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Trial registered on ANZCTR


Registration number
ACTRN12616001369415
Ethics application status
Approved
Date submitted
6/07/2016
Date registered
4/10/2016
Date last updated
22/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of the Insights program (a teacher led emotional health program) in increasing tolerance of uncertainty and resilience in secondary school students.
Scientific title
The ability of a teacher led program (the Insights Program) to reduce Intolerance of Uncertainty and strengthen Emotional Health and Resilience in secondary school students. .
Secondary ID [1] 290139 0
Nil Known
Universal Trial Number (UTN)
U1111-1185-0788
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Discomfort with uncertainty (this is associated with a range of axis one disorders). 298800 0
Catastrophic thinking. 298801 0
Beliefs in personal failure 299650 0
Anxiety 299651 0
Fear of Negative Evaluation 299652 0
Anger 299653 0
Comparisons with others 299655 0
Condition category
Condition code
Mental Health 298847 298847 0 0
Anxiety
Mental Health 300128 300128 0 0
Depression
Public Health 300129 300129 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the project is to examine the relationship between intolerance of uncertainty and a range of factors that contribute to emotional health. An emotional health program (The Insights program) is being run as part of the Year 8 or 9 curriculum (at secondary schools), The schools provide either an intervention group or a control group or both.

The 'Insights program' program is psycho-educational and school teachers themselves are trained in the program implementation (5 hour training workshop delivered by Clinical Psychologists). The teachers deliver the program during pastoral care or PDHPE time with students. The program involves 18 single period lessons (between 50 and 70 mins in length (depending on the school structure). It is delivered either weekly or fortnightly (at some schools it has been delivered, 3 times per fortnight). The delivery frequency is dependent on school preferences.

The overall objective of the project is to examine the impact of changing intolerance of uncertainty on factors which are associated with emotional health. The program aims to increase the protective factors (through a combination of education and skills training) and to reduce avoidance, ruminative thinking, discomfort with uncertainty, catastrophic thinking, envy and perfectionism in students. The program provides students with the ability to resist and evaluate the pressures that are placed on them.

Teacher training is supplemented with additional consultation as requested by each school (depending on school teacher availability). School counsellors support the training and coordination of the program at the schools. A teacher fidelity manual is used to record whether all key points are covered in each lesson. Student absences are noted per lesson in this manual. This information is added using the participant ID codes to the research database.

Resources are incorporated within the Insights program - the program covers specific topics including: understanding the role of uncertainty within interpersonal relationships, perfectionism, procrastination, self soothing and self compassion, responses to negative thoughts, body image, social media, exercise, nutrition and sleep. The program incorporates mindfulness and acceptance and covers cognitive behavioural factors required to build resilience, and adolescent physical and emotional health. The program provides students and staff with a framework to understand and discuss pressures experienced by each student.
Intervention code [1] 294766 0
Prevention
Intervention code [2] 295234 0
Treatment: Other
Intervention code [3] 295235 0
Behaviour
Comparator / control treatment
PDHPE as usual (different schools have a range of programs and curricula in place) for the control participants.
Control group
Active

