Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000194268
Ethics application status
Approved
Date submitted
5/02/2009
Date registered
20/04/2009
Date last updated
7/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program
Scientific title
For parents of young adolescents, is the ABCD parenting young adolescents program, compared with no treatment, efficacious in promoting preventative factors for adolescent risk taking?
Universal Trial Number (UTN)
Trial acronym
ABCD RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
parent-adolescent conflict 4274 0
adolescent risk-taking 4275 0
Condition category
Condition code
Other 4502 4502 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Other 4503 4503 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psycho-educational parenting intervention for parents of young adolescents (aged 10 -14 years). The program is a six session group program. Sessions are held across consecutive weeks with participants attending one two hour session per week for six weeks. The program is based on social learning principles and incorporates acceptance-based strategies. The program involves didactic and powerpoint presentation, modelling, role play, feedback and home practice.
Intervention code [1] 4002 0
Prevention
Intervention code [2] 4003 0
Behaviour
Comparator / control treatment
"No treatment" control utilising a waitlist control group. The control group did not receive the intervention during a six month wait list period
Control group
Active

Outcomes
Primary outcome [1] 5384 0
Improvements in parent-adolescent relationships from pre-intervention levels as measured on the Stress Index for Parents of Adolescents and the Authoritative Parenting Questionnaire
Timepoint [1] 5384 0
Pre-intervention, immediately post intervention, 6 month and 18 month follow-up assessment
Primary outcome [2] 5385 0
Reductions in parent-adolescent conflict from pre-intervention levels as reported on the parent version of the self report measure - the Issues Checklist.
Timepoint [2] 5385 0
At pre intervention, immediately post intervention, 6 month and 18 month follow-up assessment
Secondary outcome [1] 9052 0
improvements in adolescent behaviour from reported pre-intervention levels as reported on the Strengths and Difficulties questionnaire
Timepoint [1] 9052 0
at Pre intervention, immediately Post intervention, six month and eighteen month follow-up
Secondary outcome [2] 9053 0
improvements in parent psycho-social wellbeing from reported pre-intervention levels as reported on the Stress Index for Parents of Adolescents and the Depression, Anxiety,Stress Scale
Timepoint [2] 9053 0
at pre and immediately post intervention, and again at six month and 18 month follow-up
Secondary outcome [3] 9054 0
improvements in parenting competence and practices from pre - intervention levels as measured by the Alabama Parenting Questionnaire, and the Stress Index for Parents of Adolescents
Timepoint [3] 9054 0
at pre and immediately post intervention, and again at six month and eighteen month follow-up assessments

Eligibility
Key inclusion criteria
Participants were included if: they were parents of a child aged between 10 and 14 years, were English speaking, had custody or regular access with their children and lived in the North and West Metropolitan Region of Melbourne, Australia
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Families were excluded if: the parent or adolescent had learning or developmental difficulties, the parent or adolescent had a mental illness, the adolescent had a medical or physical disability or the adoelscents were receiving other specialist services.

