Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000672651
Ethics application status
Approved
Date submitted
17/06/2014
Date registered
26/06/2014
Date last updated
26/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A web-based randomised controlled trial exploring the impact of telephone-based practitioner support in an online parenting program.
Scientific title
A web-based randomised controlled trial comparing practitioner-supported Triple P Online, self-directed Triple P Online, and a computer-use-as-usual control group on child behaviour and parenting practices in a targeted sample of families identified as at-risk, or typically less likely to participate in traditional parenting programs.
Secondary ID [1] 284557 0
Nil
Universal Trial Number (UTN)
U1111-1156-5079
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child behaviour 292171 0
Parenting practices 292172 0
Condition category
Condition code
Mental Health 292508 292508 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 292509 292509 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Triple P is a multilevel system of behavioural family interventions that aims to prevent and treat child social, emotional and behavioural problems by enhancing parenting confidence, knowledge and skills. Triple P Online is an 8-module web-based program that fits within level 4 of the Triple P system. Modules take approximately 30-60 minutes, with each module needing to be completed (or 'unlocked') in sequence.

The program covers the key concepts of positive parenting including strategies for managing misbehaviour, teaching children new skills, and encouraging desirable behaviour. Modules are labelled as follows: 1) What is positive parenting? 2) Teaching new skills 3) Managing misbehaviour 4) Dealing with disobedience 5) Preventing problems by planning ahead 6) Making shopping fun 7) Raising confident, capable kids 8) Encouraging behaviour you like.

The program features video, interactive activities, downloadable resources, a dynamic workbook generated based on user activity, and technology-assisted reminders (e.g. SMS, email). Users are encouraged to set goals for change, and monitor and assess progress periodically throughout the program. Users are also encouraged to think about high-risk situations by combining strategies and principles learned throughout the program into a cohesive prevention plan, with the eventual aim of reducing reliance on the program so supports can be phased out.

This is a three-arm trial, with two active intervention groups and a computer-use-as-usual control condition. The two active conditions compare practitioner-supported Triple P Online with self-directed Triple P Online.

Arm 1
Participants randomised to the first arm of the trial are given access to Triple P Online as a standalone self-directed intervention. Program access expires four months from the date of first login. This arm includes minimal participant contact; specifically limited to technical support (e.g. a user has lost their password and is unable to login) or to notify of their upcoming program expiry date (one month prior to expiry and again one week prior). No clinical practitioner support is provided, and participants are able to proceed at their own pace through the program without external prompting regarding the rate or frequency of module completion.

Arm 2
Participants in this group are given the same access to Triple P Online as those in Arm 1, expiring four months from the date of first login. In addition, each parent is allocated to a practitioner trained in Level 4 Triple P, who provides up to eight telephone consultations. Consultations usually last around 15 minutes, with a maximum of 30 minutes per call.

The primary purpose of the clinical consultations is to encourage and support parental self-regulatory skills, offer psychoeducation, help tailor the program to the specific family environment, encourage and assist with goal setting, provide constructive feedback, and troubleshoot any practical or motivational barriers the parent might be experiencing. Technical support is typically referred back to the principal investigator.

Practitioners aim to schedule consultations weekly, beginning with the first session scheduled for a week after an introductory phone call from the practitioner. Parents are encouraged to complete Module 1 of the online program prior to the first telephone session, and then one module each week between phone sessions thereafter. However practitioners are able to negotiate sessions as necessary to fit around the practitioner/parent schedule, which may result in more than one week between some sessions.

If a parent keeps their phone appointment but has not progressed any further through the online program, the call will continue as best as possible maintaining the core aims of clinical support, albeit limited to a discussion of content from prior modules. The parent would then be encouraged to continue through the next online module for the following week. Regarding missed sessions, for example the parent does not answer at the arranged time, some rescheduling is allowed however parents may receive less than the full eight phone consultations if this occurs repeatedly.

Actual number of completed telephone sessions (for Arm 2) and online modules (for Arm 1 & 2) will be tracked throughout the trial for each parent.

Arm 3
This is a computer-use-as-usual control group. Parents in the control group receive no treatment during the trial, however after completion of follow-up data collection (nine months from pre-intervention assessment) parents are provided with access to Triple P Online as a self-directed program, expiring four months from date of first login. No clinical practitioner support is provided to parents in this arm.
Intervention code [1] 289584 0
Behaviour
Intervention code [2] 289585 0
Prevention
Comparator / control treatment
Parents in the control group are not provided with access to the online program during the trial period, however it is recognised that parents will continue to access typical online supports during this period, as per usual. Therefore this group is labelled a computer-use-as-usual control. See Arm 3 above for more information.
Control group
Active

