Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000866909
Ethics application status
Approved
Date submitted
15/08/2011
Date registered
15/08/2011
Date last updated
29/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Re-Frame It: A trial investigating the impact of an e-health intervention on suicide risk among school students
Scientific title
Re-Frame It: A randomised controlled trial investigating the impact of a multi-media based intervention on suicide risk among school students
Secondary ID [1] 262348 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide risk 268048 0
Condition category
Condition code
Mental Health 268188 268188 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will take the form of a personalized and interactive web-site which will deliver 8 modules of psychological therapy, employing a cognitive behavioural approach, over an 8-week period.

Each module will be uploaded on a weekly basis. So on week 1 the participant will only have access to 1 module but by week 8 they will have all 8 modules on their page. This means they can review the content as much as they wish.

The modules are as follows:

Week 1: Introduction / engagement and agenda setting
Week 2: Emotional recognition and distress tolerance
Week 3: Identification of automatic thinking
Week 4: Behavioural activation: help-seeking
Week 5: Behavioural activation: activity scheduling (including relaxation techniques)
Week 6: Problem solving: specific focus on self harming or SI
Week 7: Detecting & challenging problematic thinking and cognitive restructuring
Week 8: Wrap up and review

It is anticipated that each module will take between 15 and 20 minutes to complete.

The website will be moderated by a member of the study team.
In addition participants will receive 2 SMS messages per week, the first will remind the young person to check the website and the second will reinforce the content of that week's module. These messages will be automatically generated by the system.
Intervention code [1] 266737 0
Treatment: Other
Comparator / control treatment
Treatment as usual - i.e. support as required from the school counsellor
Control group
Active

Outcomes
Primary outcome [1] 266930 0
To reduce suicidal ideation in participants, measured using the Suicidal Ideation Questionnaire and Suicidal Ideation Questionnaire Junior
Timepoint [1] 266930 0
Post-intervention (8 weeks)
12 week follow-up
Secondary outcome [1] 276641 0
Reduce symptoms of depression, measured using the Children's Depression Rating Scale and the Reynolds Adolescent Depression Scale
Timepoint [1] 276641 0
Post-intervention (8 weeks)
12 week follow-up
Secondary outcome [2] 276642 0
Reduce symptoms of anxiety, measured using the Multidimensional Anxiety Scale for Children
Timepoint [2] 276642 0
Post-intervention (8 weeks)
12 week follow-up
Secondary outcome [3] 276643 0
Reduce feelings of hopelessness, measured using the Beck Hopelessness Scale
Timepoint [3] 276643 0
Post-intervention (8 weeks)
12 week follow-up
Secondary outcome [4] 276644 0
Increase help-seeking behaviour measured using the General and Actual Help Seeking Scales
Timepoint [4] 276644 0
Post-intervention (8 weeks)
12 week follow-up
Secondary outcome [5] 276645 0
Improve coping and problem solving skills, measured using the Coping Inventory for Stressful Situations and the Negative Problem Orientation Questionnaire
Timepoint [5] 276645 0
Post-intervention (8 weeks)
12 week follow-up
Secondary outcome [6] 276646 0
Participants will find the receipt of this intervention acceptable, measured using a specifically designed questionnaire post intervention
Timepoint [6] 276646 0
Post-intervention (8 weeks)
Secondary outcome [7] 276647 0
The intervention will not cause undue distress, measured using the Profile of Moods States
Timepoint [7] 276647 0
Post-intervention (8 weeks)
12 week follow-up

Eligibility
Key inclusion criteria
School students who have presented to the school welfare team for support and who report a recent history of suicidal ideation.
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include; known organic cause for presentation, intellectual disability, psychotic symptoms and inability to speak English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Any students who present to the school welfare team for help and report a recent (in past month) history of suicide attempt or suicidal ideation will be asked by the school welfare counsellor if they would be happy to be contacted by a member of the research team. If the young person agrees, the research assistant will arrange a meeting with them at a time and venue of the young person’s choice. The RA will provide written and verbal information about the study and if they agree to participate written consent will be obtained from the student and their parent / guardian.
Once consent is obtained the baseline assessment will take place. Following this, the participant's details will be passed to the separately located statistician who will randomly allocate them to either the treatment or control group using computer generated random numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once the baseline assessment is complete the statistician will randomise participants to either the intervention or control group, using computer generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2012
Actual
18/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
165
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 267233 0
Charities/Societies/Foundations
Name [1] 267233 0
American Foundation for Suicide Prevention
Country [1] 267233 0
United States of America
Funding source category [2] 269652 0
Government body
Name [2] 269652 0
NHMRC
Country [2] 269652 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orygen Youth Health Research Centre
Address
35 Poplar Road
Parkville
Vic, 3052
Country
Australia
Secondary sponsor category [1] 266692 0
None
Name [1] 266692 0
Address [1] 266692 0
Country [1] 266692 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269604 0
University of Melbourne
Ethics committee address [1] 269604 0
Level 5, Alan Gilbert Blding,
161 Barry St (Cnr Grattan St), Carlton
Vic 3053
Ethics committee country [1] 269604 0
Australia
Date submitted for ethics approval [1] 269604 0
Approval date [1] 269604 0
18/10/2010
Ethics approval number [1] 269604 0
1033768

Summary
Brief summary
The overall aim of this study is to examine whether or not a web-based intervention employing a cognitive-behavioural therapy approach, can reduce the risk of suicidal ideation (SI) in young people who have presented to the school counselor for help.

Secondary aims are to examine whether or not the intervention can increase coping and problem solving skills and help-seeking (these are measured as a means of understanding the underlying mechanisms that may lead to a reduction in risk). We will also assess the acceptability of the intervention, treatment adherence, how long people remain on the website and whether or not the intervention causes undue distress.

Hypotheses

The primary hypotheses are that the intervention will:

1. Reduce SI among participants

Secondary hypotheses are that the intervention will:

2. Reduce symptoms of depression, anxiety and hopelessness
3. Increase help-seeking
4. Improve coping and problem solving skills
5. Participants will find the receipt of this intervention acceptable, and
6. The intervention will not cause undue distress.
Trial website
Trial related presentations / publications
An e-health intervention for adolescents at risk of suicide and deliberate self harm: development of a randomised controlled trial – Poster presentation
International Society for Research into Internet Interventions, Sydney, Australia. April 2011

An e-health intervention for adolescents at risk of suicide and deliberate self harm: development of a randomised controlled trial
4th Asia Pacific meeting of the International Association for Suicide Prevention, Brisbane, Australia. November 2010
Public notes

Contacts
Principal investigator
Name 32721 0
Ms Jo Robinson
Address 32721 0
35 Poplar Rd Parkville VIC 3052
Country 32721 0
Australia
Phone 32721 0
+61 3 9342 2866
Fax 32721 0
Email 32721 0
[email protected]
Contact person for public queries
Name 15968 0
Ms Jo Robinson
Address 15968 0
35 Poplar Rd
Parkville
VIC
3052
Country 15968 0
Australia
Phone 15968 0
+61 412999140
Fax 15968 0
Email 15968 0
[email protected]
Contact person for scientific queries
Name 6896 0
Ms Jo Robinson
Address 6896 0
35 Poplar Rd
Parkville
VIC
3052
Country 6896 0
Australia
Phone 6896 0
+61 412999140
Fax 6896 0
Email 6896 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.