NCT02961010

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

3.1 years

First QC Date

November 8, 2016

Last Update Submit

June 26, 2019

Conditions

Keywords

school based prevention, child sexual and domestic abuse

Outcome Measures

Primary Outcomes (8)

  • Children's Knowledge of Abuse Questionnaire (CKAQ) (Tutty, 1995)

    a 33-item self-report measure used to assess children's knowledge of sexual abuse.

    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

    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

    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

    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.

    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.

    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.

    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

    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)

    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)

    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)

    3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018

  • Teacher fidelity measure

    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)

    3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

Keeping SafeBEHAVIORAL

A whole school Preventative Education programme

Intervention Group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • (1) 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Society for the Prevention fo Cruelty to Children

Belfast, Northern Ireland, BT15 3HN, United Kingdom

Location

Related Publications (17)

  • 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.

    PMID: 12643023BACKGROUND
  • Sudermann 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • Olweus D. The revised Olweus Bully/Victim Questionnaire for Students. Bergen, Norway: University of Bergen.1996

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 15538039BACKGROUND
  • Aldridge JM. Laugksch RC and Fraser BJ School -level environment and outcomes - based education in South Africa. Learning Environment Research 9: 123-147. 2006

    BACKGROUND
  • 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.

    PMID: 22809046BACKGROUND
  • Saslawsky 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.

    PMID: 3723285BACKGROUND
  • Morawska 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • Stephenson P, McElearney A, Stead J. The development of effective preventative education in primary schools in Northern Ireland: summary report. London: NSPCC, 2011.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • Stephenson P, Tracey A, McElearney A. The views of cross-sector stakeholders in relation to teaching "keeping safe" messages in primary schools in Northern Ireland. London: NSPCC, 2011.

    BACKGROUND
  • McElearney A, Brennan-Wilson A, Murphy C, Stephenson P, Bunting B. Cluster randomised controlled trial of 'whole school' child maltreatment prevention programme in primary schools in Northern Ireland: study protocol for Keeping Safe. BMC Public Health. 2018 May 3;18(1):590. doi: 10.1186/s12889-018-5492-8.

Related Links

Study Officials

  • Aisling M McElearney, PhD

    National Society for the Prevention of Cruelty to Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 10, 2016

Study Start

June 1, 2015

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

June 27, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations