The effect of occupation-centered interventions on self- determination of female adolescents at risk of Emotional-Behavioral Disorders according to MOHO
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Protocol summary
In this research, 40 adolescents at risk of Emotional-Behavioral Disorders who through Youth Self Report are screened.Then, patients are randomly divided into two control and intervention groups via block randomization and a code is allocated to each one of them.
In this research, 54 adolescents at risk of Emotional-Behavioral Disorders who through Youth Self Report are screened.Then, patients are randomly divided into two control and intervention groups via block randomization and a code is allocated to each one of them.
In this research, 4054 adolescents at risk of Emotional-Behavioral Disorders who through Youth Self Report are screened.Then, patients are randomly divided into two control and intervention groups via block randomization and a code is allocated to each one of them.
در این مطالعه 40 نوجوان در معرض خطر اختلالات هیجانی-رفتاری دارای شرایط ورود به مطالعه که از طریق آزمون غربالگری خود گزارشی نوجوان انتخاب می شوند، شرکت می کنند. شرکت کنندگان به دو گروه مداخله و کنترل از طریق بلوک های تصادفی تخصیص می یابند و به هر یک از شرکت کنندگان یک کد اختصاص داده می شود.
در این مطالعه 54 نوجوان در معرض خطر اختلالات هیجانی-رفتاری دارای شرایط ورود به مطالعه که از طریق آزمون غربالگری خود گزارشی نوجوان انتخاب می شوند، شرکت می کنند. شرکت کنندگان به دو گروه مداخله و کنترل از طریق بلوک های تصادفی تخصیص می یابند و به هر یک از شرکت کنندگان یک کد اختصاص داده می شود.
در این مطالعه 4054 نوجوان در معرض خطر اختلالات هیجانی-رفتاری دارای شرایط ورود به مطالعه که از طریق آزمون غربالگری خود گزارشی نوجوان انتخاب می شوند، شرکت می کنند. شرکت کنندگان به دو گروه مداخله و کنترل از طریق بلوک های تصادفی تخصیص می یابند و به هر یک از شرکت کنندگان یک کد اختصاص داده می شود.
The study was conducted with 40 participants in two groups of control and intervention with 20 people.Participants in the intervention group are divided into three groups of 5 to 7 people.The allocation of people in each group is done in accordance with the uniformity and participation in the interests of the participants according to the MOHO interests form. Therapeutic intervention will be provided to the intervention group for 8 sessions of 90 minutes per week (according to available resources and articles).
The study was conducted with 54 participants in two groups of control and intervention with 27 people.Participants in the intervention group are divided into three groups of 5 to 7 people.The allocation of people in each group is done in accordance with the uniformity and participation in the interests of the participants according to the MOHO interests form. Therapeutic intervention will be provided to the intervention group for 8 sessions of 90 minutes per week (according to available resources and articles).
The study was conducted with 4054 participants in two groups of control and intervention with 2027 people.Participants in the intervention group are divided into three groups of 5 to 7 people.The allocation of people in each group is done in accordance with the uniformity and participation in the interests of the participants according to the MOHO interests form. Therapeutic intervention will be provided to the intervention group for 8 sessions of 90 minutes per week (according to available resources and articles).
مطالعه با 40 شرکت کننده در دو گروه کنترل و مداخله با 20 نفر جمعیت انجام می گیرد.افراد شرکت کننده درگروه مداخله، به سه گروه 5 تا 7 نفره تقسیم می گردند. تخصیص افراد در هر گروه با توجه به یکسان سازی و اشتراک در علائق شرکت کنندگان بر اساس فرم علائق موهو انجام می پذیرد. تا در صورت امکان گروههایی با سطح علائق مشترک از لحاظ انجام آکیوپیشن های ارائه شده در طرح شکل بگیرد. مداخله درمانی به مدت 8 جلسه 90 دقیقه ای در هر هفته (با توجه به منابع و مقالات موجود) برای گروه مداخله برگزار خواهد شد.
