Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000864729
Ethics application status
Approved
Date submitted
31/07/2013
Date registered
5/08/2013
Date last updated
5/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Re-Frame IT: A randomised controlled trial investigating the impact of an Internet-based cognitive behavioural therapy intervention among school students experiencing suicidal ideation
Scientific title
Re-Frame IT: A randomised controlled trial examining the ability of an Internet-based cognitive behavioural therapy intervention to reduce suicidal ideation among secondary school students at risk of suicide when compared to treatment as usual.
Secondary ID [1] 282864 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal ideation 289677 0
Condition category
Condition code
Mental Health 289994 289994 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprises 8 modules of Cognitive Behavioural Therapy (CBT) to be delivered weekly online PLUS treatment as usual. Each module takes approximately 15-20 minutes to complete.

The 8 CBT modules incorporate standard CBT approaches commonly used with young people: engagement and agenda setting; emotional recognition and distress tolerance; identification of negative automatic thinking; behavioural activation - help-seeking and activity scheduling (including relaxation techniques); problem solving, with a specific focus on managing suicidal ideation; detecting and challenging problematic thinking, and cognitive restructuring.

The website also comprises: 2 activities per week (for example completing a mood or activity diary), a message board via which the participant can communicate with the research-therapist; a series of factsheets covering a range of related topics; plus downloadable MP3s. In addition the website lists a range of local and national helplines and services that the participant can access if in crisis.

Practitioner involvement is two-fold. First, the school counsellor will facilitate delivery of the program and will check responses to a weekly 'suicide screen'. Second, there will be involvement from a research-therapist who will remain un-blinded. She will check completed activities and respond with personalised but standardised messages. She will also check the message board and respond accordingly.
Intervention code [1] 287560 0
Treatment: Other
Intervention code [2] 287658 0
Behaviour
Comparator / control treatment
Treatment as usual as determined by the school counsellor. This may include (but is not restricted to) regular sessions with a school counsellor or psychologist, treatment at a local mental health service or a referral to the GP.
Control group
Active

Outcomes
Primary outcome [1] 290044 0
Suicidal ideation as measured by the Suicidal Ideation Questionnaire
Timepoint [1] 290044 0
Post intervention (10 weeks after baseline) plus 3 month follow-up
Primary outcome [2] 290045 0
Suicidal acts, measured by a specifically-designed questionnaire
Timepoint [2] 290045 0
Post intervention (10 weeks after baseline) plus 3 month follow-up
Secondary outcome [1] 303827 0
Depressive symptoms, measured by The Children's Depression Rating Scale-Revised and the Reynolds Adolescent Depression Scale
Timepoint [1] 303827 0
Post intervention (10 weeks after baseline) plus 3 month follow-up
Secondary outcome [2] 303830 0
Hopelessness, measured by the Beck Hopelessness Scale
Timepoint [2] 303830 0
Post intervention (10 weeks after baseline) plus 3 month follow-up
Secondary outcome [3] 303831 0
Anxiety symptoms, measured by the Multidimensional Anxiety Scale for Children
Timepoint [3] 303831 0
Post intervention (10 weeks after baseline) plus 3 month follow-up
Secondary outcome [4] 303832 0
Problem solving skills measured by Negative Problem-Oriented Questionnaire
Timepoint [4] 303832 0
Post intervention (10 weeks after baseline) plus 3 month follow-up
Secondary outcome [5] 304026 0
Increased confidence and / or perceived skill among school wellbeing staff implementing the program
Timepoint [5] 304026 0
This will be administered at the beginning and end of each schools' involvement with the program. Therefore the length of the follow up period will vary.

