Protocol summary
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Study aim
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Designing Interventions based on occupation performance coaching with four Quadrant Model of facilities learning and its effect on the participation in activities outside of school in students with Specific learning disorder
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Design
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Randomized controlled trial with intervention and control group, double-blind
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Settings and conduct
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Sampling from training and rehabilitation centers for special learning problems (5 areas in Tehran) is done. After the eligible patients fill out the consent form, they will be randomly assigned to in two group.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:
- The age of the student is between 7 and 12 years (both sexes)
- The participating families must live in Tehran
- The student has a diagnosis of a specific learning disorder.
- The student has no physical, vision, or hearing problems;
- The student should not have comorbidities such as Coping Behavior Disorder, Disseminated anxiety disorder, Depressive disorder, Separation Anxiety Disorder, and Social phobia through the Child Symptoms Questionnaire-4
- The student must score lower than the chronological age on the Vineland Adaptive Behavior Scale
- The participating parent must have a diploma or higher
Exclusion Criteria:
- Parents should not cooperate in answering questionnaires or attending intervention sessions.
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Intervention groups
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Two groups: 1) control group (interventions based on occupation performance coaching), 2) intervention group (interventions based on occupation performance coaching with four Quadrant Model of facilities learning)
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Main outcome variables
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Participation in extracurricular activities, educational status, quality of student performance in the priorities set by the family, the degree of achievement of goals set by the family, the degree of family satisfaction with the child's performance, parental involvement, parent-child relationship, executive functions
General information
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Reason for update
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1- Since in the inclusion criteria in the study for children only the Child Symptoms Questionnaire (CSI-4) is sufficient to evaluate the comorbidities, there was no need for the Vinland Adaptive Behavior Scale and it was omitted.
2- Due to the importance of the parent's participation in the study, it was necessary to assess the parent's mental health status. Therefore, in the exclusion criteria, the Depression, Anxiety, and Stress Scale-21(DASS-21) were added for parents.
3- In the section of primary outcomes, at the same time as examining participation in activities outside of school, The quality of student performance in the priorities set by the family, the degree of family satisfaction with the child's performance, and the rate of achievement of goals set by the family Is also measured, so the above three items were moved from the secondary outcomes section to the primary outcomes section.
4- In secondary outcomes, due to the importance of parental cooperation in this study, numerous questionnaires and the absence of students from school due to COVID-19, the questionnaire of Parent-Teacher Involvement Questionnaire (PTIQ) and the Child-Parent Relationship Scale (CPRS) were removed and the parent self-efficacy questionnaire was replaced.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140416017301N9
Registration date:
2021-06-24, 1400/04/03
Registration timing:
prospective
Last update:
2022-04-20, 1401/01/31
Update count:
1
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Registration date
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2021-06-24, 1400/04/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-07-06, 1400/04/15
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Expected recruitment end date
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2022-02-22, 1400/12/03
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Designing Interventions based on occupation performance coaching with four quadrant model of facilities learning and its effect on the participation in activities outside of school in students with specific learning disorder
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Public title
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Designing Interventions Based on Occupation performance with facilities learning and its effect on the participation in activities outside of school in students with specific learning disorder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The age of the student is between 7 and 12 years (both sexes)
The participating families must live in Tehran
The student has a diagnosis of a specific learning disorder. Diagnosis is made by experts from Exceptional Education Learning Disabilities Centers through the Wechsler Intelligence Test for Children, the Stanford-Binet Intelligence Test and the Woodcock Johnson Cognitive Ability Test.
The student has no physical, vision or hearing problems;
The student should not have comorbidities such as Coping Behavior Disorder, Disruptive Disorders, Disseminated anxiety disorder, Depressive disorder, Separation Anxiety Disorder, and Social phobia through the Child Symptoms Questionnaire (CSI-4).
The participating parent must have a diploma or higher
Exclusion criteria:
Parents cancel their cooperation in answering the questionnaires or referring to the intervention sessions;
Parent's unwillingness to participate in intervention sessions or answering a questionnaire;
Occurrence of problems, illnesses, life changes or events for the parent that affect the behaviors being evaluated or seriously affect the results of the study.
Lack of severe depression for the participating parent based on the Depression, Anxiety, and Stress Scale-21(DASS-21)
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Age
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From 20 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Available samples of parents of 7 to 12-year-old students referring to education and rehabilitation centers for special learning problems in Tehran, related to exceptional education (5 areas in Tehran: 1, 6, 8, 14, 18) According to the selected inclusion criteria and after agreeing to participate in this study and signing the consent form, they will be divided into two groups of control and intervention by complete randomization method (sealed envelope method).
In absolute random method (envelope and paper method), the name of groups will be written on a piece of paper and put in an envelope and the participants will be asked to choose one of the papers randomly then the patient will be placed in the intervention or control group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study is double blind.
