Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000650695
Ethics application status
Approved
Date submitted
12/06/2014
Date registered
20/06/2014
Date last updated
20/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
School-based prevention of symptoms of depression and anxiety (negative affect) in adolescents.
Scientific title
For adolescent high school students, will the Healthy Minds prevention and wellbeing program, when compared to lessons-as-usual controls, prevent the onset of negative affect.
Secondary ID [1] 284784 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptoms of depression and anxiety (negative affect) 292160 0
Condition category
Condition code
Mental Health 292496 292496 0 0
Depression
Mental Health 292497 292497 0 0
Anxiety
Public Health 292547 292547 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lessons provided in class time that teach psychological skills.

These consisted of one lesson (50 minutes) per week over 8 consecutive weeks. Skills and concepts taught include:
- costs of unhelpful perfectionism
- realistic & balanced thinking (cognitive skills)
- emotion regulation strategies
- media literacy
- self-compassion
- gratitude

Lessons were administered by a psychologist but teachers were present at all lessons.
Intervention code [1] 289575 0
Prevention
Comparator / control treatment
Lessons as usual
Control group
Active

Outcomes
Primary outcome [1] 292357 0
Mean scores on the Depression, Anxiety, Stress Scale (DASS)
Timepoint [1] 292357 0
Follow-up time points are post-intervention, 6-month follow-up & 12-month follow-up.
Secondary outcome [1] 308758 0
Scores on the Frost Multidimentional Perfectionism Scale
Timepoint [1] 308758 0
post-intervention, 6-month follow-up and 12-month follow-up

Eligibility
Key inclusion criteria
Enrolled at participating schools in the designated year level.

Age range was Year 8 to Year 10 (approximately 13 year olds to 15 year olds)
Minimum age
13 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil specific

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2011
Actual
1/02/2011
Date of last participant enrolment
Anticipated
5/09/2011
Actual
5/09/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 289400 0
University
Name [1] 289400 0
Flinders University Research Scholarship
Country [1] 289400 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 288082 0
None
Name [1] 288082 0
Address [1] 288082 0
Country [1] 288082 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291194 0
Flinders Social and Behavioural Research Ethics Committee
Ethics committee address [1] 291194 0
GPO box 2100
Adelaide SA 5001
Approval granted 21/10/10
Project approval number 5020
Ethics committee country [1] 291194 0
Australia
Date submitted for ethics approval [1] 291194 0
Approval date [1] 291194 0
21/10/2010
Ethics approval number [1] 291194 0
Project approval number 5020

Summary
Brief summary
The study was a universal prevention program targeting the onset of symptoms of depression and anxiety in adolescent school students. It target unhelpful perfectionism as a risk factor, was conducted across 4 sites, with more 750 Year 8-10 students participating.

Our hypothesis was that the intervention group would exhibit a lower rate of onset of symptoms of depression and anxiety. A prevention effect over the 6-month follow-up period was confirmed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49146 0
Dr Thomas Nehmy
Address 49146 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 49146 0
Australia
Phone 49146 0
+61 8 8201 2996
Fax 49146 0
Email 49146 0
[email protected]
Contact person for public queries
Name 49147 0
Dr Thomas Nehmy
Address 49147 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 49147 0
Australia
Phone 49147 0
+61 8 8201 2996
Fax 49147 0
Email 49147 0
[email protected]
Contact person for scientific queries
Name 49148 0
Dr Thomas Nehmy
Address 49148 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 49148 0
Australia
Phone 49148 0
+61 8 8201 2996
Fax 49148 0
Email 49148 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.