Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000908639
Ethics application status
Approved
Date submitted
11/08/2014
Date registered
26/08/2014
Date last updated
26/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Trial of Circle of Security as a Parenting Support Program for Multiproblem Families
Scientific title
Evaluation of Circle of Security Parenting Training (DVD) to improve parent and child outcomes in multiproblem families, compared to a supportive waitlist
Secondary ID [1] 285138 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parental sensitivity 292713 0
Child internalizing symptoms 292714 0
Child externalizing symptoms 292715 0
Parenting stress 292716 0
Parental reflective functioning 292717 0
Parental attachment and interpersonal style 292718 0
Parental depression 292719 0
Parental bonding 292720 0
Parenting practices 292721 0
Condition category
Condition code
Mental Health 293019 293019 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be the 8-week Circle of Security Parent DVD Program.

This program provides parents with psychoeducation based on attachment theory, using the training DVD. Parents will attend sessions with a psychologist, where they will watch the training DVD and relate the content to their own family. The DVD includes short videos and built-in moments to facilitate reflective dialogue. The program will be conducted in one-on-one sessions each taking around 1 hour, once per week for eight weeks. Only one parent is required to attend. Parents will be asked to reflect on the content between sessions.

Master and Doctoral level psychologists trained in the Circle of Security Parent DVD Training will conduct the sessions. Regular peer supervision will be held, to assist with adherence to the program.
Intervention code [1] 289990 0
Treatment: Other
Intervention code [2] 290047 0
Behaviour
Comparator / control treatment
Participants allocated to the 8-week Waitlist will be contacted weekly by phone by their allocated therapist, for brief conversations regarding family and other concerns. At the end of the 8 weeks, families will be offered the Circle of Security Parent DVD Program.
Control group
Active

Outcomes
Primary outcome [1] 292879 0
Parental sensitivity will be assessed by coding recorded parent-child interactions within a 10-minute free-play session. The measure of parent sensitivity was developed by modifying one subscale of the Emotional Availability Scales (Biringen, Robinson, & Emde, 2000). Parents will be rated from 1 (highly insensitive) to 9 (highly sensitive). Coding will include consideration of the parent’s affect, ability to respond to the child’s signals, flexibility, and accessibility to the child.
Timepoint [1] 292879 0
At treatment completion (8 weeks after randomization), and at 3 month post treatment completion (20 weeks after randomization)
Primary outcome [2] 292880 0
Parent stress will be assessed using The Parenting Stress Inventory, Third Edition (PSI-3; Abidin, 1990).
Timepoint [2] 292880 0
At treatment completion (8 weeks after randomization), and at 3 month post treatment completion (20 weeks after randomization)
Primary outcome [3] 292881 0
The 21-item Beck Depression Inventory II (BDI; Beck, Steer & Brown, 1996) will be used to assess parental depression.
Timepoint [3] 292881 0
At treatment completion (8 weeks after randomization), and at 3 month post treatment completion (20 weeks after randomization)
Secondary outcome [1] 309868 0
The parent report Behavior Assessment System for Children (BASC-2; Reynolds & Kamphaus) will be used to assess child internalizing symptoms.
Timepoint [1] 309868 0
At treatment completion (8 weeks after randomization), and at 3 month post treatment completion (20 weeks after randomization)
Secondary outcome [2] 309869 0
The parent report Behavior Assessment System for Children (BASC-2; Reynolds & Kamphaus) will be used to assess child externalizing symptoms.
Timepoint [2] 309869 0
At treatment completion (8 weeks after randomization), and at 3 month post treatment completion (20 weeks after randomization)

Eligibility
Key inclusion criteria
Parents of children aged 1 to 6 years, experiencing relationship difficulties.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

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)
Randomization of participant ID codes to treatment or supported waitlist was conducted using a coin flip process on www.random.org, prior to recruitment. Thus, participants are assigned an ID code (and corresponding treatment or waitlist group) according to the order in which they enroll in the program. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequential participant ID codes were formed (e.g., 1, 2, 3). Using coin flipper on www.random.org, where heads corresponded to treatment, and tails to waitlist, each ID code was allocated to treatment or waitlist, then participants were assigned an ID code according to the order in which they enroll the program.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Different groups of participants receive different interventions during the same time span of the study, however supported waitlist participants are also offered the intervention after they have completed the waitlist.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We plan on conducting a series of mixed ANOVAs to evaluate whether change in outcome measures from pre- to post-assessment differs between the treatment and waitlist control groups.

Based on results obtained in a previous RCT we have conducted, using similar measures in a comparable population, we calculate that we will require 80 participants (40 in each group). Specifically, at 80% power and .05 (two-sided) significance level, we calculated that we will require between 60 and 80 participants to obtain differences in measures that we obtained in our previous trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/06/2014
Actual
12/06/2014
Date of last participant enrolment
Anticipated
23/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 289748 0
Government body
Name [1] 289748 0
QLD Government, Department of Communities, Child Safety
Country [1] 289748 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Parklands Drive, Southport, QLD, 4222
Country
Australia
Secondary sponsor category [1] 288440 0
None
Name [1] 288440 0
Address [1] 288440 0
Country [1] 288440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291480 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 291480 0
Ethics committee country [1] 291480 0
Australia
Date submitted for ethics approval [1] 291480 0
13/02/2014
Approval date [1] 291480 0
22/04/2014
Ethics approval number [1] 291480 0
PSY/10/14/HREC

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

Contacts
Principal investigator
Name 50590 0
Prof Melanie Zimmer-Gembeck
Address 50590 0
Griffith University
Parklands Drive
Southport QLD 4222
Country 50590 0
Australia
Phone 50590 0
+61 (0)7 5678 9085
Fax 50590 0
Email 50590 0
[email protected]
Contact person for public queries
Name 50591 0
Elbina Avdagic
Address 50591 0
Griffith University
Parklands Drive
Southport QLD 4222
Country 50591 0
Australia
Phone 50591 0
+61 (0)7 5678 9105
Fax 50591 0
Email 50591 0
[email protected]
Contact person for scientific queries
Name 50592 0
Haley Webb
Address 50592 0
Griffith University
Parklands Drive
Southport QLD 4222
Country 50592 0
Australia
Phone 50592 0
+61 (0)7 5678 9105
Fax 50592 0
Email 50592 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.