Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000575033
Ethics application status
Not yet submitted
Date submitted
5/07/2010
Date registered
16/07/2010
Date last updated
16/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Behaviour Skill Builder: An Online Parenting Intervention for Difficult Child Behaviour
Scientific title
In parents of children with a developmental disability or intellectual disability and difficult behaviour, does a brief online parenting intervention compared to waitlist controls, reduce everyday behaviour problems and enhance parent wellbeing.
Secondary ID [1] 252147 0
Nil
Universal Trial Number (UTN)
Trial acronym
BSB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult Behaviour 257687 0
Depression 257688 0
Anxiety 257689 0
Stress 257690 0
Raising children with developmental disability, intellectual disability and difficult behaviour. 257751 0
Condition category
Condition code
Mental Health 257861 257861 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 257927 257927 0 0
Health promotion/education
Mental Health 257932 257932 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Behaviour Skill Builder (BSB) is an online interactive parenting intervention for parents of children with intellectual disability and/or developmental delay.

Participants in the intervention groups will have access to the BSB immediately on receipt of participant enrolment forms and pre-measures. Waitlist control participants will have access to the intervention six weeks after they have enrolled in the trial, on receipt of post-measures. The intervention will be administered once, in short sessions over a period of six weeks. Completion of the BSB involves approximately 1 hour of online content as well as time taken for parents to complete activities in their home or other settings, over a six week period.

It is expected that participants will complete Part 1 and 2 of the BSB (approximately 30 minutes of online content) in the first week of the intervention period. Participants are advised to complete a behaviour diary during the second week, before returning to complete Part 3 (approximately 30 minutes of online content) in the third week of the trial. Monitoring may be completed over the following three weeks.

The BSB includes strategies for managing everyday difficult behaviour based on Functional Behavioural Assessment. Parents complete a number of activities including a Behaviour Action Plan (BAP) through use of the BSB online tool. A specific BAP will be completed for each target behaviour; tailored according to the triggers, consequences and function of a difficult behaviour reported by parents.

Functional Behaviour Assessment is an approach to understanding problem behaviour by determining its purpose. The aim is to replace the problem behaviour with an alternative behaviour that has the same function, and/or reduce the frequency of its occurrence.

In Part 1 of the BSB parents are asked to identify a target child behaviour for change.

In Part 2 participants are asked to complete a detailed description of the problem behaviour and set a goal for change.

Part 3 assists parents to:

1. Identify a replacement behaviour and learn how to prompt it.

2. Encourage the replacement behaviour with attention, praise and rewards.

3. Make the difficult behaviour less likely to occur by:
- eliminating triggers
- changing the risky situations, and
- learning about backward chaining

4. Remove the positive consequences for the difficult behaviour by:
- preventing escape from the activity
- withholding the activity
- using planned ignoring, or
- changing the object so that it doesn’t give pleasurable sensations or restricting the time/place

5. Learn about back up consequences – loss of privilege or time-out.

An initial follow-up will be conducted at six-weeks, after parents have completed the online intervention. A second follow-up will be conducted 12 weeks after parents enrolled in the trial.
Intervention code [1] 256750 0
Behaviour
Comparator / control treatment
No treatment waitlist control

Email support comparator treatment:

Participants allocated to the email support comparator condition will have access to the online Behaviour Skill Builder (BSB) tool in conjunction with regular email support by a practitioner, intended to assist implementation of the BSB. Email support may involve assistance developing and implementing a behavioural action plan and/or suggestions regarding measurable, achievable behaviour change goals. Email support will be administered simultaneously to (in parallel with) the BSB. Participants will receive 1-2 emails/week for 6 consecutive weeks after a parent is allocated to the treatment condition. An initial follow-up will be conducted at six-weeks, after parents have completed the online intervention. A second follow-up will be conducted 12 weeks after parents enrolled in the trial.
Control group
Active

Outcomes
Primary outcome [1] 258723 0
Mean Score on the Disruptive/Antisocial Subscale of the Developmental Behaviour Checklist (DBC)
Timepoint [1] 258723 0
At baseline, 6 and 12 weeks after intervention commencement
Primary outcome [2] 258724 0
Mean parent score on the short form of the Depression Anxiety Stress Scale (DASS-21)
Timepoint [2] 258724 0
At baseline, 6 and 12 weeks after intervention commencement
Primary outcome [3] 258725 0
Mean parent score on the Parenting Sense of Competence scale (PSOC)
Timepoint [3] 258725 0
At baseline, 6 and 12 weeks after intervention commencement
Secondary outcome [1] 264762 0
Percentage Behaviour Goal Achievement

