Protocol summary

Summary
Objectives: The effect of child-parent relationship therapy (CPRT) on Reduction of children's severity of signs and symptoms with separation anxiety disorder by reducing maternal stress and enhance efficacy and improve the relationship between mother and children. A) Study design: Intervention, non- randomized allocated to intervention and control groups, not blind, non-placebo. The method of this study include: a population study including mothers of children 4-7 years old preschool and first-grade school in Zanjan city. The participants were 24 mothers of children who had had a diagnosis of separation anxiety disorder. Terms of Inclusion: age 6 to 7 years for having children, having a minimum grade education for mothers and children on the basis of a questionnaire score of 8 or higher for CSI-4. Exclusion major conditions: severe mental illness mother, a mental illness in children at the same time, under the guidance of education for mothers. B) Intervention or interventions studied in this research for the intervention of the training group therapy (play therapy) 10 sessions of two-hour meeting was established based on Parent-child relationships C) Intervention lasted two months. D) The primary outcome or consequences of the study: The effect of child-parent relationship therapy (CPRT) on Reduction of children's severity of signs and symptoms with separation anxiety disorder.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050127545N2
Registration date: 2017-06-02, 1396/03/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-02, 1396/03/12
Registrant information
Name
Jahangir Mohammadi Baytamar
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3342 4766
Email address
jahanmohammadi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
institution- Vice chancellor for research, Zanjan University of Medical Sciences
Expected recruitment start date
2015-10-02, 1394/07/10
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of child-parent relationship therapy (CPRT) on Reduction of children's severity of signs and symptoms with separation anxiety disorder
Public title
The effect of child-parent relationship therapy (CPRT) on Reduction of separation anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion major conditions: age 6 to 7 years for having children, having a minimum grade education for mothers and children on the basis of a questionnaire score of 8 or higher for CSI-4. Exclusion major conditions: severe mental illness mother, a mental illness in children at the same time, under the guidance of education for mothers.
Age
From 6 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Zanjan University of Medical Sciences Ethics Committee
Street address
Zanjan University Of Medical Sience, Azadi Blvd
City
Zanjan
Postal code
4515613191
Approval date
2015-07-02, 1394/04/11
Ethics committee reference number
ZUMS.REC.1394.267

Health conditions studied

1

Description of health condition studied
Separation anxiety disorder of childhood
ICD-10 code
F93.0
ICD-10 code description
Separation anxiety disorder of childhood

Primary outcomes

1

Description
Separation Anxiety
Timepoint
Pretest and Post test
Method of measurement
CSI-4 Questionnaire

Secondary outcomes

1

Description
Parental Stress
Timepoint
PSI Questionnaire
Method of measurement
Pretest and Post test

2

Description
Efficacy
Timepoint
General Self Efficacy Questionnaire
Method of measurement
Pretest and Post test

3

Description
Parent-Child Relationship
Timepoint
Inventory MCMR
Method of measurement
Pretest and Post test

Intervention groups

1

Description
Group Therapy Education (play therapy) Parent-child relationships are based on 10 two-hour sessions on experimental group
Category
Other

2

Description
No action was not subjected to the control group and intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Basij School
Full name of responsible person
Maryam Molla Rostami
Street address
Andishe Subveb
City
Zanjan

2

Recruitment center
Name of recruitment center
Baharestan School
Full name of responsible person
Asghar Adami
Street address
Street HafteTir, Alley Nasser
City
Zanjan

3

Recruitment center
Name of recruitment center
Preschool Rihanehaye Beheshti
Full name of responsible person
Zahra Hosaini
Street address
Zibashahr Phase 2 Shiraz St. 9
City
Zanjan

4

Recruitment center
Name of recruitment center
Preschool Almas Mihan
Full name of responsible person
Sakine Nazarian
Street address
Zibashahr Phase 2 Shiraz St. 2
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Zanjan University of Medical Sciences
Full name of responsible person
Soghrat Faghihzade
Street address
Zanjan University of Medical Sciences, Azadi Blvd, Zanjan.
City
Zanjan
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, Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Saeede Zenoozian
Position
PhD
Other areas of specialty/work
Street address
Zanjan University of Medical Sciences, Azadi Blvd
City
Zanjan
Postal code
Phone
+98 24 3353 4500
Fax
Email
zenoozian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Roya Ahmadizadeh
Position
Master of Clinical Psychology
Other areas of specialty/work
Street address
Beheshti Hospital, Gate the Ark, Sadi Crossroad
City
Zanjan
Postal code
Phone
+98 24 3353 4500
Fax
Email
Ahmadizadeh 1390@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Jahangir Mohammadi Baytamar
Position
Master of Clinical Psychology
Other areas of specialty/work
Street address
Beheshti Hospital, Gate the Ark, Sadi Crossroad
City
Zanjan
Postal code
Phone
+98 24 3353 4500
Fax
Email
Jahanmohammadi@zums.ac.ir; jahanmohammadi68@gmail.com
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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