Objectives: The aim of this study is prevention of anxiety and depressive disorders in adolescent population. Design: In a quasi-experimental study with control and experimental group, efficacy of anxiety and depression package in adolescent population will be performed. Setting and conduct: This study will be carried out in two phases. In the first phase, a prevention package for anxiety and depressive disorders is provided. In the second phase, the package is implemented among 80 samples, preliminary. Participants: Sampling will be selected from available student ages 11 - 18 years old, settled in Tehran. Participants are assigned randomly into two groups: experimental and control. Intervention: Prevention package is performed in group format, in 8 sessions. Control group is waiting for intervention after performing the study. Variables: Revised Children's Anxiety and Depression Scale is completed before, after, and after 3 months follow-up in two groups. Results are analyzed by co-variance method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508274178N2
Registration date:2016-12-07, 1395/09/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-07, 1395/09/17
Registrant information
Name
Abolfazl Mohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 9151
Email address
amohammadi@stu.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Psychiatry and psychology research center of Tehran University of Medical Siences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Providing and implementing Clinical trial of the prevention package for anxiety and depression in adolescent
Public title
Prevention of Anxiety and Depression in Adolescent
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 11 to 18 years old; permission from parents of participants
Exclusion criteria: having any cognitive or health problems that prevent students to participate to the program
Age
From 11 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Research Ethics Committee of Tehran university of Medical Sciences
Street address
6th floor, Central office of Tehran University of Medical Sciences, Ghods St. Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.TUMS.REC.1394.390
Health conditions studied
1
Description of health condition studied
Symptoms of anxiety
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
2
Description of health condition studied
symptoms of Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Symptoms of anxiety
Timepoint
before and after intervention and after 3 month fallow up
Method of measurement
Revised Children's Anxiety and Depression Scale (RCADS)
2
Description
Symptoms of depression
Timepoint
before and after intervention and after 3 month fallow up
Method of measurement
Revised Children's Anxiety and Depression Scale (RCADS)
Secondary outcomes
empty
Intervention groups
1
Description
Prevention package is performed in group format, in 8 sessions for experimental group.
Category
Prevention
2
Description
Control group is waiting for intervention after performing the study.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Helli High School
Full name of responsible person
Amir Teymouri
Street address
Zamanpour Alley, Mirdamadi St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Ms Karimi
Street address
Tehran University of Medical Sciences, Office of Vice-Chancellor for Research, floor 6, Ghods St., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Abolfazl Mohammadi
Position
Assistant professor/ PhD
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Ave.
City
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Fax
Email
a-mohammadi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abofazl Mohammadi
Position
Assistant professor/ PhD
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Ave.
City
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Fax
+98 21 5541 2756
Email
a-mohammadi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abolfazl Mohammadi
Position
Assistant professor/ PhD
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Ave.
City
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Fax
Email
a-mohammadi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)