مطالعه با 54 شرکت کننده در دو گروه کنترل و مداخله با 27 نفر جمعیت انجام می گیرد.افراد شرکت کننده درگروه مداخله، به سه گروه 5 تا 7 نفره تقسیم می گردند. تخصیص افراد در هر گروه با توجه به یکسان سازی و اشتراک در علائق شرکت کنندگان بر اساس فرم علائق موهو انجام می پذیرد. تا در صورت امکان گروههایی با سطح علائق مشترک از لحاظ انجام آکیوپیشن های ارائه شده در طرح شکل بگیرد. مداخله درمانی به مدت 8 جلسه 90 دقیقه ای در هر هفته (با توجه به منابع و مقالات موجود) برای گروه مداخله برگزار خواهد شد.
مطالعه با 4054 شرکت کننده در دو گروه کنترل و مداخله با 2027 نفر جمعیت انجام می گیرد.افراد شرکت کننده درگروه مداخله، به سه گروه 5 تا 7 نفره تقسیم می گردند. تخصیص افراد در هر گروه با توجه به یکسان سازی و اشتراک در علائق شرکت کنندگان بر اساس فرم علائق موهو انجام می پذیرد. تا در صورت امکان گروههایی با سطح علائق مشترک از لحاظ انجام آکیوپیشن های ارائه شده در طرح شکل بگیرد. مداخله درمانی به مدت 8 جلسه 90 دقیقه ای در هر هفته (با توجه به منابع و مقالات موجود) برای گروه مداخله برگزار خواهد شد.
General information
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54
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47
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2018-01-21, 1396/11/01
2018-01-21 00:00:00
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2018-03-20, 1396/12/29
2018-03-20 00:00:00
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2018-06-21, 1397/03/31
2018-06-21 00:00:00
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The reason for the update is to request a change in the sample size and also to report the termination of the clinical trial.Evidence, texts and research were reviewed and the probability of sample loss was considered. and the sample size increased from 40 to 54 samples, which after sampling and sample drop (7 people lost in the control group), the intervention ended with 47 patients (intervention=27) and (control=20).
The reason for the update is to request a change in the sample size and also to report the termination of the clinical trial.Evidence, texts and research were reviewed and the probability of sample loss was considered. and the sample size increased from 40 to 54 samples, which after sampling and sample drop (7 people lost in the control group), the intervention ended with 47 patients (intervention=27) and (control=20).
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علت بروزرسانی جهت درخواست تغییر حجم نمونه و همچنین گزارش خاتمه یابی کارآزمایی بالینی می باشد. به علت بررسی متون و تحقیقات، با احتساب احتمال ریزش نمونه ها حجم نمونه از 40 به 54 نمونه افزایش یافت، که پس از نمونه گیری و انجام مداخله، و بعد از ریزش نمونه ها ( ریزش7 نفر در گروه کنترل)، مداخله با 47 نفر (27 نفر در گروه مداخله) و (20 نفر در گروه کنترل) پایان یافت.
علت بروزرسانی جهت درخواست تغییر حجم نمونه و همچنین گزارش خاتمه یابی کارآزمایی بالینی می باشد. به علت بررسی متون و تحقیقات، با احتساب احتمال ریزش نمونه ها حجم نمونه از 40 به 54 نمونه افزایش یافت، که پس از نمونه گیری و انجام مداخله، و بعد از ریزش نمونه ها ( ریزش7 نفر در گروه کنترل)، مداخله با 47 نفر (27 نفر در گروه مداخله) و (20 نفر در گروه کنترل) پایان یافت.
