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Trial registered on ANZCTR


Registration number
ACTRN12616001574437
Ethics application status
Approved
Date submitted
10/11/2016
Date registered
15/11/2016
Date last updated
15/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Signposts Program for Parents of Children with a head injury
Scientific title
Managing challenging behaviour in young children post-Traumatic Brain Injury (TBI) with online clinician support - pilot
Secondary ID [1] 290474 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Traumatic Brain Injury 300843 0
Condition category
Condition code
Injuries and Accidents 300668 300668 0 0
Other injuries and accidents
Neurological 300726 300726 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Signposts for Building Better Behaviour program ('Signposts') is a manualised parenting intervention, initially developed to assist parents in managing difficult behaviour seen in children with an Intellectual Disability. The original program consists of 8 modules:
1. Introduction
2. Module 1 – Measuring your child's behaviour
3. Module 2 – Systematic use of daily interactions
4. Module 3 – Replacing difficult behaviour with useful behaviour
5. Module 4 – Planning for better behaviour
6. Module 5 – Developing more skills in your child
7. Your family as a team
8. Dealing with stress in the family

Parents are also provided with a DVD, with videos demonstrating the parenting skills described in each module, and a workbook, with homework exercises designed to help parents practice the skills learned. In general, the program teaches parents to describe and measure unwanted behaviour, analyse its antecedents and consequences, and build on the child's skills in order to promote better behaviour. For example, homework exercises may involve describing their child's strengths, developing house rules, or recording their use of time-outs.

More recently, research suggests efficacy when used with the parents of children with an Acquired Brain Injury, with the introduction of a 9th module "Dealing with a head injury in the family", where challenging behaviours are a reasonably common and persisting long-term sequelae of the injury.

The current study is investigating the feasibility of delivering the program with online clinician support, via videoconferencing. We hope that delivery through this medium may improve program access for families, where barriers such as living in rural areas or working full time would have prevented them from participating in the face-to-face format that is usually offered through rehabilitation services.

Parents will be offered to participate in either the intervention group or the wait-list control group on an alternating basis, based on the child's date of injury. Parents participating in the intervention program will be provided with hard copies of the 'Signposts' program, as well as an internet enabled iPad, loaded with the app "GoToMeeting", a videoconferencing program. Consistent with previous research investigating this program with telephone supported delivery, modules 1, 2, 7, 8, and 9 are initially provided, with subsequent modules mailed to parents on a fortnightly basis as needed.

Parents will read through the program materials in their own time, complete the homework exercises, and record their own child's behaviour, It is estimated that reading the module will take an average of 30 minutes, and practicing the skills taught should be built into the regular family routine, with approximately 5 minutes per day dedicated to recording parenting skill practice or their child's behaviour into the workbook.

Parents will then engage in fortnightly videoconference meetings with the 'Signposts' clinician, who is a trainee psychologist and has completed the 'Signposts' professional training workshop at the Parenting Research Centre, where the 'Signposts' program was originally developed. Clinical supervision will be provided by a registered Clinical Psychologist, who has also completed the 'Signposts' training.

The purpose of these videoconference meetings is to review homework, troubleshoot any difficulties, and provide positive reinforcement for parents' efforts. It is expected that the time required for these sessions should be approximately 25 minutes, but will vary substantially depending on the parent's needs. Five videoconference sessions will be conducted, and it is expected that the program takes a minimum of 10 weeks to complete.

Program adherence will be measured by whether parents successfully complete all modules of the program, and whether parents have sufficiently completed homework exercises at the time of the videoconference (as recorded by the 'Signposts' clinician during review of homework). Homework completion will be deemed sufficient if parents have at least attempted majority of the exercises and practiced the skills taught to an extent that facilitates discussion during the videoconference meeting.
Intervention code [1] 296328 0
Behaviour
Intervention code [2] 296380 0
Treatment: Other
Comparator / control treatment
The control group in this study consists of a 'treatment as usual' wait listed group. Children of parents participating in this group will continue to access services considered standard care for a traumatic brain injury, including consultation or treatment with psychologists.
If, at the conclusion of data analysis for this project, our results suggest that parents benefited from the program, the wait-list group will be offered to also complete the 'Signposts' program. It is anticipated that this may occur in late 2017.
Control group
Active