Outcomes
Primary outcome [1] 298321 0
Change in catastrophising, assessed using the CATS.
Timepoint [1] 298321 0
Data will be collected pre intervention, within three weeks post intervention and at 1 year follow up.
Primary outcome [2] 298322 0
Change in envy using the Dispositional Envy Scale.
Timepoint [2] 298322 0
Data will be collected pre intervention, within three weeks post intervention and at 1 year follow up.
Secondary outcome [1] 323843 0
.Change in intolerance of uncertainty using the Intolerance of Uncertainty Scale (12 item short form)
Timepoint [1] 323843 0
Data will be collected pre intervention, within three weeks post intervention and at 1 year follow up.
Secondary outcome [2] 323844 0
Change in ruminative thinking in vulnerable individuals using the Repetitive Thinking Questionnaire (RTQ-10)
Timepoint [2] 323844 0
Data will be collected pre intervention, within three weeks post intervention and at 1 year follow up.
Secondary outcome [3] 323845 0
To examine the longitudinal trajectory of envy in adolescence using the Dispositional Envy questionnaire.
Timepoint [3] 323845 0
Data will be collected using the Dispositional Envy scale at pre, within three weeks post intervention and one year follow up for a control group.
Secondary outcome [4] 323847 0
Examine whether there are changes in the expression of anger associated with changes in Intolerance of Uncertainty.
Timepoint [4] 323847 0
Data will be collected at pre, mid (after 9 lessons), within 3 weeks post intervention and at one year follow up using the Positive coping with Anger Subscale of the Multidimensional School Anger Inventory. This will be associated with changes scores obtained for the Intolerance of Uncertainty Scale.
Secondary outcome [5] 327109 0
Examine whether self compassion is increased in individuals with low levels of self compassion over the course of the program. Self compassion is measured using the Self-Compassion Sale (SCS-SF).
Timepoint [5] 327109 0
Self compassion is being measured at pre, mid intervention (after 9 lessons), within three weeks post intervention and at one year follow up.
Secondary outcome [6] 327691 0
Examine the impact of changes in intolerance of Uncertainty on the frequent and type of interactions participants have with social media and the tendency towards self disclosure. Components are assessed using the Intolerance of Uncertainty scale and the Distress Disclosure Index. Social Media is assessed using questions designed for this study. This is a composite outcome.
Timepoint [6] 327691 0
Data will be collected at pre, within three weeks post intervention and 1 year follow up on the type of interactions participants have on social media (qualitative and quantitative data is being collected).

Eligibility
Key inclusion criteria
Current secondary school students enrolled in the participating schools who consent to participation in the online survey.
Minimum age
12 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who do not give consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
There is no concealment to treatment group: each year group will uniformly act as a control or intervention group.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The study is longitudinal and will measure change in symptoms over time. The design will allow for a mediational analysis to examine mechanisms of change. The factors hypothesized to mediate change are discomfort with uncertainty, a tendency to ruminate and perfectionism. These transdiagnostic factors predict future onset of depression, comorbidity and/or poor response to treatment for anxiety or depression

The GEE emphasises the change between the group conditions after accounting for within subject’s variance, and is an optimal longitudinal framework over alternatives such as mixed models, for comparing change rates between randomised groups. This GEE framework of models can also be applied in multiple types count, or continuous outcomes, together showing an analysis of intervention related in multiple outcomes. Each of the primary and secondary outcome scales of interest, are considered in separate analyses. This is done in order to clarify how the intervention impacts different aspects of emotional difficulties and symptoms associated with media usage. Finally, the way in which cognitive changes can underpin the overall rate of intervention related change will be tested through a framework of moderators and mediators, following the guidelines of Schluchter (2008).
Power analysis
A simulation analysis was conducted prior to data collection in order to estimate power and sample size requirements. A model specifying count data (Poisson distribution), minimal effect size for change over time of 0.05, and a within subject’s term (minimal random intercept) was simulated using the lme4 package in R statistical software (Green & MacLeod, 2016).
The research will examine changes within subgroups. We aim for a strong level of power to detect small differences between the control group and intervention across a number of variables. A sample larger than 400 participants in the intervention and over 300 participants in the control condition was determined as minimally sufficient to detect minute effects and change over time. Processes underpinning improvement will be investigated in the intervention group, therefore, a larger sample is required for this group. The aim of recruiting 1000 participants will allow for attrition from data collection as measures are being administered within class groups during school hours.
References
Bates, D., Maechler, M., Bolker, B. & Walker, S. (2015) Fitting linear mixed-effects models using lme4. Journal of Statistical Software, 67, 1–48.
Green, P., & MacLeod, C. J. (2016). SIMR: an R package for power analysis of generalized linear mixed models by simulation. Methods in Ecology and Evolution.
Hubbard, A. E., Ahern, J., Fleischer, N. L., Van der Laan, M., Lippman, S. A., Jewell, N., ... & Satariano, W. A. (2010). To GEE or not to GEE: comparing population average and mixed models for estimating the associations between neighborhood risk factors and health. Epidemiology,21(4), 467-474.
Liang, K. Y., & Zeger, S. L. (1986). Longitudinal data analysis using generalized linear models. Biometrika, 73(1), 13-22.
Schluchter, M. D. (2008). Flexible approaches to computing mediated effects in generalized linear models: generalized estimating equations and bootstrapping. Multivariate behavioral research, 43(2), 268-288.