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elahe Hojati Abed
Full name of responsible person - Persian: الهه حجتی عابد
Position - English: PHD Student in Occupational Therapy
Position - Persian: دانشجوی دکتری تخصصی کاردرمانی
Latest degree: master
Area of specialty/work: 72
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Rehabilitation Sciences of,Iran University of Medical Sciences Madadkaran st, Shahnazari st, Madar Square. Mirdamad BLV
Street address - Persian: بلوار میرداماد- میدان مادر-خیابان شاه نظری- خیابان مددکاران-دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 15875-4391
Phone: +98 21 2222 8051
Mobile: +98 912 290 1903
Fax:
Email: Hojati.a@tak.iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elahe Hojati Abed
Full name of responsible person - Persian: الهه حجتی عابد
Position - English: PHD Student in Occupational Therapy
Position - Persian: دانشجوی دکتری تخصصی کاردرمانی
Latest degree: master
Area of specialty/work: 72
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Rehabilitation Sciences of,Iran University of Medical Sciences Madadkaran st, Shahnazari st, Madar Square. Mirdamad BLV
Street address - Persian: بلوار میرداماد- میدان مادر-خیابان شاه نظری- خیابان مددکاران-دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 15875-4391
Phone: +98 21 2222 8051
Mobile: +98 912 290 1903
Fax:
Email: hojatiabed.e@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Elahe Hojati Abed Full name of responsible person - Persian: الهه حجتی عابد Position - English: PHD Student in Occupational Therapy Position - Persian: دانشجوی دکتری تخصصی کاردرمانی Latest degree: master Area of specialty/work: 72 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Rehabilitation Sciences of,Iran University of Medical Sciences Madadkaran st, Shahnazari st, Madar Square. Mirdamad BLV Street address - Persian: بلوار میرداماد- میدان مادر-خیابان شاه نظری- خیابان مددکاران-دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 15875-4391 Phone: +98 21 2222 8051 Mobile: +98 912 290 1903 Fax: Email: Hojati.ahojatiabed.e@tak.iums.ac.iriums.ac.ir Web page address:
Protocol summary
Study aim
The effect of occupation-centered interventions on self- determination of female adolescents at risk of Emotional-Behavioral Disorders according to MOHO
Design
In this research, 54 adolescents at risk of Emotional-Behavioral Disorders who through Youth Self Report are screened.Then, patients are randomly divided into two control and intervention groups via block randomization and a code is allocated to each one of them.
Settings and conduct
The research is practical and is implemented as RCT in mental health clinic of the Faculty of Rehabilitation of Iran University of Medical Sciences on girls studying at high schools in Tehran. Data collection is done by unknowing evaluator and data is analyzed by unknown statisticians.
Participants/Inclusion and exclusion criteria
Entry requirements: age 14- 16; female gender; cutting score ( 50-70) in youth self report; studying in high school
Conditions of failure to enter:lack of cooperation; Two consecutive absences or four absentee sessions throughout the sessions
Intervention groups
The study was conducted with 54 participants in two groups of control and intervention with 27 people.Participants in the intervention group are divided into three groups of 5 to 7 people.The allocation of people in each group is done in accordance with the uniformity and participation in the interests of the participants according to the MOHO interests form. Therapeutic intervention will be provided to the intervention group for 8 sessions of 90 minutes per week (according to available resources and articles).
Main outcome variables
independent variable: occupation-centered interventions;
dependent variable: student self-determination; self-determination(parent perception); executive function; Communication and Interaction Skills; Achievement
General information
Reason for update
The reason for the update is to request a change in the sample size and also to report the termination of the clinical trial.Evidence, texts and research were reviewed and the probability of sample loss was considered. and the sample size increased from 40 to 54 samples, which after sampling and sample drop (7 people lost in the control group), the intervention ended with 47 patients (intervention=27) and (control=20).
Acronym
IRCT registration information
IRCT registration number:IRCT20171231038153N1
Registration date:2018-02-07, 1396/11/18
Registration timing:registered_while_recruiting
Last update:2020-07-29, 1399/05/08
Update count:1
Registration date
2018-02-07, 1396/11/18
Registrant information
Name
Narges Shafaroodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
shafarodi.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2018-01-21, 1396/11/01
Actual recruitment end date
2018-03-20, 1396/12/29
Trial completion date
2018-06-21, 1397/03/31
Scientific title
The effect of occupation-centered interventions on self- determination of female adolescents at risk of Emotional-Behavioral Disorders according to MOHO
Public title
The effect of occupation-centered interventions on self- determination of adolescents
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 14 to 16 years
Female gender
Gain cutting scores (above 60) in the test of Youth Self Report
Studying in high school
Exclusion criteria:
Lack of cooperation in intervention
Two consecutive absence occasions Or four absentee sessions in total
Age
From 14 years old to 16 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
54
Actual sample size reached:
47
Randomization (investigator's opinion)
Randomized
Randomization description
Three-stage cluster sampling(Education areas, schools, students)
Restricted randomization methods and Permuted block randomization will be used to select students.
