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
ACTRN12616001551482
Ethics application status
Approved
Date submitted
2/11/2016
Date registered
10/11/2016
Date last updated
2/11/2018
Date data sharing statement initially provided
2/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Intensive Family Support Service: Implementation Outcomes Evaluation
Scientific title
Evaluation of the implementation and effectiveness of the Intensive Family Support Service (IFSS) targeting families of children (0-12) who have come to the attention of child protection service for concerns of child neglect.
Secondary ID [1] 290445 0
Nil Known
Universal Trial Number (UTN)
U1111-1189-3869
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child neglect 300811 0
Condition category
Condition code
Mental Health 300632 300632 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 300633 300633 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Intensive Family Support Service (IFSS) is targeted for families with children (0 – 12) who have come to the attention of child protection service for concerns of child neglect. IFSS is an evidenced-based parenting support service which aims to provide intensive support in the home and community, to reduce neglect. The goal is to ensure children:
* are adequately supervised
* have all their basic physical needs met
* have all their health needs met
* have their emotional and developmental needs met
* have their educational needs met

IFSS is a flexible, practical and intensive service that is tailored to the individual needs of each family. Trained IFSS workers work with families in their homes and local communities (face-t0 face support with additional communication via telephone if required) to develop and enhance their parenting skills.

The intervention will be personalised based on the initial assessment that includes semi-structured interview and observations at the family's home (e.g. Family Gathering Information tool and the Child Neglect Index). This will help to identify families needs - strengths/struggles/strategies working/new skills needed. The assessment might need to take a couple of sessions depending on the family structure (other people in the family that we might need to interview). The assessment is done by the IFSS worker (they are supervised by practice coaches). Based on the assessment, goals for each family will be identified and a Family Support Plan will be developed - that matches teaching a support strategies to the family's strengths, needs and learning style. Further, a specific, time-lined action plan will be developed - what will be done, by whom and for how long. New skills will be practiced at home - based on the strategy that includes modelling of skills by the worker - practicing of skills by the caregiver - and feedback provided to the family by the worker. The intensive service may require workers to do multiple home visits/phone calls per week.

It is anticipated that each family will receive at least 2 hours of support per week until the set goals have been achieved (e.g. CNI score below 50). Subsequently, families do not necessarily receive IFSS care for the entire 12 month intervention period. Regular assessment during the family’s involvement in the program (every 3 months) will inform case closure decisions. If the family requires more than 12 months with IFSS, an assessment of the family’s circumstances is required to understand the progress made to date and whether the family is likely to achieve their goals within an extended defined timeframe. IFSS focuses on increasing parental capacity and skills rather than creating dependency or prolonging decisions about a child’s ability to safely remain with their family.

IFSS workers may provide the following support and services:

1. Develop plans and goals in partnership with families to meet their children’s needs
2. Provide ongoing assessment and support of the caregiver’s strengths and challenges
3. Provide ongoing assessment of the child's needs and case progress
4. Provide practical and structured in home assistance
5. Support the development of social support
6. Referral and coordination of services
7. Support families to access other specialist services the family needs
8. Link families to community networks.

IFSS workers have knowledge and experience working with Aboriginal and Torres Strait Islander families as well as families from low socio-economic and socially or geographically isolated regions.

Intervention adherence:
The Process and Implementation Evaluation will use data collected routinely by agencies and used to inform provider agency progress reports to external agencies (e.g., data submitted to DSS’s DEX data capture system) and internally, as well as data collected using standardised and non-standardised questionnaires completed by providers and family members, and tracking sheets completed by providers, training and coaching information collected by the PRC as part of the implementation support process, and information collected via in-depth interviews with families and agency staff regarding the implementation of IFSS. Furthermore, the evaluation will access existing available data from sources such as Centrelink records to measure the size of the target population.

The use of the IFSS model as intended (often referred to as fidelity or adherence) and the use of implementation supports to monitor and improve IFSS implementation will be measured over the duration of the evaluation period using fidelity assessment tools, data collected by practice coaches and family and provider questionnaires tailor-developed by the PRC.

