NCT03956628

Brief 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. Mainly, this study enhance the understanding of teachers and children to provide protection and confidence by following programme.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
378

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 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

September 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

May 3, 2019

Last Update Submit

May 19, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2 months

Study Arms (2)

experimental group

EXPERIMENTAL

participants in experimental group receive intervention and experimental group consists of two sub groups, teachers and students.

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.

Interventions

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.

experimental group

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • students enrolled in class 1-2
  • age range between 5-9
  • students allowed by their parents to participate in the study.

You may not qualify if:

  • students not enrolled in class 1 or 2
  • students not within age range.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zainab noor Hussain

Multan, Punjab Province, 60000, Pakistan

Location

Related Publications (2)

  • 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.

  • MacIntyre 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.

Related Links

Study Officials

  • Rizwana Amin, PhD

    Bahauddin Zakariya University Multan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are randomly assigned to control and experimental group.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 21, 2019

Study Start

September 15, 2018

Primary Completion

April 15, 2019

Study Completion

April 15, 2019

Last Updated

May 21, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

stay safe programme Access

Locations