ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

nil

Trial acronym

nil

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Anxiety

Condition category

Condition code

Mental Health

Depression

Mental Health

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]

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]

Primary Outcome 1: depression symptomatology as indicated by Mood and Feelings questionnaire

Timepoint [1]

Time-point: at baseline and immediately after the intervention

Primary outcome [2]

Primary Outcome 2: anxiety symptomatology as indicated by Spence Children's Anxiety Scale

Timepoint [2]

Time-point: at baseline and immediately after the intervention

Primary outcome [3]

Primary Outcome 3: attribution style as indicated by the Children's Attributional questionnaire

Timepoint [3]

Time-point: at baseline and immediately after the intervention

Secondary outcome [1]

Secondary Outcome 1: social and emotional functioning as indicated by Strengths and Difficulties questionnaire

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Comittee

Ethics committee address [1]

Kent Street, Bentley, WA, 6102, 
GPO Box U1987, Perth WA 6845

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

08/07/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Clare Roberts

Address

GPO Box U1987, Perth WA 6845

Country

Australia

Phone

+61 8 9266 7992,

Fax

c.roberts@curtin.edu.au.

Contact person for scientific queries

Name

Dr Rosie Rooney

Address

GPO Box U1987, Perth WA 6845

Country

Australia

Phone

+61 8 9266 3050,

Fax

r.rooney@curtin.edu.au

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.

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