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Trial registered on ANZCTR


Registration number
ACTRN12616000238471
Ethics application status
Approved
Date submitted
16/02/2016
Date registered
22/02/2016
Date last updated
22/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study evaluating the Every Moment program for foster and kinship carers of children with challenging behavioural and/or mental health needs
Scientific title
Pilot study evaluating the efficacy of the Every Moment program for foster and kinship carers of children with challenging behavioural and/or mental health needs.
Secondary ID [1] 288541 0
nil
Universal Trial Number (UTN)
Trial acronym
EM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complex/Developmental Trauma 297645 0
Foster and kinship carer depression, anxiety and stress 297656 0
Social, emotional and behavioural difficulties in children in foster and kinship care. 297657 0
Condition category
Condition code
Mental Health 297833 297833 0 0
Other mental health disorders
Mental Health 297903 297903 0 0
Anxiety
Mental Health 297904 297904 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A small sample of carers who meet inclusion criteria are invited to attend 8 x 1.5 hour education and management training sessions focusing on Safety, Trauma, Attachment, Interpersonal Relationships and Skills Building in the context of complex/developmental trauma. The sessions are presented one per week in group format and are convened and run by an Endorsed Clinical Psychologist. Adherence is assessed by a register of attendance. The sessions have been informed by reviews of applicable scientific literature and informed by 8 years of direct experience working and teaching in the areas of child protection and out of home care. Material is conveyed using presentations, participant experience and contribution, video and case scenario material.
Intervention code [1] 293919 0
Treatment: Other
Comparator / control treatment
pilot, no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297362 0
Level of behavioural difficulties displayed by children in foster and kinship care.

This will be assessed with the Strengths and Difficulties Questionnaire,
Timepoint [1] 297362 0
Data will be collected at baseline, week 2, week 4, week 6, week 8, and at follow-up at three months.
Primary outcome [2] 297412 0
Level of social difficulties displayed by children in foster and kinship care.

This will be assessed with the Strengths and Difficulties Questionnaire,
Timepoint [2] 297412 0
Data will be collected at baseline, week 2, week 4, week 6, week 8, and at follow-up at three months.
Primary outcome [3] 297413 0
Level of emotional difficulties displayed by children in foster and kinship care.

This will be assessed with the Strengths and Difficulties Questionnaire,
Timepoint [3] 297413 0
Data will be collected at baseline, week 2, week 4, week 6, week 8, and at follow-up at three months.
Secondary outcome [1] 320818 0
Secondary outcomes of interest are a reduction in depression displayed by foster and kinship carers.

This will be assessed with the Depression Anxiety and Stress Scales (DASS 21) and the Parent Child Stress Index Short Form (PSI SF)
Timepoint [1] 320818 0
Data will be collected at baseline, week 2, week 4, week 6, week 8, and at follow-up at three months.
Secondary outcome [2] 320980 0
Secondary outcomes of interest are a reduction in anxiety displayed by foster and kinship carers.

This will be assessed with the Depression Anxiety and Stress Scales (DASS 21)
Timepoint [2] 320980 0
Data will be collected at baseline, week 2, week 4, week 6, week 8, and at follow-up at three months.
Secondary outcome [3] 320981 0
Secondary outcomes of interest are a reduction in stress displayed by foster and kinship carers.

This will be assessed with the Depression Anxiety and Stress Scales (DASS 21) and the Parent Child Stress Index Short Form (PSI SF)
Timepoint [3] 320981 0
Data will be collected at baseline, week 2, week 4, week 6, week 8, and at follow-up at three months.

Eligibility
Key inclusion criteria
Foster or kinship carer of child(ren) where the child(ren) are aged 4-17 years, have lived with their current family for at least 6 months, and who reported a Total Difficulties Score on the SDQ equal to or above the "high" ("/low") range.
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria in this pilot include:
carer characteristics (significant mental health or substance use concerns, care of child for less than 6 months, inability to communicate in English to a rudimentary level) and
child characteristics (under threshold on psychometric measures: SDQ)

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)
none
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
none
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 stats

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
8/02/2016
Date of last participant enrolment
Anticipated
Actual
15/02/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292896 0
Self funded/Unfunded
Name [1] 292896 0
Country [1] 292896 0
Primary sponsor type
University
Name
University of Technology Sudney
Address
Level 4 Building 7
67 Thomas St
Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 291643 0
None
Name [1] 291643 0
Address [1] 291643 0
Country [1] 291643 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294395 0
UTS Human Research Ethics Expedited Review Committee
Ethics committee address [1] 294395 0
Ethics committee country [1] 294395 0
Australia
Date submitted for ethics approval [1] 294395 0
25/01/2016
Approval date [1] 294395 0
05/02/2016
Ethics approval number [1] 294395 0
UTS HREC REF NO. 2015000482-23.

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

Contacts
Principal investigator
Name 63558 0
Dr John McAloon
Address 63558 0
University of Technology Sydney
Level 4 Building 7
67 Thomas St
Ultimo NSW 2007

(PO Box 123)
Country 63558 0
Australia
Phone 63558 0
+61 2 9514 7240
Fax 63558 0
Email 63558 0
[email protected]
Contact person for public queries
Name 63559 0
John McAloon
Address 63559 0
University of Technology Sydney
Level 4 Building 7
67 Thomas St
Ultimo NSW 2007

(PO Box 123)
Country 63559 0
Australia
Phone 63559 0
+61 2 9514 7240
Fax 63559 0
Email 63559 0
[email protected]
Contact person for scientific queries
Name 63560 0
John McAloon
Address 63560 0
University of Technology Sydney
Level 4 Building 7
67 Thomas St
Ultimo NSW 2007

(PO Box 123)
Country 63560 0
Australia
Phone 63560 0
+61 2 9514 7240
Fax 63560 0
Email 63560 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.