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Trial registered on ANZCTR

Registration number

ACTRN12615000313538

Ethics application status

Approved

Date submitted

2/03/2015

Date registered

7/04/2015

Date last updated

19/11/2018

Date data sharing statement initially provided

19/11/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

kContact: Keeping Contact between parents and children in care. A trial of an enhanced model of contact with parents to reduce child distress and improve children's emotional safety.

Scientific title

Improving contact between children in out-of-home care and their birth parents: developing and trialling a contact intervention: Trialling an enhanced model of contact.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

kContact

Linked study record

Health condition

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

Child Welfare

Parenting

Family Contact

Mental Health

Condition category

Condition code

Mental Health

Other mental health disorders

Public Health

Other public health

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This stage involves testing the effectiveness of an enhanced model of contact (the intervention) for parents and children in Out Of Home Care who are in permanent foster care or kinship care placements. The proposed intervention draws from the protocols of two key programs “Visit Coaching” (Beyer, 2004, 2008) and a strengths based approach to supervised contact (Smith, Shapiro, Sperry, & LeBuffe, 2014). The intervention consists of increased preparation for contact for parents, provision of guidance about activities for parents and their children during contact, improving communication between all parties, and debriefing after contact.

Intervention: The intervention for each child and parent will be delivered by by the parent’s Key Worker within the out-of-home care program (the practitioner who has an existing relationship with the parent).
The intervention includes the following aims:

- To establish or maintain a constructive relationship with parents;

- To support the parent to attend visits and plan age appropriate activities to do with their child.

The intervention will include the following components:

- Orientation to discuss the intervention, expectations and concerns;

- Assessment of the children’s needs to be met in visits;

- Confirmation of attendance at visits;

- Preparation to identify the goals and aims they would like to achieve during visits with their children and plan activities that consistent with the child’s needs and the parent’s goals;

- Follow up support, feedback and planning;

- Reviews of progress and new goal setting.

Resources will be provided to staff and parents to assist in visit planning, preparation and providing post visit support to parents.

To ensure fidelity and adherance to the intervention protocol. Key workers responsible for the intervention delivery will attend training sessions, complete intervention checklists to ensure each component is provided to parents and will complete interviews prior to the intervention implementation and at follow up. The intervention will be supported by the research team until the conclusion of data collection, after approximately 9 months.

Parents will receive a 1x up to 1 hour session (including preparation and follow up) for each visit they attend with their children. The intervention will be delivered on at least 2 occasions between baseline and follow up dependent upon their case management plan.
The intervention will be administered face to face or over the phone depending upon the parent's needs.

Intervention code [1]

Behaviour

Comparator / control treatment

Control: Usual care. Children and parents in the control groups will continue to receive supervised contact services as outlined in their child protection case management plan as provided by the agencies. As this is usual care, it is not being delivered by the research team. Researchers will collect data on the services provided as part of ‘usual care’ to ensure comparisons can be made between intervention and control sites.

Control group

Active

Outcomes

Primary outcome [1]

Primary Outcome 1: Children’s emotional safety and distress related to contact as measured by the SDQ. A total score of 17 and above is considered within the clinical range.

This is a composite outcome.

Timepoint [1]

Timepoint: At initial recruitment into the study (prior to the intervention). It will also be measured at a 9 month follow up.

Secondary outcome [1]

Secondary outcome 1: Relationships between children and their parents as assessed using a qualitative interview and the Child Parent Relationship Scale.

Timepoint [1]

Timepoint: Completed pre intervention and at 9 month follow up.

Secondary outcome [2]

Secondary Outcome 2: The ability of parents to support children in the context of contact visits as assessed using a qualitative interview.

Timepoint [2]

Timepoint: Completed pre intervention and at 9 month follow up.

Secondary outcome [3]

Secondary outcome 3: The proportion of contact visits cancelled within the nine month follow-up period in comparison to a control group as assessed through self report and administrative data.

Timepoint [3]

Timepoint: Completed pre intervention and at 9 month follow up.

Eligibility

Key inclusion criteria

There are four groups of participants who will be recruited and interviewed as part of the study.

1. Children who are in permanent out-of-home care and have supervised contact managed by one of the participating agencies in ACT will be interviewed if they are aged between 8 and 14 years. Information will be collected from others about children (with consent).

2. Parents of children aged 0 to 14 years who are in permanent out-of-home care and have supervised contact managed by one of the participating agencies in ACT, NSW and Victoria.

3. Carers of these children are also eligible to participate.

4. Workers from the partner agencies allocated to the children in the study will also be invited to be interviewed.

Although parents, carers and workers are also to be interviewed, the sample is based on 180 child participants (90 in the intervention group and 90 in the control group).

Minimum age

0 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Participants with communication difficulties (cognitive or sensory, language barrier); serious psychological illnesses; and participants who do not consent to participate in the study. Participants will be assessed for suitability on a case by case basis as appropriate.

