Protocol summary

Study aim
Effectiveness of Moms Empowerment Program on the quality of parent-child relationship, PTSD symptoms, depression and use of physical punishment in mothers with intimate partner violence (IPV) experience and 6-12 old age children
Design
Two arm parallel group randomized trial with outcome assessment
Settings and conduct
For the experiment group, training sessions will be held in groups of Moms’ Empowerment Program in Sanandaj
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women who have experienced IPV in the last two years. They have children between the ages of 6 and 12 .They have PTSD symptoms. They have the possibility of commuting. They have at last a high school education. Commit to secrecy. Complete a written consent. Exclusion criteria: History of substance abuse in mothers. Taking psychiatric drugs. Participate in similar training courses over the past years. Violation of meeting obligations
Intervention groups
The Parent Training Moms Empowerment Program (MEP) will be implemented as 10 sessions of group training for test group subjects. The experimental group includes 15 mothers with intimate partner violence (IPV) experience and 6-12 old age children. who receive 10 weekly group training sessions. The control group included 15 mothers with intimate partner violence (IPV) experience and 6-12 old age children, that did not undergo any intervention
Main outcome variables
quality of parent-child relationship, PTSD symptoms, depression and use of physical punishment in mothers with intimate partner violence (IPV) experience and 6-12 old age children.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150110020629N4
Registration date: 2020-07-30, 1399/05/09
Registration timing: retrospective

Last update: 2020-07-30, 1399/05/09
Update count: 0
Registration date
2020-07-30, 1399/05/09
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 919 3686
Email address
o.isanejad@uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-07-25, 1399/05/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Moms Empowerment Program on the quality of parent-child relationship, PTSD symptoms, depression and use of physical punishment in mothers with intimate partner violence (IPV) experience and 6-12 old age children
Public title
Effectiveness of Moms Empowerment Program on the mothers with intimate partner violence (IPV) experience and 6-12 old age children.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women who have experienced IPV in the last two years. They have children between the ages of 6 and 12 . They have PTSD symptoms. They have the possibility of commuting. They have at last a high school education. Commit to secrecy. Complete a written consent.
Exclusion criteria:
History of substance abuse in mothers. Taking psychiatric drugs. Participate in similar training courses over the past years.
Age
From 16 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization design will be used. All participants will be listed between 1-30. The list randomly will be divided into two groups (experiment or A and control or B) by Graphpad.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Kurdistan
Street address
University of Kurdistan, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
15175-66177
Approval date
2020-02-15, 1398/11/26
Ethics committee reference number
IR.UOK.REC.1398.046

Health conditions studied

1

Description of health condition studied
post traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)

2

Description of health condition studied
depression
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate

Primary outcomes

1

Description
at least 0.4 effect size in reducing of PTSD grades
Timepoint
before the intervention, after interventions in post test, follow up 3 month after the last intervention
Method of measurement
Posttraumatic Stress Disorder Checklist(PCL-5)

2

Description
at least 0.4 effect size in reducing of depression grades
Timepoint
before the intervention, after interventions in post test, follow up 3 month after the last intervention
Method of measurement
Beck depression inventory- II (BDI- II)

Secondary outcomes

1

Description
Conflict managements tactics
Timepoint
before the intervention, after interventions in post test, follow up 1 month after the last intervention
Method of measurement
Revised Conflict Tactics Scale (CTS2)

2

Description
parenting style
Timepoint
before the intervention, after interventions in post test, follow up 1 month after the last intervention
Method of measurement
Alabama Parenting Questionnaire(APQ)

3

Description
Child's behavioral problems
Timepoint
before the intervention, after interventions in post test, follow up 1 month after the last intervention
Method of measurement
Child Behavioral Check List (CBCL)

4

Description
Parent-child interaction
Timepoint
before the intervention, after interventions in post test, follow up 1 month after the last intervention
Method of measurement
Parent-Child Interaction Questionnaire-Revised (PACHIQ-R)

Intervention groups

1

Description
Intervention group: After selecting the sample and performing the diagnosis and performing pre-tests, training the mothers in the sample group for 10 sessions of 1 hour as a group training, Moms’ Empowerment Program (MEP) chart based on the guide (Sandra Graham-Bergmann, 2016) for the experimental group will be executed.The first session: Becoming a Group. The second session: Fears and Worries, Parenting Under Stress. The Three Session: Child Development – What’s Usual, What’s not?The fourth session: Communicating about Family Violence. The fifth session: Family or Origin.The Sixth session: Discipline Strategies - What Works?The seven session: Safety Plans, Community Responses, Resources. The Eighth sessions: Stress Management for Moms and Kids. The nine Session: Mom Time and Having Fun with Kids. The Ten Session: Closure and Saying Goodbye.
Category
Behavior

2

Description
Control group: without intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Institution of Asoo Zaniaran
Full name of responsible person
Nagin Mohammady
Street address
Sanandaj- Suleiman khater Street
City
Sanandaj
Province
Kurdistan
Postal code
6613916553
Phone
+98 87 9182 1520
Email
Asoo.zaniarankurdistan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Kurdistan
Full name of responsible person
Dr. Kumars Karami
Street address
University of Kurdistan, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
کد پستی 1517566177
Phone
+98 87 3366 4600
Email
KKarami@uok.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Kurdistan
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Omid Isanejad
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Kurdistan, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
15175-66177
Phone
+98 87 3366 4600
Email
farhangmad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Omid Isanejad
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Kurdistan, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
1517566177
Phone
+98 914 919 3686
Email
farhangmad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Omid Isanejad
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Kurdistan, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
1517566177
Phone
+98 914 919 3686
Email
farhangmad@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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