IRCT | The effect of increasing parental involvement in the transfer process in CO-OP approach on motor-based trained and untrained occupational performance in 7 to 12 –year-old children with Specific Learning Disorders (SLD).

Protocol summary

Study aim: The effectiveness of increasing parental involvement in the transfer process in the Cognitive orientation to daily occupational performance Approach on motor-based occupational performance in untrained task in children with Specific Learning Disorders.
Design: single blind randomized controlled clinical trial
Settings and conduct: Children with Specific Learning Disabilities who meet the inclusion criteria will be selected, then randomly assigned to intervention and control groups using the randomization Block method. In both groups, the evaluation of Occupational performance of daily activities was performed by an independent assessor who was blind to the participants of the intervention and control group. In the intervention group, the CO-OP intervention will be presented to children along with the parents training protocol by the trained therapist, and in the control group, the CO-OP intervention will be presented according to the traditional protocol. At the end of the intervention, the occupational performance of daily activities will be assessed in both groups.
Participants/Inclusion and exclusion criteria: aged between 7 and 12 years; diagnosed as Specific Learning Disorders (SLD) by a pediatrician according to DSM V criteria for SLD, had problems in motor-based occupational performance; and had no other diagnosis or signs of neurological or neuromuscular disease.
Intervention groups: CO-OP approach will be conducted in 12 sessions of one hours over a period of 6 weeks. The intervention group will receive a CO-OP intervention and parent education.
Main outcome variables: Canadian Occupational Performance Measures Performance Quality Rating Scale

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20201019049080N1

Registration date: 2021-01-11, 1399/10/22

Registration timing: registered_while_recruiting

Last update: 2021-01-11, 1399/10/22

Update count: 0
Registration date: 2021-01-11, 1399/10/22

Registrant information: Name

Soraya Gharebaghy

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 2222 7124

Email address

gharebaghy_ot@yahoo.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2020-12-04, 1399/09/14
Expected recruitment end date: 2021-05-19, 1400/02/29
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effect of increasing parental involvement in the transfer process in CO-OP approach on motor-based trained and untrained occupational performance in 7 to 12 –year-old children with Specific Learning Disorders (SLD).

Public title: Effectiveness Increasing parental involvement in the transfer process in CO-OP approach on motor-based occupational performance in 7 to 12 –year-old children with Specific Learning Disorders (SLD).
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Children with an SLD diagnosis aged between 7 and 12 years old Normal or correct to normal hearing and vision. Sufficient language ability to communicate with and be understood during treatment. Report at least 5 occupational performance problems.

Exclusion criteria:

had other diagnosis or signs of neurological or neuromuscular disease.
Age: From 7 years old to 12 years old
Gender: Both

Phase

2-3

Groups that have been masked

Outcome assessor

Sample size

Target sample size: 20

Randomization (investigator's opinion)

Randomized

Randomization description

Balanced (permuted) block randomization: In this method, the number of participants in each group is the same and the size of all blocks is equal. In this study, 8 blocks with 4 participants were assigned to the intervention group and 4 participants to the control group. In this study, there are two intervention groups, we define 6 modes for quadruple blocks and we define 6 cards. Given that the sample number is 20 participants, we select 5 of the above cards by replacement. Sample defined cards: Intervention group (A), control group (B) AABB-ABAB-BABA-BBAA-ABBA-BAAB

Blinding (investigator's opinion)

Single blinded

Blinding description

single blind: Outcome assessor: The person or persons conducting the assessment are unaware of assigning participants to intervention and control groups.

Placebo

Not used

Assignment

Parallel

Other design features

A qualitative study will be conducted to design a guideline to increasing parental involvement in the transfer process in the CO-OP intervention, and given that the number of children receiving CO-OP intervention has been limited. In the qualitative phase for designing the guideline, if we do not have access to an enough amount of information, the CO-OP intervention will be presented to a number of children as pre-test and post-test without control group. And the parents of these children will be involved in the qualitative phase of the interview and the design of the intervention guide.

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Iran University of Medical Sciences-Ethical Committee

Street address

Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.