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)

This study is a cluster randomised controlled trial of an enhanced contact intervention with children in out-of-home care and their birth parents. Partner agencies are from three jurisdictions: ACT, NSW and Victoria.

Allocation to ‘intervention” and “control” sites was concealed as follows.

Randomisation in jurisdictions was undertaken at a meeting where representatives of all the participating agencies were present, to ensure transparency of the process.

As is standard in a cluster randomised trial, the intervention will be implemented across the intervention sites and all clients of that service will receive the intervention whether they are actively recruited into the study or not.

At each intervention and control site, children, parents and carers will be initially approached by workers from the Partner agencies. A researcher will provide more detail about the study. Informed Consent will be obtained from the person with parental responsibility for the child (parent, carer or the Department). Assent will also be obtained from the child after the study has been explained at a level appropriate to their age, in the ACT where children are interviewed.
For children in sibling groups simple randomisation using a randomisation table created by computer software to select the study child to be recruited and the focus of data collection in the interviews with parents, carers and workers. For eligible children without siblings no randomisation was used as the randomisation occured at the agency level.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Stratified allocation was employed in this study. Agencies were stratified by jurisdiction to ensure intervention and control sites in both the ACT and in Victoria. We paired the agency sites in both jurisdictions according to the size of the program based upon data collected from the agencies of eligible participants prior to randomisation. To minimise selection bias, for each of the nine pairs an independent researcher randomly allocated each agency (using opaque, identical, sealed envelopes) to the intervention group and the other to the control group. Simple randomisation was conducted by picking envelopes out of a box, resulting in 9 intervention and 9 control sites in the two jurisdictions. The four NSW sites were randomly selected using the above method.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

This is an open study; however, the training of agency staff and the monitoring of the fidelity of the intervention will be independent of the outcome data collection. The research team member providing the intervention training will not conduct baseline or follow up interviews with participants.

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

There are no estimates of effect size on which to base our sample size calculations, as there are no trials of contact interventions published. We have made some assumptions to determine the sample size necessary to detect change in the primary outcome variables (namely, increase children’s emotional safety and reduction in their distress related to contact) using PASS software (2014). As there are no estimates available for the matching correlation, we have used a conservative approach and estimated power using an unmatched cluster randomised design (Donner and Klar, 2000). Assuming an intracluster correlation coefficient of 0.06 (Miller-Lewis, Sawyer, Searle, Mittinty, Sawyer, Lynch, 2014) and an average cluster size of 10, randomising 18 clusters to two groups (i.e. Total n=180, i.e. 180 carers, 180 parents, 180 workers = 540 interviews) will yield 100% power to estimate an effect size of 1.0; 72% power to estimate an effect size of 0.5; and 39% power to estimate an effect size of 0.33.

NVivo will be used to analyse qualitative data, and quantitative data will be analysed using SPSS.

Comparisons of the control and intervention groups will be made at baseline by calculating descriptive statistics to assess randomisation. Analysis for the continuous primary outcome, SDQ, will be performed using a linear mixed model to allow for the matched, clustered design of the trial. We will adjust for the baseline value and any potential confounding variables that display baseline imbalance between intervention groups. Secondary outcomes will be analysed in a similar way. For dichotomous variables, we will use a generalised linear mixed model, which extends the standard logistic regression model to account for the clustered data. The qualitative data will be coded for themes and used to add additional context to the quantitative data.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

16/03/2015

Actual

18/03/2015

Date of last participant enrolment

Anticipated

30/11/2015

Actual

28/08/2018

Date of last data collection

Anticipated

30/06/2018

Actual

31/08/2018

Sample size

Target

180

Accrual to date

Final

183

Recruitment in Australia

Recruitment state(s)

ACT,NSW,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Research Council

Address [1]

GPO Box 2702
Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

University

Name [2]

Australian Catholic University

Address [2]

PO Box 256 DICKSON ACT 2602

Country [2]

Australia

Funding source category [3]

University

Name [3]

University of Melbourne

Address [3]

Parkville, Victoria, 3010

Country [3]

Australia

Funding source category [4]

Government body

Name [4]

ACT Community Services Directorate,

Address [4]

GPO Box 158 Canberra, City ACT 2601

Country [4]

Australia

Funding source category [5]

Charities/Societies/Foundations

Name [5]

Centre for Excellence in Child and Family Welfare

Address [5]

Level 5, 50 Market Street, Melbourne VIC 3000

Country [5]

Australia

Funding source category [6]

Charities/Societies/Foundations

Name [6]

Barnardos Australia

Address [6]

60-64 Bay Street Ultimo NSW 2007

Country [6]

Australia

Funding source category [7]

Charities/Societies/Foundations

Name [7]

