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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] 285923 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
kContact
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child Welfare 293846 0
Parenting 293847 0
Family Contact 293848 0
Mental Health 293849 0
Condition category
Condition code
Mental Health 294149 294149 0 0
Other mental health disorders
Public Health 294150 294150 0 0
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] 290899 0
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] 294441 0
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] 294441 0
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] 313313 0
Secondary outcome 1: Relationships between children and their parents as assessed using a qualitative interview and the Child Parent Relationship Scale.
Timepoint [1] 313313 0
Timepoint: Completed pre intervention and at 9 month follow up.
Secondary outcome [2] 313314 0
Secondary Outcome 2: The ability of parents to support children in the context of contact visits as assessed using a qualitative interview.
Timepoint [2] 313314 0
Timepoint: Completed pre intervention and at 9 month follow up.
Secondary outcome [3] 313315 0
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] 313315 0
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] 290502 0
Government body
Name [1] 290502 0
Australian Research Council
Country [1] 290502 0
Australia
Funding source category [2] 290503 0
University
Name [2] 290503 0
Australian Catholic University
Country [2] 290503 0
Australia
Funding source category [3] 290504 0
University
Name [3] 290504 0
University of Melbourne
Country [3] 290504 0
Australia
Funding source category [4] 290505 0
Government body
Name [4] 290505 0
ACT Community Services Directorate,

Country [4] 290505 0
Australia
Funding source category [5] 290506 0
Charities/Societies/Foundations
Name [5] 290506 0
Centre for Excellence in Child and Family Welfare
Country [5] 290506 0
Australia
Funding source category [6] 290507 0
Charities/Societies/Foundations
Name [6] 290507 0
Barnardos Australia
Country [6] 290507 0
Australia
Funding source category [7] 290508 0
Charities/Societies/Foundations
Name [7] 290508 0
Marymead Child and Family Centre
Country [7] 290508 0
Australia
Funding source category [8] 301220 0
Government body
Name [8] 301220 0
NSW Family and Community Services
Country [8] 301220 0
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] 289201 0
University
Name [1] 289201 0
University of Melbourne, Department of Social Work
Address [1] 289201 0
Parkville, MELBOURNE VIC 3010
Country [1] 289201 0
Australia
Secondary sponsor category [2] 297182 0
Government body
Name [2] 297182 0
NSW Family and Community Services (FACS)
Address [2] 297182 0
4-6 Cavill Avenue
Ashfield 2130 NSW
Country [2] 297182 0
Australia
Other collaborator category [1] 278276 0
Individual
Name [1] 278276 0
Professor Morag McArthur (Chief Investigator)
Director Institute of Child Protection Studies
Address [1] 278276 0
Australian Catholic University PO Box 256 DICKSON ACT 2602
Country [1] 278276 0
Australia
Other collaborator category [2] 278277 0
Individual
Name [2] 278277 0
Associate Professor Stephanie Taplin (Chief Investigator)
Associate Director Institute of Child Protection Studies
Address [2] 278277 0
Australian Catholic University PO Box 256 DICKSON ACT 2602
Country [2] 278277 0
Australia
Other collaborator category [3] 278278 0
Individual
Name [3] 278278 0
Professor Cathy Humphreys (Chief Investigator)
Alfred Felton Chair in Child and Family Welfare Social Work
Address [3] 278278 0
University of Melbourne, Melbourne Victoria 3010
Country [3] 278278 0
Australia
Other collaborator category [4] 278279 0
Individual
Name [4] 278279 0
Austin Kenney (Partner Investigator)
Address [4] 278279 0
Community Services Directorate
GPO Box 158 Canberra, City ACT 2601
Country [4] 278279 0
Australia
Other collaborator category [5] 278280 0
Individual
Name [5] 278280 0
Marilyn Webster (Partner Investigator)
Address [5] 278280 0
Centre for Excellence in Child and Family Welfare
Level 5, 50 Market Street, Melbourne VIC 3000
Country [5] 278280 0
Australia
Other collaborator category [6] 278281 0
Individual
Name [6] 278281 0
Amanda Tobler (Partner Investigator)
Address [6] 278281 0
Marymead Child and Family Centre PO Box 4260 Kingston ACT 2604
Country [6] 278281 0
Australia
Other collaborator category [7] 278282 0
Individual
Name [7] 278282 0
Annette Kelly-Edgerton (Partner Investigator)
Address [7] 278282 0
Barnardos Australia 60-64 Bay Street Ultimo NSW 2007
Country [7] 278282 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292161 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 292161 0
Ethics committee country [1] 292161 0
Australia
Date submitted for ethics approval [1] 292161 0
Approval date [1] 292161 0
13/11/2014
Ethics approval number [1] 292161 0
2014 272N; 2014 273N

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

Contacts
Principal investigator
Name 53418 0
A/Prof Stephanie Taplin
Address 53418 0
Institute of Child Protection Studies, Australian Catholic University
PO Box 256 DICKSON ACT 2602
Country 53418 0
Australia
Phone 53418 0
61 2 62091319
Fax 53418 0
Email 53418 0
stephanie.taplin@acu.edu.au
Contact person for public queries
Name 53419 0
A/Prof Stephanie Taplin
Address 53419 0
Institute of Child Protection Studies, Australian Catholic University
PO Box 256 DICKSON ACT 2602
Country 53419 0
Australia
Phone 53419 0
+61 2 62091319
Fax 53419 0
Email 53419 0
stephanie.taplin@acu.edu.au
Contact person for scientific queries
Name 53420 0
A/Prof Stephanie Taplin
Address 53420 0
Institute of Child Protection Studies, Australian Catholic University
PO Box 256 DICKSON ACT 2602
Country 53420 0
Australia
Phone 53420 0
+61 2 6209 1319
Fax 53420 0
Email 53420 0
stephanie.taplin@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The ethical approval does not allow for data sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
284Study 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
SourceTitleYear of PublicationDOI
EmbaseKContact, an enhanced intervention for contact between children in out-of-home care and their parents: protocol for a cluster randomised controlled trial.2015https://dx.doi.org/10.1186/s12889-015-2461-3
N.B. These documents automatically identified may not have been verified by the study sponsor.