Recruitment
Recruitment status
Active, not recruiting
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 in Australia
Recruitment state(s)
ACT,NSW
Recruitment postcode(s) [1] 13565 0
2061 - Milsons Point
Recruitment postcode(s) [2] 18620 0
2066 - Lane Cove
Recruitment postcode(s) [3] 13415 0
2073 - Pymble
Recruitment postcode(s) [4] 13416 0
2132 - Croydon
Recruitment postcode(s) [5] 13414 0
2135 - Strathfield
Recruitment postcode(s) [6] 13417 0
2617 - Belconnen

Funding & Sponsors
Funding source category [1] 293620 0
Other
Name [1] 293620 0
Participating Secondary Schools wish to remain anonymous
Address [1] 293620 0
c/o Macquarie University, North Ryde, NSW, 2109
Country [1] 293620 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd,
North Ryde, 2109, NSW
Country
Australia
Secondary sponsor category [1] 292827 0
None
Name [1] 292827 0
Address [1] 292827 0
Country [1] 292827 0
Other collaborator category [1] 279067 0
Individual
Name [1] 279067 0
Associate Professor Peter McEvoy
Address [1] 279067 0
Room 401.314
School of Psychology and Speech Pathology
Curtin University
Kent St, Bentley WA 6102
Western Australia
Country [1] 279067 0
Australia
Other collaborator category [2] 279068 0
Individual
Name [2] 279068 0
Associate Professor Maree Abbott
Address [2] 279068 0
School of Psychology
Clinical Psychology Unit
School of Psychology
Room 320, Level 3, M02F
94 Mallett St, Camperdown,
THE UNIVERSITY OF SYDNEY NSW 2050
Country [2] 279068 0
Australia
Other collaborator category [3] 279069 0
Individual
Name [3] 279069 0
Dr Madeleine Ferrari
Address [3] 279069 0
Australian Catholic University
School of Psychology
Faculty of Health Sciences
Level 1/C1.44, Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135
Country [3] 279069 0
Australia
Other collaborator category [4] 279070 0
Individual
Name [4] 279070 0
Professor Ron Rapee
Address [4] 279070 0
School of Psychology
Macquarie University, North Ryde, NSW, 2109
Country [4] 279070 0
Australia
Other collaborator category [5] 279177 0
Individual
Name [5] 279177 0
Dr Anne McMaugh
Address [5] 279177 0
School of Education
Level 9, C3A Building
Macquarie University, NSW 2109, Australia
Country [5] 279177 0
Australia
Other collaborator category [6] 279178 0
Individual
Name [6] 279178 0
Mr Eyal Karin
Address [6] 279178 0
Macquarie University, North Ryde, NSW, 2109
Country [6] 279178 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295166 0
Macquarie University HREC
Ethics committee address [1] 295166 0
Balaclava Road, North Ryde
NSW, 2109, Australia
Ethics committee country [1] 295166 0
Australia
Date submitted for ethics approval [1] 295166 0
17/02/2015
Approval date [1] 295166 0
31/10/2015
Ethics approval number [1] 295166 0
5201500115

Summary
Brief summary
The aim of the project is to examine the effectiveness of a PDHPE program. The program will be run as part of the year 8 or 9 curriculum. The overall objective of the project is to investigate the ability of the Insights program to lower intolerance of uncertainty and envy in students.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65902 0
Dr Danielle Einstein
Address 65902 0
Macquarie University
Department of Psychology
Building C3A
c/- Balaclava Road, North Ryde
NSW, 2109, Australia
Country 65902 0
Australia
Phone 65902 0
+61 401936310
Fax 65902 0
Email 65902 0
danielle.einstein@mq.edu.au
Contact person for public queries
Name 65903 0
Dr Danielle Einstein
Address 65903 0
Macquarie University
c/- Balaclava Road, North Ryde
NSW, 2109, Australia
Country 65903 0
Australia
Phone 65903 0
+61401936310
Fax 65903 0
Email 65903 0
danielle.einstein@mq.edu.au
Contact person for scientific queries
Name 65904 0
Dr Danielle Einstein
Address 65904 0
Macquarie University
c/- Balaclava Road, North Ryde
NSW, 2109, Australia
Country 65904 0
Australia
Phone 65904 0
+ 61401936310
Fax 65904 0
Email 65904 0
danielle.einstein@mq.edu.au

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