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Trial registered on ANZCTR


Registration number
ACTRN12614000896673
Ethics application status
Approved
Date submitted
17/07/2014
Date registered
22/08/2014
Date last updated
22/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of a Self-Development Coaching Program on the Psychological Health and Academic Performance among Dental and Medical Students in Saudi Arabia
Scientific title
Does a self-development coaching program "How to be an ultra Super Student" in compare to a placebo program, lead to improvements in depression, anxiety, stress, self-efficacy, satisfaction with life, and academic performance in dental and medical student at Makkah, Saudi Arabia?
Secondary ID [1] 284778 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 292148 0
anxiety 292149 0
stress 292150 0
self-efficacy level 292151 0
satisfaction with life level 292152 0
academic performance level 292154 0
Condition category
Condition code
Public Health 292482 292482 0 0
Epidemiology
Mental Health 292483 292483 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"How to Be an Ultra Super Student" is a self-development coaching program developed and has been run by a self-development coach and trainer since 2008. The contents were derived from the coach personal experiences and from reading and practicing self-development for years. The content was not validated neither formed according to evidence-based resources in 2008. Nevertheless, the program has been under the coach continues adjustments using coachees’ feedback. The program aims mainly to improve students' academic performance and improve their psychological health. The program is not using psychological therapeutic approaches, but rather uses series of skills and conceptual ideas about studying and coping with challenges during the academic journey, so participants can use them if they want.
The program is delivered as live course in a large lecture theatre at students’ free time where participants are supplied by each program's booklet and the program's audio CD. The program modules are: (1) Unleash your inner power: where information about self-efficacy and goals in life are discussed. (2) Manage your time effectively: different models and tips to utilize studying time efficiently. (3) The maximum usefulness of universities' lecture: different solutions to increase lecture time efficiency. (4) How to study and memorize effectively: skills with exercise to memorize better. (5) Dealing with exams: practical tips to deal with exams' time. (6) Religious teaches: Islamic teaches augment the previous skills and values in the Saudi religious cultural.
The CD content: (1) 24 study-motivation audio files. (2) Short version of muscle relaxation and positive messages. (3) Long version of muscle relaxation and positive messages. The program's way of conduction are: motivational voice tone and body language, success and Islamic stories (Parable), famous people and Islamic quotes (Metaphor), recontextualized ideal, personification of some values, showing movie clips, direct interacting with audience, and give coachee the freedom to choose among program’s techniques that suits him/her. The program is conducted over 2 days, 5 hours/day.

Intervention code [1] 289901 0
Behaviour
Intervention code [2] 289902 0
Lifestyle
Comparator / control treatment
"Learning and Success in Health Faculties"program was developed during the preparation for this study only. The program was only offered to those in the control group for the purposes of this study and it is not part of the University curriculum. It aims to provide information about learning in health faculties and the factors leading to success according to a scientific literature review. It also gives a brief on scientific research in public health field. All the information that is provided in the LSHF are scientifically validated materials that are taken from academic articles or academic books. The program is delivered as live course in a large lecture theatre at students’ free time where participants are supplied by each program's booklet and the program's audio CD.
Program modules are: (1) blooms' Taxonomy, (2) scientific data about variables association with success in health faculties such as the language, income, etc., with no practical points, (3) active learning potential use in health faculties, and (4) the importance of scientific research. CD contents are: 24 audio files resembling the content of the program. Program's conduction way is as the normal and standard university way of presenting a lecture that allow for short question to be answered be answered alone or in groups. The program is conducted in one day for 4 hours.

Control group
Placebo

Outcomes
Primary outcome [1] 292347 0
Depression (DASS-21 depression sub-scale)
Timepoint [1] 292347 0
Baseline (before the intervention by 3 months) , immediately before the intervention, after the intervention with one week, and after the intervention by 5 weeks.
Primary outcome [2] 292348 0
Anxiety (DASS-21 anxiety sub-scale)
Timepoint [2] 292348 0
Baseline (before the intervention by 3 months) , immediately before the intervention, after the intervention with one week, and after the intervention by 5 weeks.
Primary outcome [3] 292349 0
Stress (DASS-21 stress sub-scale)
Timepoint [3] 292349 0
Baseline (before the intervention by 3 months) , immediately before the intervention, after the intervention with one week, and after the intervention by 5 weeks.
Secondary outcome [1] 308746 0
Credibility and expectancy mean score using (Credibility and Expectancy Questionnaire CEQ).
Timepoint [1] 308746 0
Immediately before the intervention, and after the intervention with one week.
Secondary outcome [2] 308747 0
coach and coaching characteristics rating by participants: 11 question to ask about: Coachee satisfaction with the program, using personal experience of the coach, coaching program relevance, coach’s ability to get coachee’s attention, coach confidence, coach as a role model, having experience in the coach’s program content, coach convincing level, coach motivation level, coach ability to influence the coachee emotional, and coach empathy
Timepoint [2] 308747 0
Only after the intervention by a week
Secondary outcome [3] 309628 0
Academic performance, measured by students' academic grades
Timepoint [3] 309628 0
Before the intervention at the 1st semester, and after the intervention by 3 months at the end of the second semester.
Secondary outcome [4] 309629 0
Self-efficacy mean score using (General Self-Efficacy Scale GSE)
Timepoint [4] 309629 0
Baseline (before the intervention by 3 months) , immediately before the intervention, after the intervention with one week, and after the intervention by 5 weeks.
Secondary outcome [5] 309630 0
Satisfaction with life mean score (using Satisfaction With Life Scale SWLS).
Timepoint [5] 309630 0
Baseline (before the intervention by 3 months) , immediately before the intervention, after the intervention with one week, and after the intervention by 5 weeks.

