Protocol summary

Summary
Aim: This study evaluates the effectiveness of the "Friends for Life" cognitive behavioral program in reducing the symptoms of anxiety and depression in children. This study is a controlled trial with one pre intervention and two post intervention measurements. The study sample consists of 248 male students aged 10 years were screened using the Revised Children’s Manifest Anxiety (RCMA) and the Children’s Depression Inventory (CDI) in terms of mild to moderate symptoms of anxiety and depression. Of the subjects, 40 students met the inclusion criteria (RCMA>17, CDI=9 to 35, the absence of other psychiatric disorders require medical treatment) and they were randomized into intervention versus wait list comparison groups. The Strengths and Difficulties Questionnaire (SDQ), the Depression, Anxiety, Stress Scale (DASS) were filled out by parents of both groups. The children in the intervention group received the "Friends for Life" cognitive behavioral training program for eight 1 hour weekly sessions. Control group were placed on the waiting list. RCMA, CDI, DASS, SDQ were filled out again in both groups directly after, and 3 months after the end of the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201506215280N18
Registration date: 2017-07-28, 1396/05/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-28, 1396/05/06
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences.
Expected recruitment start date
2013-10-07, 1392/07/15
Expected recruitment end date
2014-10-07, 1393/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness of the "Friends for Life" Program on Children’s Anxiety and Depression
Public title
Evaluation of the Effectiveness of the "Friends for Life" Program on Children’s Anxiety and Depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Revised Children’s Manifest Anxiety >17; Children's Depression Inventory =9-35, the absence of other psychiatric disorders require medical treatment. Exclusion criteria: Absence rate as 2 or more educational sessions; lack of fulfillment or defects of the questionnaires; experience of recent stressful event (past 6 months)
Age
From 9 years old to 10 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random numbers table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Administration Center(Qoreishi Building), Daneshgah St., Mashhad, Iran.
City
Mashhad
Postal code
Approval date
2014-06-25, 1393/04/04
Ethics committee reference number
922855

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Organic anxiety disorder

2

Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Mild depressive episode

Primary outcomes

1

Description
Depression, Anxiety, Stress
Timepoint
Baseline. after the sessions and after 3 months.
Method of measurement
DASS: Depression, Anxiety, Stress

2

Description
Children's Depression
Timepoint
Baseline. after the sessions and after 3 months.
Method of measurement
Children's Depression Inventory

3

Description
Children's Anxiety
Timepoint
Baseline, after the sessions and after 3 months.
Method of measurement
RCMA: Revised Children's Manifest Anxiety

4

Description
Strengths and Difficulties
Timepoint
Baseline, after the sessions and after 3 months.
Method of measurement
SDQ: Strengths and Difficulties Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The children in the intervention group received the "Friends for Life" cognitive-behavioral training program for eight 1 hour weekly sessions.
Category
Treatment - Other

2

Description
The control group received a standard treatment and they were placed in waiting list.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn e Sina Hospital
Full name of responsible person
Street address
Ibn-e-Sina Hospital, Horeameli Avenue, Mashhad, Iran.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mahyar Mirheydari
Street address
Administration Center(Qoreishi Building), Daneshgah St., Mashhad, Iran.
City
Mashhad
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, Mashhad 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
Mashhad University of Medical sciences
Full name of responsible person
Dr Azam sadat Heydari
Position
specialist
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital, Horeameli Avenue, Mashhad, Iran.
City
Mashhad
Postal code
Phone
+98 51 3711 2701
Fax
Email
Heydarias@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Psychiatry and Behavioral Sciences Research Center.
Full name of responsible person
Dr Fatemeh Moharrari
Position
specialist
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital, Horeameli Avenue, Mashhad, Iran.
City
Mashhad
Postal code
Phone
+98 51 3711 2701
Fax
Email
Heydaria4@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Azam sadat Heydari
Position
specialist
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital, Horeameli Avenue, Mashhad, Iran.
City
Postal code
Phone
00
Fax
Email
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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