Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12606000399594
Ethics application status
Approved
Date submitted
11/09/2006
Date registered
12/09/2006
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of the Resilient Families school-based parent education program in promoting adolescent health
Scientific title
The effectiveness of a school-based parent education program in the promotion of adolescent health: a randomised trial
Universal Trial Number (UTN)
Trial acronym
Resilient Families Evaluation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent health behaviour 1365 0
Condition category
Condition code
Mental Health 1458 1458 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Resilient Families intervention is a school-based, prevention program designed to help students and their parents develop knowledge, skills, and support networks to promote adolescent health and wellbeing during the first two years of secondary school (Years 7 and 8 in Victoria, Australia). The five intervention components are 1) a 10-session student curriculum delivered by Year 7 teachers during "Health or Pastoral Care" classes; 2) The Parenting Adolescents Quiz. A parent education evening delivered in a 2-hour, large-group, evening forum offered for all Year 7 parents at the school; 3) Parenting Adolescents: A Creative Experience. An 8-session, parent education program conducted with small-groups of Year 7 and 8 parents who volunteer to attend 2-hour evenings at the school; 4) Policies and programs implemented by the school to build a "community of parents" and improve communication with and support for parents during the early secondary school years; 5) Parent education handbooks mailed to all Year 8 parents. Twelve schools have been randomly selected and have agreed to implement the intervention and they are being compared with 12 randomly selected control schools that were not offered the five intervention components. Students and parents complete similar surveys in both the intervention and control schools to enable evaluation.
Intervention code [1] 1335 0
Prevention
Comparator / control treatment
12 randomly selected control schools that were not offered the five intervention components.
Control group
Active

Outcomes
Primary outcome [1] 2010 0
Mental health: Center for Epidemiological Studies Depression Scale (CES-D).
Timepoint [1] 2010 0
Measured annually with reference to recent symptoms (past month) to enable comparison of changes from baseline (Year 7) to program completion (Year 8) and 1-year follow-up (Year 9).
Secondary outcome [1] 3483 0
Alcohol, tobacco, drug use, violence and school commitment.
Timepoint [1] 3483 0
All measured annually to enable comparison of changes from baseline (Year 7) to program completion (Year 8) and 1-year follow-up (Year 9). The three behavioural measures are based on reference periods of the past month and year. School commitment refers to attitudes at each survey point.

Eligibility
Key inclusion criteria
SCHOOLS: A random sample of Victorian, metropolitan Government and Catholic Schools were approached.
STUDENTS AND PARENTS: Students and their parents were universally targeted within school Year 7.
Minimum age
12 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
SCHOOLS: Non-metropolitan and Independent schools were not approached and non-consenting schools were replaced.
STUDENTS AND PARENTS: Where parents did not return signed consent, students and parents were excluded from the survey and in the intervention schools these parents were not sent the parent education handbook.

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)
Stratified school allocation within school type (Government versus Catholic) and school disadvantage
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2004
Actual
1/03/2004
Date of last participant enrolment
Anticipated
Actual
1/07/2005
Date of last data collection
Anticipated
Actual
15/12/2006
Sample size
Target
2500
Accrual to date
Final
2539
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1595 0
Government body
Name [1] 1595 0
National Health and Medical Research Council
Country [1] 1595 0
Australia
Primary sponsor type
Individual
Name
Associate Professor John Toumbourou
Address
Country
Secondary sponsor category [1] 1401 0
None
Name [1] 1401 0
No secondary sponsor
Address [1] 1401 0
Country [1] 1401 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3019 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 3019 0
Ethics committee country [1] 3019 0
Australia
Date submitted for ethics approval [1] 3019 0
02/12/2002
Approval date [1] 3019 0
25/02/2003
Ethics approval number [1] 3019 0
020679
Ethics committee name [2] 3020 0
Bayside
Ethics committee address [2] 3020 0
Ethics committee country [2] 3020 0
Australia
Date submitted for ethics approval [2] 3020 0
24/11/2003
Approval date [2] 3020 0
04/02/2004
Ethics approval number [2] 3020 0
Ethics committee name [3] 3021 0
Berwick
Ethics committee address [3] 3021 0
Ethics committee country [3] 3021 0
Australia
Date submitted for ethics approval [3] 3021 0
24/11/2003
Approval date [3] 3021 0
04/02/2004
Ethics approval number [3] 3021 0
Ethics committee name [4] 3022 0
Deer Park
Ethics committee address [4] 3022 0
Ethics committee country [4] 3022 0
Australia
Date submitted for ethics approval [4] 3022 0
24/11/2003
Approval date [4] 3022 0
04/02/2004
Ethics approval number [4] 3022 0
Ethics committee name [5] 3023 0
Eumemmering
Ethics committee address [5] 3023 0
Ethics committee country [5] 3023 0
Australia
Date submitted for ethics approval [5] 3023 0
24/11/2003
Approval date [5] 3023 0
04/02/2004
Ethics approval number [5] 3023 0
Ethics committee name [6] 3024 0
Heathmont
Ethics committee address [6] 3024 0
Ethics committee country [6] 3024 0
Australia
Date submitted for ethics approval [6] 3024 0
24/11/2003
Approval date [6] 3024 0
04/02/2004
Ethics approval number [6] 3024 0
Ethics committee name [7] 3025 0
Taylors Lakes
Ethics committee address [7] 3025 0
Ethics committee country [7] 3025 0
Australia
Date submitted for ethics approval [7] 3025 0
24/11/2003
Approval date [7] 3025 0
04/02/2004
Ethics approval number [7] 3025 0
Ethics committee name [8] 3026 0
Caroline Chisholm
Ethics committee address [8] 3026 0
Ethics committee country [8] 3026 0
Australia
Date submitted for ethics approval [8] 3026 0
24/11/2003
Approval date [8] 3026 0
04/02/2004
Ethics approval number [8] 3026 0
Ethics committee name [9] 3027 0
Marian,
Ethics committee address [9] 3027 0
Ethics committee country [9] 3027 0
Australia
Date submitted for ethics approval [9] 3027 0
24/11/2003
Approval date [9] 3027 0
04/02/2004
Ethics approval number [9] 3027 0
Ethics committee name [10] 3028 0
Regional College Melton
Ethics committee address [10] 3028 0
Ethics committee country [10] 3028 0
Australia
Date submitted for ethics approval [10] 3028 0
24/11/2003
Approval date [10] 3028 0
04/02/2004
Ethics approval number [10] 3028 0
Ethics committee name [11] 3029 0
Santa Maria
Ethics committee address [11] 3029 0
Ethics committee country [11] 3029 0
Australia
Date submitted for ethics approval [11] 3029 0
24/11/2003
Approval date [11] 3029 0
04/02/2004
Ethics approval number [11] 3029 0
Ethics committee name [12] 3030 0
St Columbas
Ethics committee address [12] 3030 0
Ethics committee country [12] 3030 0
Australia
Date submitted for ethics approval [12] 3030 0
24/11/2003
Approval date [12] 3030 0
04/02/2004
Ethics approval number [12] 3030 0
Ethics committee name [13] 3031 0
St Pauls
Ethics committee address [13] 3031 0
Ethics committee country [13] 3031 0
Australia
Date submitted for ethics approval [13] 3031 0
