Protocol summary

Study aim
Determining the Effectiveness of Group Counseling with Cognitive-Behavioral Approach for the Outcome of Extreme Mentally Controlled Girls in Mashhad's Welfare Center in Mashhad, 1996-97
Design
The statistical population of this study is all girls aged 14-18 years old, who are kept in Mashhad. After registered the self-differentiation questionnaire is filled up for everyone. For example, if the number of these people is 100 (according to sample size 60), the percentile of 60 obtained by individuals is calculated, and those who scored lower than they are entered into the study and by a block size of 4 to two The intervention group (30 people) and the control group (30 people) are allocated.
Settings and conduct
The place of the study is public centers of Ali Asghar and the angels in Mashhad. After the formation of two groups, the counseling for the intervention group was performed and running questionnaire to both groups and then the results were analyzed and compared.
Participants/Inclusion and exclusion criteria
Entry requirements: living in a welfare institution, declaring cooperation in providing the information required by the girls surveyed, aged 14-18 years, the person is not currently receiving other psychological treatment, does not suffer from severe psychiatric disorders, evidence of physical illness It does not require treatment. And exclusion criteria: not attending counseling sessions, attending other counseling and training sessions simultaneously.
Intervention groups
Intervention is a group that holds group counseling sessions to promote self- Differentiation
Main outcome variables
The rate of change in girls' differentiation scores and comparison with control group

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180116038390N1
Registration date: 2018-01-29, 1396/11/09
Registration timing: prospective

Last update: 2018-01-29, 1396/11/09
Update count: 0
Registration date
2018-01-29, 1396/11/09
Registrant information
Name
Bi Bi Halimeh Kazemeini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3732 7053
Email address
kazemeini@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of cognitive-behavioral group counseling on the self-differentiation of derelict and unsupervised girls over puberty
Public title
Effectiveness of cognitive-behavioral group counseling on the self-differentiation of derelict and unsupervised girls over puberty
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
In the institution of well-being Girls under review will be required to provide information they need Aged 14-18 years old
Exclusion criteria:
Take part in other training and consulting sessions simultaneously Severe psychiatric disorders are affected The person is currently receiving another psychological treatment Evidence is based on the presence of a medical condition that requires treatment.
Age
From 14 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, all eligible people in each center are identified and registered. Then the self-differentiation questionnaire is filled up for everyone. For example, if the number of these people is 100 (according to sample size 60), the percentile of 60 obtained by individuals is calculated, and those who scored lower than they are entered into the study and by a block size of 4 to two The intervention and control groups are assigned.
Blinding (investigator's opinion)
Triple blinded
Blinding description
To prevent information leakage between the two groups, we will hold counseling sessions away from the eyes of the control group. Also, to blind the person collecting information from another person who is not informed to the group, it will be used to fill in the questionnaires after the intervention in two groups. We will also not inform the data analyst of the group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Seventh Tir Square, Shahrood University of Medical Sciences
City
shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2018-01-06, 1396/10/16
Ethics committee reference number
IR.SHMU.REC.1396.143

Health conditions studied

1

Description of health condition studied
self differentiation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Self-Esteem Score from Self-Identification Questionnaire
Timepoint
Before the intervention and one week after the study
Method of measurement
Self-differentiation questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Conducting counseling sessions to promote self-discovery in girls. Weekly sessions are a one-hour session and each session is two hours on specific days, along with reception during meetings, and a total of 8 sessions.
Category
Behavior

2

Description
Control group: A group with no experimental intervention is selected and compared to the intervention group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorasan Razavi Welfare Organization
Full name of responsible person
Tahmina Shakib
Street address
Azadi Street, between Shahada and Zarrineh crossroads, between freedom 8 and 10
City
mashhad
Province
Razavi Khorasan
Postal code
9149614783
Phone
+98 51 3223 1206
Email
info@behzisti.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Seventh Tir Square, Shahroud University of Medical Sciences and Health Services
City
shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
info@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Bi Bi Halimeh Kazemeini
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Seventh Tir Square, Shahroud University of Medical Sciences and Health Services
City
shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
kazemeini@shmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Zahra Motaghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Seventh Tir Square, Shahroud University of Medical Sciences and Health Services
City
shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 982332395054
Email
zhrmotaghi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Bi bi Halimeh Kazemeini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Seventh Tir Square, Shahroud University of Medical Sciences and Health Services
City
Shahrood
Province
Semnan
Postal code
9149614783
Phone
+98 23 3239 5054
Email
kazemeini@shmu.ac.ir

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
Not applicable
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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