Studying the effect of a designed pretend play interventional planning on the play participation of 4-8 years old Tehranian children with Attention Deficit Hyperactivity Disorder (ADHD)
The effect of occupational therapy protocol with the focus of pretend play on improving play skills and participation in children with ADHD
the effect of OT protocol with the focus of pretend play on improving the score of pretend play (ChIPPA) and the participation questionnaire (CPQ and I-CPAS)
Design
double-blind clinical trials in parallel groups will perform in a pre-estimated 81 samples that may change after the pilot study on a limited number (8 people). The announcement of the study will be published on social media and more specifically in the Iranian association of attention deficit - hyperactivity disorder.
Focused groups will be designed for children with ADHD and their stakeholders. semi-structural interviews and baseline assessments of participation and play and also diagnosis of ADHD will be done. According to the interview content, some measurements will be added.
Regarding results of questionnaires and interviews, 16 sessions of occupational therapy intervention with a focus on pretend play will be completed. after the 8th week, all the tests will perform again.
For the follow-up, after 8 weeks we will take tests again.
Settings and conduct
Iranian Association of attention deficit hyperactivity disorder
If we cannot get all the samples here, we will cover other samples from the occupational therapy and rehabilitation clinics in Tehran.
Interventions will be delivered by trained occupational therapists who do not have access to measurements results.
The assessment will be done by another person and statistical analysis will be done by a third person (the main researcher)
Participants/Inclusion and exclusion criteria
children with attention deficit hyperactivity disorder
between4-8 years old
based in Tehran
no other major disorder
Intervention groups
in-person intervention
online intervention
Main outcome variables
play and play skills (pretend play)
participation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211106052975N1
Registration date:2021-12-13, 1400/09/22
Registration timing:prospective
Last update:2021-12-13, 1400/09/22
Update count:0
Registration date
2021-12-13, 1400/09/22
Registrant information
Name
Minoo Dabiri Golchin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0037
Email address
minoodabiri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of a designed pretend play interventional planning on the play participation of 4-8 years old Tehranian children with Attention Deficit Hyperactivity Disorder (ADHD)
Public title
Play in children with Attention Deficit Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
earning 34 or more in Conner's scale
set in Tehran and speaking Persian
Internet access
able to read and write (parents)
Age limit between 4-8 years old
Exclusion criteria:
comorbidity of Autism, cerebral palsy, mental retardation
no intent to continue the project from the children side or their parents
receiving play therapy interventions or other interventions that research committee assume them as disruptor
absence more than two sessions
Age
From 4 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
two kinds of interventions are in-person and online
two therapists (in-person and online) are unaware of each other
secondary evaluations and baseline evaluation will be done by another person
Statistical analysis will be done by a third person.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of University of Social Welfare and Rehabilitation Sciences
Street address
koodakyar st, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2021-11-17, 1400/08/26
Ethics committee reference number
IR.USWR.REC.1400.203
Health conditions studied
1
Description of health condition studied
attention deficit hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
play
Timepoint
before intervention, right after intervention (after 8 weeks), 8 weeks later
Method of measurement
The "Child Initiated Pretend Play Assessment" (ChIPPA)
2
Description
Participation
Timepoint
0-8-16 weeks after intervention
Method of measurement
"Children Participation Questionnaire"
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Children with ADHD who receive in-person interventions. Intervention will deliver in 8 weeks, twice a week (16 sessions). These interventions will be delivered by trained occupational therapists with a protocol that is designed during participatory action research. The content of these sessions is focused on pretend play. Each session is 45 minutes.
Category
Rehabilitation
2
Description
Intervention group: Children with ADHD that receive online interventions. These interventions are same as the first group interventions but parents are provided with the protocol. Parents will deliver by intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Association of ADHD
Full name of responsible person
Hooshang Mirzaie
Street address
Mirdamad street
City
Tehran
Province
Tehran
Postal code
۰۲۱۲۲۹۲۳۵۷۲
Phone
+98 21 2292 3572
Email
iaadhd@yahoo.com
Web page address
https://iaadhd.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamid Reza Khankeh
Street address
Koodakyar street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
hamid.khankeh@ki.se
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
Minoo Dabiri Golchin
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Koodakyar st, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0037
Fax
Email
minoodabiri@yahoo.com
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
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Koodakyar street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0037
Email
hooshang_mirzaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Minoo Dabiri Golchin
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Koodakyar st, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0037
Fax
Email
minoodabiri@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
No - There is not 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
IDP: after making participants unrecognizable, data will be published in an article. in this paper, we will describe play and participation relations among different age groups. these variables relations will be assessed with demographic characteristics and will be published.
study protocol: will publish in a paper
Statistical analysis: will publish in the paper
Informed consent form: Is published in proposal
clinical study report: will publish in a paper
When the data will become available and for how long
IDP: after the baseline assessments will be accessible. public access is defined for 1401.
other documents: depended on the acceptance process, will be accessible in 1401
To whom data/document is available
After publishing the paper, it will be accessible for researchers.
Under which criteria data/document could be used
The access depends on the journal that we will publish the work.
From where data/document is obtainable
reach out to mdabiriot@gmail.com for any related information
What processes are involved for a request to access data/document
we cannot reveal data before publishing them in journals. Please be patient for publication.