Eligibility
Key inclusion criteria
1. Suicidal ideation in the past month
2. Aged 14-18
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Intellectual disability
2. Psychotic symptoms
3. An 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)
Participants (n=170) will be recruited over a 2-year period via each school’s student wellbeing coordinator (SWC). Following obtaining written consent, a baseline assessment will be conducted to ascertain eligibility. If eligible, the participant will be randomised into the treatment or control group by using a randomisation list prepared by an independent statistician. The randomisation list (generated using random number generator computer software) is stratified by school and is incorporated into an online randomisation computer program. After each randomisation, the project manager will inform the SWC concerned, who will then administer the appropriate treatment to the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculation:The primary outcome of interest is changes in suicidal ideation from baseline measured at ten and 20 weeks. This will be measured by the SIQ. No previous studies have tested the effects of an Internet-based CBT intervention on suicidal ideation, however one previous study has reported moderate to large effect sizes in terms of reduced suicidal ideation, for face-to-face CBT among young people. If we assume that alpha is set at 0.05 and power at 0.80, then a sample size of 58 is required for each of the two groups (total n = 116) to detect a medium effect size. This is based on using the general linear model to compare the intervention and control groups with the baseline values of an outcome measure as the covariate. It is assumed (conservatively) that the covariate would explain 10% of the variance in the dependent variable. Using data from the pilot study, the intra-cluster correlation corresponding to the schools is estimated to be 0.023, which in turn gives an estimate of 1.1 for the design effect. So in order to take account of the clustering effect of the schools, the sample size needs to be inflated to 128 (116 x 1.1).
A previous RCT conducted by the study team with a similar population had a dropout rate of 24%. The proposed study differs in that the intervention will be delivered by school staff and all follow-up assessments will be conducted at school. It will also employ a shorter follow-up period, however we have estimated a dropout rate of 24% meaning that we need to recruit 169 students (128/0.76) into the study. We estimate that we can get about 6 students from each school, so we need to recruit 28 schools.


Statistical analysis: At each follow-up time point the general linear model will test for the treatment factor, i.e. to compare the intervention and control groups for each outcome measure. Corresponding baseline values of each outcome measure will be used as the covariate. In addition, possible effect of site will be examined by introducing a school factor in the analysis. Multi-level modeling will be used to compare the two groups in terms of the trend over time for each outcome. Both last observation carried forward and multiple imputation techniques will be considered if missing data are substantial. Interim analysis will be conducted twice yearly, or upon request to facilitate the safety monitoring of the project.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287643 0
Charities/Societies/Foundations
Name [1] 287643 0
beyondblue
Country [1] 287643 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] 286384 0
None
Name [1] 286384 0
Address [1] 286384 0
Country [1] 286384 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289613 0
University of Melbourne Human Research and Ethics Committee
Ethics committee address [1] 289613 0
Ethics committee country [1] 289613 0
Australia
Date submitted for ethics approval [1] 289613 0
Approval date [1] 289613 0
03/07/2013
Ethics approval number [1] 289613 0

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

Contacts
Principal investigator
Name 41570 0
Ms Jo Robinson
Address 41570 0
Orygen Youth Health Research Centre
35 Poplar Road
Parkville
Vic, 3052
Country 41570 0
Australia
Phone 41570 0
+61 3 9342 2866
Fax 41570 0
Email 41570 0
[email protected]
Contact person for public queries
Name 41571 0
Kate Templer
Address 41571 0
Orygen Youth Health Research Centre
35 Poplar Road
Parkville
Vic, 3052
Country 41571 0
Australia
Phone 41571 0
+61 3 9342 2851
Fax 41571 0
Email 41571 0
[email protected]
Contact person for scientific queries
Name 41572 0
Jo Robinson
Address 41572 0
Orygen Youth Health Research Centre
35 Poplar Road
Parkville
Vic, 3052
Country 41572 0
Australia
Phone 41572 0
+61 3 9342 2866
Fax 41572 0
Email 41572 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
SourceTitleYear of PublicationDOI
EmbaseInternet-based cognitive behavioural therapy for young people with suicide-related behaviour (Reframe-IT): a randomised controlled trial.2017https://dx.doi.org/10.1136/eb-2017-102719
N.B. These documents automatically identified may not have been verified by the study sponsor.