Specifically, program fidelity data will be gathered using:
* A brief IFSS Dynamic Fidelity Questionnaire: This questionnaire will capture caregivers’ perceptions about the quality and content of the service being delivered in the home-visit setting, including the working relationship between the IFSS worker and the caregiver. Administration of this tool will be via a smartphone/tablet app completed at the end of one home visiting session with each client every three months (at the same time as CNI collection). The measure will be completed independently by a caregiver, who will be handed the tablet or smartphone to independently complete the brief survey. Such data will be shared with workers and agencies only at an aggregate level (i.e., in non-identifiable form presented as group data across workers) by PRC and used to give feedback to all workers from a particular agency as a group as a quality assurance method aimed at improving fidelity to the IFSS model.
* Data collected about the type, frequency and duration of quality assurance or implementation support strategies adopted (e.g., dates of training and coaching session, duration and content of coaching sessions): Data will be captured by PRC Practice Coaches regarding which coach did what, with who, for how long, as well as making note of whether workers are completing assessments at the time they are due (e.g., CNI with families every 3 months). Practice Coaches, and used by the implementation team to target and refine the implementation supports provided to sites as part of the CQI process, as well as to measure the quantity of different types of implementation supports delivered to each IFSS caseworker. This data will be entered by PRCH Practice Coaches, and used in the evaluation to assess the correlation between implementation supports provided and family outcomes achieved.
* Ratings of IFSS workers’ adherence and competence in delivery of the intervention will be made by Practice Coaches at regular intervals, by attending and observing worker and parent sessions. This information will be entered into the PRC’s coaching database by PRC Practice Coaches, and used by the implementation team to target and refine the implementation supports provided to sites as part of the CQI process. Furthermore, this data will be used for the evaluation, to track changes in workers’ adherence to the IFSS model and competence in delivering IFSS. This data will be used to determine the association between worker fidelity to the model and family outcomes.
* Collection of information about staff tenure and turnover will be regularly captured to identify the potential impact of staffing changes on the ability of the provider to reach the intended target population and to meet the needs of children and families referred to IFSS.
Intervention code [1] 296298 0
Behaviour
Intervention code [2] 296299 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300044 0
Primary Outcome: A change in total score on the Child Neglect Index (CNI).

The CNI is a widely used brief instrument designed to provide child welfare practitioners and researchers with a reliable and valid measure of the type and severity of neglect (Trocme, 1996). The CNI has demonstrated evidence for a moderate correlation with other measures of child wellbeing (e.g., r = -.65 with the Child Well-Being scale), good test-retest reliability (i.e., scores ranged from .83 to .91) and good inter-rater reliability (scores ranged from .69 to .95) (Trocme, 1996). In addition to providing a quantitative indication of child safety, health and wellbeing, the CNI also allows practically meaningful interpretation of results. The CNI domains cover Physical Care (Food/Nutrition and Clothing and Hygiene), Provision of Health Care (Physical Health Care, Mental Health Care, and Development and Educational Care), and Supervision (Physical Harm/Sexual Assault/Criminal Activity). In consultation with the scale’s developer, the PRC added an additional domain – ‘Warm and Responsive Parenting’ which was used in the previous evaluation of IFSS (Mildon et al., 2014). Each scale is rated on a five level severity scale, ranging from adequate to seriously inadequate. For all scales, an inadequate or neglect rating requires either evidence of impairment or harm or exposure to situations that could cause harm. Scoring of the CNI provides subscale scores and a Total score, calculated incorporating consideration of the child’s age.
Timepoint [1] 300044 0
The CNI is completed by IFSS workers at service initiation (baseline) and again every 3 months, until service completion (due to successful goal achievement) or termination of services (e.g., due to family moving out of service catchment area). A final CNI is completed where possible at the close of service delivery for each child.
Primary outcome [2] 300079 0
A change in sub-scale score in 'Physical Care' on the CNI indicative of parents strengths and weaknesses relating to the remediation of child neglect.

Instrument: CNI.
Timepoint [2] 300079 0
The CNI is completed by IFSS workers at service initiation (baseline) and again every 3 months, until service completion (due to successful goal achievement) or termination of services (e.g., due to family moving out of service catchment area). A final CNI is completed where possible at the close of service delivery for each child.
Primary outcome [3] 300129 0
A change in sub-scale score in 'Provision of Health Care' on the CNI indicative of parents strengths and weaknesses relating to the remediation of child neglect.

Instrument: CNI.
Timepoint [3] 300129 0
The CNI is completed by IFSS workers at service initiation (baseline) and again every 3 months, until service completion (due to successful goal achievement) or termination of services (e.g., due to family moving out of service catchment area). A final CNI is completed where possible at the close of service delivery for each child.
Secondary outcome [1] 328907 0
Primary Outcome: A change in sub-scale score in 'Supervision' on the CNI indicative of parents strengths and weaknesses relating to the remediation of child neglect.