24/11/2003
Approval date [13] 3031 0
04/02/2004
Ethics approval number [13] 3031 0
Ethics committee name [14] 3032 0
Dandenong
Ethics committee address [14] 3032 0
Ethics committee country [14] 3032 0
Australia
Date submitted for ethics approval [14] 3032 0
24/11/2003
Approval date [14] 3032 0
04/02/2004
Ethics approval number [14] 3032 0
Ethics committee name [15] 3033 0
Lyndhurst
Ethics committee address [15] 3033 0
Ethics committee country [15] 3033 0
Australia
Date submitted for ethics approval [15] 3033 0
24/11/2003
Approval date [15] 3033 0
04/02/2004
Ethics approval number [15] 3033 0
Ethics committee name [16] 3034 0
Mordialloc
Ethics committee address [16] 3034 0
Ethics committee country [16] 3034 0
Australia
Date submitted for ethics approval [16] 3034 0
24/11/2003
Approval date [16] 3034 0
04/02/2004
Ethics approval number [16] 3034 0
Ethics committee name [17] 3035 0
Thomas Carr
Ethics committee address [17] 3035 0
Ethics committee country [17] 3035 0
Australia
Date submitted for ethics approval [17] 3035 0
24/11/2003
Approval date [17] 3035 0
04/02/2004
Ethics approval number [17] 3035 0
Ethics committee name [18] 3036 0
Williamstown
Ethics committee address [18] 3036 0
Ethics committee country [18] 3036 0
Australia
Date submitted for ethics approval [18] 3036 0
24/11/2003
Approval date [18] 3036 0
04/02/2004
Ethics approval number [18] 3036 0
Ethics committee name [19] 3037 0
St Albans
Ethics committee address [19] 3037 0
Ethics committee country [19] 3037 0
Australia
Date submitted for ethics approval [19] 3037 0
24/11/2003
Approval date [19] 3037 0
04/02/2004
Ethics approval number [19] 3037 0
Ethics committee name [20] 3038 0
Mercy
Ethics committee address [20] 3038 0
Ethics committee country [20] 3038 0
Australia
Date submitted for ethics approval [20] 3038 0
24/11/2003
Approval date [20] 3038 0
04/02/2004
Ethics approval number [20] 3038 0
Ethics committee name [21] 3039 0
Parade
Ethics committee address [21] 3039 0
Ethics committee country [21] 3039 0
Australia
Date submitted for ethics approval [21] 3039 0
24/11/2003
Approval date [21] 3039 0
04/02/2004
Ethics approval number [21] 3039 0
Ethics committee name [22] 3040 0
Presentation
Ethics committee address [22] 3040 0
Ethics committee country [22] 3040 0
Australia
Date submitted for ethics approval [22] 3040 0
24/11/2003
Approval date [22] 3040 0
04/02/2004
Ethics approval number [22] 3040 0
Ethics committee name [23] 3041 0
St Aloysius
Ethics committee address [23] 3041 0
Ethics committee country [23] 3041 0
Australia
Date submitted for ethics approval [23] 3041 0
24/11/2003
Approval date [23] 3041 0
04/02/2004
Ethics approval number [23] 3041 0
Ethics committee name [24] 3042 0
St Helena
Ethics committee address [24] 3042 0
Ethics committee country [24] 3042 0
Australia
Date submitted for ethics approval [24] 3042 0
24/11/2003
Approval date [24] 3042 0
04/02/2004
Ethics approval number [24] 3042 0
Ethics committee name [25] 3043 0
St Monica's
Ethics committee address [25] 3043 0
Ethics committee country [25] 3043 0
Australia
Date submitted for ethics approval [25] 3043 0
24/11/2003
Approval date [25] 3043 0
04/02/2004
Ethics approval number [25] 3043 0

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

Contacts
Principal investigator
Name 27942 0
Address 27942 0
Country 27942 0
Phone 27942 0
Fax 27942 0
Email 27942 0
Contact person for public queries
Name 10524 0
Associate Professor John Toumbourou
Address 10524 0
Centre for Adolescent Health, Department of Paediatrics, University of Melbourne, 2 Gatehouse Street, Parkville, VIC, 3052.
Country 10524 0
Australia
Phone 10524 0
03 93456535
Fax 10524 0
03 93456502
Email 10524 0
[email protected]
Contact person for scientific queries
Name 1452 0
Associate Professor John Toumbourou
Address 1452 0
Centre for Adolescent Health, Department of Paediatrics, University of Melbourne, 2 Gatehouse Street, Parkville, VIC, 3052.
Country 1452 0
Australia
Phone 1452 0
03 93456535
Fax 1452 0
03 93456502
Email 1452 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.