetration/victimization.
Adaptation of the Multidimensional Neglectful Behaviour Scale (Kantor et al., 2004)
Time frame: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
This 38-item measure is used as a screening tool for neglect. This measure has been adapted to be used as knowledge measure. 10 items across a range of neglect concepts will be used and presented as true/false questions.
Administrative school level data on children's behaviour
Time frame: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
to be collated as a proxy measure of skills in recognising, telling and reporting abusive behaviour. This includes child in need/ child at risk disclosures, concerns raised, support received from external agencies.
Revised Children's Manifest Anxiety Scale (RCMAS 2) short 10 item (Reynold and Paget (1981)
Time frame: twice across 2 years; time 1 May/June 2017, time 2 May/June 2018
a 10 item short version of the RCMAS - 'What I Think and Feel' used to assess children's self-reported anxiety
6 secondary outcomes
Survey on Perceived Confidence in, and Attitudes towards approaches to Teaching and Learning about Sensitive Issues in Health & Personal Development (Lynagh et al., 2010)
Time frame: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
Subscale of the Teacher Willingness to Teach Sexual Health Education Questionnaire (Cohen et al., 2012)
Time frame: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
The School Level Environment Survey (SLEQ) (Rentoul & Fraser, 1983; Aldridge et al., 2006)
Time frame: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
Teacher fidelity measure
Time frame: 3 times across 2 years; time 0 November/December 2016, time 1 May/June 2017, time 2 May/June 2018
Adaptation of 2 scales from the Parenting and Child Sexuality Questionnaire (Morawska et al., 2015)
Time frame: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
Parents' current and future confidence measure (Walsh et al., 2012).
Time frame: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018
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 27 Jun 2019.
- Background: PubMed 12643023Dake JA, Price JH, Murnan J. Evaluation of a child abuse prevention curriculum for third-grade students: assessment of knowledge and efficacy expectations. J Sch Health. 2003 Feb;73(2):76-82. doi: 10.1111/j.1746-1561.2003.tb03576.x.
- BackgroundSudermann M, Marshall L. and Loosely S. Evaluation of the London (Ontario) community group treatment programme for children who have witnessed woman abuse. Journal of Aggression, Maltreatment and Trauma 3(1): 127-146, 2000.
- BackgroundTutty L. The revised Children's Knowledge of Abuse Questionnaire: development of a measure of children's understanding of sexual abuse prevention concepts. Social Work Research 19(2): 112-120, 1995.
- BackgroundLynagh M.Gilligan G. and Handley T. Teaching about, and dealing with, sensitive issues in schools: How confident are pre-service teachers? Asia-Pacific Journal of Health, Sport and Physical Education 1 (3/4) 2010
- BackgroundOlweus D. The revised Olweus Bully/Victim Questionnaire for Students. Bergen, Norway: University of Bergen.1996
- BackgroundCohen JN. Byers SE. and Sears HA. Factors Affecting Canadian Teachers' Willingness to Teach Sexual Health Education. Sex Education: Sexuality, Society and Learning, 12 (3): 299-316, 2012.
- Background: PubMed 15538039Kantor GK, Holt MK, Mebert CJ, Straus MA, Drach KM, Ricci LR, MacAllum CA, Brown W. Development and preliminary psychometric properties of the multidimensional neglectful behavior scale-child report. Child Maltreat. 2004 Nov;9(4):409-28. doi: 10.1177/1077559504269530.
- BackgroundAldridge JM. Laugksch RC and Fraser BJ School -level environment and outcomes - based education in South Africa. Learning Environment Research 9: 123-147. 2006
- Background: PubMed 22809046Walsh K, Brandon L, Chirio L. Mother-child communication about sexual abuse prevention. J Child Sex Abus. 2012;21(4):399-421. doi: 10.1080/10538712.2012.675424.
- Background: PubMed 3723285Saslawsky DA, Wurtele SK. Educating children about sexual abuse: implications for pediatric intervention and possible prevention. J Pediatr Psychol. 1986 Jun;11(2):235-45. doi: 10.1093/jpepsy/11.2.235. No abstract available.
- BackgroundMorawska A, Walsh A, Grabski M, Fletcher R. Parental confidence and preferences for communicating with their child about sexuality. Sex Education 15(3): 235-48, 2015.
- BackgroundMcElearney A, Scott J, Adamson G, Turtle K, McBride O, Stephenson P. Keeping safe: establishing the need to teach 'keeping safe' messages in primary schools in Northern Ireland: what do children currently know and understand? London: NSPCC, 2011.
- 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.
Aisling M McElearney, PhD principal investigator
National Society for the Prevention of Cruelty to Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keeping Safe in people with Child Maltreatment, run by National Society for the Prevention of Cruelty to Children at 1 site in United Kingdom.
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 1 inclusion and 3 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 27 Jun 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 United Kingdom. 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's Knowledge of Abuse Questionnaire (CKAQ) (Tutty, 1995) (time frame: 3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018). The study lists 8 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 NCT02961010, which also lists 17 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 27 Jun 2019.