The effect of intergenerational interaction on mental and social health of older adults
Design
This study is a clinical trial with control group. Samples will randomly be assigned into an intervention (n = 20) and a control (n = 20) group using an online random number generator. All seniors are grandparents of the students.
Settings and conduct
The study will be conducted in the Ghazal girls' nonprofit elementary school in Qom. Six 90-minute sessions of game-based intergenerational interaction will be held between the seniors in the intervention group and their grandchildren. The sessions will be held once a week, in six consecutive weeks.
Participants/Inclusion and exclusion criteria
*Inclusion:
Elderly :
Grandfather or grandmother of the child, having no known cognitive, motor, visual, auditory, and communication impairments, and willingness to participate in the study.
Children: Interest in playing with the elderly, parental consent for participation of their children in the study, age range between 8 to 12 years.
*Exclusion:
Elderly:
Absence of more than two sessions by the elderly, the occurrence of a particular disease affecting the mental health of the elderly during the study.
Children:
Absence of more than two sessions by the child
Intervention groups
Six 90-minute sessions of intergenerational interaction will be held in the form of a game between seniors and their grandchildren. There are two playlists, one containing games that the elderly are mastered in and the other containing games that children are mastered in. In each session, a game will be selected of each list by the elderly and the children. Then, the seniors and the child will teach the selected games to each other and will play it together. The control group receives no intervention and only will complete the study instruments.
Main outcome variables
Psychological health; Social health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190918044816N1
Registration date:2020-02-18, 1398/11/29
Registration timing:registered_while_recruiting
Last update:2020-02-18, 1398/11/29
Update count:0
Registration date
2020-02-18, 1398/11/29
Registrant information
Name
Nasrin Torabian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3890 9786
Email address
torabian-n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-12, 1398/07/20
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intergenerational interaction on the elderly’s psychological and social health
Public title
The effect of intergenerational interaction on the elderly’s health
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Grandfather or grandmother of the child
Ability to move independently with or without assistive devices
Ability to see and hear with or without glasses and hearing aids
Ability to speak and verbal communication
Consent to participate in the study
Lack of a known cognitive impairment
Eight to 12 years old student interested in playing with seniors
Parental consent for student's participation in the study
Exclusion criteria:
Absence of more than two sessions by the elderly
The occurrence of a particular disease affecting the mental health of the elderly during the study
Absence of more than two sessions by the child
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
First, one of the schools in Qom will be selected conveniently. Then a list of the students in the age range of 8-12 years will be obtained from the school’s authorities. Afterward, an invitation letter will be sent to the students’ families and invite them to participate in the study if they have older adults aging 60 and over. Among the families with inclusion criteria who expressed their willingness, 40 eligible elderly-child couples will be selected. Then, the study supervisor will randomly assign the couples into two groups via an online random number generator (i.e. https://www.sealedenvelope.com/simple-randomiser/v1/lists). Then the generated numbers will be written on small cards and the cards will be placed into envelopes. The second researcher who performs the protocol will not be aware of the content of envelopes. In the first visit with the participants (before the start of the intervention), the second researcher will ask each couple to pick an envelope and the researcher will execute the protocol accordingly.
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 Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Qotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2019-09-23, 1398/07/01
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1398.042
Health conditions studied
1
Description of health condition studied
Psychological health
ICD-10 code
Z00
ICD-10 code description
Encounter for general examination without complaint, suspected or reported diagnosis
2
Description of health condition studied
Social health
ICD-10 code
Z60.0
ICD-10 code description
Problems of adjustment to life-cycle transitions
Primary outcomes
1
Description
Mental Health Score
Timepoint
Before, at the end, and four weeks after the intervention
Method of measurement
Goldberg’s General Health Questionnaire ( GHQ28)
2
Description
Social Health Score
Timepoint
Before, at the end, and four weeks after the intervention
Method of measurement
The 33-item Keyes social health questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Six 90-minute sessions of intergenerational interaction will be held in the form of a game between seniors and their grandchildren. There are two playlists, one containing games that the elderly are mastered in and the other containing games that children are mastered in. In each session, a game will be selected of each list by the elderly and the children. Then, the seniors and the child will teach the selected games to each other and will play it together.
Category
Behavior
2
Description
Control group: The control group receives no intervention, and only will complete the study instruments at time similar to the intervention group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghazal girls' nonprofit elementary school in Qom
Full name of responsible person
Zohre Mirzaei
Street address
No.48, Alley 2, Savaran Ave.
City
Qom
Province
Ghoum
Postal code
3718638674
Phone
+98 25 3890 9786
Email
torabian1364@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Banafsheh
Street address
Kashan University of Medical Sciences, Qotb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
banafsheh_h@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical 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
Kashan University of Medical Sciences
Full name of responsible person
Nasrin Torabian
Position
Master of Science student in Geriatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.48 , Alley 2, Savaran Ave.
City
Qom
Province
Ghoum
Postal code
3718638674
Phone
+98 25 3890 9786
Email
torabian1364@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Adib-Hajbaghery
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand Road, Kashan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Kashan
Province
Isfehan
Postal code
8715988111
Phone
+98 31 5554 0021
Email
adib1344@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Nasrin Torabian
Position
Master of Science student in Geriatrics Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.48 , Alley 2, Savaran Ave.
City
Qom
Province
Ghoum
Postal code
3718638674
Phone
+98 25 3890 9786
Email
torabian1364@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available