Effectiveness of self-assertiveness skill training on self-esteem and anxiety of adolescent with bipolar I disorder (BID) parent
Design
This research has two groups of control and intervention.The sample size is 30 for the intervention group and 30 for the control group. In this study, the study design is parallel. Type of trial is equivalence.
Settings and conduct
Self-assertiveness skill training will be performed on 30 adolescents with parent with type 1 bipolar disorder in a psychiatric department of Ebne sina hospital in Mashhad.
Participants/Inclusion and exclusion criteria
Inclusion criteria: conscious consent to participate in the study by adolescent and healthy parents. the parent have diagnosed BID with a psychiatrist's approval. the age of adolescent between 11 to 18 years old. earn a score of at least 8 from the beck anxiety score. earn score 43 and less than cooper smith self-esteem. not married. not having drug addiction
Non-Inclusion criteria: participate in other psychological programs during the intervention period history of psychiatric use or history of mental illness Unwillingness to participate in the study
Intervention groups
In the intervention group, the training of assertiveness skills was performed at 9 sessions, during 3 weeks, eachsession 90-minute , the meeting in one of the educational classes of the avicenna department of psychiatry and one hour before the appointment.
In the control group, they do not receive training from the researcher and the routine process is done
Main outcome variables
Adolescent self-esteem, adolescent anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190521043660N1
Registration date:2020-06-08, 1399/03/19
Registration timing:retrospective
Last update:2020-06-08, 1399/03/19
Update count:0
Registration date
2020-06-08, 1399/03/19
Registrant information
Name
Hasan Salimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3479 2409
Email address
salimihs961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-11, 1398/04/20
Expected recruitment end date
2020-02-09, 1398/11/20
Actual recruitment start date
2019-07-01, 1398/04/10
Actual recruitment end date
2020-02-04, 1398/11/15
Trial completion date
2020-03-15, 1398/12/25
Scientific title
The effect of training self-assertiveness skill on self-esteem and anxiety of adolescent with Bipolar I Disorder (BID) parent.
Public title
The effect of training self-assertiveness skill on self-esteem and anxiety of adolescent.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The parents have diagnosed BID with a psychiatrist approval.
The age of adolescent between 11 to 19 years old.
Conscious consent to participate in the study by healthy adolescent and parent.
Exclusion criteria:
Participate in the other psychological programs to the during the intervention.
History of used drug psychiatric.
History of psychiatric disorder.
Age
From 11 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Non-random sampling (Inclusion of people in the study) will be available. then randomly assigned to two intervention and control groups in a balanced block design (4-person blocks). Thus, we have six models for preparing quadruple blocks (AABB, ABAB, ABBA, BBAA, BAAB, BABA). Here (intervention group = A) and (B= control group). Then, by drawing lots, the order of the blocks will be determined. Finally, random sampling of adolescents study will be based on the order of these blocks.
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 Mashhad Medical Sciences
Street address
Mashhad, Ibn Sina St.-doctora Four-Way
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.032
Health conditions studied
1
Description of health condition studied
Bipolar I disorder
ICD-10 code
F31.1
ICD-10 code description
Bipolar disorder, current episode manic without psychotic features
Primary outcomes
1
Description
Self-Esteem
Timepoint
Self-esteem before the intervention, immediately after the intervention and one month after the end of the intervention
Method of measurement
Cooper Smith Self-Esteem Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the assertiveness Training Program will be implementing the nine-point practical guideline. The training sessions will be 90 minutes. The intervention will be performing 3 times a week, the groups of 10 to 12 in the three groups and 21 days intervals between the groups. The sessions will be performed in the Psychiatry Department of the Ibn Sina Hospital, one hour before the appointment on Mondays, Wednesdays, and Fridays between 14 and 16 o'clock. To training assertiveness, The researchers should be use lectures and PowerPoint, discussions between small groups, role play, and homework. The class will be separated according to gender. The main content was determined by the educational intervention and considering the texts in life skills training books (life skills book of the Ministry of Health) and practical guidelines, Motabi and Kazem Zadeh. During the intervention, the subjects actively participate in the curriculum and carry out teaching-learning activities with their participation.
Category
Lifestyle
2
Description
Control group: 30 Adolescent who will be randomly selected and will not receive any training, and completion of questionnaires will be conducted simultaneously with the intervention group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
IbnSina Hospital
Full name of responsible person
Fatemeh Moharri
Street address
Horr Ameli Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2701
Email
Info@Ebnesinahospital.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghody
Street address
University Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vpresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hasan Salimi
Position
Master of Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahonar Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 51 5700 2404
Email
salimihs961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hasan Salimi
Position
Master of Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahonar Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 51 5700 2404
Email
salimihs961@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hasan Salimi
Position
Master of Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahonar Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 51 5700 2404
Email
salimihs961@mums.ac.ir
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
Information about the outcome of the main message The ability to transfer the sharing
When the data will become available and for how long
One year after sharing results
To whom data/document is available
Our data will only be available to researchers working in academia.
Under which criteria data/document could be used
With the permission of Mashhad University of Medical Sciences, data will be available.
From where data/document is obtainable
Research Deputy of Mashhad University of Medical Sciences
What processes are involved for a request to access data/document
You must apply for deputy from Mashhad University of Medical Sciences