Instrument: CNI.
Timepoint [1] 328907 0
The CNI is completed by IFSS workers at service initiation (baseline) and again every 3 months, until service completion (due to successful goal achievement) or termination of services (e.g., due to family moving out of service catchment area). A final CNI is completed where possible at the close of service delivery for each child.
Secondary outcome [2] 328914 0
Primary Outcome: A change in sub-scale score in 'Warm and Responsive Parenting' on the CNI indicative of parents strengths and weaknesses relating to the remediation of child neglect.

Instrument: CNI.
Timepoint [2] 328914 0
The CNI is completed by IFSS workers at service initiation (baseline) and again every 3 months, until service completion (due to successful goal achievement) or termination of services (e.g., due to family moving out of service catchment area). A final CNI is completed where possible at the close of service delivery for each child.
Secondary outcome [3] 328915 0
Secondary Outcome: An indication of the effectiveness of IFSS, measured as the proportion of participants exiting due to goals being met

Instrument: Case Exit Form, developed for the research.
Timepoint [3] 328915 0
Information about when and why each family exited the IFSS program, will be collected by provider agencies at service exit and reported back on a quarterly basis.
Secondary outcome [4] 328955 0
Secondary Outcome: Family satisfaction with IFSS

Instrument: Client Exit Form developed for the purpose of the research.
Timepoint [4] 328955 0
Completed at family exit from service
Secondary outcome [5] 329121 0
Outcome: Identification of drivers and barriers to service delivery from the perspective of different IFSS stakeholders

Instruments: Semi-structured interviews as well as the administration of the Evidence-Based Practices Attitudes Scale (EBPAS) (Aarons, 2005) and a questionnaire to measure of agency’s readiness to implement IFSS (incorporating items specifically developed by the research team relevant to the readiness for IFSS implementation as well as items adapted from the Readiness for Organizational Change Scale; Holt et al., 2007).
Timepoint [5] 329121 0
The agency readiness measure will be administered as an initial step to implementation and will give an indication of each sites readiness to move through the implementation process and when best to initiate service delivery.

The EBPAS is completed at the initial face-to-face worker training prior to service delivery.

Semi-structured interviews will be completed in the continuum of stages of implementation I(from pre-implementation, to early implementation, to full implementation through to sustainability).
Secondary outcome [6] 329122 0
Outcome: Exploration of the impact of IFSS on service families from the perspective of different IFSS stakeholders

Instrument; Semi-structured interviews
Timepoint [6] 329122 0
It is anticipated that semi-structured interviews will be completed at full implementation and sustainability stages of service implementation

Eligibility
Key inclusion criteria
. Families of children aged 0 to 12 years who have come to the attention of child protection services for child neglect.
2. Family lives in funded IFSS areas : Northern Territory and select communities within the Anangu Pitjantjatjara Yankunyatjatjara (APY) Lands of South Australia.

Referral pathways include:
- via State or Territory child protection agency
- community referrals (e.g., schools)

In selected remote service areas, Priority of Access will apply in service areas where there is a limited child protection footprint . This will ensure that families on Child Protection Income Management (CPIM) continue to have priority access to the service, but also allow for other families in the community who may not be on CPIM or engaged with child protection authorities to access the program while there are vacancies.

Overall, participation is voluntary.
Minimum age
0 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The research will comprise two components:
1. The Outcomes Evaluation which will employ methods adopted from traditional program evaluation designs, measuring the effects of Intensive Family Support Service (IFSS) on key child and family outcomes (e.g., using the Child Neglect Index), and using qualitative and data capture methods to explore the impact of IFSS for children and families, as well as views on the strengths and weaknesses of the IFSS.
2. The Process and Implementation Evaluation which will employ CQI methods to measure implementation support elements of service delivery and worker development using detailed process and implementation data provided by the agencies or collected by the Parenting Research Centre (PRC) through training and coaching processes. This aspect of the evaluation will contribute information about the determinants of outcomes associated with IFSS, the fidelity of implementation of IFSS, and the availability of the service to eligible families (reach).
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size calculation:
A priori power analysis for a t-test indicated a sample size of 34 families will be needed to have 80% power to detect a medium sized effect when employing .05 level of statistical significance (for repeated measure ANOVA - within factors - 24 families; for regression analysis with 5 IVs - 91 families) - as based on GPower analyses.

