My Early Relational Trust-Informed Learning (MERTIL) for Parents: A study protocol for a brief, universal, online, preventative parenting program to enhance relational health.

Background: Early relational health is a key determinant of childhood development, and relational trauma in the parent-infant dyad can instigate a cascading pattern of infant risk. Fortunately, early relational trauma is detectable and modifiable. In 2018, Australian Maternal and Child Health (MCH) nurses participated in MERTIL (My Early Relational Trauma -Informed Learning), a program to identify and prevent relational trauma. Program evaluations revealed nurses felt competent and confident to identify and respond to relational trauma; however, response capacity was inhibited by inadequate parent referral options. In response, MERTIL for Parents (My Early Relational Trust -Informed Learning) was developed, which is an online, evidence-based, self-paced parenting program that focuses on enhancing parental knowledge of relational trust and its significance for infant development. This low-cost, accessible prevention resource targets emerging relational concerns to reduce later service system engagement. The potential for universal preventative online programs that target parental and relational wellbeing remains under-explored. This paper reports on a protocol for implementing a pilot study describing nurses and parents perspectives on program feasibility and efficacy. Methods: This study is a mixed-methods, parallel-armed, uncontrolled, repeated measures design. We aim to recruit 28 MCH nurses who will in turn recruit 480 parents with a child aged 0-5 years. All parents will receive MERTIL for Parents entailing a 40-minute video, tipsheets, worksheets, and support resources. Parent data will be obtained at three periods: pre-program, program exit, and program follow-up. Nurse data will be collected at two periods: parent recruitment completion and program follow-up. Data collection will occur through surveys and focus groups. Primary parent outcomes will be socioemotional assessing program efficacy. Nurses and parents will each report on study program feasibility. Discussion: This protocol describes the feasibility and efficacy of a new online parenting program, MERTIL for Parents, with pilot field studies commencing in July 2022. We anticipate that this resource will be a valuable addition to various child and family services, for use in individual support and group work.

3 70 in August 2022. We anticipate that this resource will be a valuable addition to various child 71 and family services, for use in individual support and group work.
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(which was not certified by peer review)
The copyright holder for this preprint this version posted July 17, 2022. This protocol describes the feasibility and efficacy of a new online parenting program, 91 MERTIL for Parents, describing MCH nurses' and parents' perspectives on program 92 feasibility and efficacy, with pilot field studies soon to commence. This study is a mixed-93 methods, parallel-armed (i.e., MCH nurses and parents), uncontrolled, repeated measures 94 design. We aim to recruit 48 MCH nurses who will in turn recruit 480 parents with a child 95 aged 0-5 years (inclusive) displaying early signs of relational trauma. All participants will 96 receive access to the MERTIL for Parents program, which entails a 40-minute video, tip 97 sheets, worksheets, and support resources. Parent and nurse data collection will occur through 98 surveys and focus groups. Primary parent outcomes will be socioemotional to examine . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

(which was not certified by peer review)
The copyright holder for this preprint this version posted July 17, 2022. ; https://doi.org/10.1101/2022.07.14.22277633 doi: medRxiv preprint 5 99 program efficacy; such outcomes will include child-parent relationship quality and parental 100 reflective functioning. Nurses and parents will each report on study program feasibility. It is 101 anticipated that this resource will be a valuable addition to a wide range of child and family 102 services, for use in individual support and group work.

129
Despite the availability and evidence supporting these in-person parenting programs, 130 many families, particularly those experiencing numerous vulnerabilities, face multiple 131 barriers in accessing these programs (10, 11). For parents who live in regional centres and 132 rural or remote locations, attending in-person programs, typically city-based, is an 133 accessibility obstacle. Transportation access is also an issue for in-person parent service 134 participation (12, 13). Such programs are additionally cost prohibitive to many due to their 145 Universal online parenting programs 146 Online or app-based program delivery provides an avenue to address these limitations, 147 provided intended users have adequate technology access, reliable internet connection, and . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted July 17, 2022. ; https://doi.org/10.1101/2022.07.14.22277633 doi: medRxiv preprint 7 148 are digitally literate. Online universal parenting programs can be either entirely or partially 149 self-guided. In partially self-guided programs, clinician support is provided at varying 150 frequencies via online, phone, or in-person modalities (19). Prior meta-analytic research on 151 the efficacy of self-guided and partially self-guided online parenting programs has reported 152 benefits at the parent, child, and dyadic level. Specifically, at the parent level, programs have 153 been shown to enhance elements such as positive parenting perceptions, behaviours, 154 satisfaction, efficacy, and confidence, while lowering parental mental health problems (e.g., 170 Such benefits may in turn reduce costs and barriers to program engagement and enhance 171 program reach.
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The copyright holder for this preprint this version posted July 17, 2022. ; https://doi.org/10.1101/2022.07.14.22277633 doi: medRxiv preprint 8 172 Due to their significant preventative potential, online parent resources may reduce the 173 need for later intervention. This may occur by supporting and motivating parents with new 174 knowledge and behavioural skills to independently enhance their parent-child relationship, in 175 turn reducing later burden on service systems. Public health initiatives such as these may 176 empower parents to alter relational trajectories early on, within a preventative approach that 177 is parent-led and strengths-based. This may assist to disrupt emerging disadvantage before is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

