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Published in: Trials 1/2021

Open Access 01-12-2021 | Study protocol

A Community-enabled Readiness for first 1000 Days Learning Ecosystem (CRADLE) for first-time families: study protocol of a three-arm randomised controlled trial

Authors: See Ling Loy, Thilagamangai, Joyce Teo, Sze Wern Chan, Nurul Khairani Abdul Razak, