Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000282088
Ethics application status
Approved
Date submitted
1/04/2010
Date registered
8/04/2010
Date last updated
10/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing the effects of the Positive Thinking Program: a longitudinal evaluation in 8-9 year old children
Scientific title
A Longitudinal study of an enhanced Aussie Optimism: Positive Thinking Program in preventing internalising disorders in 8-9 year old children in Independent Goverment schools in Perth Metropolitan area.
Secondary ID [1] 1511 0
18931
Healthway
Universal Trial Number (UTN)
Trial acronym
Aussie Optimism Program: Positive Thinking Skills (AOP:PTS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 256992 0
Condition category
Condition code
Mental Health 257145 257145 0 0
Depression
Mental Health 257146 257146 0 0
Anxiety
Public Health 257258 257258 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thirty primary schools will be selected from all the Independent Goverments and private schools in Perth Metropolitan area. They will be assigned at random to either the intervention or control condition. School principals will be invited to participate with the understanding that follow-up assessments will take place at post-test, 6 months and 18, months. A visit and presentation to each of the school principals and teachers involved in the implementation will then follow whereby the rationale and methodology are explained. This presentation will highlight the manner in which the program can be integrated into the regular school curriculum and will encourage individual teachers to become supporters and advocates for the program. The teachers will be trained in running groups and the principles of the "Positive Thinking" over a 1 day (8 hours) training course run by clinical psychologists who are members of the research team. The training workshop involves information, activity demonstrations, activity practice, feedback and implementation planning. Teachers in the intervention condition will be provided with programs manual and resources. The full involvement of Year 4 &5 teachers in the selected schools will be critical to the program's success so time will be taken to emphasize the benefits and outcomes for teachers. They will complete an implementation checklist after each session to assess program integrity. 5 x 1 hour coaching sessions will be offered with the intervention schools and teachers. Parents will be addressed as part of the usual parent teacher meetings that are held at the beginning of the year. This project will be fully explained and any questions that are raised will be answered. The active consent of children and parents will be sought after the study has been fully explained to them via school meetings and formal information and consent form.
In April 2010, the assessment battery will be administered to the children in the 15 intervention schools to provide baseline pre-test measures of depressive symptoms, attribution style, anxiety, demographic and emotional competence. At the same time, two trained psychologists will assess any child scoring over 17 on the Children's Depression Inventory (CDI) and 42 on the Spence Children's Anxiety Scale (SCAS) using The Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition(DSM-IV): Child version (ADIS-C). Follow-up times with the children will be organised in a confidential manner to avoid stigmatisation. For cases where depressive or anxiety disorders are identified, parents will be contacted, and the results of the assessment will be discussed with them. Identified children will be referred for psychological assistance if parents request this. The same procedure will be repeated at the 6 and 18 month follow-up intervals. And additional reply paid envelopes will be provided so that parents can seal their responses. After each follow-up session, a newsletter will be sent to parents and teachers thanking for their involvement, updating the progress, and collecting any changes of address information from parents.
The weekly intervention sessions will be run in the usual class room groups and the interview session will focus on confidentiality. The mixed sex groups will be conducted by teachers at the school at designated times that are convenient over 10 weekly one-hour sessions. Process measures for children will be administered at the conclusion of each session. The social validity of the program will be measured by the use of social acceptability questionnaires for all key stakeholders, children, parents, and teachers. The instruments that will be used are: 1) Children's Attributional Style Questionnaire (CASQ; Seligman et al.,1984), 2) CDI (Kovacs, 1992), 3) SCAS (Spence,1998), 4) The Assessment of Children's Emotional Skills (ACES; Schultz, Trentacosta, Izard, Leaf, & Mostow, 2004), 5) ADIS-C (Silverman & Albano, 1996), 6) The Extended Strengths & Difficulties Questionnaires (SDQ-P; Goodman, 1999), 7) Implementation Checklist assessing the degree that teachers have covered the specified information in AOP:PTS program and 8) Demographic information on socioeconomic status, ethnic origin, family structure, family health and history of mental health problems. Administration of the program will be closely monitored by the chief-investigators for adherence to assigned intervention program via log books, reports, interviews and observations made by research assistants and friendly follow-up sessions to help teachers get through the program and by addressing any problems that they might have. Dosage effects will be measured via attendance of students at session.
Intervention code [1] 256168 0
Prevention
Intervention code [2] 256217 0
Early detection / Screening
Intervention code [3] 256218 0
Diagnosis / Prognosis
Comparator / control treatment
The control group will run their regular Health and Physical Education Curriculum as usual during the intervention period. Parents will be addressed as part of the usual parent teacher meetings that are held at the beginning of the year. This project will be fully explained and any questions that are raised will be answered. The active consent of children and parents will be sought after the study has been fully explained to them via school meetings and formal information and consent form.
In April 2010, the assessment battery will be administered to the children in the 15 control schools to provide baseline pre-test measures of depressive symptoms, attribution style, anxiety, demographic and emotional competence. At the same time, two trained psychologists will assess any child scoring over 17 on the CDI and 42 on the SCAS using the ADIS-C. Follow-up times with the children will be organised in a confidential manner to avoid stigmatisation. For cases where depressive or anxiety disorders are identified, parents will be confidentially contacted, and the results of the assessment will be discussed with them. Identified children will be referred for psychological assistance if parents request this. The same procedure will be repeated at the 6 and 18 month follow-up intervals. And additional reply paid envelope will be provided so that parents can seal their responses. After each follow-up session, a newsletter will be sent to parents and teachers thanking for their involvement, updating the progress, and collecting any changes of address information from parents. Process measures for children will be administered at the conclusion of each session. The instruments that will be used are: 1) CASQ (Seligman et al.,1984), 2) CDI (Kovacs, 1992), 3) SCAS (Spence,1998), 4) ACES; (Schultz, Trentacosta, Izard, Leaf, & Mostow, 2004), 5) ADIS-C (Silverman & Albano, 1996), 6) SDQ-P (Goodman, 1999) and 7) Demographic information on socioeconomic status, ethnic origin, family structure, family health and history of mental health problems.
Control group
Active