Participants (in both intervention and control groups) and the examiner (outcome assessor) are also blind (all assessments at all stages of the study by an experienced occupational therapist working with the child and their family who have previously been tested by the researcher. They are trained and done completely blind to the type of intervention in each family).
Also, after the interventions in both groups, the test results will be analyzed by a blind statistician from both groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-04-18, 1400/01/29
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Ethics committee reference number
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IR.IUMS.REC.1400.060
Health conditions studied
1
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Description of health condition studied
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Specific Learning Disorder
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ICD-10 code
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F81
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ICD-10 code description
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Specific developmental disorders of scholastic skills
Primary outcomes
1
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Description
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Participate in extracurricular activities including basic activities of daily living, instrumental activities of daily living, play, leisure, social participation and sleep performance
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Timepoint
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Before intervention, after intervention , follow up after 1/5 month of intervention
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Method of measurement
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Children Participation Assessment Scale -Parent Version (CPAS-P)
2
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Description
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The quality of student performance in the priorities set by the family
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Timepoint
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Before intervention, after intervention , follow up after 1/5 month of intervention
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Method of measurement
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Canadian Occupational Performance Measure (COPM)
3
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Description
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Degree of family satisfaction with the child's performance
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Timepoint
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Before intervention, after intervention , follow up after 1/5 month of intervention
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Method of measurement
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Canadian Occupational Performance Measure (COPM)
4
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Description
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Rate of achievement of goals set by the family
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Timepoint
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Before intervention, after intervention , follow up after 1/5 month of intervention
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Method of measurement
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Goal Attainment Scale (GAS)
Secondary outcomes
1
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Description
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Student's educational status (grades obtained in school, which are obtained by the student and entered in the school transcript)
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Timepoint
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Before intervention, after intervention , follow up after 1/5 month of intervention
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Method of measurement
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Shades of Academic Adequacy of the Ministry of Education
2
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Description
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Executive functions include two parts: behavior regulation index (inhibit, shift, emotional control) and metacognition index (working memory, initiation, plan, organization of materials, monitor)
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Timepoint
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Before intervention, after intervention , follow up after 1/5 month of intervention
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Method of measurement
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Behavior Rating Inventory of Executive Function (BRIEF)
3
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Description
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Self-efficacy of parent
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Timepoint
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Before intervention, after intervention , follow up after 1/5 month of intervention
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Method of measurement
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The Sherer General Self-Efficacy Scale (SGSES)
Intervention groups
1
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Description
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Intervention group: Occupation performance coaching interventions are presented to the intervention group in the form of three areas of structural process, emotional support, and information exchange along with the Four Quadrant Model of Facilitated learning. The content of the sessions based on the inventor of this method and Dr. Kessler, in general, is as follows. Also, the necessary changes will be applied after the pilot phase of the study: Session 1: Introducing and explaining the details of the intervention and setting goals by completing questionnaires (initial assessments). Objectives as specific as possible, measurable, and achievable in 10 to 12 sessions. Session 2: Start the problem-solving process for one of the goals and provide a printout of the problem-solving process. In this session, the parent determines that he or she will perform at least two different actions during the next week regarding the goal. Session 3: Review the first goal and start the next goals (one to two actions for each goal). Sessions 4 to 8: Assessing progress in all goals by considering the learning needs of parents and adding the Four Quadrant Model of Facilitated Learning to them to get acquainted with the structure and method of teaching goals to their child. session 9: Review of goals and aggregation to end the of sessions. Session 10 to 12: Deciding on goals that have not been achieved and ending the intervention with completing secondary evaluations
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Category
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Rehabilitation
2
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Description
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Control group: Occupation performance coaching interventions are presented to the control group in the form of three areas of structural process, emotional support, and information exchange. The content of the sessions based on the inventor of this method and Dr. Kessler, in general, is as follows. Also, the necessary changes will be applied after the pilot phase of the study: Session 1: Introducing and explaining the details of the intervention and setting goals by completing questionnaires (initial assessments). Objectives as specific as possible, measurable, and achievable in 10 to 12 sessions. Session 2: Start the problem-solving process for one of the goals set and provide a printout of the problem-solving process. In this session, the parent determines that he or she will perform at least two different actions regarding the goal in the coming week. Session 3: Review the first goal and start the next goals (one to two actions for each goal). Sessions 4 to 8: Examining progress on all goals. Session 9: Review of goals and aggregation to end of sessions. Session 10 to 12: Deciding on goals that have not been achieved and ending the intervention with completing secondary evaluations
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Not Decided
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When the data will become available and for how long
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Not Decided
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To whom data/document is available
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Not Decided
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Under which criteria data/document could be used
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Not Decided
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From where data/document is obtainable
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Not Decided
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What processes are involved for a request to access data/document
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Not decided
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Comments
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