Evaluating the effect of peer group counseling on adolescents with parents with mood disorders
Design
Randomized clinical trial using SPSS software randomly 50 people for the intervention group and 50 people for the control group.
Settings and conduct
Randomized clinical trial on children aged 12 to 18 years with patients with major depression and bipolar disorder performed at Kargarnejad Hospital in Kashan.
The psychiatrist reviews the questionnaires and interviews without knowing the type of study group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Adolescents aged 12 to 18 years,
Parents who have been diagnosed mood disorder based on DSM 5 and a psychiatrist diagnosis
Awareness that parents have a psychiatric illness.
Written consent of parents or primary caregivers to attend group meetings,
Willingness to attend the program,
No psychiatric illness in adolescents.
Exclusion criteria:
Lack of consent
Children do not want to participate or continue working in the group
Age less than 12 and more than 18 years
Adolescent psychiatric illness
Absence of more than two sessions in a group
Intervention groups
The intervention group consisted of 50 people (including groups of 6 to 10 persons) and the control group of 50 persons. In the first group, people attend a 45- to 50-minute session each week for eight consecutive weeks. No intervention is performed on the control group (waiting list)
Both groups answer the "Connor and Davidson Resilience" and "Rosenberg Self-Esteem" questionnaires at the beginning and end of 8 weeks.
Main outcome variables
Connor & Davidson test score (subscale of perception of individual competence, trust in individual instincts and tolerance of negative emotions, positive acceptance of change and safe relationships, control, spiritual effects)
Rosenberg self-esteem test score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210804052078N1
Registration date:2022-04-01, 1401/01/12
Registration timing:registered_while_recruiting
Last update:2022-04-01, 1401/01/12
Update count:0
Registration date
2022-04-01, 1401/01/12
Registrant information
Name
Tayebeh Panjehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3264 6466
Email address
panjehpour-t@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Peer Group Support on resilience and Self-esteem in adolescents of parents with mood Disorder
Public title
Peer Group Support on resilience and Self-esteem in adolescents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents aged 12 to 18 years
Parents who have been diagnosed mood disorder based on DSM 5
Awareness that parents have a psychiatric illness
Written consent of parents or primary caregivers to attend group
Willingness to attend the program
No psychiatric illness in adolescents
Exclusion criteria:
Lack of consent
adolescents do not want to participate or continue participation in the group
Age less than 12 and more than 18 years
Adolescents with psychiatric illness
Absence in more than two sessions
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The study population will be first extracted from the children of 12 to 18 years old of parents with major depression or bipolar disorder who are undergoing outpatient treatment in Kargarnejad Clinic or Hospital and will be assigned a unique number. Using SPSS software, 50 people will be randomly selected for the intervention group and 50 people for 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 Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences,Qotb Ravandi Blvd.
City
kashan
Province
Isfehan
Postal code
73474-87159
Approval date
2022-02-12, 1400/11/23
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.177
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
2
Description of health condition studied
Bipolar Disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Resilience
Timepoint
Weeks 0, 8
Method of measurement
Connor & Davidson Questionnaire
2
Description
Self esteem
Timepoint
Weeks 0, 8
Method of measurement
Rosenberg Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50 children aged 12 to 18 years with patients with major depression and bipolar disorder, in groups of 6 to 10, for 8 consecutive weeks, one session of 45 to 50 minutes per week. The group is trained by the facilitator according The Kids in Control program is guided by the concepts in Supportive Psychotherapy Learning Guide, Depression: Family Education Guide, Bipolar Disorder Education Guide, and pamphlets on the COPMI website. At the beginning of the sessions and at the end of the eighth week, the Conner and Davidson Resilience Questionnaire and Eisenberg Self-Esteem Questionnaire will be completed by the participants.
Category
Behavior
2
Description
Control group: Fifty children aged 12 to 18 years with patients with major depression and bipolar disorder are included in the study as a waiting list. In the beginning and eighth week, the Conner and Davidson Resilience Questionnaire and Eisenberg Self-Esteem Questionnaire are completed by the participants.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kargarnezhad Hospital ,Kashan
Full name of responsible person
Tayebeh Panjehpour
Street address
Blvd Ghotbe Ravandi
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
Panjehpour-t@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafshe
Street address
Kashan University of Medical Sciences,Qotb Ravandi BLvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
Banafshe57@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
10
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
Kashan University of Medical Sciences
Full name of responsible person
Tayebeh Panjehpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Kargarnezhad Hospital ,Qotb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
Panjehpour-t@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Assarian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Kargarnezhad Hospital, Qotb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
Fa-assar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Assarian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Kargarnezhad Hospital,Qotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
Fa-assar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic characteristics of parents and adolescents, raw scores of Connor & Davidson test and Rosenberg test
When the data will become available and for how long
Access period starts one year after the results are published
To whom data/document is available
Researchers working for academic and scientific institutes
Under which criteria data/document could be used
For metanalyses and systematic reviews and head to head studies
From where data/document is obtainable
Research Center of the Vice Chancellor for Research of Kashan University of Medical Sciences
What processes are involved for a request to access data/document
Sending a request letter to the Vice Chancellor for Research of Kashan University of Medical Sciences approved by the supervisor attending of the project