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Effectiveness cognitive behavior therapy based on Coping Cat in reducing anxiety, depression and behavioral symptoms in children with anxiety disorders ranged from 8 to 10 year-old

Protocol summary

Summary
Objective: The current research intended to investigate the effectiveness of cognitive behavior therapy based on Coping Cat in reducing anxiety, depression, attention deficit/hyperactivity, somatic, oppositional defiant, conduct symptoms in children with generalized anxiety disorder, separation anxiety disorder and social anxiety disorder ranged from 8 to 10 year-old. Design: the general plan of this study was experimental pre-test and post-test with control group and follow-up periods. Inclusion criterion: Having diagnostic criteria for anxiety disorders; eight to 10 year-old children. Exclusion criteria: Having any kind of psychosis disorder; having pervasive developmental disorder; giving another psychological treatment prior to or simultaneous with treatment. Setting and conduct: First, participants were selected and they were randomly assigned to research groups. Then, the instruments which were used in the research were completed by participants in three steps of before treatment, at the end of treatment, and after a follow-up period. At the end, the desired treatment carried out individually to each research participant. Participants: The sample of the present research included 20 children between 8 to 10 year-old who were referred from Rozbeh Hospital with the diagnosis of anxiety in generalized anxiety disorder, separation anxiety disorder and social anxiety disorder. Intervention: Cognitive behavioral therapy based on Coping Cat was implemented in 16 sessions for experimental group and the waiting list control group did not receive any treatment. Results: Cognitive behavioral therapy based on Coping Cat was effective in reducing anxiety, depression, attention deficit/ hyperactivity, somatic, oppositional defiant, conduct symptoms in 8 to 10 year-old

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013090414565N1
Registration date: 2014-05-24, 1393/03/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-24, 1393/03/03
Registrant information
Name
Firouzeh Zarghami
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 6602 1735
Email address
firouzeh_zarghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahed University
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-07-25, 1391/05/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness cognitive behavior therapy based on Coping Cat in reducing anxiety, depression and behavioral symptoms in children with anxiety disorders ranged from 8 to 10 year-old
Public title
Effectiveness cognitive behavior therapy based on Coping Cat in reducing symptoms in children with anxiety disorders ranged from 8 to 10 year-old
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: Having diagnostic criteria for anxiety disorders; eight to 10 year-old children; patient' parent consent for participate in research; the availability of the patient during treatment and follow-up period; stable on the same dose if use psychotropic medications. Exclusion criteria: Having any kind of psychosis disorder; having pervasive developmental disorder; giving another psychological treatment such as cognitive behavior therapy and behavior therapy prior to or simultaneous with treatment.
Age
From 8 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
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
Ethics committee of Shahed University
Street address
Shahed University, Tehran- Gom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran
City
Tehran
Postal code
009833191​18651
Approval date
2012-05-14, 1391/02/25
Ethics committee reference number
130/25347

Health conditions studied

1

Description of health condition studied
Generalized anxiety disorder of childhood
ICD-10 code
F93.8
ICD-10 code description
Overanxious disorder

2

Description of health condition studied
Social anxiety disorder of childhood
ICD-10 code
F93.2
ICD-10 code description
Social anxiety disorder of childhood

3

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
Attention deficit/hyperactivity symptoms
Timepoint
Before treatment, at the end of treatment, and after a 1/5 and 3-month follow-up
Method of measurement
Child Behavior Checklist

2

Description
Anxiety symptoms
Timepoint
Before treatment, at the end of treatment, and after a 1/5 and 3-month follow-up
Method of measurement
Child Behavior Checklist

3

Description
Depression symptoms
Timepoint
Before treatment, at the end of treatment, and after a 1/5 and 3-month follow-up
Method of measurement
Child Behavior Checklist

4

Description
Oppositional defaint symptoms
Timepoint
Before treatment, at the end of treatment, and after a 1/5 and 3-month follow-up
Method of measurement
Child Behavior Checklist

5

Description
Somatic symptoms
Timepoint
Before treatment, at the end of treatment, and after a 1/5 and 3-month follow-up
Method of measurement
Child Behavior Checklist

6

Description
Conduct symptoms
Timepoint
Before treatment, at the end of treatment, and after a 1/5 and 3-month follow-up
Method of measurement
Child Behavior Checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention was 16 sessions (each session is 45 minutes in a week) of cognitive behavior therapy based on Coping Cat schedule. The Coping Cat program is a cognitive-behavioral intervention that helps children recognize and analyze anxious feelings and develop strategies to cope with anxiety-provoking situations. The program focuses on four related components: (1) recognizing anxious feelings and physical reactions to anxiety; (2) clarifying feelings in anxiety-provoking situations; (3) developing a coping plan; and (4) evaluating performance and administering self-reinforcement.
Category
Behavior

2

Description
The control group received no intervention and was placed on a waiting list for treatment.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Zahra Shahrivar
Street address
Roozbeh Hospital, South Kargar Avenue, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr.kiasalari
Street address
Shahed University, Tehran- Gom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Firouzeh Zarghami
Position
M.S in Clinical Psychology
Other areas of specialty/work
Street address
Shahed University, Tehran- Gom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran
City
Tehran
Postal code
009833191​18651
Phone
+98 21 6602 1735
Fax
Email
firouzeh_zarghami@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Firouzeh Zarghami
Position
M.S in Clinical Psychology
Other areas of specialty/work
Street address
Shahed University, Tehran- Gom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran
City
Tehran
Postal code
009833191​18651
Phone
+98 21 6602 1735
Fax
Email
firouzeh_zarghami@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Firouzeh Zarghami
Position
M.S in Clinical Psychology
Other areas of specialty/work
Street address
Shahed University, Tehran- Gom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran
City
Tehran
Postal code
009833191​18651
Phone
+98 21 6602 1735
Fax
Email
firouzeh_zarghami@yahoo.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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