Marymead Child and Family Centre

Address [7]

PO Box 4260 Kingston ACT 2604

Country [7]

Australia

Funding source category [8]

Government body

Name [8]

NSW Family and Community Services

Address [8]

2-4 Cavill Avenue
Ashfield NSW 2131

Country [8]

Australia

Primary sponsor type

University

Name

Australian Catholic University, Institute of Child Protection Studies

Address

PO Box 256 DICKSON ACT 2602

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Melbourne, Department of Social Work

Address [1]

Parkville, MELBOURNE VIC 3010

Country [1]

Australia

Secondary sponsor category [2]

Government body

Name [2]

NSW Family and Community Services (FACS)

Address [2]

4-6 Cavill Avenue
Ashfield 2130 NSW

Country [2]

Australia

Other collaborator category [1]

Individual

Name [1]

Professor Morag McArthur (Chief Investigator)
Director Institute of Child Protection Studies

Address [1]

Australian Catholic University PO Box 256 DICKSON ACT 2602

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Associate Professor Stephanie Taplin (Chief Investigator)
Associate Director Institute of Child Protection Studies

Address [2]

Australian Catholic University PO Box 256 DICKSON ACT 2602

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Professor Cathy Humphreys (Chief Investigator)
Alfred Felton Chair in Child and Family Welfare Social Work

Address [3]

University of Melbourne, Melbourne Victoria 3010

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Austin Kenney (Partner Investigator)

Address [4]

Community Services Directorate
GPO Box 158 Canberra, City ACT 2601

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Marilyn Webster (Partner Investigator)

Address [5]

Centre for Excellence in Child and Family Welfare
Level 5, 50 Market Street, Melbourne VIC 3000

Country [5]

Australia

Other collaborator category [6]

Individual

Name [6]

Amanda Tobler (Partner Investigator)

Address [6]

Marymead Child and Family Centre PO Box 4260 Kingston ACT 2604

Country [6]

Australia

Other collaborator category [7]

Individual

Name [7]

Annette Kelly-Edgerton (Partner Investigator)

Address [7]

Barnardos Australia 60-64 Bay Street Ultimo NSW 2007

Country [7]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Catholic University Human Research Ethics Committee

Ethics committee address [1]

Australian Catholic University PO Box 968 NORTH SYDNEY NSW 2059

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/11/2014

Ethics approval number [1]

2014 272N; 2014 273N

Summary

Brief summary

kContact is a three-year study to develop and trial an enhanced model of managing and supporting contact between children in care and their birth parents. The aim is to reduce current and future distress related to contact, improve children's relationships with their parents.

Trial website

http://www.acu.edu.au/about_acu/faculties,_institutes_and_centres/centres/institute_of_child_protection_studies/kcontact_project

Trial related presentations / publications

Taplin, S. & Bullen, T. (2016) kContact: a trial of a supervised contact intervention for children in out-of-home care and their parents. 21st ISPCAN International Congress on Child Abuse and Neglect. Calgary, Canada. 29-31 August 2016. 
Bullen, T. & Taplin, S. (2016) kContact study: Characteristics and perspectives of parents having supervised contact with their children in out-of-home care. 21st ISPCAN International Congress on Child Abuse and Neglect. Calgary, Canada. 29-31 August 2016. 
Bullen, T., Taplin, S., McArthur, M., Humphreys, C. Kertesz, M. (2017) Interventions to improve supervised contact visits between children in out of home care and their parents: A systematic review. Child & Family Social Work. 22(2), 822–833.
Taplin, S., Bullen, T., McArthur, M., Humphreys, C. Kertesz, M, Dobbins. T. (2015) kContact, an enhanced intervention for contact between children in out-of-home care and their parents: protocol for a cluster randomised controlled trial. BMC Public Health. 15 (1).

Public notes

Contacts

Principal investigator

Name

A/Prof Stephanie Taplin

Address

Institute of Child Protection Studies, Australian Catholic University
PO Box 256 DICKSON ACT 2602

Country

Australia

Phone

61 2 62091319

Fax

[email protected]

Contact person for public queries

Name

A/Prof Stephanie Taplin

Address

Institute of Child Protection Studies, Australian Catholic University
PO Box 256 DICKSON ACT 2602

Country

Australia

Phone

+61 2 62091319

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof Stephanie Taplin

Address

Institute of Child Protection Studies, Australian Catholic University
PO Box 256 DICKSON ACT 2602

Country

Australia

Phone

+61 2 6209 1319

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

The ethical approval does not allow for data sharing.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
284	Study protocol					367590-(Uploaded-16-11-2018-11-56-09)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	KContact, an enhanced intervention for contact between children in out-of-home care and their parents: protocol for a cluster randomised controlled trial.	2015	https://dx.doi.org/10.1186/s12889-015-2461-3

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically