Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000200886
Ethics application status
Approved
Date submitted
15/02/2012
Date registered
17/02/2012
Date last updated
12/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Triple P-Positive Parenting Program for Indonesian Parents
Scientific title
A randomized-controlled trial of a brief intervention of Triple P-Positive Parenting Program to increase parenting competence of Indonesian parents.
Secondary ID [1] 279946 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Triple P
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parenting practices 285863 0
Child emotional and behavioural problems 285875 0
Condition category
Condition code
Mental Health 286046 286046 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 286061 286061 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A brief intervention of Triple P will be delivered as seminar series, which provides parents with strategies to promote child positive behaviour and to manage child difficult behaviour. Participating parents will be divided randomly into two groups, intervention group and wait-list control group. The intervention group will immediately receive the Triple P seminar series in three-week period. There are three seminars that will be delivered: The Power of Positive Parenting; Raising Confident, Competent Children; and Raising Resilient Children. Each seminar will take about 90 minutes. All written materials are translated into Indonesian. The seminar will be presented by a trained practitioner in Indonesian.
Intervention code [1] 284276 0
Behaviour
Comparator / control treatment
The comparison for the intervention group is a wait-list control group. The wait-list control group will receive the same seminar series once the intervention groups have completed the program.
Control group
Active

Outcomes
Primary outcome [1] 286529 0
Parent outcomes, consisting of: (1) Parent confidence as measured by the Child Adjustment and Parent Efficacy Scale (CAPES); (2) Dysfunctional parenting practice as measured by the Parenting and Family Adjustment Scale (PAFAS) and the Parenting Scale; (3) Parenting stress as measured by the Parenting and Family Adjustment Scale (PAFAS); (4) Family relationships , as measured by the Parenting and Family Adjustment Scale (PAFAS); and (5) Couple relationships as measured by the Parenting and Family Adjustment Scale (PAFAS). The CAPES and PAFAS are self-report measures.
Timepoint [1] 286529 0
Pre-intervention, Post-intervention, and 6-month follow-up
Primary outcome [2] 286530 0
Child emotional and behavioural outcome as measured by parent rating on child behavioural and emotional problems in the Child Adjustment and Parent Efficacy Scale (CAPES).
Timepoint [2] 286530 0
Pre-intervention, Post-intervention, and 6-month follow-up.
Secondary outcome [1] 296090 0
Service outcome indicating parent acceptability and parent satisfaction with the intervention. This will be evaluated through parent rating (Parent Acceptability Questionnaire and Parent Satisfaction Survey).
Timepoint [1] 296090 0
Post-intervention

Eligibility
Key inclusion criteria
Participants will be recruited if they are eligible in the following criteria:
-Indonesian parents or carers with a typical developing child aged 2-12 years old;
-Parents or carers currently live with their child;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Parents or carers having a child with health problems or disabilities (e.g., physical or intellectual disability, or developmental disorder);
- Parents or carers do not live currently with their child;
- Parents or carers have difficulties with reading and writing;
-Parents or carers receiving on-going support from other program or professionals in regards to their child adjustment.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Parents will be voluntarily participated in the study. Their eligibility will be assessed by the researcher over the telephone. After parents receive a brief explanation of the study and indicate verbal consent to participate, a package of questionnaire (pre-intervention assessment) will be sent to them via internet or mail. Participating parents will be randomly assigned to intervention group or wait-list control group after they complete the questionnaire.

The procedure for allocating the treatment is as follows: A person who is not involved in the trial will generate the treatment allocation sequence using a computer random generation number. The person will record this in a folded piece of paper and placed it in sequentially numbered, sealed and opaque envelopes. Once parents have completed the pre-intervention assessment, the researcher will open the sealed envelope and informed parents their allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated list of random number will be used to allocate the participants into 1 of 2 groups. The method employed is block randomization.
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
2/04/2012
Actual
22/03/2012
Date of last participant enrolment
Anticipated
Actual
25/05/2012
Date of last data collection
Anticipated
Actual
6/02/2013
Sample size
Target
120
Accrual to date
Final
143
Recruitment outside Australia
Country [1] 4134 0
Indonesia
State/province [1] 4134 0
East Java

Funding & Sponsors
Funding source category [1] 284717 0
University
Name [1] 284717 0
University of Queensland
Country [1] 284717 0
Australia
Funding source category [2] 284718 0
Self funded/Unfunded
Name [2] 284718 0
Agnes Sumargi
Country [2] 284718 0
Australia
Primary sponsor type
Individual
Name
Assoc.Prof. Kate Sofronoff (primary supervisor of Agnes Sumargi)
Address
School of Psychology,
Sir Fred Schonell Drive,
St Lucia,
Brisbane,
Qld 4072
Country
Australia
Secondary sponsor category [1] 283618 0
Individual
Name [1] 283618 0
Agnes Sumargi (primary investigator)
Address [1] 283618 0
School of Psychology,
Sir Fred Schonell Drive,
St Lucia,
Brisbane,
Qld 4072
Country [1] 283618 0
Australia
Other collaborator category [1] 260547 0
Individual
Name [1] 260547 0
Dr. Alina Morawska (associate supervisor of Agnes Sumargi)
Address [1] 260547 0
School of Psychology,
Sir Fred Schonell Drive,
St Lucia,
Brisbane,
Qld 4072
Country [1] 260547 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286723 0
The University of Queensland Ethics Committee (Behavioural and Social Sciences Ethical Review Committee)
Ethics committee address [1] 286723 0
Ethics committee country [1] 286723 0
Australia
Date submitted for ethics approval [1] 286723 0
Approval date [1] 286723 0
15/07/2011
Ethics approval number [1] 286723 0
2011000714

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

Contacts
Principal investigator
Name 33780 0
Dr Agnes Sumargi
Address 33780 0
Faculty of Psychology
Widya Mandala Catholic University
Pakuwon City campus
Raya Kalisari Selatan 1
Surabaya
Indonesia
Country 33780 0
Indonesia
Phone 33780 0
+623199005299
Fax 33780 0
Email 33780 0
[email protected]
Contact person for public queries
Name 17027 0
Agnes Sumargi
Address 17027 0
Faculty of Psychology
Widya Mandala Catholic University
Pakuwon City campus
Raya Kalisari Selatan 1
Surabaya
Indonesia
Country 17027 0
Indonesia
Phone 17027 0
+623199005299
Fax 17027 0
Email 17027 0
[email protected]
Contact person for scientific queries
Name 7955 0
Agnes Sumargi
Address 7955 0
Faculty of Psychology
Widya Mandala Catholic University
Pakuwon City campus
Raya Kalisari Selatan 1
Surabaya
Indonesia
Country 7955 0
Indonesia
Phone 7955 0
+623199005299
Fax 7955 0
Email 7955 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.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA Randomized-Controlled Trial of the Triple P-Positive Parenting Program Seminar Series with Indonesian Parents2014https://doi.org/10.1007/s10578-014-0517-8
N.B. These documents automatically identified may not have been verified by the study sponsor.