Outcomes
Primary outcome [1] 258083 0
Primary outcome 1: The intervention group will report lower levels of depressive symptoms than the control group and this outcome will be assessed by the CDI.
Timepoint [1] 258083 0
Timepoint: At post-test (at completion of 10 week intervention), 6 and 18-month follow-ups.
Primary outcome [2] 258091 0
Primary outcome 2: The intervention group will report lower levels of anxiety symptoms than the control group and this outcome will be assessed by the SCAS.
Timepoint [2] 258091 0
Timepoint: At post-test (at completion of 10 week intervention), 6 and 18-month follow-ups
Secondary outcome [1] 263679 0
Secondary outcome 1: Parents in the intervention group will report lower levels of internalising and externalising symptomatology in their children than the parents in the control group and this outcome will be assessed by the SDQ-P.
Timepoint [1] 263679 0
Timepoint 1: At post-test (at completion of 10 week intervention), 6 and 18-month follow-ups
Secondary outcome [2] 263687 0
Secondary outcome 2: The intervention group will report a more positive attribution style than the control group and this outcome will be assessed by the CASQ.
Timepoint [2] 263687 0
Timepoint 2: At post-test (at completion of 10 week intervention), 6 and 18-month follow-ups
Secondary outcome [3] 263688 0
Secondary outcome 3: The intervention group will report higher levels of emotional attribution accuracy than the control group and this outcome will be assessed by the ACES.
Timepoint [3] 263688 0
Timepoint 3: At post-test (at completion of 10 week intervention), 6 and 18-month follow-ups
Secondary outcome [4] 263689 0
Secondary outcome 4: The proportion of control group children diagnose as clinical will be significantly greater than the intervention group and this outcome will be assessed by the ADIS-C.
Timepoint [4] 263689 0
Time point 4: Pre (Baseline test) and post test (at completion of 10 week intervention), 6 and 18 months after the intervention
Secondary outcome [5] 263690 0
Secondary outcome 5: The proportion of intervention group children diagnose as healthy and remain healthy will significantly greater than the control group and this outcome will be assessed by the CDI and SCAS.
Timepoint [5] 263690 0
Timepoint 5: Pre (Baseline test) and post test (at completion of 10 week intervention), 6 and 18 months follow-ups.
Secondary outcome [6] 263691 0
Secondary outcome 6: Children who recieve a high dose of the program will report lower levels of internalising symptoms compared to children who receive a low-dose of the program and these outcomes will be assessed by the CDI and SCAS.
Timepoint [6] 263691 0
Timepoint 6:Post-test (at completion of 10-week intervention), 6 and 18 months follow-ups.
Secondary outcome [7] 263692 0
Secondary outcome 7: Students, parents, and teachers will rate the program as socially acceptable and this outcome will be assessed by the Implementation Checklist.
Timepoint [7] 263692 0
Timepoint 7: Pre (Baseline test) and post test (at completion of 10 week intervention), 6 and 18 months follow-ups.

Eligibility
Key inclusion criteria
The target population consists of Year 4 and 5 students from Independent Goverment and private schools in the Perth Metropolitan area. These schools are targeted because research has shown that private schools have the potential to engender a school culture through aspects such as bullying and pressure to achieve higher level standards that may challenge students' mental health (Watt, 2003). Power considerations dictated that we recruit relatively large schools that have access to about 150 Year 4 and 5 students. We will select these schools from the lower end of the Socioeconomic status (SES) scale. Although SES ratings for Independent Goverment and private schools tend to be relatively high compared to State Schools, students from lower SES private schools should still provide more scope for improvement on the outcome measures than students from higher SES private schools. The sampling strategies involves recruiting private schools with large numbers of Year 4 & 5s, and relatively low SES.
Minimum age
8 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Year 4 and 5 from public schools in Perth metropolitan area and surrounding surburbs.

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)
Fifteen schools were randomly selected from the population of non-government schools in Western Australia (WA) which was dictated by considerations of statistical power, that the selected schools had at least 56 Grade 4 students and at least 38 Grade 5 students. Each of the 15 schools was then matched to another school from the population according to socio-economic status and the number of students in Grades 4 and 5. For each matched pair, one school was then randomly allocated to the intervention group and the other school was allocated to the control group.
Allocation concealment procedure was applied by computer central randomisation method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
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
Completed
Date of first participant enrolment
Anticipated
19/04/2010
Actual
20/09/2010
Date of last participant enrolment
Anticipated
Actual
27/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
1177
Accrual to date
Final
868
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2639 0
6155
Recruitment postcode(s) [2] 2640 0
6059
Recruitment postcode(s) [3] 2641 0
6923
Recruitment postcode(s) [4] 2642 0
6955
Recruitment postcode(s) [5] 2643 0
6065
Recruitment postcode(s) [6] 2644 0
6024
Recruitment postcode(s) [7] 2645 0
6401
Recruitment postcode(s) [8] 2646 0
6028
Recruitment postcode(s) [9] 2647 0
6062
Recruitment postcode(s) [10] 2648 0
6026
Recruitment postcode(s) [11] 2649 0
6060
Recruitment postcode(s) [12] 2650 0
6530
Recruitment postcode(s) [13] 2651 0
6052
Recruitment postcode(s) [14] 2652 0
6156
Recruitment postcode(s) [15] 2653 0
6231
Recruitment postcode(s) [16] 2654 0
6233
Recruitment postcode(s) [17] 2655 0
6110
Recruitment postcode(s) [18] 2656 0
6054
Recruitment postcode(s) [19] 2657 0
6100
Recruitment postcode(s) [20] 2658 0
6076
Recruitment postcode(s) [21] 2659 0
6531
Recruitment postcode(s) [22] 2660 0
6025
Recruitment postcode(s) [23] 2661 0
6210
Recruitment postcode(s) [24] 2662 0
6941
Recruitment postcode(s) [25] 2663 0
6936
Recruitment postcode(s) [26] 2664 0
6164
Recruitment postcode(s) [27] 2665 0
6969
Recruitment postcode(s) [28] 2666 0
6018

Funding & Sponsors
Funding source category [1] 256712 0
Government body
Name [1] 256712 0
Healthway
Country [1] 256712 0
Australia
Primary sponsor type
Individual
Name
Dr. Rosie Rooney
Address
School of Psychology and Speech Pathology,
Curtin University of Technology,
GPO Box U1987 Perth, WA 6845.
Country
Australia
Secondary sponsor category [1] 256000 0
Individual
Name [1] 256000 0
Dr. Shari Hassan
Address [1] 256000 0
School of Psychology and Speech Pathology,
Curtin University of Technology,
GPO Box U1987 Perth, WA 6845.
Country [1] 256000 0
Australia
Other collaborator category [1] 1168 0
Individual
Name [1] 1168 0
Associate Prof. Clare Roberts
Address [1] 1168 0
School of Psychology and Speech Pathology,
Curtin University of Technology,
GPO Box U1987 Perth, WA 6845.
Country [1] 1168 0
Australia
Other collaborator category [2] 1171 0
Individual
Name [2] 1171 0
Dr. Robert Kane
Address [2] 1171 0
School of Psychology and Speech Pathology,
Curtin University of Technology,
GPO Box U1987 Perth, WA 6845.
Country [2] 1171 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258726 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 258726 0
Ethics committee country [1] 258726 0
Australia
Date submitted for ethics approval [1] 258726 0
07/12/2009
Approval date [1] 258726 0
05/03/2010
Ethics approval number [1] 258726 0
165/2009

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

Contacts
Principal investigator
Name 30957 0
A/Prof Associate Prof. Rosie Rooney
Address 30957 0
School of Psychology and Speech Pathology, Curtin University, GPO Box U1987, Perth, Western Australia 6845
Country 30957 0
Australia
Phone 30957 0
+61 8 9266 3050 (Perth, WA)
Fax 30957 0
Email 30957 0
[email protected]
Contact person for public queries
Name 14204 0
Dr. Rosie Rooney
Address 14204 0
School of Psychology and Speech Pathology,
Curtin University of Technology,
GPO Box U1987,
Perth, Western Australia 6845
Country 14204 0
Australia
Phone 14204 0
+61 8 9266 3050 (Perth, WA)
Fax 14204 0
+61 8 9266 2464 (Perth, WA)
Email 14204 0
[email protected]
Contact person for scientific queries
Name 5132 0
Robert Kane
Address 5132 0
School of Psychology and Speech Pathology,
Curtin University of Technology,
GPO Box U1987,
Perth, Western Australia 6845
Country 5132 0
Australia
Phone 5132 0
+61 8 9266 7992 (Perth, WA)
Fax 5132 0
+61 8 9266 2464 (Perth, WA)
Email 5132 0
[email protected]

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