Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000199718
Ethics application status
Not yet submitted
Date submitted
15/02/2013
Date registered
19/02/2013
Date last updated
19/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing rates of eating disorder detection and treatment in adolescence
Scientific title
A randomised controlled trial of a school-based education and training intervention vs. a waitlist control condition: Effects on treatment-seeking in secondary school students with eating disorders and other mental health problems, and on mental health literacy in secondary school students, their parents and their teachers.
Secondary ID [1] 281968 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating disorders 288392 0
Depression. 288393 0
Anxiety. 288394 0
Self-harm. 288395 0
Condition category
Condition code
Mental Health 288739 288739 0 0
Eating disorders
Mental Health 288740 288740 0 0
Depression
Mental Health 288741 288741 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention forms Phase 2 of a two-phase research project. In Phase 1, students, teachers and parents affiliated with participating secondary schools will be invited to complete online questionnaires regarding perceived rates of mental health problems in adolescence, options for treatment for mental health problems in adolescence, and (for students only) their experiences with mental health difficulties and whether they had sought treatment for those difficulties. Phase 1 will last approximately 2 weeks, with participants being able to complete questionnaires online on one occasion at any point during those 2 weeks.

After this initial phase, schools will be randomly allocated to an immediate Phase Two condition or a delayed Phase Two condition.

The Phase 2 process will include the following:
1. Students, teachers and parents will be provided with feedback from the first phase of the research. In particular, they will be given information on rates of mental health problems in adolescents and how these compare to estimated rates by students, parents and teachers. They will also be given information on evidence-based treatment options for mental health problems. This feedback will occur via school assemblies and newsletters. The information presented will not identify any individual participants from Phase 1, and will make use of pooled data only.

2. Student councellors and other key teachers at the participating schools will be invited to attend a meeting with the Investigator about current management strategies for mental health problems in the school. The Investigator will provide summaries of guidelines on screening for eating disorders, depression and anxiety in adolescents; how to manage the physical and mental health-related risks associated with these conditions; and how to approach students and/or their parents with concerns. The Investigator will also provide self-help treatment materials for use with students if they are interested in, and suitable for, management within the school system.

3. After this meeting, teachers will be invited to contact the Investigator if they have any queries or questions over the coming months. A follow-up meeting will be scheduled for 2-3 months after the initial meeting.

Phase 2 will last for approximately 5 months in total.

At the conclusion of Phase 2, students, parents and teachers will be re-invited to complete online questionnaires regarding perceived rates of mental health problems in adolescence, options for treatment for mental health problems in adolescence, and (for students only) their experiences with mental health difficulties and whether they had sought treatment for those difficulties. These questionnaires make use of questions / items used in previous research in this area, as well as two formal, stand alone questionnaire measures: the Strengths and Difficulties Questionnaire and the Eating Disorder Examination-Questionnaire. These latter two questionnaires assess mental health related difficulties and are for student completion only.

Participants in the immediate intervention group will complete online questionnaire measures on 2 occasions: at baseline (Phase 1) and approximately 5 months later at the end of Phase 2. At each time point, questionnaires may be completed by participants in their own time and on a computer of their choosing, and should take no more than 15 minutes (for parents and teachers) to 30 minutes (for students).
Intervention code [1] 286534 0
Early detection / Screening
Intervention code [2] 286535 0
Behaviour
Comparator / control treatment
The waitlist control condition involves a gap of approximately 5 months between Phase 1 (completing online questionnaires) and Phase 2 (as outlined above; a school-based intervention designed to increase rates of mental health literacy and treatment-seeking).

The Phase 2 process will be identical to that for the immediate intervention group, but participants at schools allocated to the waitlist control condition will be asked to complete online questionnaires after the 5 month waiting period (immediately before they start Phase 2) as well as at the end of the Phase 2 intervention. Thus, they will complete measures on 3 occasions: at baseline (Phase 1), 5 months later before starting Phase 2, and 5 months after that at the end of Phase 2. At each time point, questionnaires may be completed by participants in their own time and on a computer of their choosing, and should take no more than 15 minutes (for parents and teachers) to 30 minutes (for students).
Control group
Active

Outcomes
Primary outcome [1] 288881 0
The primary outcome for students will be rates of mental health treatment amongst adolescents with elevated eating disorder, depression and/or anxiety symptoms.

