Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001443785
Ethics application status
Approved
Date submitted
21/10/2022
Date registered
11/11/2022
Date last updated
11/11/2022
Date data sharing statement initially provided
11/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a national helpline service (ForWhen) to support perinatal and infant mental health
Scientific title
Evaluation of a national patient navigation program (ForWhen) to support perinatal and infant mental health
Secondary ID [1] 307051 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal Mood and Anxiety Disorders 326196 0
Condition category
Condition code
Mental Health 323496 323496 0 0
Anxiety
Mental Health 323497 323497 0 0
Depression
Mental Health 323498 323498 0 0
Psychosis and personality disorders
Mental Health 323499 323499 0 0
Other mental health disorders
Reproductive Health and Childbirth 325018 325018 0 0
Antenatal care
Reproductive Health and Childbirth 325019 325019 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The ForWhen program is a national Australian navigation service which helps to connect parents and carers experiencing mental health concerns during the perinatal period with appropriate mental health support in their local area. Clients access the service by contacting the ForWhen helpline, which connects them to a ForWhen Navigator located in their state/territory. ForWhen Navigators assess clients' mental health concerns and needs, offer emotional support and psychoeducation, and coordinate referrals for clients experiencing moderate to severe perinatal and infant mental health concerns to professional mental health support.

ForWhen navigators are clinically trained professionals (e.g., nurses, social workers, psychologists) employed on the program. Navigators conduct an initial assessment with all clients lasting approximately 60 minutes. Navigators typically conduct follow-up with clients to offer further emotional support and psychoeducation, and ensure they have successfully accessed referred services, although the frequency and overall duration of follow-up varies based on individual client needs (e.g., once per week for 4 weeks, until first appointment with a perinatal psychologist).

This study is an evaluation of the ForWhen program. The ForWhen program is available to anyone who wishes to access it, regardless of whether or not they choose to participate in this study. A mixed-methods evaluation design will be utilised, including a review of de-identified routinely collected service data between February 2022 and June 2024, and a range of additional qualitative and quantitative data collected at various points over the 3-year evaluation period in order to achieve the evaluation aims.

Routinely collected service data includes data relating to individual clients and service provision collected by navigators and managed via a Customer Relationship Management (CRM) database. At program entry (baseline), navigators administer the Kessler Psychological Distress Scale (K10) as part of a routine mental health assessment, and collect client data including demographic information and identified psychosocial risk factors during an intake interview. Throughout each client’s engagement with the program, individual service provision data including number and mode of contacts with the navigator, services provided by the navigator (e.g., psychoeducation), and the number and types of referrals made, are routinely recorded by navigators in the CRM database. At program exit (discharge), an optional survey is emailed to participants which assesses satsifaction with the ForWhen program. At follow-up (10 weeks post-discharge), an additional optional survey is emailed to participants, which includes the K10 and questions about engagement with referred services.

During a 6-month period in the second year of the program, the research/evaluation team will recruit ForWhen clients to an opt-in ‘snapshot study’ to evaluate the program’s impact on additional parent and infant outcomes. All clients who access ForWhen during this study period will be eligible to participate, and will receive an invitation phone call from a member of the research team within one week of their first contact with the ForWhen navigator. Those who opt-in will be asked to complete a series of validated questionnaires at baseline (within one week of accessing the service) and follow-up (10-12 weeks after program exit) either online or over the phone with a member of the research team. These questionnaires will take approximately 10-20 minutes to complete. Participants will provide written informed consent for this data to be linked to their client information held in the CRM database.

Finally, clients who opt to participate in the 'snapshot study' will be invited to participate in a semi-structured interview about their experiences with the ForWhen program during the 10-12 week follow-up. Those who opt-in will complete a debrief interview with a member of the research team via phone, lasting approximately 15-20 mins.

Semi-structured interviews will also be conducted with stakeholders (navigators, managers, steering committee members) of the ForWhen program during Yr 1 and Yr 3 of its implementation. ForWhen stakeholders will be invited to participate in these interviews by a member of the research/evaluation team via email and will provide informed written consent. Interviews will be conducted via video conferencing software or phone, and last approximately 60 minutes.
Intervention code [1] 323502 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331246 0
Impact of the ForWhen program on clients' levels of psychological distress.

This outcome will be measured by comparing participants' pre-post scores on the Kessler Psychological Distress Scale (K10). The K10 will be administered to all participants at baseline (program admission), and at 10 weeks following case closure (program discharge), as part of ForWhen routinely collected service data. Data will be analysed from those participants who opt to complete both the baseline and follow-up measures.
Timepoint [1] 331246 0
As part of ForWhen routinely collected service data, the K10 will be administered at baseline (program admission), and 10 weeks after case closure (program discharge).
Primary outcome [2] 331247 0
Client satisfaction with the ForWhen program.