Percentage Behaviour Goal Achievement is calculated using Goal Attainment Scaling (GAS) as parents complete the Behaviour Skill Builder (BSB). The BSB asks participants to enter the current frequency (or duration or end product) of a behaviour, then identify a goal for change (target). The GAS then calculates what frequency (or product or duration) would be equal to 25%, 50% and 75% goal achievement (where baseline = 0% and target = 100%). While monitoring the target behaviour participants can take a record of the behaviour occurred in 7 day periods. The tool will calculate and report percentage goal achievement.
Timepoint [1] 264762 0
The BSB will calculate and report Percentage Behaviour Goal Achievement as each participant completes the relevant section of the online intervention. Timing is at participants discretion, it is estimated that parents will complete the BSB within a six-week intervention period. The final GAS percentage will be available immediately after completion of the online intervention.
Secondary outcome [2] 264763 0
Parent total behaviour vignettes test score
Timepoint [2] 264763 0
At baseline, 6 and 12 weeks after intervention commencement
Secondary outcome [3] 264764 0
Global Behaviour Ratings Score

Global Behaviour Rating Scores are measured according to four sliding scales which ask parents to visually rate the: behaviour frequency, confidence managing the mis-behaviour, associated stress, and behaviour severity. A Global Behaviour Rating Score of 0-10 is calculated for each of the four scales.
Timepoint [3] 264764 0
Global Behaviour Ratings will be assessed at baseline and during the ongoing monitoring of the behaviour, after parents have completed a Behaviour Action Plan. The frequency of measurement is at a participants discretion as ongoing monitoring is not compulsory. Participants can elect to complete the sliding scale measures when they enter their behaviour record, at any time (or not at all), however only their most recent assessment will be recorded for analysis.

Eligibility
Key inclusion criteria
To be eligible for inclusion participants must be able to read and understand written English and living in Australia at the time of trial. They will need access to email and internet, preferably with a Broadband connection. Participants must also have a child with behaviour difficulties in the mild to moderate range aged between 3 and 9 years.

Behaviour difficulties in the mild-moderate range are defined as everyday behaviour problems that impact family wellbeing to the extent that reducing the behaviour difficulty would positively impact family, and individual, wellbeing. Examples of everyday behaviour difficulties include tantrums and not responding to requests/instructions. Parents who report that the mis-behaviour is very severe and/or report high levels of associated stress, are advised to select a different (easier) behaviour to work on with the Behaviour Skill Builder and seek professional help with the severe mis-behaviour.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If the child with difficult behaviour is not within the age range (3 to 9 years) or if the child is currently receiving services for the target behaviour they will not be eligible to participate in the study. If the parent does not read and understand English they will also be excluded from the current study.

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)
Interested parents will be advised to contact the Parenting Research Centre (via email or phone) for further information about the trial. A research assistant will send email invitations to interested parents to participate and will collect their contact details at first contact with the Parenting Research Centre

Potential participants will be sent a plain language statement and informed consent form along with brief demographic questionnaire and pre-intervention measures.

Participants are enrolled in the trial on receipt of the signed consent form and completed pre-intervention measures. Measures will be received in an unidentified reply paid envelope marked with the trial acronym. Unopened envelopes will be marked in order of receipt, which will determine an individual’s sequence in following randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A permuted block randomisation method will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants will be randomly allocated to receive the online intervention program in either self-administered or email support parallel conditions.
A control group will invited to complete the self-administered condition 6 weeks after the intervention groups.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257244 0
Government body
Name [1] 257244 0
Parenting Research Centre via funding from the New South Wales Government Department of Aging, Disability & Home Care (ADHC)
Country [1] 257244 0
Australia
Primary sponsor type
Other
Name
Parenting Research Centre
Address
Parenting Research Centre
Level 5, 232 Victoria Parade
East Melbourne
VIC 3002
Country
Australia
Secondary sponsor category [1] 256487 0
None
Name [1] 256487 0
Address [1] 256487 0
Country [1] 256487 0
Other collaborator category [1] 251365 0
University
Name [1] 251365 0
Monash University
Address [1] 251365 0
Monash University
Clayton campus
Wellington Road
Clayton
Victoria 3800
AUSTRALIA
Country [1] 251365 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259264 0
Ethics committee address [1] 259264 0
Ethics committee country [1] 259264 0
Date submitted for ethics approval [1] 259264 0
05/07/2010
Approval date [1] 259264 0
Ethics approval number [1] 259264 0

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

Contacts
Principal investigator
Name 31360 0
Address 31360 0
Country 31360 0
Phone 31360 0
Fax 31360 0
Email 31360 0
Contact person for public queries
Name 14607 0
Cathy Bent
Address 14607 0
Parenting Research Centre
Level 5. 232 Victoria Parade
East Melbourne
VIC 3002
Country 14607 0
Australia
Phone 14607 0
+61 3 86603538
Fax 14607 0
+61 3 86603599
Email 14607 0
[email protected]
Contact person for scientific queries
Name 5535 0
Jan Matthews
Address 5535 0
Parenting Research Centre
Level 5. 232 Victoria Parade
East Melbourne
VIC 3002
Country 5535 0
Australia
Phone 5535 0
+61 3 86603521
Fax 5535 0
+61 3 86603599
Email 5535 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
No additional documents have been identified.