Outcomes
Primary outcome [1] 292368 0
Child disruptive behaviour scores assessed using the Eyberg Child Behaviour Inventory (ECBI; Eyberg & Pincus, 1999), determined for both the Intensity and Problem subscales.
Timepoint [1] 292368 0
Assessed at baseline, post-intervention (four months from baseline), and follow-up (nine months from baseline).
Primary outcome [2] 292369 0
Ineffective and coercive parenting styles as measured using the Parenting Scale (PS; Arnold, O'Leary, Wolff & Acker, 1993). The Parenting Scale yields three subscales: Laxness, Overreactivity, and Hostility, plus a Total score.
Timepoint [2] 292369 0
Assessed at baseline, post-intervention (four months from baseline), and follow-up (nine months from baseline).
Secondary outcome [1] 308790 0
Demographic data will be collected through a Family Background Questionnaire (FBQ). The FBQ collects information such as family structure, cultural background, education and employment, and current financial situation.
Timepoint [1] 308790 0
Baseline only
Secondary outcome [2] 308791 0
Parental self-efficacy will be assessed using the Parenting Tasks Checklist (PTC; Sanders & Woolley, 2005). This measure assesses both task-specific and setting-specific self-efficacy.
Timepoint [2] 308791 0
Assessed at baseline, post-intervention (four months from baseline), and follow-up (nine months from baseline).
Secondary outcome [3] 308792 0
The Parent Problem Checklist (PPC; Dadds & Powell, 1991) will be used to assess the level of conflict between partners around parenting their child where the primary parent is married, living with a partner or in a de facto relationship. Scores on both the Problem and Extent subscales can be derived.
Timepoint [3] 308792 0
Assessed at baseline, post-intervention (four months from baseline), and follow-up (nine months from baseline).
Secondary outcome [4] 308793 0
The perceived level of relationship satisfaction will be assessed using the Relationship Quality Index (RQI; Norton, 1983).
Timepoint [4] 308793 0
Assessed at baseline, post-intervention (four months from baseline), and follow-up (nine months from baseline).
Secondary outcome [5] 308794 0
Parental adjustment will be assessed using the 21-item version of the DASS (Depression, Anxiety and Stress scale; Lovibond & Lovibond, 1995). This measure is considered to have good discriminant validity, yielding scores on three subscales of depression, anxiety and stress.
Timepoint [5] 308794 0
Assessed at baseline, post-intervention (four months from baseline), and follow-up (nine months from baseline).
Secondary outcome [6] 308795 0
The Parental Anger Inventory (PAI; Hansen & Sedlar, 1998) provides a measure of parental anger as experienced in response to their child's difficult behaviours. It provides both a Problem (how many behaviours are currently a problem) and Intensity (the extent of the parent's anger response to these behaviours) subscore.
Timepoint [6] 308795 0
Assessed at baseline, post-intervention (four months from baseline), and follow-up (nine months from baseline).
Secondary outcome [7] 308796 0
A new measure designed to investigate mechanisms of change potentially activated through the intervention will also be used in this trial. This is a brief, 15-item scale that taps a range of cognitive, behavioural and affective mechanisms that are thought to be related to program outcomes. This unvalidated scale will initially be used primarily for exploratory purposes to begin establishing a theoretical link between program outcomes and the primary mechanisms that may be most responsible for driving these outcomes.
Timepoint [7] 308796 0
Assessed at baseline, post-intervention (four months from baseline), and follow-up (nine months from baseline).
Secondary outcome [8] 308797 0
The Client Satisfaction Questionnaire is an adaptation of the Therapy Attitude Inventory developed by Eyberg (1993). It is used to establish a measure of overall participant satisfaction with the program and level of support received, and also provides space for feedback around whether the program met the parent's needs, or led to perceived improvements in their child's behaviour. Some further adaptations were included for this trial to investigate preferences around handheld devices (e.g. smartphone/tablet usage) and support options (e.g. practitioner supported vs self-directed).
Timepoint [8] 308797 0
Post-intervention only, for active intervention groups.
Secondary outcome [9] 308881 0
The Parent Daily Report (PDR) is a brief, semi-structured interview conducted with a subsample of parents where both positive and problematic child behaviours that have occurred in the last 24 hours are discussed. Parents are asked to report on the frequency of specific behaviours, and describe in detail how they managed or responded to these behaviours. Further information such as the parent's attributions for the behaviour are explored. Each interview typically takes around 15-20 minutes to complete and are voice recorded for later coding by an independent person. This interview functions as a secondary, multi-informant method of data collection that reduces reliance on self-report questionnaires.
Timepoint [9] 308881 0
Assessed at baseline, post-intervention (four months from baseline), and follow-up (nine months from baseline) for a randomly selected subsample of parents. At each timepoint, three phone interviews are completed resulting in a total of nine interviews each.

Eligibility
Key inclusion criteria
1. One or more children between the ages of 2 and 9 years.
2. Concerns regarding their child's behaviour, particularly relating to aggressive behaviour and/or social problems
3. One or more of the following criteria:

- At least one parent (if in a dual-parent household) has completed no further education beyond high school. Completion of a trade certificate or apprenticeship would mean this criterion has not been met.

