Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001047482
Ethics application status
Approved
Date submitted
30/07/2016
Date registered
5/08/2016
Date last updated
10/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
FCB1-3: Family Child Behaviour Therapy for Children Aged one to three years
Scientific title
The efficacy of Behavioural Family Intervention plus Parent Coaching in addressing behavioural difficulties in toddlers.
Secondary ID [1] 289689 0
nil
Universal Trial Number (UTN)
Trial acronym
FCB1-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Behavioural Difficulties with Toddlers 299546 0
Condition category
Condition code
Mental Health 299537 299537 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in FCB1-3 are clinic referred parents who report clinically significant levels of behavioural and/or parenting difficulties in their child(ren) aged 1-3. n=30 parents who meet inclusion criteria are invited to participate in 6x90 minute treatment sessions that address parenting difficulties in the context of early child behaviour problems. Each session comprises a 50 minute PARENT-TIME session followed by a 40 minute KID-TIME session.

Behaviorally based programs, also known as Behavioural Family Intervention and Parent Management Training, commonly identify parents as the potential mechanisms of change in child behaviour. The interventions achieve change through the engagement of parents in one of two distinct modes. They either involve

1. the delivery of parenting information to parent(s) in session in the absence of their children, assessment of which is undertaken session by session via parental self-report
2. the direct coaching of parents as they interact with their children, the assessment of which is undertaken session by session via self-report in conjunction with observational coding during session

The current study seeks to trail a combination of both sessional engagement of parents on their own which, in the current research is termed PARENT-TIME and direct coaching of parents and their children which, in the current research is termed KID-TIME. Drawing on clinic referred children aged between one and three years, and undertaken at UTS: Family Child Behaviour, the current study seeks to assess the potential to increase treatment response by combining these two distinct modes of treatment delivery in a clinic referred population.

The sessions are presented to individual families, one per week, and are run by provisionally registered psychologists under the supervision of an Board approved and Endorsed Clinical Psychologist. Treatment gains are assessed session by session. The sessions have been informed by reviews of applicable scientific literature and informed by the CI's 15 years research and clinical work in the area. Sessional material is presented in a discussive manner that emphasises the families expertise in their own situation and utilises presentation and case scenario material.
Intervention code [1] 295351 0
Treatment: Other
Intervention code [2] 295352 0
Prevention
Intervention code [3] 295483 0
Behaviour
Comparator / control treatment
Pilot, no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298999 0
Child behaviour assessed with the Child Behaviour Checklist (CBCL) (Achenbach and Restoria, 2001). CBCL completed by parent(s)
Timepoint [1] 298999 0
Child behaviour will be assessed at intake and then two weekly until program completion. Followup will be undertaken at three months post.
Primary outcome [2] 299000 0
Parental Distress assessed with the Parental Distress Index - Short Form (PSI-SF) (Abdin, 1995). PSI-SF completed by parent(s)
Timepoint [2] 299000 0
Parental Distress will be assessed at intake and then two weekly until program completion. Followup will be undertaken at three months post.
Primary outcome [3] 299001 0
Parental Skills assessed by observation according to operationally defined criteria and coded for frequency against a benchmark. Criteria have been designed for this study. Skills that are assessed are:
Verbal reinforcement skills
Facial reinforcement skills
Physical reinforcement skills
Show (Demonstate) skills
Suggest (Prompt) skills
Timepoint [3] 299001 0
Parental Skills will be assessed at intake and then two weekly until program completion. Followup will be undertaken at three months post.
Secondary outcome [1] 325845 0
Moderating and mediating variables identified in intake information and treatment progress will be assess against treatment outcome.
Potential moderators (Parent: age, gender, ethnicity, marital / relationship status, child care arrangements, level of education, number of children, gross annual income and current mental health diagnosis. Child: age, gender, ethnicity, previous psychological/psychiatric treatment and prior diagnosis) and potential mediators (parent self-control, acquisition of Show, Suggest and Support skills including vocal, facial and physical support interactions) will be assessed against treatment outcome (CBCL, PSI-SF, DASS.
Timepoint [1] 325845 0
Moderating and mediating variables in treatment outcome will be informed by psychometric assessment undertaken at intake and at two weekly intervals thereafter until treatment completion and at three months post treatment.
Secondary outcome [2] 326318 0
DASS - 21 Depression Anxiety Stress Scales (Lovibond and Lovibond, 1994)
Timepoint [2] 326318 0
Parental Depression Anxiety Stress will be assessed at intake and then two weekly until program completion. Followup will be undertaken at three months post.

Eligibility
Key inclusion criteria
Enrollment on this study will be require parents of families where the target child is aged between 1 and 3 years to be referred into the research as a result of difficulties parenting and parental report places the child(ren) in the in the clinical range on one of the sub-scales of the CBCL 1.5 - 5.
Minimum age
1 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants will be excluded on the basis that significant marital/relationship difficulties, significant mental health difficulties, unmanaged substance use, and/or child protection concerns are identified. In these cases, appropriate referrals will be sought for the clients should they wish to pursue this as an option.

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
Single group
Other design features
Pilot
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Multivariate statistical analyses
mediational and moderational analyses

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/08/2016
Actual
15/08/2016
Date of last participant enrolment
Anticipated
30/09/2017
Actual
Date of last data collection
Anticipated
30/09/2017
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 13649 0
2007 - Ultimo

Funding & Sponsors
Funding source category [1] 294105 0
University
Name [1] 294105 0
University of Technology Sydney
Country [1] 294105 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Level 4 Building 7, 67 Thomas St, Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 292941 0
None
Name [1] 292941 0
na
Address [1] 292941 0
na
Country [1] 292941 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295588 0
UTS Human Research Ethics Expedited Review Committee
Ethics committee address [1] 295588 0
Ethics committee country [1] 295588 0
Australia
Date submitted for ethics approval [1] 295588 0
13/07/2016
Approval date [1] 295588 0
27/07/2016
Ethics approval number [1] 295588 0
UTS HREC REF NO. 2015000482-28.

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

Contacts
Principal investigator
Name 67450 0
Dr Dr John McAloon
Address 67450 0
University of Technology Sydney
Level 4 Building 7
67 Thomas St,
Ultimo
NSW 2007 (PO Box 123)
Country 67450 0
Australia
Phone 67450 0
+61 2 9514 7240
Fax 67450 0
Email 67450 0
[email protected]
Contact person for public queries
Name 67451 0
John McAloon
Address 67451 0
University of Technology Sydney
Level 4 Building 7
67 Thomas St,
Ultimo
NSW 2007 (PO Box 123)
Country 67451 0
Australia
Phone 67451 0
+61 2 9514 7240
Fax 67451 0
Email 67451 0
[email protected]
Contact person for scientific queries
Name 67452 0
John McAloon
Address 67452 0
University of Technology Sydney
Level 4 Building 7
67 Thomas St,
Ultimo
NSW 2007 (PO Box 123)
Country 67452 0
Australia
Phone 67452 0
+61 2 9514 7240
Fax 67452 0
Email 67452 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 371098-(Uploaded-12-06-2019-10-53-38)-Basic results summary.docx
Plain language summaryNo Thirty-one families, with a toddler who met clinic... [More Details]

Documents added automatically
No additional documents have been identified.