Outcomes
Primary outcome [1] 300092 0
Child behaviour, measured through the Child Behaviour Checklist (parent report)
Timepoint [1] 300092 0
Immediately following program completion, and four months post-completion
Primary outcome [2] 300093 0
Parent satisfaction of the program when delivered with clinician support via videoconferencing, measured through a consumer satisfaction scale developed for the program.
Timepoint [2] 300093 0
Immediately following program completion
Primary outcome [3] 300167 0
Assessment of the feasibility of conducting the program with this mode of clinician support is measured through data collected on the program adherence (the number of parents who successfully complete all modules and videoconference meetings involved in the program, as a proportion of the number of parents who begin the program). Also, the number of technology difficulties that occur, if any, will be recorded, as these threaten the feasibility of using videoconferencing in clinical practice.
Timepoint [3] 300167 0
Data collection for this occurs throughout, and is completed at completion of the intervention
Secondary outcome [1] 328999 0
Parent mental health, measured through the Depression, Anxiety and Stress Scales (DASS)
Timepoint [1] 328999 0
Immediately following program completion, and four months post-completion
Secondary outcome [2] 329000 0
Parents' sense of satisfaction and self-efficacy in their parenting role, measured through the Parenting Sense of Competency questionnaire.
Timepoint [2] 329000 0
Immediately following program completion, and four months post-completion
Secondary outcome [3] 329001 0
Parenting disciplinary styles, as measured through the Parenting Style questionnaire
Timepoint [3] 329001 0
Immediately following program completion, and four months post-completion
Secondary outcome [4] 329002 0
Family functioning, as measured through the McMaster Family Assessment Device
Timepoint [4] 329002 0
Immediately following program completion, and four months post-completion

Eligibility
Key inclusion criteria
Participants are the primary caregivers (hereon referred to as parents) of at least one child who has sustained a Traumatic Brain Injury within the prior five years. The parents of children aged 2.0 to 6.11 at the time of injury, who sustained mild, moderate or severe injuries will be eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria are that medical records suggest that: parents and children do not have sufficient English skills, that the child has a prior history of significant neurological or developmental disorder, a diagnosed severe psychiatric disorder in the parent, or documented evidence that the TBI was non-accidental.
Parents may not have previously completed the 'Signposts' program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
This trial is a pilot, and therefore the sample size was based on similar pilots in this field, and on a number from which conclusions about the program's preliminary feasibility can be drawn.
T-test comparisons will be made to compare outcome data with data collected pre-intervention, as well as comparisons with follow up data collected four months post-intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/09/2014
Date of last participant enrolment
Anticipated
31/01/2017
Actual
Date of last data collection
Anticipated
31/08/2017
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6890 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 14558 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 294890 0
Other
Name [1] 294890 0
Murdoch Childrens Research Institute
Country [1] 294890 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
50 Flemington Rd
Parkville, VIC, 3052
Country
Australia
Secondary sponsor category [1] 293727 0
None
Name [1] 293727 0
Address [1] 293727 0
Country [1] 293727 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296269 0
Royal Childrens Hospital HREC
Ethics committee address [1] 296269 0
The Royal Childrens Hospital
50 Flemington Road
Parkville, VIC, 3052
Ethics committee country [1] 296269 0
Australia
Date submitted for ethics approval [1] 296269 0
08/11/2013
Approval date [1] 296269 0
20/11/2013
Ethics approval number [1] 296269 0
24011

Summary
Brief summary
The Signposts for Building Better Behaviour program is a manualised parenting intervention, initially developed to assist parents in managing difficult behaviour seen in children with an Intellectual Disability. More recently, research suggests efficacy when used with the parents of children with an Acquired Brain Injury, where challenging behaviours are a reasonably common and persisting long-term sequelae of the injury.

The current study is investigating the feasibility, consumer satisfaction, and preliminary efficacy of delivering the program with online clinician support, via videoconferencing. We hope that delivery through this medium may improve program access for families, where barriers such as living in rural areas or working full time would have prevented them from participating in the face-to-face format that is usually offered through rehabilitation services.

It is expected that the program will have a high level of parent satisfaction, when delivered with this mode of clinician support. It is also expected that relative to those who received treatment as usual, those who completed 'Signposts' will report:
1. Lower levels of child behaviour problems, both internalising and externalising
2. Lower levels of parental distress
3. Lower levels of dysfunctional parenting
4. Higher levels of family functioning
5. Higher levels of satisfaction in the parenting role.
Further, it is predicted that these effects will be maintained post-intervention, with no significant increases in behaviour problems, parental distress or dysfunction, and no significant decreases in family functioning or parent role satisfaction, reported at 4-month post-intervention follow-up.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70206 0
A/Prof Cathy Catroppa
Address 70206 0
Child Neuropsychology
Murdoch Childrens Research Institute
50 Flemington Rd
Parkville, VIC, 3052
Country 70206 0
Australia
Phone 70206 0
+61 3 99366638
Fax 70206 0
Email 70206 0
[email protected]
Contact person for public queries
Name 70207 0
Cathy Catroppa
Address 70207 0
Child Neuropsychology
Murdoch Childrens Research Institute
50 Flemington Rd
Parkville, VIC, 3052
Country 70207 0
Australia
Phone 70207 0
+61 3 99366638
Fax 70207 0
Email 70207 0
[email protected]
Contact person for scientific queries
Name 70208 0
Cathy Catroppa
Address 70208 0
Child Neuropsychology
Murdoch Childrens Research Institute
50 Flemington Rd
Parkville, VIC, 3052
Country 70208 0
Australia
Phone 70208 0
+61 3 99366638
Fax 70208 0
Email 70208 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

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