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Trial record 11 of 1153 for:    (child OR Children Or youth) AND (violence OR abuse)

Evaluating the Effectiveness of Keeping Safe - a School Based Intervention Aimed at Preventing Abuse

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ClinicalTrials.gov Identifier: NCT02961010
Recruitment Status : Active, not recruiting
First Posted : November 10, 2016
Last Update Posted : August 7, 2017
Sponsor:
Collaborator:
Department of Education Northern Ireland
Information provided by (Responsible Party):
National Society for the Prevention of Cruelty to Children

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.


Condition or disease Intervention/treatment Phase
Child Maltreatment Behavioral: Keeping Safe Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : June 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: Intervention Group
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
A whole school Preventative Education programme

No Intervention: Wait-list Control Group
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.



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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 Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    includes a teacher comfort subscale comprising 26-items. This subscale has been adapted to include topics specific to the Keeping Safe programme.

  3. 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 ]
    a 24 item measure that assesses school culture from the perspective of the teacher. This will be adapted to ensure it is culturally appropriate.

  4. 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 ]
    to completion of the CPD training programme and implementation /teaching of keeping safe programme

  5. 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 ]
    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

  6. 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 ]
    2 questions adapted to assess parents' current and future confidence to talk to their children about keeping safe



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  1. children attending special sector primary schools in Northern Ireland.
  2. 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
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961010


Locations
United Kingdom
National Society for the Prevention fo Cruelty to Children
Belfast, Northern Ireland, United Kingdom, BT15 3HN
Sponsors and Collaborators
National Society for the Prevention of Cruelty to Children
Department of Education Northern Ireland
Investigators
Principal Investigator: Aisling M McElearney, PhD National Society for the Prevention of Cruelty to Children

Additional Information:
Publications:
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.
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.
Aldridge JM. Laugksch RC and Fraser BJ School -level environment and outcomes - based education in South Africa. Learning Environment Research 9: 123-147. 2006
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.
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.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Society for the Prevention of Cruelty to Children
ClinicalTrials.gov Identifier: NCT02961010     History of Changes
Other Study ID Numbers: NIKS001
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by National Society for the Prevention of Cruelty to Children:
school based prevention, child sexual and domestic abuse