City

Tehran

Province

Tehran

Postal code

1545913487
Approval date: 2019-08-23, 1398/06/01
Ethics committee reference number: IR.IUMS.REC.1398.062

Health conditions studied

1

Description of health condition studied: Specific Learning Disorders
ICD-10 code: F81.0
ICD-10 code description: Specific reading disorder

2

Description of health condition studied: Disorder of written expression
ICD-10 code: F81.81
ICD-10 code description: Disorder of written expression

3

Description of health condition studied: Mathematics disorder
ICD-10 code: F81.2
ICD-10 code description: Mathematics disorder

Primary outcomes

1

Description: motor-based occupational performance and satisfaction of performance in trained and untrained tasks
Timepoint: pre intervention- post intervention and two month after intervention (follow-up)
Method of measurement: Canadian Occupational Performance Measure (COPM)

2

Description: motor-based occupational performance in trained and untrained tasks
Timepoint: pre intervention- post intervention and two month after intervention (follow-up)
Method of measurement: Performance Quality Rating Scale (PQRS)

Secondary outcomes

1

Description: Motor skills
Timepoint: Pre intervention, Post intervention
Method of measurement: Bruninks Oseretsky Test of Motor Proficiency Measure

Intervention groups

1

Description: Intervention group: CO-OP intervention with increasing parental involvement guideline. Over 12 individualized sessions (10 treatment and one pre and post test session), at the rate of one or two a week, each child will learn the Goal-Plan-Do-Check strategy and then apply it in learning to perform the target skills. Through guided discovery, the therapist will enable the child to discover the domain-specific strategies required for task performance. Verbalization, by both therapist and child, of discovered strategies will be used to guide performance and to promote strategy learning. Bridging techniques will be used to promote transfer and generalization. Treatments will be administered by qualified occupational therapists who will receive specific CO-OP training. All treatment sessions will last approximately 60 minutes. This intervention will be done along with two sessions of direct teaching of the basic principles of the CO-OP approach to parents and practicing these principles during the child intervention sessions. Parents at home will then help the child with additional goals chosen by the child. And are present during the sessions and practice and observe a variety of guided detection methods as scheduled. Two parent training sessions last 60 minutes. And at the end of the child's educational sessions, the parents will review the session and learn for 15 minutes.
Category: Rehabilitation

2

Description: Control group: CO-OP intervention. Over 12 individualized sessions (10 treatment and one pre and post test session), at the rate of one or two a week, each child will learn the Goal-Plan-Do-Check strategy and then apply it in learning to perform the target skills. Through guided discovery, the therapist will enable the child to discover the domain-specific strategies required for task performance. Verbalization, by both therapist and child, of discovered strategies will be used to guide performance and to promote strategy learning. Bridging techniques will be used to promote transfer and generalization. Treatments will be administered by qualified occupational therapists who will receive specific CO-OP training. All treatment sessions will last approximately 60 minutes.
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Exceptional education in Mashhad

Full name of responsible person

Soraya Gharebaghy

Street address

School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, Tehran, Iran.

City

Tehran

Province

Tehran

Postal code

1545913487

Phone

+98 21 2222 7124

Email

gharebaghy_ot@yahoo.com

1

Sponsor: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Dr. Narges Shafaroodi

Street address

Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.

City

Tehran

Province

Tehran

Postal code

1545913487

Phone

+98 21 2222 7124

Email

shafarodi.n@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Iran 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

Iran University of Medical Sciences

Full name of responsible person

Narges Shafaroodi

Position

Associate Proffesor

Latest degree

Ph.D.

Other areas of specialty/work

Occupational Therapy

Street address

Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.

City

Tehran

Province

Tehran

Postal code

1545913487

Phone

+98 21 2222 7124

Email

shafarodi.n@iums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Malahat AkbarFahimi

Position

Associate professor

Latest degree

Ph.D.

Other areas of specialty/work

Occupational Therapy

Street address

Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.

City

Tehran

Province

Tehran

Postal code

158754391

Phone

+98 21 2222 2059

Email

malahatfahimi@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Soraya Gharebaghy

Position

Student

Latest degree

Master

Other areas of specialty/work

Occupational Therapy

Street address

Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.

City

Tehran

Province

Tehran

Postal code

158754391

Phone

+98 21 2222 2059

Email

gharebaghy_ot@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: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: Part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long: Access period starts 6 months after the results are published
To whom data/document is available: Occupational Therapist, and researcher in the Occupational therapy
Under which criteria data/document could be used: Use the reported results for clinical work
From where data/document is obtainable: Iran university of Medical Science, School of Rehabilitation Sciences, Occupational Therapy department
What processes are involved for a request to access data/document: The data and results of the study are available in the final version of the dissertation and are available at the Faculty of Rehabilitation.
Comments

The effect of increasing parental involvement in the transfer process in CO-OP approach on motor-based trained and untrained occupational performance in 7 to 12 –year-old children with Specific Learning Disorders (SLD).