- Single-parent household, including divorced, widowed or unmarried parents.

- Not able to meet essential household expenses in the last 6 months, OR perceived financial difficulty (spending more than they get, or just enough money to get through to the next pay day).

- Currently experiencing significant conflict with their partner around parenting issues, as measured by the problem scale of the Parent Problem Checklist. The cutoff used was 5 or more 'Yes' responses to the question "Has this issue been a problem for you and your partner in the last 4 weeks". A score greater than 5 is considered to be in the clinical range.

- Parental adjustment difficulties as determined by the Kessler-10, a brief, 10-item measure of psychological distress used to screen for depression and anxiety. A score of 22 or higher was used as a cutoff.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- The target child has a disability and/or chronic illness, including language or speech impairment
- The parent is currently seeing a professional for parenting support, primarily relating to their child’s behaviour difficulties
- The parent is currently enrolled in a parenting program
- The parent is receiving psychological/psychiatric help or counselling (personal/marital)
- The parent is intellectually and/or hearing impaired
- The parent is not able to read/write English without assistance
- The parent is excluded if they do not have access to a laptop or desktop computer for personal use, or do not have access to high-speed internet (e.g. broadband/adsl or higher, due to videos in the program)

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)
Participants initially register interest on an information website by providing their contact details through a simple web form. Individuals on the register are then contacted via telephone by the primary researcher or a research assistant for a screening interview to determine eligibility. Participation requirements and random allocation procedures are also further explained during this call and verbal consent is obtained as a prerequisite for eligibility. At this point, providing eligibility criteria have been met, parents may be asked to participate in a series of nine Parent Daily Report (PDR) telephone interviews. Declining to participate in these interviews does not disqualify a parent from being eligible to participate in the trial. A random number generator is used during the screening call to determine whether parents will be requested to participate in PDR interviews, giving approximately a one-in-three chance of being asked in order to obtain a subsample of participants.

Following screening, eligible participants are emailed a link to an online consent form leading into the pre-intervention questionnaires also completed online.

Following completion of pre-assessment, participants are randomised to one of three groups: start Triple P Online now (self-directed); start Triple P Online now with telephone support; start Triple P Online in 9 months (control group).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated sequence of random numbers was created and imported into a MySQL database. After completion of baseline assessment, the primary researcher clicks a link in the participant management software that searches the database for the next available number in the randomly generated sequence and allocates the participant accordingly. An automated email is also sent at this point to the participant to inform them of their allocated group. This method ensures no direct knowledge by the primary researcher of a participant's group allocation prior to 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
A priori power analysis was performed using G*Power software to determine a reasonable sample size for the study. Sample size was determined based on repeated-measures MANOVA with interactions, with two primary outcomes and three measurement timepoints (number of measurements = 6). A small effect size of 0.2 was set, given that two of the groups are active intervention groups. Consistent with convention a Type I error rate of 0.05 was used, along with Power of 0.8, yielding a total sample size of 208 participants.

Traditional analysis of variance approaches are expected to be used for data analysis, although multi-level modelling will be preferred if there is sufficient power to perform these calculations, given the more robust nature of the approach for handling missing data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
23/05/2012
Date of last participant enrolment
Anticipated
31/03/2014
Actual
1/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
208
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA

Funding & Sponsors
Funding source category [1] 289424 0
University
Name [1] 289424 0
University of Queensland
Country [1] 289424 0
Australia
Primary sponsor type
Individual
Name
Jamin Day
Address
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 288111 0
None
Name [1] 288111 0
Address [1] 288111 0
Country [1] 288111 0
Other collaborator category [1] 278004 0
Individual
Name [1] 278004 0
Prof Matthew R. Sanders
Address [1] 278004 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country [1] 278004 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291187 0
University of Queensland Behavioural & Social Sciences Ethical Review Committee
Ethics committee address [1] 291187 0
Ethics committee country [1] 291187 0
Australia
Date submitted for ethics approval [1] 291187 0
15/02/2012
Approval date [1] 291187 0
14/03/2012
Ethics approval number [1] 291187 0

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

Contacts
Principal investigator
Name 48162 0
Mr Jamin Day
Address 48162 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country 48162 0
Australia
Phone 48162 0
+61 7 3346 7689
Fax 48162 0
Email 48162 0
[email protected]
Contact person for public queries
Name 48163 0
Jamin Day
Address 48163 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country 48163 0
Australia
Phone 48163 0
+61 7 3346 7689
Fax 48163 0
Email 48163 0
[email protected]
Contact person for scientific queries
Name 48164 0
Jamin Day
Address 48164 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country 48164 0
Australia
Phone 48164 0
+61 7 3346 7689
Fax 48164 0
Email 48164 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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