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The copyright holder for this preprint this version posted July 17, 2022. ; https://doi.org/10.1101/2022.07.14.22277633 doi: medRxiv preprint 9 197 outcomes and even fewer have reported familial outcomes associated with online parent 198 program participation (e.g., 23). Finally, despite MCH nurses completing MERTIL and 199 providing parenting support, they do not have a recommended suite of online parenting 200 programs within their toolbox to assist clients (29). MCH service practice guidelines focus on 201 health promotion, child development and to a lesser extend parent mental health; however, 202 nurses need evidence-based interventions to enhance dyadic relationships. This study aims to 203 address these resource and knowledge gaps. is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

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The copyright holder for this preprint this version posted July 17, 2022. ; https://doi.org/10.1101/2022.07.14.22277633 doi: medRxiv preprint 11 247 sheets, parent worksheets, and professional support contacts. All secondary program elements 248 will be developed by the study authors. See Table 2  288 uncontrolled, mixed-methods, repeated measures study design. Nurses will complete two 289 assessments (post-parent recruitment and three-month post-program) and parents will 290 complete three assessments (pre-program, program exit, and three-month post-program). All 291 nurse and parent data collection and completion will be conducted independently and in 292 parallel.
293 Participants 294 Eligible study participants will be twofold: 1) Australian MCH nurses, and 2) Australian 295 parents. See Fig 3 for an outline of all study participants.
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The copyright holder for this preprint this version posted July 17, 2022. ; https://doi.org/10.1101/2022.07.14.22277633 doi: medRxiv preprint 13 296 Eligibility criteria 297 Nurses 298 Nurses will i) have completed MERTIL, and ii) work at a participating pilot MCH site, in 299 metropolitan and regional/rural Victorian and New South Wales Local Government Areas 300 (LGAs) and iii) be able to make a follow-up phone call to each of the parents they refer to the 301 program, to gather feedback. Three programs sit within the MCH umbrella: 1) Universal 302 service, 2) Enhanced service and 3) 24-hour MCH Telephone Line (29). Participants will be 303 comprised of Universal and Enhanced services MCH nurses. The Universal MCH service is 304 available to all families, while the Enhanced MCH service supports families who meet strict 305 'at-risk' criteria, with limited places. Study participation invitations will be sent to MCH 306 nurses who work in both the Universal and Enhanced MCH services. For nurses who decide 307 to participate, free access to MERTIL (My Early Trauma-Informed Learning) will be 308 provided for the duration of the pilot study. This is the training program MCH nurses 309 completed in 2018 and will allow them to refresh their knowledge of and skills in identifying 310 early relational trauma, if necessary. Nurses will also have ongoing access to MERTIL for 311 Parents.
312 Parents 313 Consenting parent participants will: i) be the parent of a child 0-5 years (inclusive) or 314 currently pregnant, ii) be recommended to participate in the program by an MCH nurse from 315 a participating pilot site, iii) aged 18 years and over, iv) currently reside in Australia, and v) 316 feel comfortable to complete questionnaires and program materials in English.
317 Sample size/power calculation 318 Power analysis was conducted using the G*Power 3.1 software to determine the required 319 sample size for this study (34). A single group within study design would require 199 320 participants to identify a small to moderate statistically significant effect (.20) at p<.05, with . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

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The copyright holder for this preprint this version posted July 17, 2022. is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

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The copyright holder for this preprint this version posted July 17, 2022. ; https://doi.org/10.1101/2022.07.14.22277633 doi: medRxiv preprint 15 346 (www.mertil.com.au). Nurses will provide parents with a printed flyer with MERTIL for 347 Parents details to aid this process. For parents who verbally agree to participate, MCH nurses 348 will follow-up with a phone call or email, to gauge parents' responses to the program.

349
During the study pilot phase, all individuals who arrive at the MERTIL for Parents 350 website landing page will be invited to join the research. Specifically, parents will be met 351 with a webpage popup with a brief research overview and the option to hear more about the 352 study. If they select to hear more about the research, they will be automatically prompted to 353 enter their first name and email address. This will trigger emailing of consent forms. Once the 354 completed forms are submitted, the pre-program parent survey will be automatically emailed 355 to the participant. Completing this survey will grant parents access to the MERTIL for 356 Parents program content.

Nurses
359 Following informed consent, MCH nurses will attend a 120-minute web-based information 360 and training session on MERTIL for Parents. This session will provide a study overview to 361 promote program familiarisation, discuss parent program engagement, and explain the 362 implementation options for parents accessing both the Universal and Enhanced MCH 363 services. Immediately following this session, nurses will be emailed and asked to complete an 364 online survey to report their first impressions of MERTIL for Parents regarding factors such 365 as perceived program content, length, and suitability.