Analysis plan:
Analysis will involve visual inspection and statistical analysis of trends over time, aggregated across families by site/provider. At a minimum, repeated measures ANOVA of the CNI scores while controlling for key demographic and case-level factors will be performed to analyse change in CNI scores with intervention. Where possible (i.e., for agencies providing data about the implementation of IFSS, such as participation in coaching and fidelity to the IFSS model) we will also explore the effects of implementation-relevant variables on overall changes in CNI scores.

If sample size allows, we will increase the complexity of analysis by using multi-level modelling to account for the nesting of multiple observations in individuals, and nesting of cases within sites. For instance, multi-level growth curve analysis or hierarchical linear modelling (HLM) may enable us to detect whether intervention effects (i.e., changes in CNI scores over time) are related to a predictor (e.g., site or score at intake), as such variables can be added as predictors in a model proposed to explain intervention effects (van den Noorgate & Onghema, 2003a, 2003b).

Where sample size permits, statistical analysis may also include the calculation of difference scores (e.g., Hedges g) and standardised effect size scores, which would allow examination of whether intervention effects for different subgroups have the same magnitude. We can also use standardized effect sizes to see whether effects from this evaluation are of the same magnitude as effects from studies of other child neglect-focused interventions using between-groups designs including randomised controlled trials. Therefore, standardised effect size calculations give us an indication of the relative strength of the effect of the IFSS intervention, compared to other family support and parenting interventions.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
14/11/2016
Actual
1/03/2017
Date of last participant enrolment
Anticipated
Actual
23/08/2017
Date of last data collection
Anticipated
30/06/2018
Actual
23/08/2017
Sample size
Target
91
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
NT,SA

Funding & Sponsors
Funding source category [1] 294860 0
Government body
Name [1] 294860 0
Australian Department of Social Services (DSS)
Country [1] 294860 0
Australia
Primary sponsor type
Other
Name
Parenting Research Centre
Address
Level 5, 232 Victoria Parade
East Melbourne, VIC 3002
Country
Australia
Secondary sponsor category [1] 293701 0
None
Name [1] 293701 0
Address [1] 293701 0
Country [1] 293701 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296243 0
Central Australian Human Research Ethics Committee (EC00155)
Ethics committee address [1] 296243 0
Ethics committee country [1] 296243 0
Australia
Date submitted for ethics approval [1] 296243 0
31/08/2016
Approval date [1] 296243 0
16/09/2016
Ethics approval number [1] 296243 0
HREC-16-431
Ethics committee name [2] 296244 0
Parenting Research Centre Human Research Ethics Committee (EC00437)
Ethics committee address [2] 296244 0
Ethics committee country [2] 296244 0
Australia
Date submitted for ethics approval [2] 296244 0
31/08/2016
Approval date [2] 296244 0
16/09/2016
Ethics approval number [2] 296244 0
HREC-16-431
Ethics committee name [3] 299149 0
Top End (Menzies) HREC
Ethics committee address [3] 299149 0
Ethics committee country [3] 299149 0
Australia
Date submitted for ethics approval [3] 299149 0
28/06/2017
Approval date [3] 299149 0
26/07/2017
Ethics approval number [3] 299149 0
2017-2897

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

Contacts
Principal investigator
Name 70114 0
Dr Catherine Wade
Address 70114 0
Parenting Research Centre
Level 5, 232 Victoria Parade
East Melbourne, VIC, 3002
Country 70114 0
Australia
Phone 70114 0
+6138660 3519
Fax 70114 0
Email 70114 0
[email protected]
Contact person for public queries
Name 70115 0
Catherine Wade
Address 70115 0
Parenting Research Centre
Level 5, 232 Victoria Parade
East Melbourne, VIC, 3002
Country 70115 0
Australia
Phone 70115 0
+61386603519
Fax 70115 0
Email 70115 0
[email protected]
Contact person for scientific queries
Name 70116 0
Catherine Wade
Address 70116 0
Parenting Research Centre
Level 5, 232 Victoria Parade
East Melbourne, VIC, 3002
Country 70116 0
Australia
Phone 70116 0
+61386603519
Fax 70116 0
Email 70116 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Early cessation of research.


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.