This outcome will be measured using the Navigation Satisfaction Tool (NAVSAT). The satisfaction items will be administered as part of a survey distributed to all participants at case closure (program discharge), as part of ForWhen routinely collected service data. Data will be analysed from those participants who opt to complete the survey.
Timepoint [2] 331247 0
As part of ForWhen routinely collected service data, the NAVSAT will be administered at case closure (program discharge).
Primary outcome [3] 331251 0
Client experiences of the ForWhen program.

This outcome will be measured through semi-structured interviews with clients of the ForWhen program, to synthesise feedback on how the ForWhen program can best meet clients' needs and improve clinical outcomes.

Clients who opt to particpate in the 'snapshot study' will be invited to participate in a semi-structured debrief interview during the 10 week follow-up. These interviews will be conducted by a member of the research/evaluation team via phone, and last approximately 15-20 minutes.
Timepoint [3] 331251 0
As part of the 'snapshot study', this data will be collected from participants 10-12 weeks after case closure (program discharge). These interviews will be conducted during Yr 2 of the program implementation.
Secondary outcome [1] 409307 0
Barriers and facilitators to program success.

This composite outcome will be assessed through semi-structured interviews with stakeholders (e.g., navigators, managers, steering committee members) of the ForWhen program. ForWhen stakeholders will be invited via email to participate in a semi-structured interview with a member of the research/evaluation team. These interviews will be conducted via video conferencing software or phone, and will last approximately 60 minutes. Interviews will be conducted during Yr 1 and Yr 3 of program implementation.
Timepoint [1] 409307 0
Semi-structured interviews with ForWhen stakeholders will be conducted during Yr 1 and Yr 3 of program implementation.
Secondary outcome [2] 409308 0
Referrers' satisfaction with the ForWhen navigation program.

This outcome will be measured using the Navigation Satisfaction Tool (NAVSAT). The satisfaction items will be administered as part of a survey distributed to all participants at case closure (program discharge), including referrer users (e.g., health professionals), as part of ForWhen routinely collected service data. Data will be analysed from those participants who opt to complete the survey.
Timepoint [2] 409308 0
As part of ForWhen routinely collected service data, the NAVSAT will be administered at case closure (program discharge).
Secondary outcome [3] 414882 0
Collaborative relationship between clients and ForWhen Navigators, as assessed by clients.

This outcome will be measured using the 5-item Consultation and Relational Empathy (CARE) Measure, administered as part of a survey distributed to all clients at case closure (program discharge), as part of ForWhen routinely collected service data. Data will be analysed from those participants who opt to complete the survey.
Timepoint [3] 414882 0
As part of ForWhen routinely collected service data, the CARE will be administered at case closure (program discharge).
Secondary outcome [4] 414883 0
ForWhen service reach and coverage.

This outcome will be measured through a review of deidentified routinely collected service data, including client demographic information such as age, sex, location (postcode), language, and cultural background. This case-level data will be automatically collected for all clients of the ForWhen program and retrospectively reviewed by our research team.
Timepoint [4] 414883 0
As part of ForWhen routinely collected service data, this information will be recorded throughout clients' engagement with the service in the CRM database, Client data will be accessed at case closure (program discharge).
Secondary outcome [5] 414884 0
Client-reported parental self-efficacy.

This outcome will be measured by comparing participants' pre-post scores on the Me as a Parent – short form (MaaP-SF). During a 6-month period, all clients of the ForWhen service will be invited to participate in an optional 'snapshot study', in which they will complete some additional questionnaires administered by the research/evaluation team via phone or online survey. The MaaP-SF will be administered to all 'snapshot study' participants at baseline (program admission), and at 10 weeks following case closure (program discharge). Data will be analysed from those participants who opt to complete both the baseline and follow-up measures.
Timepoint [5] 414884 0
As part of the 'snapshot study', this data will be collected from participants at baseline (program admission), and 10 weeks after case closure (program discharge).
Secondary outcome [6] 414885 0
Client-reported quality of life.

This outcome will be measured by comparing participants' pre-post scores on the Personal Wellbeing Index (PWI). During a 6-month period, all clients of the ForWhen service will be invited to participate in an optional 'snapshot study', in which they will complete some additional questionnaires administered by the research/evaluation team via phone or online survey. The PWI will be administered to all 'snapshot study' participants at baseline (program admission), and at 10 weeks following case closure (program discharge). Data will be analysed from those participants who opt to complete both the baseline and follow-up measures.
Timepoint [6] 414885 0
As part of the 'snapshot study', the PWI will be administered at baseline (program admission), and 10 weeks after case closure (program discharge).
Secondary outcome [7] 414886 0
Client-reported help-seeking behaviours.

This outcome will be measured by comparing participants' pre-post scores on the General Help-Seeking Questionnaire (GHSQ). During a 6-month period, all clients of the ForWhen service will be invited to participate in an optional 'snapshot study', in which they will complete some additional questionnaires administered by the research/evaluation team via phone or online survey. The GHSQ will be administered to all 'snapshot study' participants at baseline (program admission), and at 10 weeks following case closure (program discharge). Data will be analysed from those participants who opt to complete both the baseline and follow-up measures.
Timepoint [7] 414886 0
As part of the 'snapshot study', the GHSQ will be administered at baseline (program admission), and 10 weeks after case closure (program discharge).
Secondary outcome [8] 414887 0
Client-reported self-compassion and self-care.

This outcome will be measured by comparing participants' pre-post scores on questions developed by the Parenting Research Centre (PRC). During a 6-month period, all clients of the ForWhen service will be invited to participate in an optional 'snapshot study', in which they will complete some additional questionnaires administered by the research/evaluation team via phone or online survey. The PRC questions will be administered to all 'snapshot study' participants at baseline (program admission), and at 10 weeks following case closure (program discharge). Data will be analysed from those participants who opt to complete both the baseline and follow-up measures.
Timepoint [8] 414887 0
As part of the 'snapshot study', the PRC questions will be administered at baseline (program admission), and 10 weeks after case closure (program discharge).
Secondary outcome [9] 414888 0
Client-reported parent and infant bonding.

This outcome will be measured by comparing participants' pre-post scores on the Mother-to-Infant Bonding scale (MIBS). During a 6-month period, all clients of the ForWhen service will be invited to participate in an optional 'snapshot study', in which they will complete some additional questionnaires administered by the research/evaluation team via phone or online survey. The MIBS will be administered to all 'snapshot study' participants at baseline (program admission), and at 10 weeks following case closure (program discharge). Data will be analysed from those participants who opt to complete both the baseline and follow-up measures.
Timepoint [9] 414888 0
As part of the 'snapshot study', the MIBS will be administered at baseline (program admission), and 10 weeks after case closure (program discharge).
Secondary outcome [10] 414982 0
Economic cost-benefit analysis of the intervention.

This outcome will be assessed via a resource audit and analysis of pre-post K10 scores to conduct a cost-benefit analysis of the program's clinical effectiveness. The cost/benefit analysis will be conducted using a comparison of the observed costs and clinical effects, compared to a modelled counterfactual had the ForWhen program not been provided.
Timepoint [10] 414982 0
As part of ForWhen routinely collected service data, the K10 will be administered at baseline (program admission), and 10 weeks after case closure (program discharge). A retrospective resource audit will be conducted during Yr 3 of program implementation.
Secondary outcome [11] 415675 0
Impact of the ForWhen program on clients' uptake of mental health services: type of service accessed.

At 10 weeks after case closure (program discharge), all participants will be sent a brief survey asking about their engagement with mental health services, including the type of service accessed, as part of ForWhen routinely collected service data. Data will be analysed from those participants who complete the survey.
Timepoint [11] 415675 0
As part of ForWhen routinely collected service data, 10 weeks after case closure (program discharge).
Secondary outcome [12] 415676 0
Impact of the ForWhen program on clients' uptake of mental health services: frequency of engagement.

At 10 weeks after case closure (program discharge), all participants will be sent a brief survey asking about their engagement with mental health services, including the frequency of engagement, as part of ForWhen routinely collected service data. Data will be analysed from those participants who complete the survey.
Timepoint [12] 415676 0
As part of ForWhen routinely collected service data, 10 weeks after case closure (program discharge).
Secondary outcome [13] 415677 0
Impact of the ForWhen program on clients' uptake of mental health services: service ongoing or completed.

At 10 weeks after case closure (program discharge), all participants will be sent a brief survey asking about their engagement with mental health services, including whether this engagement is ongoing or completed, as part of ForWhen routinely collected service data. Data will be analysed from those participants who complete the survey.
Timepoint [13] 415677 0
As part of ForWhen routinely collected service data, 10 weeks after case closure (program discharge).
Secondary outcome [14] 415678 0
ForWhen Navigation activities: services provided.

This outcome will be measured through a review of deidentified routinely collected service data from the ForWhen program documenting services provided by the Navigator (e.g., psychoeducation). This case-level data will be automatically collected for all clients of the ForWhen program and retrospectively reviewed by the research/evaluation team.
Timepoint [14] 415678 0
As part of ForWhen routinely collected service data, this information will be recorded throughout clients' engagement with the service in the CRM database, Client data will be accessed at case closure (program discharge).
Secondary outcome [15] 415679 0
ForWhen Navigation activities: number of contacts with clients.

This outcome will be measured through a review of deidentified routinely collected service data from the ForWhen program documenting the number and frequency of interactions between Navigator and clients. This case-level data will be automatically collected for all clients of the ForWhen program and retrospectively reviewed by the research/evaluation team.
Timepoint [15] 415679 0
As part of ForWhen routinely collected service data, this information will be recorded throughout clients' engagement with the service in the CRM database, Client data will be accessed at case closure (program discharge).
Secondary outcome [16] 415680 0
ForWhen Navigation activities: mode of contact with clients.

This outcome will be measured through a review of deidentified routinely collected service data from the ForWhen program documenting the mode of contact between Navigators and clients (e.g., phone, email, SMS). This case-level data will be automatically collected for all clients of the ForWhen program and retrospectively reviewed by the research/evaluation team.
Timepoint [16] 415680 0
As part of ForWhen routinely collected service data, this information will be recorded throughout clients' engagement with the service in the CRM database, Client data will be accessed at case closure (program discharge).
Secondary outcome [17] 415683 0
ForWhen Navigation activities: referrals provided

This outcome will be measured through a review of deidentified routinely collected service data from the ForWhen program documenting the number and type of referrals provided to clients by Navigators (e.g., to community mental health services, parenting support). This case-level data will be automatically collected for all clients of the ForWhen program and retrospectively reviewed by the research/evaluation team.
Timepoint [17] 415683 0
As part of ForWhen routinely collected service data, this information will be recorded throughout clients' engagement with the service in the CRM database, Client data will be accessed at case closure (program discharge).

Eligibility
Key inclusion criteria
Participants include individuals aged 18 years and above who have accessed the ForWhen program, either as a client (parent/carer), family member or friend, or health professional/referrer. Eligible clients of the ForWhen program include parents or carers experiencing mental health concerns during the perinatal period (conception to 2 years postpartum).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who were assessed as 'out of scope' of the ForWhen program will be excluded. This may include those not experiencing significant mental health concerns, or those who are not parents or carers during the perinatal period (conception to 2 years postpartum).

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Changes in levels of psychological distress (K10), parenting self-efficacy (MaaP-SF), personal wellbeing (PWI), help-seeking behaviour (GHSQ), self-compassion and self-care (PRC questions), and parent-infant bonding (MIBS) from program entry to follow-up will be examined using a linear mixed models repeated measures design. The clinical significance of differences on study variables (from baseline to follow-up) will be assessed using Cohen’s d with effect sizes evaluated using Cohen’s (1988) guidelines. Survey data will be analysed quantitatively and qualitatively; semi-structured interviews will be transcribed verbatim and analysed using thematic analysis. Outcome variables will also be examined by subpopulation (e.g., symptom severity on intake, demographic factors), to assess whether different groups experience varying outcomes, and by program dosage (e.g., number of contacts with ForWhen navigator, duration from entry to exit, services provided), to identify factors that impact effectiveness and potential moderators of change. The cost/benefit analysis will be conducted using a comparison of the observed costs and clinical effects (expected non-inferiority) compared to a modelled counterfactual had the ForWhen program not been provided.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2022
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
800
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 23380 0
Karitane - Carramar
Recruitment postcode(s) [1] 38777 0
2163 - Carramar

Funding & Sponsors
Funding source category [1] 311358 0
Government body
Name [1] 311358 0
Australian Government Department of Health
Country [1] 311358 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
The University of New South Wales
High St
Kensington NSW 2033
Country
Australia
Secondary sponsor category [1] 312746 0
None
Name [1] 312746 0
Address [1] 312746 0
Country [1] 312746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310851 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 310851 0
Ethics committee country [1] 310851 0
Australia
Date submitted for ethics approval [1] 310851 0
Approval date [1] 310851 0
19/11/2021
Ethics approval number [1] 310851 0

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

Contacts
Principal investigator
Name 119090 0
A/Prof Jane Kohlhoff
Address 119090 0
Karitane, PO Box 241, Villawood NSW 2163
Country 119090 0
Australia
Phone 119090 0
+610297942300
Fax 119090 0
Email 119090 0
[email protected]
Contact person for public queries
Name 119091 0
Jane Kohlhoff
Address 119091 0
Karitane, PO Box 241, Villawood NSW 2163
Country 119091 0
Australia
Phone 119091 0
+610297942300
Fax 119091 0
Email 119091 0
[email protected]
Contact person for scientific queries
Name 119092 0
Jane Kohlhoff
Address 119092 0
Karitane, PO Box 241, Villawood NSW 2163
Country 119092 0
Australia
Phone 119092 0
+610297942300
Fax 119092 0
Email 119092 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


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.