The effect of family-centered educational early intervention on mental health and quality of life of mothers of children with down syndrome
Design
Single blind randomized educational trial with parallel control group
Settings and conduct
In membership mothers of down syndrome society in Isfahan in 2018, after inviting to a general educational workshop, General Health Questionnaire (GHQ) will be completed. Seventy eligible mothers will be randomly assigned into experimental and control groups. Both groups will be evaluated before of training workshop and three months later by the Depression Anxiety and Stress Scale (DASS21) and World Health Organization Quality Of Life BREF (WHOQOL-BREF).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1 - Having a child with trisomy 21 by genetic karyotype
2 -Child's age 6 to 72 months
3 - Having informed consent
4 - Having no severe orthopedic problems or malformations, seizure, uncontrolled thyroid disturbances, severe congenital heart problems ( in need for surgery ), severe visual or auditory problems
5 - more than 23 score of the maternal health questionnaire
6- mother's ability to read, understand and answer the questions
Exclusion criteria:
1 - Mental or physical illness of the mother or the child during the three months of intervention
2 - Previous participation mothers in similar training programs
3 - Having another child with chronic illness
Intervention groups
In each group, a general education workshop is organized separately.
In the intervention group, we will conduct a booklet and theoretical and practical training to respond to specific needs in each mothers and weekly follow-up counseling sessions, but we will weekly routine follow-up in the control group.
Main outcome variables
Mental health؛ Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181117041673N1
Registration date:2018-12-30, 1397/10/09
Registration timing:registered_while_recruiting
Last update:2018-12-30, 1397/10/09
Update count:0
Registration date
2018-12-30, 1397/10/09
Registrant information
Name
Sahar Sadeghi Sedeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1785 1460
Email address
sm.sadeghi163@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered early educational intervention on mental health and quality of life in mothers of children with down syndrome
Public title
The effect of family-centered educational intervention on mental health of mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a child with trisomy 21 by genetic karyotype
Mother's ability to read, understand and answer the question
Having informed consent
Child with 6 to 72 months of age
Having no severe orthopedic problems or malformations, seizure, uncontrolled thyroid disturbances, severe congenital heart problems (in need for surgery), severe visual or auditory problems, and history of the neonatal infections (meningitis, encephalitis)
Exclusion criteria:
Previous participation in similar educational courses
Having another child with chronic illness
No participation in educational workshop
Age
From 19 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization:
In the membership list of the down syndrome society, block randomization will be formed 80 blocks based on the mothers ability to read and write and score more than 23 of the general health questionnaire(GHQ).Two random samples will be selected, by flipping a coin (head for intervention and tail for control) in each block.
Blinding (investigator's opinion)
Single blinded
Blinding description
general educational workshop for both intervention and control groups separately
Weekly and similar follow up in both groups
Educational intervention in the first group and routine intervention in the control group
Register data with codes 1 and 2,Which is not specified for the data analyzer
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar Ave., Daneshjo Blvd., Evin Ave.
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2018-03-09, 1396/12/18
Ethics committee reference number
ir.uswr.rec.1396.308
Health conditions studied
1
Description of health condition studied
Mental Health
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Quality of life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mental Health
Timepoint
Before the intervention and at the end of the intervention
Method of measurement
World Health Organization Quality Of Life BREF
2
Description
Depression
Timepoint
Before the intervention and at the end of the intervention
Method of measurement
Depression َAnxiety and Stress scale(DASS21)
3
Description
Stress
Timepoint
Before the intervention and at the end of the intervention
Method of measurement
Depression َAnxiety and Stress scale(DASS21)
4
Description
Anxiety
Timepoint
Before the intervention and at the end of the intervention
Method of measurement
Depression َAnxiety and Stress scale(DASS21)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A 4-hour workshop will be conducted to educate mothers of children with down syndrome about the problems their children are facing, the effects on mothers and how to deal with them.Then In 4 meeting 2 hours, will be taught the theoretical and practical management of the sensory, motor, communication and activities of daily living deficits for each mother and follow-up phone calls would be placed every 7 days to 3 months.
Category
Lifestyle
2
Description
Control group: Education of Problems with Down Syndrome Children and their effects on family members and how to deal with them in a 4-hour workshop and weekly routine consultation and fallowing for 3 months .
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Aseman Nili Down Syndrome Society of Isfahan
Full name of responsible person
Nozhat Ahmadi
Street address
No.49, Ayatollah Khademi Ave., Foroghi Ave.
City
Isfahan
Province
Isfehan
Postal code
3815437890
Phone
+98 31 3335 0774
Fax
+98 31 3335 9751
Email
info@asemannili.ir
Web page address
http://asemannili.org
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Amir Massoud Arab Loodaricheh
Street address
Kodakyar Ave., Daneshjo Blvd., Evin Ave.
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Fax
+98 21 2218 0121
Email
pr@uswr.ac.ir
Web page address
https://www.uswr.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Hooshang Mirzaie
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Kodakyar Ave., Daneshjo Blvd., Evin Ave.
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Email
ho.mirzaie@uswr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hooshang Mirzaie
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Kodakyar Ave., Daneshjo Blvd., Evin Ave.
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Email
ho.mirzaie@uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hooshang Mirzaie
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Kodakyar Ave., Daneshjo Blvd., Evin Ave.
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Email
ho.mirzaie@uswr.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The final results of the intervention will be published as article.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available