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)
Intake worker classified families as eligible/ineligible during an initial contact. Only eligible families were sent registration information. Randomisation was completed at a separate timepoint after return of written consent forms via mail. Randomisation was via central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A web-based computerised randomisation plan generator using the method of randomly permuted blocks was used to generate the sequence of randomisation
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
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1444 0
3028
Recruitment postcode(s) [2] 1445 0
3025
Recruitment postcode(s) [3] 1446 0
3084
Recruitment postcode(s) [4] 1447 0
3019
Recruitment postcode(s) [5] 1448 0
3047
Recruitment postcode(s) [6] 1449 0
3056
Recruitment postcode(s) [7] 1450 0
3055
Recruitment postcode(s) [8] 1451 0
3057
Recruitment postcode(s) [9] 1452 0
3428
Recruitment postcode(s) [10] 1453 0
3429
Recruitment postcode(s) [11] 1454 0
3061
Recruitment postcode(s) [12] 1455 0
3260
Recruitment postcode(s) [13] 1456 0
3053
Recruitment postcode(s) [14] 1457 0
3054
Recruitment postcode(s) [15] 1458 0
3058
Recruitment postcode(s) [16] 1459 0
3066
Recruitment postcode(s) [17] 1460 0
3048
Recruitment postcode(s) [18] 1461 0
3030
Recruitment postcode(s) [19] 1462 0
3089
Recruitment postcode(s) [20] 1463 0
3076
Recruitment postcode(s) [21] 1464 0
3078
Recruitment postcode(s) [22] 1465 0
3060
Recruitment postcode(s) [23] 1466 0
3088
Recruitment postcode(s) [24] 1467 0
3059
Recruitment postcode(s) [25] 1468 0
3081
Recruitment postcode(s) [26] 1469 0
3079
Recruitment postcode(s) [27] 1470 0
3075
Recruitment postcode(s) [28] 1471 0
3012
Recruitment postcode(s) [29] 1472 0
3044
Recruitment postcode(s) [30] 1473 0
3072
Recruitment postcode(s) [31] 1474 0
3016
Recruitment postcode(s) [32] 1475 0
3757
Recruitment postcode(s) [33] 1476 0
3049
Recruitment postcode(s) [34] 1477 0
3095
Recruitment postcode(s) [35] 1478 0
3073
Recruitment postcode(s) [36] 1479 0
3121
Recruitment postcode(s) [37] 1480 0
3064
Recruitment postcode(s) [38] 1481 0
3752
Recruitment postcode(s) [39] 1482 0
3074

Funding & Sponsors
Funding source category [1] 4457 0
Government body
Name [1] 4457 0
Victorian Department of Human Services
Country [1] 4457 0
Australia
Primary sponsor type
Other
Name
Parenting Research Centre
Address
Level 5, 232 Victoria Parade
East Melbourne VICTORIA 3002
Country
Australia
Secondary sponsor category [1] 4016 0
None
Name [1] 4016 0
Address [1] 4016 0
Country [1] 4016 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6513 0
Victorian Department of Human Services Human Research Ethics Committee
Ethics committee address [1] 6513 0
Ethics committee country [1] 6513 0
Australia
Date submitted for ethics approval [1] 6513 0
Approval date [1] 6513 0
16/12/2004
Ethics approval number [1] 6513 0
87/04
Ethics committee name [2] 6514 0
Victorian Department of Education
Ethics committee address [2] 6514 0
Ethics committee country [2] 6514 0
Australia
Date submitted for ethics approval [2] 6514 0
Approval date [2] 6514 0
18/02/2005
Ethics approval number [2] 6514 0
SOS002861
Ethics committee name [3] 6515 0
Catholic Education Office
Ethics committee address [3] 6515 0
Ethics committee country [3] 6515 0
Australia
Date submitted for ethics approval [3] 6515 0
Approval date [3] 6515 0
23/02/2004
Ethics approval number [3] 6515 0
GE05-0009

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

Contacts
Principal investigator
Name 29254 0
Address 29254 0
Country 29254 0
Phone 29254 0
Fax 29254 0
Email 29254 0
Contact person for public queries
Name 12501 0
Kylie Burke
Address 12501 0
Parenting Research Centre
Level 5, 232 Victoria Parade
East Melbourne VICTORIA 3002
Country 12501 0
Australia
Phone 12501 0
+61 3 8660 3500
Fax 12501 0
+61 3 8660 3599
Email 12501 0
[email protected]
Contact person for scientific queries
Name 3429 0
Kylie Burke
Address 3429 0
Parenting Research Centre
Level 5, 232 Victoria Parade
East Melbourne VICTORIA 3002
Country 3429 0
Australia
Phone 3429 0
+61 3 8660 3500
Fax 3429 0
+61 3 86603599
Email 3429 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.

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