Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001184561
Ethics application status
Approved
Date submitted
7/10/2015
Date registered
3/11/2015
Date last updated
3/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
An efficacy study of two dissemination strategies for the enhance Aussie Optimism: Social Life Skills and Optimistic Thinking Skills program.
Scientific title
A longitudinal study of two dissemination strategies for the enhanced Aussie Optimism: Social Life Skills and Optimistic Thinking Skills programs in preventing social and emotional problems, anxiety and depressive disorders, and suicidal ideation in 10-11 years old children in 63 Government Primary Schools in Perth, Western Australia.
Secondary ID [1] 286169 0
ARC LP0347559
Universal Trial Number (UTN)
U1111-1171-1088
Trial acronym
AUSSIE OPTIMISM PROGRAM: Social Life Skills and Optimistic Thinking Skills (AOP: SLS and OTS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 296559 0
Condition category
Condition code
Mental Health 294508 294508 0 0
Depression
Mental Health 294510 294510 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study evaluated the efficacy of two different dissemination strategies for the enhanced Aussie Optimism: Social Life Skills (SLS) and Optimistic Thinking Skills (OTS) programs in Western Australia, incorporated with a self-directed parent and families program.

Grade 6 students (aged 10-11 years) and their parents from primary schools within three Western Australia Department of Education school districts were recruited to participate in a randomised field trial of the dissemination of the Aussie Optimism Program. 63 primary schools were recruited from three education districts and randomly assigned to one of the three conditions: i) Aussie Optimism with teacher training, ii) Aussie Optimism with teacher training plus coaching and iii) a usual care condition that received the regular Western Australian Health Education Curriculum. Principals were invited to participate by way of a letter and follow-up phone call. These described the project aims and methods, what this means for schools, teachers and parents, and which condition the school had been assigned to. Once the principal consented, a visit and presentation was made to the school staff. The principals were asked to sign a Memorandum of Understanding stating that they agree to participate in the research, that they agree to implement the program, the number of teachers who will implement the program, & receive training and coaching, depending on the dissemination condition. Teachers were provided with information forms & were asked to sign consent forms to indicate consent to take part in the study. Information & consent forms were sent home to parents in sealed envelopes to all grade 6 students. Children of Parents who did not consent for their children to participate in the research had accessed to the program but did not complete the questionnaires.

Teachers in the intervention condition received 8-hour training in the SLS and OTS. Each program contain ten 60-minute modules that can be incorporated into regular primary school classes for health education or personal development. The modules include didactic information, interactive activities, games, cooperative learning tasks, cross curriculum applications, worksheets, and homework activities to help students generalise skills outside of the school setting. Parents booklets inform parents of the content of the programs and provide evidence on how to support their child's use of the skills in the home environment.

SLS was developed to overcome interpersonal skills such as poor social skills and problem solving, lack of social support and friendship difficulties. OTS targets cognitive vulnerabilities such as pessimistic attribution style, and negative self-perceptions and future expectations.

The self-directed family program, Aussie Optimism for Families and Parents (F & P), was provided for parents of Grade 7 students in the second half of the year when schools and families were preparing students for secondary school. The F & P program aims to enhance family protective factors for young adolescents over the transition to secondary school. Topics such as working together as a family, building new friendships, stress management in times of transition, and cultivating an optimistic perspective are discussed and families are encouraged to make plans to assist their teenagers over time. The F & P program is a self-directed booklet delivered to the parents via their grade 7 child.
The program was distributed at an initial meeting (1 x hour) with parents (regardless of whether year/class groups, or individual parents) so that aims, contents, and activities can be explained, and there was opportunity for questions. This is associated with increased fidelity, commitment, and school community ownership of the program.
After the F & P was distributed, parents were given about 8-40 weeks to complete the program at home on their own. At the end of 10 weeks a follow-up questionnaire was posted, and if not returned, there was follow-up telephone contact (15 minutes) from a facilitator (school psychologist or teacher who has completed SLS and OTS training).
A checklist (based on the content of the program) , 5-item rating scale (usefulness, enjoyment, relevance, compatibility with family values and beliefs, presentation, delivery), and series of open-ended questions was used to monitor adherence to the program.
The whole program was implemented over two years: SLS in grade 6, OTS in grade 7, and F & P in the second half of Grade 7. All learning outcomes were compatible with the Western Australia Department of Education 's Curriculum Framework for Health Education..

The 8-hour teacher training workshop for each SLS and OTS includes skills practice and feedback on the program activities and discussion of implementation issues for individual classrooms. The majority of teachers taught either SLS or OTS; teachers who taught OTS also administered the P & F program in Grade 7. While teachers in both intervention groups received program manuals, resources, and student workbooks, teachers in the training/coaching condition were able to access up to five hours of coaching per year to support them in program implementation. The coaching was provided by school psychologists who were accredited trainers in AOP programs and had experienced in school- based intervention programs. Teachers in this condition accessed coaching at their own convenience for a variety of issues including individualising the program to meet the needs of their students, advice on how to implement certain activities and motivate students, advice on how to adapt the content for children with special needs, encouraging parent participation, and assistance with dealing with referrals for children with more serious problems.

In order to assess and compare between group differences in social, emotional and mental health conditions, the following instruments were used:
Students: Extended Strengths & Difficulties questionnaires - student version (SDQ-S; Goodman, 1999). Students who scored in the clinical range on the SDQ-S Emotional symptoms subscale were interviewed with the computerised Diagnostic Interview for Children and Adolescents (DICA-IV; Reich, Welner, & Herjanic, 1997).

Parent Measures - Demographic Questionnaire and Extended Strengths & Difficulties Questionnaires (SDQ - P) (Goodman, 1999). The SDQ-P measures externalising and internalising problems at home.

Teachers (intervention groups only ) : Implementation checklists, Levels of Use questionnaire, Organisational Climate Questionnaire, Concerns Based Adoption Questionnaire and Program Adoption Questionnaire (Steckler et al. 1992).

Students and parents completed the questionnaires at pre and post-test, after completing the program components at the end of grade 6 &7, & at 12-months follow-up at the end of grade 8. Students questionnaires were administered in class time by trained research assistants, blind to the dissemination conditions.

Parental questionnaires were sent home with the students & parents returned them to their child's school in a sealed envelope at the grade 6 & 7 assessment points. At the 8th grade assessment, the questionnaires were mailed to parents and requested that they forwarded their questionnaires to Curtin University in pre-paid envelopes.
Intervention code [1] 291309 0
Prevention
Comparator / control treatment
Students in the control condition received their regular health education lessons, which were related to the development of self-management and interpersonal skills. Teachers used a variety of resources and teaching strategies. These lessons had similar learning outcomes to AOP. Control group teachers received training and resources in AOP in the second year of the research project. All the information and consent forms were sent home to parents in the sealed envelopes . Students and their parents completed the set of questionnaires : 1) )Extended Strengths & Difficulties questionnaires - student version (SDQ-S; Goodman, 1999) and 2) Parent Measures - Demographic Questionnaire. Students and parents completed the questionnaires at pre-test, after completing the program components at the end of grade 6 & 7, & at 12-months follow-up at the end of grade 8. Students who scored in the clinical range on the SDQ-S Emotional symptoms subscale were interviewed with the computerised Diagnostic Interview for Children and Adolescents (DICA-IV; Reich, Welner, & Herjanic, 1997).

Teachers and administration staff completed the Organisational Climate Questionnaires, Concerns Based Adoption Questionnaires and Program Adoption Questionnaires (Steckler et al. 1992).
Control group
Active

Outcomes
Primary outcome [1] 295286 0
Proportion of students showing an increase in pro-social behaviour and decrease in total difficulties as assessed by SDQ-S.
Timepoint [1] 295286 0
At post-test 1 (at the end of Grade 6), post test 2 (at the end of Grade 7) and follow-up (at the end of grade 8)
Primary outcome [2] 296424 0
Proportion of students showing decrease incidences of anxiety and depressive disorders and suicidal ideation/behaviour, and increased recovery from these clinical disorders as measured by DICA-IV.
Timepoint [2] 296424 0
At post-test 1(at the end of Grade 6), post-test 2( at the end of Grade 7) and one year follow-up (at the end of Grade 8).
Secondary outcome [1] 315267 0
The proportion of students showing an increase in pro-social behaviour and decrease in total difficulties reported by the parents as assessed by SDP - P.
.
Timepoint [1] 315267 0
At post-test 1 (at the end of Grade 6), post-test 2 (at the end of Grade 7) and one year follow-up (at the end of grade 8).
Secondary outcome [2] 318409 0
The proportion of the school staff showing an increase in the awareness on mental health promotion in school as assessed by Concerns Based Adoption Questionnaires.
Timepoint [2] 318409 0
At post-test 1 (at the end of Grade 6), post-test 2 (at the end of Grade 7) and one year follow-up (at the end of grade 8).
Secondary outcome [3] 318410 0
The proportion of school staff showing an increase in the confidence skills to implement AOP at school as assessed by The Program Adoption Questionnaire.
Timepoint [3] 318410 0
At post-test 1 (before the intervention) and at post-test 2 (after the intervention).

Eligibility
Key inclusion criteria
The targeted population consisted of Grade 6 students (aged 10-11 years) & their parents from 91 government primary schools within three Western Australia education districts
(Fremantle, Rockingham and Mandurah). The schools were stratified by an index of socioeconomic status, school size & number of grade 6 & split 6/7 classes. The students have sufficient English language ability to complete the programs and questionnaires, and not reported to have any significant learning disability.

Minimum age
9 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Grade 6 students from Independence and Private Schools in Fremantle, Rockingham and Mandurah.

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)
The three education districts (Mandurah, Rockingham and Fremantle) selected contain 92 primary school. With a conservative school participation rate of 75% and student participation rate of 90%, it is expected to recruit 3150 students from 140 classes in 72 primary schools. The targeted population consisted of Grade 6 students (aged 10-11 years) & their parents from primary schools within three WA Department of Education metropolitan districts and were recruited to participate in a randomised field trial of the dissemination of the AOP. The schools were stratified by an index of socioeconomic status, school size, & number of grade 6 & split 6/7 classes.
Schools were randomly assigned to three conditions: a usual care control condition, & two intervention conditions representing the two different dissemination strategies within the stratified groupings.

The sample were followed for two years as they moved to high schools. Random assignment of schools to one of three conditions will be completed before pre-testing, so that schools in the three conditions are matched for possible confounding variables such as socioeconomic status, school size, number of grade 6 & split 6/7 classes students per school. 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
The research design generated a hierarchical data structure in which time was nested within student, student was nested within teacher, and teacher was nested within school.
Because higher - level of nesting produces intra-group dependency in the lower level data, the intra class correlation (ICC: A measure of intra-group dependency) was calculated prior to data analysis. "Unacceptably" large ICCs indicate the multilevel modelling approach to analysing nested data. These hypotheses can be adequately tested with multilevel models consisting of just one level of nesting - students/ parents within classes, or staff members within schools. The student/parent models require about 60 classes, and the staff member models require about 70 schools, for an 80% chance of capturing medium to large effects (e.g. Cohen, 1988). Because we had more than 60 classes, the student/parent models should be sensitive to smaller effects.

The psychometric data (SDQ-S total difficulties, SDQ-S social skills, SDQ-P total difficulties, SDQ-P social skills) were analysed with a Generalised Linear Mixed Model (GLMM: Bryk & Raudenbush, 1987) as implemented through SPSS'S (Version 22) GENLINMIXED procedure. In order to optimise the likelihood of convergence, a separate GLMM was tested for each outcome. Each GLMM assumed normal probability distribution for the outcome and linked it to the fixed effects (group, time, Group x Time) with an identity function. If the outcome did not have normal distribution, then the parameter estimates of the covariance matrix were computed with robust statistics.
DICA assessments were conducted at pre-test, post-test 2 and follow-up. The DICA data (incidence : yes, no: recovery: yes, no) were analysed with a GLMM that assumed a binomial probability distribution for the outcome and linked it to the fixed effects (group, time, Group x Time) with a logit function. In order to optimise the likelihood of convergence, a separate GLMM analysis was run for each outcome.

Sixty-three of the 91 government primary schools from three education districts in Western Australia ( Fremantle, Rockingham and Mandurah) were recruited in the study. Of the 3288 Grade 6 students enrolled in the recruited schools, 2288 students and 2097 of their parents agreed to participate. The students were aged between 9.67 and 12.45 years. 1118 were female and 1170 were male.
There were 863 students in the training group only, 794 students in the training/coaching group, and 630 students in the usual care control group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/02/2003
Date of last participant enrolment
Anticipated
Actual
15/12/2006
Date of last data collection
Anticipated
Actual
Sample size
Target
3150
Accrual to date
Final
2288
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 9831 0
6210 - Mandurah
Recruitment postcode(s) [2] 9832 0
6168 - Rockingham
Recruitment postcode(s) [3] 9833 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 291458 0
Government body
Name [1] 291458 0
Australian Research Council
Country [1] 291458 0
Australia
Primary sponsor type
Individual
Name
Dr. Robert Kane
Address
School of Psychology and Speech Pathology,
Curtin University, Kent Street, Bentley, WA 6102.
GPO Box U1987,
Perth, WA 6845.
Country
Australia
Secondary sponsor category [1] 290137 0
Individual
Name [1] 290137 0
Associate Prof. Rosanna Rooney
Address [1] 290137 0
School of Psychology and Speech Pathology,
Curtin University, Kent Street, Bentley, WA 6102.
GPO Box U1987, Perth, WA 6845.
Country [1] 290137 0
Australia
Other collaborator category [1] 278496 0
Individual
Name [1] 278496 0
Dr. Shari Hassan
Address [1] 278496 0
School of Psychology and Speech Pathology,
Curtin University, Kent Street, Bentley
WA 6102
GPO Box U1987
Perth, WA 6845
Country [1] 278496 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293007 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 293007 0
Ethics committee country [1] 293007 0
Australia
Date submitted for ethics approval [1] 293007 0
13/11/2002
Approval date [1] 293007 0
21/01/2003
Ethics approval number [1] 293007 0
232/2002

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

Contacts
Principal investigator
Name 54906 0
Dr Robert Kane
Address 54906 0
School of Psychology and Speech Pathology,
Curtin University, GPO Box U1987,
Perth, Western Australia 6845.
Country 54906 0
Australia
Phone 54906 0
+61 8 9266 7515
Fax 54906 0
+61 8 9266 2464
Email 54906 0
[email protected]
Contact person for public queries
Name 54907 0
Rosanna Rooney
Address 54907 0
School of Psychology and Speech Pathology,
Curtin University, GPO Box U1987,
Perth, Western Australia 6845.
Country 54907 0
Australia
Phone 54907 0
+61 8 9266 3050
Fax 54907 0
+61 8 9266 2464
Email 54907 0
[email protected]
Contact person for scientific queries
Name 54908 0
Rosanna Rooney
Address 54908 0
School of Psychology and Speech Pathology,
Curtin University, GPO Box U1987,
Perth, Western Australia 6845.
Country 54908 0
Australia
Phone 54908 0
+61 8 9266 3050
Fax 54908 0
+61 8 9266 2464
Email 54908 0
[email protected]

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