Protocol summary

Summary
(1) Objectives: The aim of this study is to examine the effect of psycho -educational group therapy of emotional intelligence on enhancing of emotional intelligence of adolescents with ADHD. (2) Design: This research is an experimental study with “pre-test, post-test and follow-up with control group” design. (3) Setting and conduct: The sample size of this study estimated 76 persons that randomly 38 persons in control group and 38 persons in experimental group allocated. Instruments for data gathering are Demographic Questionnaire, The Revised Conner’s Parent Rating Scale (CPRS-R) and Emotion Intelligence Questionnaire. (4) Eligibility criteria for participants are patients with diagnosis of ADHD disorder; with age range 11 to 16 years old; having the ability to listen and sit in group therapy sessions; having the ability to respond to written questions; who are treated with methylphenidate; and who do not have any other physical illness or mental disorder according to the diagnosis of psychiatrist. Exclusion Criteria including the patients who discharge before the completion of group therapy sessions and absence of more than two sessions of group therapy. (5) Intervention: Firstly the pre-test will be done in both groups. The experimental group will attend 10 sessions of 90 minutes in group therapy. The control group will not receive any intervention in this duration. Then the post-test and follow up respectively one week and three months after intervention will be done in both groups and then the results of two groups will be compared with together. (6) The main outcome variable will be Increasing of emotional intelligence.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201609186834N11
Registration date: 2016-10-30, 1395/08/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Hossein Ebrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1475 1709
Email address
ebrahimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice- Chancellor, Tabriz University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Psycho-educational Group Therapy of Emotional Intelligence on Enhancing of Emotional Intelligence of Adolescents with ADHD
Public title
The Effect of Psycho-educational Group Therapy of Emotional Intelligence on Enhancing of Emotional Intelligence of Adolescents with ADHD
Purpose
Supportive
Inclusion/Exclusion criteria
Eligibility criteria for participants are patients with diagnosis of ADHD; with age range of 11 to 16 years old; having the ability to listen and sit in group therapy sessions; having the ability to respond to written questions; who are treated with methylphenidate; and who do not have any other physical illness or mental disorder according to the diagnosis of psychiatrist. Exclusion Criteria including the patients who discharge before the completion of group therapy sessions and absence of more than two sessions of group therapy.
Age
From 11 years old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Tabriz University of Medical Sciences, Research Vice- Chancello
Street address
Third floor, No 2 Building of Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.TBZMED.REC.1395.803

Health conditions studied

1

Description of health condition studied
Attention deficit and hyperactivity disorder
ICD-10 code
F90, F90.0
ICD-10 code description
Hyperkinetic disorders; Disturbance of activity and attention

Primary outcomes

1

Description
Increasing Emotional Intelligence
Timepoint
Before intervention, one week and three months after finishing the intervention
Method of measurement
Emotional Intelligence Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Firstly, the pre-test will be done. Intervention group will receive group therapy 10 sessions. Then, the post-test and follow-up will be done.
Category
Prevention

2

Description
Control group: Firstly, the pre-test will be done. This group will not receive any intervention. Then, the post-test and follow-up will be done. Finally, the differences of pre-test, post-test and follow-up of two groups are compared.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Psychiatric Hospital
Full name of responsible person
Dr Arash Mohaggegi
Street address
Tabriz Razi Psychiatric Hospital, Elgoli Boulevard
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Vice- Chancellor, Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Rashidi
Street address
Third floor, No 2 Building of Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice- Chancellor, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Parinaz Omrani
Position
MS in Psychiatric Nursing, Student
Other areas of specialty/work
Street address
Psychiatric Nursing Group, Tabriz Nursing and Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 3335 0456
Fax
Email
Parinaz.omrani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hossein Ebrahimi
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Psychiatric Nursing Group, Tabriz Nursing and Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 3475 1709
Fax
Email
Ebrahimih@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parinaz Omrani
Position
MS in Psychiatric Nursing, Student
Other areas of specialty/work
Street address
Psychiatric Nursing Group, Tabriz Nursing and Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 3335 0456
Fax
Email
Parinaz.omrani@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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