Protocol summary

Summary
(1) Objectives: The aim of this study is to examine the effects of cognitive group therapy on empowerment of parents with autistic child in autism institute of Tabriz city, 2012. (2) Design: this research is an experimental study with “pre-test and post-test with control group” design. (3) Setting and conduct: the sample size of this study estimated 80 persons that randomly 40 persons in control group and 40 persons in experimental group allocated. Instrument for data gathering and measuring is Family Empowerment Scale. (4) Participants including major eligibility criteria: Parents of autistic children (4-18 years) at least 6 months of diagnosis of autism is passed; lack of cognitive impairment of parents; lack of physical problems or severe physical or mental illness of parents according to themselves report; getting empowerment score less than 45, not to be step father or step mother of parents; and having at least 5th elementary degree in education. (5) Intervention: Firstly the pre-test will be done in both groups. The experimental group will attend 6 sessions of 90 minutes in group therapy. The control group will not receive any intervention in this duration. Finally the post-test will be done in both groups and the results of two groups will be compared with together. (6) The main outcome variable: increasing family empowerment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201204246834N3
Registration date: 2012-06-19, 1391/03/30
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-06-19, 1391/03/30
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
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive group therapy on empowerment of parents with autistic child in autism institute of Tabriz city, 2012.
Public title
The effect of cognitive group therapy on empowerment of parents with autistic child in autism institute of Tabriz city, 2012.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Parents of autistic children (4-18 years) at least 6 months of diagnosis of autism is passed; lack of cognitive impairment of parents; lack of physical problems or severe physical or mental illness of parents according to themselves report; getting empowerment score less than 45, not to be step father or step mother of parents; and having at least 5th elementary degree in education.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
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, Vice chancellor for research
Street address
Third floor, Central Building- No 2, Golgasht Street
City
Tabriz
Postal code
Approval date
2012-06-12, 1391/03/23
Ethics committee reference number
2736/4/5

Health conditions studied

1

Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Childhood autism

Primary outcomes

1

Description
Family empowerment
Timepoint
One week after finishing intervention
Method of measurement
Family Empowerment Scale

Secondary outcomes

1

Description
Age
Timepoint
Pre-test
Method of measurement
Personal-social questionnaire

2

Description
Gender
Timepoint
Pre-test
Method of measurement
Personal-social questionnaire

3

Description
Marital ststus
Timepoint
Pre-test
Method of measurement
Personal-social questionnaire

4

Description
Degree
Timepoint
Pre-test
Method of measurement
Personal-social questionnaire

5

Description
Job
Timepoint
Pre-test
Method of measurement
Personal-social questionnaire

6

Description
Income
Timepoint
Pre-test
Method of measurement
Personal-social questionnaire

7

Description
Illness duration
Timepoint
Pre-test
Method of measurement
Personal-social questionnaire

Intervention groups

1

Description
Intervention group: first, the pre-test will be done. Intervention group will receive 6 sessions cognitive group therapy by the researcher. Then, the post-test will be done. Finally, the differences of family empowerment of pre-test and post-test are compared with each other.
Category
Other

2

Description
Control group: this group will not receive any intervention. The differences of family empowerment of pre-test and post-test are measured and are compared with each other.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Autism Institute of Tabriz
Full name of responsible person
Dr. Ayyoub Malek
Street address
No 45, baghmisheh
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, 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
Vice chancellor for research, 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

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
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 1479 0364
Fax
Email
Ebrahimih@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact

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
Loading...