ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

EM

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Complex/Developmental Trauma

Foster and kinship carer depression, anxiety and stress

Social, emotional and behavioural difficulties in children in foster and kinship care.

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

Anxiety

Mental Health

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]

Treatment: Other

Comparator / control treatment

pilot, no control

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Level of behavioural difficulties displayed by children in foster and kinship care.

This will be assessed with the Strengths and Difficulties Questionnaire,

Timepoint [1]

Data will be collected at baseline, week 2, week 4, week 6, week 8, and at follow-up at three months.

Primary outcome [2]

Level of social difficulties displayed by children in foster and kinship care.

This will be assessed with the Strengths and Difficulties Questionnaire,

Timepoint [2]

Data will be collected at baseline, week 2, week 4, week 6, week 8, and at follow-up at three months.

Primary outcome [3]

Level of emotional difficulties displayed by children in foster and kinship care.

This will be assessed with the Strengths and Difficulties Questionnaire,

Timepoint [3]

Data will be collected at baseline, week 2, week 4, week 6, week 8, and at follow-up at three months.

Secondary outcome [1]

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]

Data will be collected at baseline, week 2, week 4, week 6, week 8, and at follow-up at three months.

Secondary outcome [2]

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]

Data will be collected at baseline, week 2, week 4, week 6, week 8, and at follow-up at three months.

Secondary outcome [3]

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]

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]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UTS Human Research Ethics Expedited Review Committee

Ethics committee address [1]

University of Technology Sydney
Level 4 Building 7
67 Thomas St
Ultimo NSW 2007

 (PO Box 123)

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/01/2016

Approval date [1]

05/02/2016

Ethics approval number [1]

UTS HREC REF NO. 2015000482-23.

Summary

Brief summary

In 2013-14 18,950 children and young people were in out-of-home care (OOHC) in NSW. 
A substantial proportion of those in foster or kinship care arrangements are, or have been in foster or kinship care arrangements that have broken down. Approximately 60 per cent of those placed in foster care placements are placed with two or more foster families following their removal from their birth parents, a portion were placed with significantly more (FACS, 2013-14).
A significant proportion of children in foster and kinship care arrangements have experienced some form of maltreatment. Reviews differ but some find children in foster care have social and emotional problems at between three and ten times those of children in the general population (Dorsey, Burns, Southerland, Cox, Wagner, & Farmer, 2012).Fisher, Gunnar, Dozier, Bruce  & Pears, 2006; Nilsen, 2007). Their behaviour has significant implications for their social, emotional and academic development, and the stability of their living arrangements (Cook et al, 2005; Nilsen, 2007).
Children who have suffered abuse &/or neglect present with a cluster of symptoms currently known as Complex Trauma (Cook et al, 2005, van der Kolk, Bessel,2005). The outcomes for these children include social, emotional behavioural and cognitive challenges. This is important as childhood behavioural and emotional difficulties are among the best predictors of mental health difficulties in adolescence and adulthood.
Foster and kinship care arrangements provide an immensely important opportunity to change the trajectories of children who have had their development impacted by early maltreatment (Fisher et al, 2006; Nilsen, 2007). Given the emotional and behavioural challenges that children in foster and kinship care can display, this potential can be very difficult and foster and kinship care placements often break down as a result of these pressures (Nilsen, 2007). 
Currently neurodevelopmental science and clinical psychological treatment evidence identifies a range of treatment components that has the potential to both inform foster and kinship carer training and allow foster and kinship carers an opportunity to understand and engage characteristics of presentation of children in their care. UTS: familychildbehaviour has developed Every Moment, an innovative program of trauma informed Foster and Kinship Care for carers looking after children with challenging behavioural &/or mental health needs.
The primary purpose of this study is to evaluate whether the Every Moment program can contribute to reductions in difficulties experienced by foster and kinship carers in looking after children who have experienced early maltreatment and also whether Every Moment can contribute reducing difficulties for children that commonly follow early maltreatment.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr John McAloon

Address

University of Technology Sydney
Level 4 Building 7
67 Thomas St
Ultimo NSW 2007

(PO Box 123)

Country

Australia

Phone

+61 2 9514 7240

Fax

Email

[email protected]

Contact person for public queries

Name

John McAloon

Address

University of Technology Sydney
Level 4 Building 7
67 Thomas St
Ultimo NSW 2007

(PO Box 123)

Country

Australia

Phone

+61 2 9514 7240

Fax

Email

[email protected]

Contact person for scientific queries

Name

John McAloon

Address

University of Technology Sydney
Level 4 Building 7
67 Thomas St
Ultimo NSW 2007

(PO Box 123)

Country

Australia

Phone

+61 2 9514 7240

Fax

Email

[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.