Eligibility
Key inclusion criteria
1. Students in the 2nd/3rd years.
2. Medical/dental students
3. Students from Umm Al-Qura University
Minimum age
20 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Already attended (How to be an Ultra Super Student) program during his/her academic life in the university.
2. Has a major psychological disorder (on psychological medication or seeing psychiatrist for mental disease)
3. Did not sign the study consent.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study was advertised via large roll up posters and students were recruited at the first term via invitation’s envelopes that contained coloured flyer about the programs, study information sheet and the consent form. After receiving participants signed consent, participated were randomly allocated into interventional group (IG) and control group (CG) by the principle investigator.
When the principle investigator received students consent forms, participants listed were exactly as they were received without any manipulation or rearrangement to their IDs or for any reasons. After that, the principle investigator generated a random numbers list (using excel commands) and put it in front of participants ID. It was determined before that each participant that got an odd number (from the random list) will be allocated to the study group, and each even number was allocated to the control group. This step was not influence any point in this process by any way, by rearranging or choosing specific list.

The students and research assistants who managed the study protocol and data collection were blinded. The intervention was conducted at the first week of the second term. Students knew their assigned group before the conducting both programs by one week.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were stratified into medical and dental strata, then randomised into interventional and control group using computer generated random number tables done by the principle investigator using Excel software.
These numbers were random by chance. It was not based on students birthday, or their ID in the university or any other factor. After that, we put students list into the tables. Participants with odd number were allocated to the interventional group, with the participants with even number were allocated to the control group.
Every student has a chance of 50% to be at either group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
It should be note that the principle investigator who ran the intervention by himself was not blinded. However, the research assistants who advertised the study, helped in conducting the intervention, and collected the data, were blinded.

Also, the students know their assigned group: Program A/ Program B, however, non of them know that "program A" was the main intervention. All students were invited to participate in this study that offered a chance to be on either groups on random bases. Each student who agreed to participate was informed with his program before a week of both program, so they would attend the program on the sepceific day and time. However, no student knew that this was that program A was the self-development program that we aimed to study. Students on both groups thought that researchers wanted to assess the effectivness of both groups.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Repeated measure ANCOVA
Post hocL paired t-test and independent t-test

A sample size of 130 (65 at each group) participants was needed. A study power of 90 (B=0.1), alpha=0.05, minimal clinical difference of 4 points in any of the psychological health means, and an average standard deviation of 7 derived from a recent well-designed coaching RCT which used DASS-21. 130 was multiplied by 1.5 for the design effect (multiple follow-up). This number was again multiplied by 1.5 for the estimated non-response rate (50%) and multiplied by 1.2 for estimated drop-out during the follow-up (20%), with the result that 351 students.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6222 0
Saudi Arabia
State/province [1] 6222 0
Makkah

Funding & Sponsors
Funding source category [1] 289618 0
University
Name [1] 289618 0
Faculty of Dentistry, Umm Al-Qura University
Address [1] 289618 0
Faculty of Dentistry, Umm Al-Qura University,
Makkah (21955)
P.O. Box 715
Saudi Arabia
Country [1] 289618 0
Saudi Arabia
Primary sponsor type
University
Name
Faculty of dentistry, Umm Al-Qura University
Address
Faculty of Dentistry, Umm Al-Qura University,
Makkah (21955)
P.O. Box 715
Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 288305 0
University
Name [1] 288305 0
Queensland University of Technology
Address [1] 288305 0
Postal address:
Faculty of Health, QUT
Victoria Park Road
Kelvin Grove QLD 4059
Country [1] 288305 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291360 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 291360 0
Queensland University of Technology
Research Ethics Unit
Level 4, 88 Musk Avenue
Kelvin Grove, QLD, 4059
Ethics committee country [1] 291360 0
Australia
Date submitted for ethics approval [1] 291360 0
Approval date [1] 291360 0
06/09/2012
Ethics approval number [1] 291360 0
1200000411

Summary
Brief summary
This project is being undertaken as part of PhD study.
The purpose of this project is to evaluate the effect of a self-development coaching program on the psychological health and academic performance among dental and medical students in Saudi Arabia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49130 0
Mr Khalid Aboalshamat
Address 49130 0
Queensland University of Technology (QUT)
Faculty of Health, school of public health and social work
O-Block, Room C603,Victoria Park Road
Kelvin Grove 4059 QLD, Brisbane, Australia
Country 49130 0
Australia
Phone 49130 0
+61 7 3138 5523
Fax 49130 0
Email 49130 0
dr.khalid.sh@hotmail.com
Contact person for public queries
Name 49131 0
Mr Khalid Aboalshamat
Address 49131 0
Queensland University of Technology (QUT)
Faculty of Health, school of public health and social work
O-Block, Room C603,Victoria Park Road
Kelvin Grove 4059 QLD, Brisbane, Australia
Country 49131 0
Australia
Phone 49131 0
+61 7 3138 5523
Fax 49131 0
Email 49131 0
dr.khalid.sh@hotmail.com
Contact person for scientific queries
Name 49132 0
Mr Khalid Aboalshamat
Address 49132 0
Queensland University of Technology (QUT)
Faculty of Health, school of public health and social work
O-Block, Room C603,Victoria Park Road
Kelvin Grove 4059 QLD, Brisbane, Australia
Country 49132 0
Australia
Phone 49132 0
+61 7 3138 5523
Fax 49132 0
Email 49132 0
dr.khalid.sh@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary