| Randomisation unit | Individual |
| Sample size | Each of the three sites anticipates enrolling 60 participants (30 per arm). The total target sample size is therefore 180 participants (90 per arm) with an anticipated 135 (75%) providing 6-month data. As reported by Teare et al, who assessed the sample size requirements of external pilot RCTs, this sample size will be sufficient to estimate the critical parameters of continuous or binary primary outcomes for the definitive RCT (of n=70/120 for continuous/binary outcomes), including poverty or poor parental mental health.46 The sample size was chosen pragmatically and in discussion with the participating sites as being possible relative to the study duration. |
| Intervention arm | Financial counselling |
| Control arm | Usual care plus money advice information |
| Inclusion criteria | The parent or caregiver of a young child aged from birth to 5 years old. A client of the participating CFH services. Living inside the geographical boundaries serviced by the participating financial counselling organisations. Reporting at least one risk factor for financial hardship, as screened by the CFH nurse (see box 1).
The research is designed to include families with low literacy and who speak languages other than English. All communication can be conducted by phone or video, and interpreters are engaged to support families as required/requested. Due to the constraints of the pilot funding and resources, participating caregivers in the culturally diverse NSW site need to be fluent in at least one of the four most common languages: English, Arabic, Assyrian and Vietnamese.47 The main study documents will also be translated into these languages to increase engagement with potential participants. |
| Exclusion criteria | Participants meeting any of the following criteria at screening or enrolment are excluded from the pilot study:Do not comprehend the recruitment invitation using phone/video communication and interpreters as required/requested (eg, due to substantial cognitive disability). Already enrolled and assigned a research participant ID. Have no mechanism for contact (telephone or email). Already an active client in a financial counselling service.
Participants identified as high risk for high-impact consequences (ie, assets or income at immediate risk, loss of accommodation or loss of access to essential utilities likely) are not randomised; this group (termed ‘priority 1’) is referred directly to financial counselling. For those who consent, research data are collected to inform the feasibility of the study. |
Outcome of feasibility trial for progressing to large-scale trial
(Stop–Go criteria) | Definite Go (‘green light’) defined as:≥50% of eligible participants consenting to pilot trial. ≥60% of those in the intervention arm receiving the intervention. ≥60% retention of consented participants to 6-month follow-up questionnaire.
Definite Stop (‘red light’) defined as:<30% of eligible participants consenting to pilot trial. <30% of those in the intervention arm receiving the intervention. <30% retention of consented participants to 6-month follow-up questionnaire.
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| Primary outcome: feasibility | Number/proportion of:Potential participants who agree to complete screening survey (nurse report based on service records). Eligible clients who consent to participate (nurse and study records). Intervention participants who access, attend and complete the financial counselling intervention (financial counsellor report, participant report). Participants who complete the 6-month follow-up data collection questionnaire (collected by phone or in person) (study completion records).
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| Secondary outcomes: impact | Measured at 3 and 6 months post-enrolment via participant report:Household income, sources of income and types of loans, measured using questions adapted from the Household, Income and Labour Dynamics in Australia (HILDA)39 Survey and Longitudinal Study of Australian Children (LSAC).40 Meeting household costs, using questions adapted from the HILDA39 Survey, Australian Research Alliance for Children and Youth Nest Survey,3 and Community Understanding of Poverty and Social Exclusion Survey.41 Caregiver general health, measured using the General Health Questionnaire 148 49 and the EuroQol five-dimensional questionnaire.43 50 Caregiver mental health, measured using Depression, Anxiety, Stress Scale short-form.51 Parenting efficacy, using questions from the LSAC.40 Use of financial services, measured with study-designed questions.
And at 6 months post-enrolment via interview:Nurse, financial counsellor and caregiver views on the feasibility of the research processes, and impacts on caregivers and children.
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| Randomisation procedure | A statistician prepares the randomisation schedule using block randomisation. Participants are randomly assigned to either control or intervention arm with a 1:1 allocation following a computer-generated randomisation schedule stratified by site, using permuted blocks. |
| Blinding (masking) | The researchers assessing the outcomes and analysing the data are blind to randomisation status. |