Protocol summary
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Study aim
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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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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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).
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Main outcome variables
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independent variable: occupation-centered interventions;
dependent variable: student self-determination; self-determination(parent perception); executive function; Communication and Interaction Skills; Achievement
General information
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Reason for update
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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).
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Acronym
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IRCT registration information
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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
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Registration date
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2018-02-07, 1396/11/18
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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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2018-01-21, 1396/11/01
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Expected recruitment end date
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2018-03-20, 1396/12/29
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Actual recruitment start date
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2018-01-21, 1396/11/01
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Actual recruitment end date
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2018-03-20, 1396/12/29
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Trial completion date
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2018-06-21, 1397/03/31
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Scientific title
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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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Public title
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The effect of occupation-centered interventions on self- determination of adolescents
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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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
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Age
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From 14 years old to 16 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
54
Actual sample size reached:
47
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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
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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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2017-12-28, 1396/10/07
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Ethics committee reference number
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9321525001 .IR.IUMS.REC.1396
Health conditions studied
1
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Description of health condition studied
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َََAt risk of Emotional-behavioral disorders
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ICD-10 code
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F01-F99
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ICD-10 code description
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Behavioral and emotional disorders with onset usually occurring in childhood and adolescence.
Primary outcomes
1
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Description
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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.
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Timepoint
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At the begining of interventio; At the end of intervention (after 8 weeks) and after 10 weeks (follow up)
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Method of measurement
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Self-Determination Student Scale
2
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Description
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Self-Determination Parent Perception Scale: Parents' perceptions of their child's self-determination behaviors, abilities and skills.
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Timepoint
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At the Beginning of intervention ; At the end of intervention (after 8 weeks) and after 10 weeks (follow up)
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Method of measurement
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Self-Determination Parent Perception Scale (PPS)
Secondary outcomes
1
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Description
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Communication and Interaction Skills: Refers to behaviors that one can communicate with others through these behaviors, which leads to positive responses and negative responses.
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Timepoint
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At the Beginning of intervention; At the end of intervention (after 8 weeks) and after 10 weeks (follow up).
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Method of measurement
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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
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Description
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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.
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Timepoint
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At the Beginning of intervention; At the end of intervention (after 8 weeks) and after 10 weeks (follow up).
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Method of measurement
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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
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Description
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Academic Achievement: The ability to prove success in acquiring an outcome for which learning experiences are projected.
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Timepoint
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First semester;The end of the academic year
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Method of measurement
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In this study, academic achievement is the average of the second-order scores of school.
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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Control group: Includes 20 students at risk for emotional-behavioral disorders that do not receive any intervention.
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Category
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Behavior
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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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be 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