Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000480785
Ethics application status
Approved
Date submitted
11/03/2013
Date registered
30/04/2013
Date last updated
24/07/2019
Date data sharing statement initially provided
24/07/2019
Date results information initially provided
24/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of an online parenting programme for parents of 3-4 year-old children.
Scientific title
A randomized controlled trial evaluating the efficacy of Triple P Online with parents of preschool children with hyperactive/ inattentive behaviour difficulties.
Secondary ID [1] 282395 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperactive child behaviour 288090 0
Inattentive child behaviour 288091 0
Parenting practices 288092 0
Condition category
Condition code
Public Health 288463 288463 0 0
Health promotion/education
Mental Health 288464 288464 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Triple P Positive Parenting Program is a multilevel parenting and family support strategy that aims to prevent behavioural, emotional and developmental problems in children. Triple P Online is a self-administered, interactive parenting programme, delivered via the internet. The programme aims to teach parents the use of 17 core child-management strategies. There are eight sequenced modules: 1) What is positive parenting?; 2) Skills for encouraging behaviour you like; 3) Teaching new skills; 4) Managing misbehaviour; 5) Dealing with disobedience; 6) Preventing problems by planning ahead; 7) Making shopping fun; and 8) Raising confident, capable kids.

Triple P Online incorporates elements designed to engage participants and improve knowledge acquisition, positive self-efficacy, and behaviour activation. These elements include: 1) user-friendly navigation; 2) video-based modelling of parenting skills, and diverse parent ‘voxpops’ describing their experiences; 3) personalized content including goal setting, review and feedback; 4) interactive exercises to prompt parental problem solving, decision making and self-regulation; 5) downloadable worksheets and podcasts to review session content; and 5) automated text messaging and email prompting to increase the likelihood of programme completion. The programme also provides parents with a customizable and printable workbook that records programme content, parents’ goals and responses to exercises.

The programme will take 30 minutes per week for a period of eight weeks.


Two telephone consultations with a Triple P practitioner will be added to the programme in order to maximize participation in the programme and enhance parental problem-solving and self-regulation skills. These telephone sessions will take at least ten minutes, but not more than 30 minutes and willl take place in week two and four of the study. A randomised controlled trial design will be used to evaluate the effects of participation in the online parenting programme in comparison with a wait-list control group.
Intervention code [1] 286317 0
Prevention
Intervention code [2] 286318 0
Behaviour
Comparator / control treatment
The control group will receive no treatment during the trial. Participants allocated to the control group will be offered access to the Triple P Online programme six months after the intervention group has finished the programme, after the trial has finished and all data have been collected.
Control group
Active

Outcomes
Primary outcome [1] 288626 0
A decrease in hyperactive/ inattentive child behaviour.
- Measured by the Conners Early Childhood Behaviour questionnaire (Conners EC-BEH) Inattention/ Hyperactivity subscale, completed by the primary caregiver.
Timepoint [1] 288626 0
Pre-intervention, post-intervention and at 6-month follow-up (i.e. 6 months after completion of treatment).
Primary outcome [2] 289428 0
A decrease in hyperactive/ inattentive child behaviour.
- Measured by the Conners EC-BEH short form Inattention/ Hyperactivity subscale, completed by the secondary caregiver.
Timepoint [2] 289428 0
Pre-intervention, post-intervention and at 6-month follow-up (i.e. 6 months after completion of treatment).
Secondary outcome [1] 300649 0
Reduction of less optimal parenting practices as measured by the Parenting Scale (PS).
Timepoint [1] 300649 0
Pre-intervention, post-intervention, and at 6-month follow-up.
Secondary outcome [2] 300650 0
Increase in self-reported authoritative parenting as measured by the Parenting Styles and Dimensions Questionnaires (PSDQ) authoritative parenting scale.
Timepoint [2] 300650 0
Pre-intervention, post-intervention, and at 6-month follow-up.
Secondary outcome [3] 300653 0
Increase in parent satisfaction and efficacy. Measured by the Parenting Sense of Competence Scale (PSOC).
Timepoint [3] 300653 0
Pre-intervention, post-intervention, and at 6-month follow-up.
Secondary outcome [4] 300655 0
Decrease in symptoms of depression, anxiety and stress reported by parents. Measured by the Depression Anxiety Stress Scales (DASS-21).
Timepoint [4] 300655 0
Pre-intervention, post-intervention, and at 6-month follow-up.
Secondary outcome [5] 301461 0
A decrease in teacher reported hyperactive/ inattentive child behaviour.
- Measured by the Strengths and Difficulties Questionnaire-Hyperactivity scale (SDQ).
Timepoint [5] 301461 0
Pre-intervention, post-intervention, and at 6-month follow-up.
Secondary outcome [6] 301619 0
An improvement in the child's social functioning measured by preschool teacher ratings on the Child Behaviour Scale (CBS).
Timepoint [6] 301619 0
Pre-intervention, post-intervention, and at 6-month follow-up.
Secondary outcome [7] 301656 0
Client satisfaction as measured by the Client Satisfaction Questionnaire, completed by the primary caregiver.
Timepoint [7] 301656 0
6-month follow-up.

Eligibility
Key inclusion criteria
- Parent has a child of 3- or 4-year old.
- The target child has an elevated level of hyperactivity and/ or inattention according to following measures:
'Werry-Weiss-Peters questionnaire' (score of 14 or higher) and the preschool version of the clinical interview 'Parental Account of Child Symptoms (PACS)' (score of 16 or higher), and parental concern over impairment based on a score of 1 or more on the PACS perceived severity scale or impact scale
- Parent has access to a computer and broadband internet.
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Parent who is currently seeing a professional for the child’s behaviour difficulties (rationale: if the target child is receiving support from another service, then it will be difficult to disentangle potential benefits gained from the provided programme from those gained by this external support).

- Parent/s is currently seeing a health professional for emotional or psychological problems (rationale: if parents are receiving support from another service, then it will be difficult to disentangle potential benefits gained from the provided programme from those gained by this external support).

- Parents with a child suffering from a developmental disability, i.e., autism, intellectual disability, or chronic illness (rationale: the self-help version of Triple P is designed for children with behavioural problems that are otherwise normally developing. A modified version of Triple P, Stepping Stones Triple P, has been specifically designed to meet the unique needs of parents who have children with a developmental or health disability.

- Parents who are not able to read an English newspaper without assistance (rationale: the written online materials of this programme are not suitable for parents who cannot read a newspaper without assistance).

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)
Parents interested in participating in the study are asked to self-refer to the researcher. Information about the study protocol is explained and a screening interview is conducted to determine participant eligibility. Written informed consent is collected and pre-intervention measures are then administered. Randomization to condition is conducted at the level of individual children in sequence of completion of pre-intervention measures.

The holder of the allocation schedule is off-site and emails the result.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated list of random is used to allocate to condition.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
- the experimental group receives the intervention straight after completing the first set of questionnaires;
- the control group receives no intervention during the trial. The control group receives the intervention after all three sets of questionnaires at the three different time points have been completed, after all data have been collected.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2013
Actual
11/02/2013
Date of last participant enrolment
Anticipated
30/09/2014
Actual
15/09/2014
Date of last data collection
Anticipated
Actual
23/06/2015
Sample size
Target
65
Accrual to date
Final
53
Recruitment outside Australia
Country [1] 4791 0
New Zealand
State/province [1] 4791 0

Funding & Sponsors
Funding source category [1] 286558 0
University
Name [1] 286558 0
University of Auckland
Country [1] 286558 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Faculty of Education, University of Auckland
Private Bag 92601, Symonds Street
Auckland 1150
New Zealand
Country
New Zealand
Secondary sponsor category [1] 285342 0
None
Name [1] 285342 0
Address [1] 285342 0
Country [1] 285342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288625 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 288625 0
Research Integrity Unit
University of Auckland
Private Bag 92601, Symonds Street
Auckland 1150
Ethics committee country [1] 288625 0
New Zealand
Date submitted for ethics approval [1] 288625 0
Approval date [1] 288625 0
21/11/2012
Ethics approval number [1] 288625 0
2012/8376

Summary
Brief summary
A randomized controlled trial design will be used to evaluate the effectiveness of the online version of the self-help Triple P Positive Parenting Program (TPOL) in comparison to a waitlist control group, in a sample of parents of preschool children with hyperactive/ inattentive behaviour problems. Parents will also receive two telephone support calls from a Triple P Practitioner,
in order to maximize programme participation and enhance parental problem-solving and self-regulation skills.

Pre-intervention, post-intervention and 6-month follow-up assessment will be collected on a range of parenting and child behaviour measures. The waitlist control group will gain access to the online programme after the assessments on all three time points are completed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37042 0
Dr Louise Keown (Nike Franke's main supervisor)
Address 37042 0
School of Learning, Development, and Professional Practice
Faculty of Education,
Epsom Campus,
University of Auckland
Private Bag 92601
Symonds Street Auckland 1150
Country 37042 0
New Zealand
Phone 37042 0
64 (0)9 623 8899 ext 86435
Fax 37042 0
Email 37042 0
[email protected]
Contact person for public queries
Name 37043 0
Dr Nike Franke
Address 37043 0
Faculty of Education, University of Auckland
Private Bag 92601, Symonds Street
Auckland 1150
Country 37043 0
New Zealand
Phone 37043 0
64 (0)9 623 8899 Ext. 48788
Fax 37043 0
Email 37043 0
[email protected]
Contact person for scientific queries
Name 37044 0
Dr Nike Franke
Address 37044 0
Faculty of Education, University of Auckland
Private Bag 92601, Symonds Street
Auckland 1150
Country 37044 0
New Zealand
Phone 37044 0
64 (0)9 623 8899 Ext. 48788
Fax 37044 0
Email 37044 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The raw data as collected through quantitative measures used in the study
When will data be available (start and end dates)?
start date: 1 June 2017
end date: not determined
Available to whom?
1. Parenting and Family Support Centre at the University of Queensland
2. The PAINT-P study (http://www.paint-studies.nl/en/12322-2/)
Available for what types of analyses?
1. Predictors of outcome and completion as combined with other Triple P Online studies
2. Potentially a range of meta-analyses. For each potential paper I have the possibility to opt out.
How or where can data be obtained?
Further data cannot be obtained.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.