366
Nurses will be asked to make contact (phone call preferred) with parents they referred 367 to the program, within two weeks of recommending MERTIL for Parents. On completion of 368 all parent recommendations, a follow-up email survey will be conducted, assessing program 369 use, perceived parent impacts, program engagement, ideas for program refinement, and wider 370 implementation. Online focus group interviews will follow to elaborate on survey responses, . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

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The copyright holder for this preprint this version posted July 17, 2022. ; https://doi.org/10.1101/2022.07.14.22277633 doi: medRxiv preprint 16 371 assess nurses' views and experiences of the program, potential barriers to implementation, 372 and to identify further uses and applications of MERTIL for Parents. These elements will 373 ensure MERTIL for Parents' co-designed nature endures. See Fig 4 for  . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

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The copyright holder for this preprint this version posted July 17, 2022. To evaluate program efficacy, participants will complete identical self-report measures pre-411 program and three-month post-program (see Table 3 Table 3 419 displays outcomes and associated measures that will be used to evaluate MERTIL for Parents 420 pre-and post-program.
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The copyright holder for this preprint this version posted July 17, 2022. ; https://doi.org/10.1101/2022.07.14.22277633 doi: medRxiv preprint 494 Program data management 495 All MCH nurse and parent survey data will be disseminated through Moodle, an online 496 learning management system stored on a secure server, with data transferred securely for 497 analyses. All study data and participant information will be stored securely as per the criteria 498 required by the La Trobe University Human Ethics Committee.
499 Data analysis strategy 500 Quantitative 501 All statistical analyses will be conducted using the software IBM SSPS Statistics (43).
502 Descriptive statistics will be generated to identify nurse and parent population characteristics 503 and to evaluate parent and nurse program perceptions. To determine parenting change in dyad 504 attachment, relational function, maternal mental health, from pre-program to three-months 505 post-program, inferential statistics will be used (i.e., univariate, bivariate, and multivariate 506 analyses) such as t-tests, chi-squared analyses, ANOVA, and regression analyses.
507 Qualitative 508 Focus groups 509 All parent and nurse focus group interview data will be audio-recorded, transcribed verbatim, 510 and deidentified. Thematic and content analysis will be used to identify themes and sub-511 themes from MCH nurse and parent transcript responses (44).
512 Free-text surveys responses 513 For any nurse or parent free-text survey responses, thematic analysis will also be used to 514 identify response themes and sub-themes.
515 Data collection commencement 516 Pilot field studies, including recruitment and data collection, will commence in August 2022 517 with data collection concluding in November 2022.

518
Discussion . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

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The copyright holder for this preprint this version posted July 17, 2022. 533 Finally, as with all research, there is a risk that attrition rates may be high. All parent data 534 will be self-report in nature, and interpretation of findings will therefore be subject to these 535 limitations.
536 Strengths and opportunities 537 There are multiple strengths to the present study: First, the mixed-methods design of this 538 study allows for greater understanding of the program's impact compared with either 539 qualitative-or quantitative-only designs. Second, diversity of parent demographics and needs 540 will be ensured through recruitment of participants from both the Universal and Enhanced 541 MCH services in both metropolitan and regional locations. Third, socioemotional-specific 542 content may fill an important gap in the available online parenting program market. Fourth, 543 the program's reach is expected to be wide due to the online delivery method. Finally, strong . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted July 17, 2022. ; https://doi.org/10.1101/2022.07.14.22277633 doi: medRxiv preprint 23 544 completion is expected due to 1) the program's brief nature, 2) the engaging, non-545 judgemental, and supportive program content; and 3) the contribution of MCH nurses, infant 546 mental health experts, and parents in co-designing the program.

Conclusion
548 This study will examine implementation feasibility and efficacy of an evidence-based, online, 549 universal, self-directed parenting program, MERTIL for Parents. Multi-informant data from 550 parents and nurses will inform future iterations of MERTIL for Parents and universal online 551 relational programs. 552 553 Acknowledgements: We wish to thank the maternal child health nurses, early childhood 554 mental health clinicians, and parents who co-designed MERTIL for Parents. 555 556 Data availability statement: Not applicable as data collection has not commenced. Once all 557 study data is collected, the data supporting the findings of this study will be available from 558 the corresponding author, JO, upon reasonable request. CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted July 17, 2022. ; https://doi.org/10.1101/2022.07.14.22277633 doi: medRxiv preprint 24 569 570 . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted July 17, 2022. ; https://doi.org/10.1101/2022.07.14.22277633 doi: medRxiv preprint . CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted July 17, 2022. ; https://doi.org/10.1101/2022.07.14.22277633 doi: medRxiv preprint