This will be assessed in the following way:
(i) For students with above-average scores on the Strengths and Difficulties Questionnaire or Eating Disorder Examination-Questionnaire, the number of "yes" responses to "In the last 3 months, have you experienced any mental health difficulties?" will be considered.

(ii) For students who respond "yes" to "In the last 3 months, have you experienced any mental health difficulties?", the number of students saying "yes" to "Did you seek or receive help from anyone else for these difficulties?" will be considered.

"Yes" responses to both questions would be expected to increase if the intervention is successful.
Timepoint [1] 288881 0
Baseline (Phase 1) and at the end of Phase 2.
Primary outcome [2] 288883 0
The primary outcome for parents and teachers will be self-reported ability to (i) access information about mental health problems in adolescents and (ii) access support for their child or a student if they were concerned about their mental health.

This will be assessed in the following way:
(i) Proportion of "yes" responses to the item "Would you know where to find information about mental health difficulties in adolescents, if you wanted to do so (e.g., pamphlets, books, information leaflets, options for treatment)?"

(ii) Proportion of "yes" responses to the item "If your adolescent / a student you taught was experiencing mental health difficulties, would you know how to help them access treatment or support for those difficulties?"

"Yes" responses to both questions would be expected to increase if the intervention is successful.
Timepoint [2] 288883 0
Baseline (Phase 1) and at the end of Phase 2.
Secondary outcome [1] 301234 0
Mental health literacy, as indicated by the number of "agree" responses to a set of questions regarding mental health problems, their treatment and their effects. Examples of items include "Mental illness can happen to anybody" and "I would be happy to have a person with a mental illness become a close friend".

This outcome applies to students, parents and teachers.
Timepoint [1] 301234 0
Baseline (Phase 1) and at the end of Phase 2.
Secondary outcome [2] 301236 0
Adolescent's self-reported mental health difficulties, as indicated by mean scores on the Eating Disorder Examination-Questionnaire and Strengths and Difficulties Questionnaire.

This outcome applies to students only.
Timepoint [2] 301236 0
Baseilne (Phase 1) and at the end of Phase 2.

Eligibility
Key inclusion criteria
The inclusion criteria for individual participants are (i) being affiliated with a participating secondary school in the Perth metropolitan area and (ii) providing informed consent.

Inclusion criteria for schools are (i) being located within the Perth metropolitan area; (ii) providing co-educational secondary education; (iii) being a Catholic or Independent school; (iv) having secondary school enrollments of at least 400 students; and (v) informed consent from the Principal of the school.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Government (public) schools are excluded due to the typically greater challenges of conducting research within the government school system.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 286745 0
University
Name [1] 286745 0
The University of Western Australia
Country [1] 286745 0
Australia
Primary sponsor type
Individual
Name
Dr Karina Allen
Address
Telethon Institute for Child Health Research
Centre for Child Health Research
The University of Western Australia
M560
35 Stirling Hwy
Crawley WA
Australia 6009
Country
Australia
Secondary sponsor category [1] 285527 0
None
Name [1] 285527 0
None.
Address [1] 285527 0
Country [1] 285527 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288817 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 288817 0
Ethics committee country [1] 288817 0
Australia
Date submitted for ethics approval [1] 288817 0
15/02/2013
Approval date [1] 288817 0
Ethics approval number [1] 288817 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37910 0
Dr Karina Allen
Address 37910 0
Telethon Institute for Child Health Research
Centre for Child Health Research
The University of Western Australia
M560
35 Stirling Hwy
Crawley WA
Australia 6009
Country 37910 0
Australia
Phone 37910 0
+61 8 64887428
Fax 37910 0
Email 37910 0
[email protected]
Contact person for public queries
Name 37911 0
Karina Allen
Address 37911 0
Telethon Institute for Child Health Research
Centre for Child Health Research
The University of Western Australia
M560
35 Stirling Hwy
Crawley WA
Australia 6009
Country 37911 0
Australia
Phone 37911 0
+61 8 64887428
Fax 37911 0
Email 37911 0
[email protected]
Contact person for scientific queries
Name 37912 0
Karina Allen
Address 37912 0
Telethon Institute for Child Health Research
Centre for Child Health Research
The University of Western Australia
M560
35 Stirling Hwy
Crawley WA
Australia 6009
Country 37912 0
Australia
Phone 37912 0
+61 8 64887428
Fax 37912 0
Email 37912 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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