Effectiveness of group cognitive-behavor based parenting in anxiety and depression symptoms in children with cancer and the role of mechanism of change in treatment
The aim of this study will be to evaluate the effectiveness of group intervention based cognitive-behavioral parenting on the symptoms of depression and anxiety in children with cancer. The role of mediators in treatment as a mechanism of change will also be investigated.
Design
The study population will include all children between 7 and 10 years old with cancer referred to Ali Asghar Hospitals and Children's Medical Center, from which 40 people will be selected by available sampling method. (10 people will be considered for the drop-out). And by simple random method and through lottery, they will be placed in 2 groups of drug therapy and drug therapy in addition to "from Timid To Tiger" parenting intervention.
Settings and conduct
The intervention " from Timid to Tiger" is performed for ten 2-hour group sessions. This study will be performed in the Oncology Clinic of Ali Asghar Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria will include: the child has a type of cancer, and at least 6 months have passed since the diagnosis of cancer and the acute course of the disease, the child's score internalization subscale of CBCL scale should be higher than the cut-off point, and on the basis of the K-SADs scale will receive the diagnosis of major depressive disorder. Exclusion criteria will also include: the child or parent has moderate to severe learning disabilities, the child has psychotic disorder, and the child has end-stage cancer.
Intervention groups
The present study will consist of two groups, one group receiving the tretment as usual, which is pharmacotherapy, and the other group receiving the treatment as usual in addition to parent-based intervention.
Main outcome variables
The severity of anxiety and depression symptoms in children with cancer as a result of treatment will be investigated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200728048237N1
Registration date:2020-08-25, 1399/06/04
Registration timing:registered_while_recruiting
Last update:2020-08-25, 1399/06/04
Update count:0
Registration date
2020-08-25, 1399/06/04
Registrant information
Name
Mehri Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4447 9826
Email address
moradi.me@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-25, 1399/06/04
Expected recruitment end date
2021-01-23, 1399/11/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of group cognitive-behavor based parenting in anxiety and depression symptoms in children with cancer and the role of mechanism of change in treatment
Public title
Cognitive-behavioral based parenting effect on depression in children with cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The child has a type of cancer
At least 6 months have passed since the diagnosis of cancer and the acute phase of the disease
The child's score on the internalization subscale of CBCL scale should be higher than the cut-off point
Based on the K-SADs scale, the child is diagnosed with depressive disorder
Exclusion criteria:
The child or parent has moderate to severe learning disabilities (the parent or child is unable to read and write)
The child has psychotic disorder,
The child's cancer is in the end stage of the disease
Age
From 7 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The population will include all children between 7 and 10 years old with cancer referred to Ali Asghar hospital and Children's Medical Center.40 people will be selected by available sampling method and by simple sampling and through lottery, they will be allocated in 2 groups of drug therapy and drug therapy plus parenting treatment.
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences., Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-11-05, 1398/08/14
Ethics committee reference number
IR.IUMS.REC.1398.851
Health conditions studied
1
Description of health condition studied
depressive disorders
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
2
Description of health condition studied
cancer
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Anxiety disorders
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Severity of depressive symptoms
Timepoint
Before the intervention, the fifth session, immediately after the intervention, and two months after the intervention
Method of measurement
Child Depression Inventory
2
Description
Severity of depressive symptoms
Timepoint
Before the intervention, the fifth session, immediately after the intervention, and two months after the intervention
Method of measurement
Spence Children’s Anxiety Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: drug therapy. This group will receive thetretment as usual, which is medication for anxiety disorders and depression, according to the diagnosis of the center's psychiatrist. The prescription drug for these disorders is usually a class of Selective Serotonin Reuptake Inhibitors (SSRIs). Depending on the severity of the disease and the side effects of the drug, the psychiatrist will use the appropriate drug. This treatment is usually used in the relevant group and the researcher will not change it. The psychiatrist visits the clients once a month.
Category
Treatment - Drugs
2
Description
Intervention group: Pharmacotherapy in addition to parenting education. In this group, in addition to the treatment as usual, which is drug therapy, parenting education will be done for parents. The executive protocol includes 10 two-hour sessions that will be held weekly for parents. The treatment is done in groups and children are not present in this intervention. The present intervention is designed to reduce the symptoms of anxiety and depression in children. This intervention is based on the cognitive-behavioral model and its purpose is to cognitive restructuring the thoughts and beliefs of parents and children.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar hospital
Full name of responsible person
Shala Ansari
Street address
Ali Asghar Hospital., No 193., Dastgerdi St., Modares Highway
City
Tehran
Province
Tehran
Postal code
19198167766
Phone
+98 21 2222 2041
Email
aach@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Abbas Motevalian
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
motevalian.a@iums.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
mehri moradi
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 1., School of Behavioral Sciences and Mental Health (Tehran Institute of Psychiatry)., Mansouri Ave., Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
moradi.me@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehri Moradi
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 1, School of Behavioral Sciences and Mental Health (Tehran Institute of Psychiatry)., Mansour Ave., Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
0098 66551655
Email
moradi.me@tak.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehri Moradi
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 1, School of Behavioral Sciences and Mental Health (Tehran Institute of Psychiatry)., Mansour Ave., Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
0098 66551655
Email
moradi.me@tak.iums.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
Not applicable
Title and more details about the data/document
The full intervention protocol and informed consent form will be attached to the dissertation. All sessions will be recorded and along with the spss file will be submitted to the department of Clinical Psychology of school of Behavioral Sciences and Mental Health and the supervisor.
When the data will become available and for how long
After completing the dissertation and publishing articles
To whom data/document is available
Supervisors, consultants and other researchers
Under which criteria data/document could be used
The results will be reported in full in the dissertation. And researchers can contact the researcher for meta-analysis to get the information they need.
From where data/document is obtainable
Researchers should refer to Ms. Mehri Moradi and email address moradi.me@tak.iums.ac.ir. The final results will also be mentioned in the dissertation and a copy of the dissertation will be presented in the central library of Iran University of Medical Sciences. The results will also be published in scientific journals.
What processes are involved for a request to access data/document
The researcher can correspond with Ms. Moradi via email in order to receive the documents, and if there is no violation of confidentiality and ethical principles , she will be answered within a week