Randomization tool is Random number table .
allocation concealment is done as intervention and control groups are not known
Blinding (investigator's opinion)
Single blinded
Blinding description
Collection of research data are conducted by evaluators who are unaware of the participants in the intervention and control group.
Analysis of the research data is analyzed by statisticians who are unaware of the groups
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 medical sciences
Street address
Iran University of Medical Sciences, Hemat Highway next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-12-28, 1396/10/07
Ethics committee reference number
9321525001 .IR.IUMS.REC.1396
Health conditions studied
1
Description of health condition studied
َََAt risk of Emotional-behavioral disorders
ICD-10 code
F01-F99
ICD-10 code description
Behavioral and emotional disorders with onset usually occurring in childhood and adolescence.
Primary outcomes
1
Description
student self-determination is a 92-item self-report instrument that measures both affective and cognitive aspects of the student’s self-determination.including General Positive, General Negative, Specific Positive, and Specific Negative. The general subscales relate to a student’s sense of global self-determination, while the specific subscales relate primarily to application in their education, home, and related environmental settings. The positive subscales indicate self-determination in areas of perceived strength, while the negative subscales indicate areas of perceived weakness in self-determination.
Timepoint
At the begining of interventio; At the end of intervention (after 8 weeks) and after 10 weeks (follow up)
Method of measurement
Self-Determination Student Scale
2
Description
Self-Determination Parent Perception Scale: Parents' perceptions of their child's self-determination behaviors, abilities and skills.
Timepoint
At the Beginning of intervention ; At the end of intervention (after 8 weeks) and after 10 weeks (follow up)
Method of measurement
Self-Determination Parent Perception Scale (PPS)
Secondary outcomes
1
Description
Communication and Interaction Skills: Refers to behaviors that one can communicate with others through these behaviors, which leads to positive responses and negative responses.
Timepoint
At the Beginning of intervention; At the end of intervention (after 8 weeks) and after 10 weeks (follow up).
Method of measurement
In this research, Communication skills include 20 items that are classified into three areas of physicality , information exchange and relations Which is measured by the communication and interaction skills assessment(ACIS).
2
Description
Executive function:Executive functions are an idiomatic term that covers all of the complex cognitive processes that are required for task-oriented, difficult or new assignment tasks.
Timepoint
At the Beginning of intervention; At the end of intervention (after 8 weeks) and after 10 weeks (follow up).
Method of measurement
In this research, execution function is measured by three software programs, TOWER OF LONDON TEST; Go No Go; BART TASK.The decision making, problem solving, and risk-taking are evaluated.
3
Description
Academic Achievement: The ability to prove success in acquiring an outcome for which learning experiences are projected.
Timepoint
First semester;The end of the academic year
Method of measurement
In this study, academic achievement is the average of the second-order scores of school.
Intervention groups
1
Description
Intervention group: The content of the intervention will be based on the protocol contained in the STEPS To Self-Determination Curriculum, with permission from the authors of the book.Designing a set of occupations based on the interests and culture of adolescents participating in intervention and Confirming at a meeting of experts .Participants in the intervention group are divided into three groups of 5 to 7 people.Assignment of people in each group is done in accordance with the uniformity and participation in the interests of the participants according to the form of MOHO Interests.The intervention will be held for 8 sessions of 90 minutes per week (according to available resources and articles) for the intervention group.
Category
Behavior
2
Description
Control group: Includes 20 students at risk for emotional-behavioral disorders that do not receive any intervention.