Comparing the Effect of Internet-based Cognitive Behavioral Therapy (ICBT) and Art Therapy with Painting Approach in Generalized Anxiety Disorders in Children
Comparing the Effect of Internet-Based Cognitive Behavioral Therapy (ICBT) and Art Therapy with Painting Approach in Generalized Anxiety Disorders in Children
Design
Clinical Trial with Control Group, with Parallel Groups and One-Way Blind and Randomized with Number Table, Sample Size 45 People
Settings and conduct
Generalized Anxiety Disorder in Children Aged 8 to 10 Years Referred to Zare Hospital and Touba clinic, One-Way Blind
Participants/Inclusion and exclusion criteria
-Children 8 to 10 Years Old with Generalized Anxiety Disorder
-No Severe Anxiety Disorder
- Do Not Have Mood Disorders, Do Not Have Attention Deficit Hyperactivity Disorder, Do Not Have Bsessive-Compulsive Disorder
-Absence of Suicidal Thoughts
-Absence of Physical Illnesses and Disabilities
-No Current Use of Psychotropic Drugs
Intervention groups
Cases of Anxiety Disorders are Matched as much as Possible, Then Randomly Divided Into Three Groups That Should be as Homogeneous as Possible and Cognitively Close to Each Other (Two Intervention Groups and a Control Group of Waiting List People They are Selected for Interventions and Will be Excluded From the Study Whenever They Develop Symptoms and the Necessary Measures Will be Taken for Them)
-- Skype Service (Web-Based Training) ICBT by Assistant Psychiatrist and Art Therapy Based on Painting by Ms. Fattahi Master of Arts Who has a Certificate of Art Therapy with Work Experience with the Child and is Done in Person (For Each of the Treatment Groups 8 The Session is 45 to 60 Minutes and one Session Per week).
-- The Control Group (Control) Does Not Receive Medication During the Course and Only Supportive Interventions are Considered for them.
Main outcome variables
The Main Purpose of This Study is to Achieve Practical Consequences and be Aware of the Effect of Two Specific Treatment Methods to Solve Children's Anxiety Disorders and Compare Them.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220512054830N1
Registration date:2022-09-20, 1401/06/29
Registration timing:retrospective
Last update:2022-09-20, 1401/06/29
Update count:0
Registration date
2022-09-20, 1401/06/29
Registrant information
Name
ladan fouladi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3339 7305
Email address
ladanfouladi.1990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-14, 1401/03/24
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Internet-based Cognitive Behavioral Therapy (ICBT) and Art Therapy with Painting Approach in Generalized Anxiety Disorders in Children
Public title
Comparing the Effect of Internet-based Cognitive Behavioral Therapy (ICBT) and Art Therapy with Painting Approach in Generalized Anxiety Disorders in Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 8 to 10 Years Old with Generalized Anxiety Disorder
Exclusion criteria:
Absence of Severe Anxiety Disorder
No Mood Disorders, no Attention Deficit Hyperactivity Disorder No Obsessive Compulsive Disorder
Lack of Suicidal Thoughts
Absence of Physical Illnesses and Disabilities
No Current Use of Psychotropic Drugs
Age
From 8 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Table 8 Blocks of Six by Block Randomization Method
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are Aware of The Group They are in and what Actions are to be Taken for them, but the Clinical Caregiver, Researcher, Evaluator, and Data Analyst are Unaware of it.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Saeed Fooladi's House, Danesh Alley, Felestin 13, Felestin Street
City
Sari
Province
Mazandaran
Postal code
4815655193
Approval date
2022-02-08, 1400/11/19
Ethics committee reference number
IR.MAZUMS..REC.1400.9170
Health conditions studied
1
Description of health condition studied
Generalized Anxiety Disorders
ICD-10 code
F41.1
ICD-10 code description
Generalized Anxiety Disorder
Primary outcomes
1
Description
Spence Anxiety Questionnaire Score
Timepoint
Before the Intervention, Immediately After the Intervention and Two Months After.
Method of measurement
Spence Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: The Service is Done Through Skype (Web-Based Training) ICBT by a Psychiatric Assistant and Under the Supervision of a Child and Adolescent Psychiatrist. Intervention Group 2: Art Therapy Based on Painting is Done in Person.
Category
Treatment - Other
2
Description
Control Group: They Do not Receive Medication During the Course and Only Supportive Interventions are Considered for Them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zare Psychiatric and Burn Hospital
Full name of responsible person
Ladan Fooladi
Street address
Zare hospital, Sari-Neka road
City
Sari
Province
Mazandaran
Postal code
4843185774
Phone
+98 11 3328 3886
Email
ladanfouladi.1990@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ladan Fooladi
Street address
Zare hospital, Sari-Neka road
City
Sari
Province
Mazandaran
Postal code
4843185774
Phone
+98 11 3328 3886
Email
ladanfouladi.1990@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?