Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000803998
Ethics application status
Not yet submitted
Date submitted
23/07/2011
Date registered
1/08/2011
Date last updated
1/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of the "Circle Of Security Parenting" parent education group intervention on a New Zealand community sample
Scientific title
In parents of young children, is the "Circle of Security Parenting" programme more effective than no intervention for increasing parental reflective functioning, sense of competence and capacity to respond to children's negative emotions?
Secondary ID [1] 262679 0
Nil
Universal Trial Number (UTN)
U1111-1123-0886
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parental sense of competence 268381 0
Parental capacity for dealing with children's emotions 270398 0
Parental reflective functioning 270399 0
Condition category
Condition code
Mental Health 268518 268518 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The "Circle of Security Parenting" parent education programme - a programme where parents learn about their child's attachment needs and how to respond to them, and reflect on and discuss their experiences with their child(ren) and relevant experiences from their own childhoods. The programme consists of one 1.5 hour session per week for 8 weeks. Groups are based on DVD episodes and are led by a facilitator. Group size may vary from 5 to 30+. Groups may be attended by either parent or both parents together.
Intervention code [1] 267020 0
Behaviour
Comparator / control treatment
Wait list control group who will be offered the intervention at the earliest possible time after spending 8 weeks on a waiting list.
Control group
Active

Outcomes
Primary outcome [1] 269278 0
Mean 'Parenting Sense of Competence Scale' scores
Timepoint [1] 269278 0
At baseline and at end of intervention.
Secondary outcome [1] 279278 0
Mean 'Coping with Toddlers' Negative Emotions Scale' scores
Timepoint [1] 279278 0
At baseline and at end of intervention.
Secondary outcome [2] 279279 0
Mean 'Parental Reflective Functioning Questionnaire' scores
Timepoint [2] 279279 0
At baseline and at end of intervention.

Eligibility
Key inclusion criteria
Parents of a child aged 12 - 48 months
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-English speakers will not be able to participate in the study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. Subjects will be allocated on a first-come-first-served basis into a treatment group or a wait-list control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3743 0
New Zealand
State/province [1] 3743 0
Wellington

Funding & Sponsors
Funding source category [1] 267510 0
Self funded/Unfunded
Name [1] 267510 0
Country [1] 267510 0
Primary sponsor type
Individual
Name
Roslyn Markham, NSW Institute of Psychiatry
Address
5 Fleet St
North Parramatta
NSW 2151
Country
Australia
Secondary sponsor category [1] 266551 0
Individual
Name [1] 266551 0
Kate Dent Rennie
Address [1] 266551 0
78 Hautana St
Lower Hutt 5010

Masters Student - NSW Institute of Psychiatry
Country [1] 266551 0
New Zealand
Other collaborator category [1] 252121 0
Individual
Name [1] 252121 0
Nicola Atwool
Address [1] 252121 0
Office of the Children's Commissioner,
P O Box 5610,
Lambton Quay,
Wellington 6145
Country [1] 252121 0
New Zealand
Other collaborator category [2] 252122 0
Individual
Name [2] 252122 0
Michelle Ball
Address [2] 252122 0
7 Opou Rd
French Bay
Auckland 0604

Director - Attune Consulting
Country [2] 252122 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269473 0
Ethics committee address [1] 269473 0
Ethics committee country [1] 269473 0
Date submitted for ethics approval [1] 269473 0
25/07/2011
Approval date [1] 269473 0
Ethics approval number [1] 269473 0

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

Contacts
Principal investigator
Name 32906 0
Address 32906 0
Country 32906 0
Phone 32906 0
Fax 32906 0
Email 32906 0
Contact person for public queries
Name 16153 0
Kate Dent Rennie
Address 16153 0
78 Hautana St
Lower Hutt 5010
Country 16153 0
New Zealand
Phone 16153 0
+64 4 568 9821
Fax 16153 0
Email 16153 0
[email protected]
Contact person for scientific queries
Name 7081 0
Kate Dent Rennie
Address 7081 0
78 Hautana St
Lower Hutt 5010
Country 7081 0
New Zealand
Phone 7081 0
+64 4 568 9821
Fax 7081 0
Email 7081 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.