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Clinical Trials/NCT02961010
NCT02961010CompletedNot Applicable

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

National Society for the Prevention of Cruelty to Children2 sites in 1 country6,300 target enrollmentStarted: June 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
6,300
Locations
2
Primary Endpoint
Children's Knowledge of Abuse Questionnaire (CKAQ) (Tutty, 1995)

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
4 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • (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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

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.

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

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.

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.

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

Secondary Outcomes

  • 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)
  • 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)
  • Parents' current and future confidence measure (Walsh et al., 2012).(3 times across 2 years; time 0 baseline March/June 2016, time 1 May/June 2017, time 2 May/June 2018)
  • 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)
  • Teacher fidelity measure(3 times across 2 years; time 0 November/December 2016, time 1 May/June 2017, time 2 May/June 2018)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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