Protocol summary

Summary
This is a randomized controlled clinical trial. The purposes of this study are: 1- to determine different forms of maternal child abuse 2- to evaluate implementation of mother–training program to prevent child abuse. The trial will be performed on 600 mothers of four groups of children (infancy, toddler, preschool age, school age), who refer to Amirkala hospital, Bobol, Iran, to take medical services for their children. After illuminate the most form of maternal child abuse in the four groups, in the first stage the target group enter in the second stage. Then their child care skills (their knowledge and skills about child growth and development, mothering role and control of angry) will be examined. The researcher assign eligible participants into the experimental and control groups randomly. Experimental group receive intervention and control group receive no intervention in this stage. The maternal knowledge and skill for child caring is the main outcome and will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105046381N1
Registration date: 2011-08-20, 1390/05/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-08-20, 1390/05/29
Registrant information
Name
Zahra Esmaeeli Douki
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 15122673425
Email address
esmaeeli@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2007-07-23, 1386/05/01
Expected recruitment end date
2009-06-22, 1388/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of mother-training program to prevent child abuse
Public title
Mother training program to prevent child abuse
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Persian language; possessing 5 years old child that made low score in measurement of developmental aspects of life (physical, Social and cognitive); mothers and their children who can able to answers the questioners; mothers who have educational levels at least elementary school or more; mothers who are from nuclear family (father, mother, brother and sister), mothers who are responsible to take care of their children. Exclusion criteria: mother’s course of education is in psychological sciences; having history of psychiatric diseases; addiction, employed mothers in medical health centres.
Age
From 1 year old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 600
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Moalem Street, Moalem Square
City
Sari
Postal code
4816715793
Approval date
2007-03-12, 1385/12/21
Ethics committee reference number
85-142

Health conditions studied

1

Description of health condition studied
child abuse
ICD-10 code
Z61.6
ICD-10 code description
Problems related to alleged physical abuse of child

2

Description of health condition studied
child abuse
ICD-10 code
T74.3
ICD-10 code description
Psychological abuse

Primary outcomes

1

Description
Frequency of maternal child abuse
Timepoint
Before and 8 weeks after intervention
Method of measurement
questionnaire & checklist

Secondary outcomes

empty

Intervention groups

1

Description
Experimental group will receive intervention via educational package by face to face method, 2 session per week for 4 weeks.
Category
Prevention

2

Description
Control group receive no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Amirkola teaching therapeutic pediatric center
Full name of responsible person
Zahra Esmaeeli Douki
Street address
Mazandaran, Bab
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of mazandadaran university of medical sciences
Full name of responsible person
Dr. Ahmadali Enayati
Street address
Moalem square, Moalem street
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of mazandadaran university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra Esmaeili Douki
Position
Msc., Member of faculty
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery School
City
Sari
Postal code
Phone
+98 15 1226 7342
Fax
Email
zdouki@yahoo.com, nasibeh83@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Nazanin Vaezzadeh
Position
MSc., Member of faculty
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery School
City
Sari
Postal code
Phone
+98 15 1226 7342
Fax
Email
nvaezzadeh@yahoo.com ; nasibehn83@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra Esmaeili
Position
MSc., member of faculty
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery School
City
Sari
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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