The aim of this study was to the effect of family-based empowerment program on self-efficacy and mental health of autistic mothers.
Design
This study was a randomized clinical trial with two groups (intervention and control), pre and post-test design, and not-blinded.
Settings and conduct
This study was conducted on 60 mothers with autism child that were randomly divided into two groups (n = 30).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Non-participation in similar programs before and after intervention.
Exclusion criteria: Absence of more than 2 sessions in the training program.
Intervention groups
Intervention group: in intervention group was conducted the family-centered empowerment program in four stages (increasing knowledge, promoting self-efficacy, self-esteem and mental health and evaluation), and during 11 sessions training with face-to-face method, one week's session for 60 to 90 minutes, during 11 weeks.
Control group: in control group, was conducted routine education for 11 weeks, too.
Main outcome variables
The main outcome variables in this study included: clinical competence and satisfaction that in both groups was assessed before the intervention and the end of eleventh session with General Health Questionnaire-28 (GHQ-28) and General Self- Efficacy Scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181009041294N1
Registration date:2018-10-16, 1397/07/24
Registration timing:registered_while_recruiting
Last update:2018-10-16, 1397/07/24
Update count:0
Registration date
2018-10-16, 1397/07/24
Registrant information
Name
Nesa Hasanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3223 1061
Email address
hasanpoury2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-12, 1397/07/20
Expected recruitment end date
2019-01-10, 1397/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Family-based Empowerment Program on Self-Efficacy and Mental Health of Autistic Mothers
Public title
The Effect of Empowerment Program on Self-Efficacy and Mental Health of Mothers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Non-participation in similar programs before and after intervention
Exclusion criteria:
Absence of more than 2 sessions in the training program
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The mothers divided to intervention and control group with simple randomization method (with random digits table). In this way, each mother assigned a code and mothers randomly divided into two groups.
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 Azad University, Tehran Medical Sciences Branch
Street address
Azad University, Tehran Medical Sciences Branch, Khaghani St.
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2018-10-06, 1397/07/14
Ethics committee reference number
IR.IAU.TMU.REC.1397.165
Health conditions studied
1
Description of health condition studied
Self-Efficacy
ICD-10 code
-
ICD-10 code description
-
2
Description of health condition studied
Mental Health
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Self-Efficacy
Timepoint
Before the intervention and the end of eleventh session
Method of measurement
General Self- Efficacy Scale
2
Description
Mental Health
Timepoint
Before the intervention and the end of eleventh session
Method of measurement
General Health Questionnaire-28 (GHQ-28)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in intervention group was conducted the family-centered empowerment program in four stages (increasing knowledge, promoting self-efficacy, self-esteem and mental health and evaluation), and during 11 sessions training with face-to-face method, one week's session for 60 to 90 minutes, during 11 weeks.
Category
Prevention
2
Description
Control group: in control group, was conducted routine education for 11 weeks, too.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ava
Full name of responsible person
Reza Dehghani
Street address
Ava Autism Center, Daneshamouz St
City
Mashhad
Province
Razavi Khorasan
Postal code
9784118478
Phone
+98 51 3609 8424
Email
Dehghanif@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
Azad University, Tehran Medical Sciences Branch, Khaghani St
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
HashemianF@aiu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nesa Hasanpour
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Azad University, Tehran Medical Sciences Branch, Faculty of Nursing and Midwifery, Khaghani St