Determine effectiveness of teaching compassion skills on mother-child attachment and parenting style in mothers with children aged 3-5
Design
This is a randomized clinical trial with a parallel design and a control group. This non-blinded study will be conducted on 40 eligible mothers. A simple randomization method is used, and the participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted at the Hafizeh Health Center in Kermanshah, is non-blinded. In the first meeting to start the study, a book on Compassion will be provided to the participants for reading.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with a child aged 3-5; Age between 18-45 years
Physical health of the child; Proficient in Persian language to communicate
Having a minimum level of literacy at the end of primary school; Informed consent; Resident of Kermanshah City
Exclusion criteria: Divorce history; History of taking psychotropic drugs; History of mental or physical disorder in the child
Intervention groups
The intervention group will receive compassion training in eight 120-minute group sessions (with 10 people in each group) weekly.The control group will not receive the intervention.
Main outcome variables
Attachment, parenting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N226
Registration date:2024-09-10, 1403/06/20
Registration timing:prospective
Last update:2024-09-10, 1403/06/20
Update count:0
Registration date
2024-09-10, 1403/06/20
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-20, 1403/06/30
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of teaching compassion skills on mother-child attachment and parenting style in mothers with children aged 3-5
Public title
Effectiveness of teaching compassion skills on mother-child attachment and parenting style in mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with a child aged 3-5
Age between 18-45 years
Physical health of the child
Proficient in Persian language to communicate
Having a minimum level of literacy at the end of primary school
Informed consent
Resident of Kermanshah city
Exclusion criteria:
Divorce history
History of taking psychotropic drugs
History of mental or physical disorder in the child
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Using the simple random method. The names of the participants are written on the card. The cards are put into a box that cannot be seen from outside. One of the colleagues of the plan is asked to remove one card from the container at a time. The names of the 20 cards that are selected first are placed in the intervention group and the second 20 selected cards are placed in the control group.
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2024-08-21, 1403/05/31
Ethics committee reference number
IR.KUMS.REC.1403.251
Health conditions studied
1
Description of health condition studied
Attachment behavior
ICD-10 code
P00
ICD-10 code description
Fetus and newborn affected by maternal conditions that may be unrelated to present pregnancy
Primary outcomes
1
Description
Attachment
Timepoint
Before the intervention, immediately after the end of the last session of the intervention (eighth session) and four weeks after the end of the intervention
Method of measurement
Using the attachment questionnaire
2
Description
Parenting
Timepoint
Before the intervention, immediately after the end of the last session of the intervention (eighth session) and four weeks after the end of the intervention
Method of measurement
Using parenting questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive compassion training in eight 120-minute group sessions (with 10 people in each group) weekly.
Category
Behavior
2
Description
The control group will not receive the intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafezia Health Center
Full name of responsible person
Sara Faghihi
Street address
Next to Hafezeh Middle School for Girls, 45 meters from the second Hafezieh St
City
Kermanshah
Province
Kermanshah
Postal code
6715813149
Phone
+98 83 3836 7909
Email
sara.faghihi65@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Marziyeh Kaboudi
Position
A member of the university faculty
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd,Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
fkaboudi@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Marziyeh Kaboudi
Position
A member of the university faculty
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd,Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
fkaboudi@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Marziyeh Kaboudi
Position
A member of the university faculty
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd,Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
fkaboudi@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD