Protocol summary

Study aim
Objective of this study: The effectiveness of tele coaching on occupational performance and executive function in children with attention deficit hyperactivity disorder
Design
single-blind, randomized controlled clinical trial on 30 clients
Settings and conduct
In order to conduct this study, COPM, GAS, BRIEF and Sensory Profile 2 evaluations are performed as a single blind by another occupational therapist who is blind to the control and intervention groups.
Participants/Inclusion and exclusion criteria
Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) by a child psychiatrist Age range 6 to 11 years No severe behavioral disorders Has a minimum of caregiver reading and writing literacy Internet access and ability to use it for caregiver Lack of care of the person with another disability by the caregiver No differences between parents The caregiver does not have severe mental disorders
Intervention groups
Children in both groups continue their usual treatment, which includes routine occupational therapy (sensory integration). In addition, the mother (primary caregiver) of the child in the intervention group also participates in tele coaching sessions, which will be considered by video call through the WhatsApp platform, and in case of problems such as internet interruption, the session with call will continue. Coaching sessions will consider all three key components of the OPC, including parental emotional support, information exchange, and a structured problem-solving process.
Main outcome variables
occupational performance, satisfaction of occupational performance, executive function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220206053951N1
Registration date: 2022-06-02, 1401/03/12
Registration timing: registered_while_recruiting

Last update: 2022-06-02, 1401/03/12
Update count: 0
Registration date
2022-06-02, 1401/03/12
Registrant information
Name
Sima Dehghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 9884
Email address
sdehghani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-08-11, 1401/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Tele Coaching on occupational performance and executive function on children with Attention Deficit Hyperactivity Disorder
Public title
The effectiveness of Tele Coaching on occupational performance and executive function on children with Attention Deficit Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) by a child psychiatrist Age range 6 to 11 years No severe behavioral disorders, which according to the Strength and Difficulties Questionnaire (SDQ) score 20 to 40 indicates severe behavioral problems. Has a minimum of caregiver reading and writing literacy Internet access and ability to use it for caregiver Lack of care of the person with another disability by the caregiver No differences between parents The caregiver does not have severe mental disorders, which according to the General Health Questionnaire (GHQ) score of 60 and above on a general scale indicates severe distress.
Exclusion criteria:
Age
From 6 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
After the evaluation, the occupational therapist provides an envelope to the mothers (primary caregivers) to select a card from the intervention and control group. The arrangement of the cards will be random and card A represents the intervention group and card B represents the control group. In this study, random sampling will be performed simply.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to conduct this study, COPM, GAS, BRIEF and Sensory Profile 2 evaluations are performed as a single blind by another occupational therapist who is blind to the control and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran, Khajeh Abdullah, Abuzar Ghaffari St., 6th Alley, No. 23
City
Tehran
Province
Tehran
Postal code
1661638175
Approval date
2022-03-15, 1400/12/24
Ethics committee reference number
IR.TUMS.FNM.REC.1400.235

Health conditions studied

1

Description of health condition studied
Attention Deficit Hyperactivity Disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
occupational performance
Timepoint
Three phases before intervention (pre-test), after intervention (post-test) and follow-up 2 weeks later (follow up)
Method of measurement
Canadian Occupational Performance Measure

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Tele occupational performance coaching
Category
Rehabilitation

2

Description
Control group: Traditional occupational therapy (Sensory integration)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Dr. Mahdieh Salehi
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2041
Email
sdehghani@razi.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran, Enghelab St., Pich Shemiran, corner of Safi Alishah St., School of Rehabilitation
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
sdehghani@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sima Dehghani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 23, 6th Alley, Abuzar Ghaffari St., Khajeh Abdullah, Tehran
City
Tehran
Province
Tehran
Postal code
1661638175
Phone
+98 21 2286 9884
Fax
Email
sdehghani@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sima Dehghani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 23, 6th Alley, Abuzar Ghaffari St., Khajeh Abdullah, Tehran
City
Tehran
Province
Tehran
Postal code
1661638175
Phone
+98 21 2286 9884
Fax
Email
sdehghani@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sima Dehghani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 23, 6th Alley, Abuzar Ghaffari St., Khajeh Abdullah, Tehran
City
Tehran
Province
Tehran
Postal code
1661638175
Phone
+98 21 2286 9884
Fax
Email
sdehghani@razi.tums.ac.ir

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Changes in occupational performance and satisfaction of clients and their families
When the data will become available and for how long
3 months after printing the results
To whom data/document is available
All researchers working in academic and scientific institutions
Under which criteria data/document could be used
Self study in the new intervention used in research/ Occupational performance coachin
From where data/document is obtainable
Faculty of Rehabilitation, Tehran University of Medical Sciences
What processes are involved for a request to access data/document
After the article is published in the journal, the applicant can access the published information
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