Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000793213
Ethics application status
Approved
Date submitted
9/09/2009
Date registered
11/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Prevention of Depressive Symptoms in Children in a Rural Setting
Scientific title
The effect of a mental health promotion program, called Positive Thinking Skills, on depressive and anxiety symptomatology, attribution style, and social and emotional functioning in children aged 8 to 9 years of age in a rural setting.
Secondary ID [1] 1003 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 243703 0
Anxiety 243809 0
Condition category
Condition code
Mental Health 239966 239966 0 0
Depression
Mental Health 239967 239967 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mental health promotion program, titled, Positive Thinking Skills. Consists of ten, 60 minute weekly sessions, taught in schools by regular school teachers. The program is based on cognitive and behavioural theories, and includes strategies to promote emotional competence, social and cognitive skills to prevent depression and anxiety. All activities are developmentally appropriate for 8 – 9 year olds. The lessons focus on identifying feelings in self and others, promoting awareness of a range of feelings and how they are expressed. Cognitive and behavioural skills will be taught using games, activities and role plays. The sessions include: Week 1 - confidentiality and group rules; Week 2: Identifying my Feelings; Week 3: Comfortable and Uncomfortable Feelings; Week 4: Feelings and Situations; Week 5: Catching Your Thoughts; Week 6: Being Brave; Week 7: Thought, Feeling Connection; Week 8: Helpful and Unhelpful Thinking; Week 9: Changing your Thoughts; Week 10: Self -Esteem and Being Brave.
Intervention code [1] 241241 0
Prevention
Comparator / control treatment
Usual Care Condition, this being the delivery of the Western Australian Department of Education, Heatlh Curriculum
Control group
Active

Outcomes
Primary outcome [1] 240765 0
Primary Outcome 1: depression symptomatology as indicated by Mood and Feelings questionnaire
Timepoint [1] 240765 0
Time-point: at baseline and immediately after the intervention
Primary outcome [2] 240766 0
Primary Outcome 2: anxiety symptomatology as indicated by Spence Children's Anxiety Scale
Timepoint [2] 240766 0
Time-point: at baseline and immediately after the intervention
Primary outcome [3] 240767 0
Primary Outcome 3: attribution style as indicated by the Children's Attributional questionnaire
Timepoint [3] 240767 0
Time-point: at baseline and immediately after the intervention
Secondary outcome [1] 257438 0
Secondary Outcome 1: social and emotional functioning as indicated by Strengths and Difficulties questionnaire
Timepoint [1] 257438 0
Time-point: at baseline and immediately after the intervention

Eligibility
Key inclusion criteria
Children aged between 8 to 9 years of age and have received consent to participate from both parent/guardian and child; attending Wagin and Corrigin District High Schools, Western Australia.
Minimum age
8 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The flip of a coin will be the method used to allocate the two schools in the control or intervention condition.
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243615 0
Self funded/Unfunded
Name [1] 243615 0
Country [1] 243615 0
Primary sponsor type
University
Name
Curtin University of Technology
Address
Kent Street, Bentley, WA, 6102,
GPO Box U1987, Perth WA 6845
Country
Australia
Secondary sponsor category [1] 237064 0
None
Name [1] 237064 0
Address [1] 237064 0
Country [1] 237064 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243742 0
Curtin University Human Research Ethics Comittee
Ethics committee address [1] 243742 0
Kent Street, Bentley, WA, 6102,
GPO Box U1987, Perth WA 6845
Ethics committee country [1] 243742 0
Australia
Date submitted for ethics approval [1] 243742 0
Approval date [1] 243742 0
08/07/2009
Ethics approval number [1] 243742 0
HR63-2009

Summary
Brief summary
This study aims to use an updated and more developmentally appropriate version of the Positive Thinking Skills Program to investigate the efficacy of the intervention amongst children aged 8-9 years old, in a rural setting. Rural areas have been identified to pose an increased risk of depression and other mental health problems (Kane, Day & Roberts, 2000), and therefore this program will provide a valuable mental health prevention program in an identified area of need. The program will be provided universally to children by their teachers and hence will avoid stigmatisation of children identified as at risk. This project is significant as it has the potential to impact upon the prevalence of depression amongst a much younger group of children (8- 9 years) than most of the current research demonstrates (Rooney, Roberts, Kane, Pike, Winsor, White & Brown, 2006). The potential prevention of internalising disorders in middle childhood may also result in a positive long term impact in various areas of a child’s life such as family, peer relationships academic performance and recreational activities as well as a reduction of the risk of further episodes of depression in adolescence and adulthood (Kovacs & Devlin, 1998).
Hypotheses
It is predicted that the Positive Thinking Skills program will be associated with fewer depressive symptoms; improved social and emotional functioning; a more positive attiributional style and fewer anxiety symptoms.
H1: Compared to the control group, the intervention group will report lower levels of depressive symptomatology at post-test (as measured by the Mood and Feelings Questionnaire )
H2: Compared to the control group, the intervention group will report higher levels of social and emotional functioning at post-test (as measured by the Strengths and Difficulties Questionnaire)
H3: Compared to the control group, the intervention group will report lower levels of anxiety symptomatology at post-test (as measured by the Spence Children’s Anxiety Scale)
H4: Compared to the control group, the intervention group will report a less pessimistic attribution style (as measured by the Children’s Attributional Questionnaire)
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 30166 0
Address 30166 0
Country 30166 0
Phone 30166 0
Fax 30166 0
Email 30166 0
Contact person for public queries
Name 13413 0
Dr Clare Roberts
Address 13413 0
GPO Box U1987, Perth WA 6845
Country 13413 0
Australia
Phone 13413 0
+61 8 9266 7992,
Fax 13413 0
Email 13413 0
[email protected].
Contact person for scientific queries
Name 4341 0
Dr Rosie Rooney
Address 4341 0
GPO Box U1987, Perth WA 6845
Country 4341 0
Australia
Phone 4341 0
+61 8 9266 3050,
Fax 4341 0
Email 4341 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.