localization of the Program for the Education and Enrichment of Relational Skills (PEERS)for adults with Autism Spectrum Disorder and Investigating the effect of PEERS on Their Social Functions A Randomized Control Trial.
Translation and localization of Program for the Education and Enrichment of Relational Skills (PEERS) in young adults
Study of Effectiveness of PEERS in social functioning of patients
Design
This is a mixed method study and will be conducted in two steps. In first step, Persian translation and validation will be done. For the second step, a randomized clinical trial will be done in a sample of 18-30 year old patients diagnosed with ASD. Randomized allocation will be done and control group will be in waiting list
Settings and conduct
Adult ASD patients admitted in outpatient autism Clinic in Tehran
Participants/Inclusion and exclusion criteria
Inclusion:
Confirmed diagnosis of autism with AQ higher than cutoff
verbal IQ>70
Informed consent for 15 weekly session and doing tasks
A family member who is cooperative to participate in parallel sessions
vineland adoptive behavior score>85
not being treated in any other interventions except for standard care
no present comorbidity with acute phases of bipolar or psychotic disorders
Exclusion:
Emergence of acute psychiatric symptoms (suicidal idea, aggression, psychosis)
not participating in more than 3 sessions
Intervention groups
Intervention: 16 session (90 min) of PEERS and parallel session for caregiver or friend
Control: Waiting list
Main outcome variables
Communicative skills
Social interacations
Empathy
Emotional Intelligence
Lonliness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110630006923N3
Registration date:2021-03-13, 1399/12/23
Registration timing:prospective
Last update:2021-03-13, 1399/12/23
Update count:0
Registration date
2021-03-13, 1399/12/23
Registrant information
Name
Elham Shirazi
Name of organization / entity
Iran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 2209 5680
Email address
eshirazi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
localization of the Program for the Education and Enrichment of Relational Skills (PEERS)for adults with Autism Spectrum Disorder and Investigating the effect of PEERS on Their Social Functions A Randomized Control Trial.
Public title
Effect of Program for the Education and Enrichment of Relational Skills (PEERS)for adults with Autism Spectrum Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of autism with AQ higher than cutoff
verbal IQ>70
Informed consent for 15 weekly session and doing tasks
A family member who is cooperative to participate in parallel sessions
vinland adoptive behavior score>85
not being treated in any other interventions except for standard care
no present comorbidity with acute phases of bipolar or psychotic disorders
Exclusion criteria:
Not participating in more than 3 sessions
emergence of acute psychiatric symptoms ( aggression, psychosis, suicidal thoughts )
Age
From 16 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Iran University of Medical Sciences
Street address
Hemmat Highway, Iran University of medical sciences, school of medicine
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-01-31, 1399/11/12
Ethics committee reference number
IR.IUMS.REC.1399.1158
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84
ICD-10 code description
Pervasive developmental disorders
Primary outcomes
1
Description
Social Skills
Timepoint
pre and post intervention
Method of measurement
Social Skills Rating System (SSRS)
2
Description
empathy
Timepoint
pre and post intervention
Method of measurement
Empathy Qoutient
3
Description
Emotional intelligent
Timepoint
pre and post intervention
Method of measurement
Bar-On's measure of emotional and social intelligence
4
Description
Lonliness
Timepoint
pre and post intervention
Method of measurement
Social and Emotional Loneliness Scale for Adults (SELSA-S)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 16 sessions (90 min) of PEERS and parallel sessions for family members or friends
Category
Treatment - Other
2
Description
Control group: waiting list
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Adult developmental disorders clinic
Full name of responsible person
Javad Alaghband-rad
Street address
South Kargar, Roozbeh Hospital
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 9151
Email
jalaghbandrad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences, Deputy of Research
Full name of responsible person
Seyyed Abbas Motevallian
Street address
Iran University of Medical Sciences Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
shirazi_elham@yahoo.com
Grant name
high quality article grant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences, Deputy of Research
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
Iran University of Medical Sciences
Full name of responsible person
Elham Shirazi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
shirazi_elham@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Elham Shirazi
Position
Associate Professor, Board of Subspeciality of Child and Adolescent Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Tehran Institute of Psychiatry, Shahid Mansouri St, Niayesh St, Sattarkhan St, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6655 1515
Fax
Email
eshirazi@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Elham Shirazi
Position
Associate Professor, Board of Subspeciality of Child and Adolescent Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Tehran Institute of Psychiatry, Shahid Mansouri St, Niayesh St, Sattarkhan St, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6655 1515
Fax
Email
shirazi.e@iums.ac.ir
Web page address
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Clinical study report and consent
When the data will become available and for how long
6 months after publication of results
To whom data/document is available
Researchers in Academic Institutions
Under which criteria data/document could be used
only for research purposes
From where data/document is obtainable
Dr Elham Shirazi, Principal Researcher
What processes are involved for a request to access data/document
After receiving the requests, it will be answered in a month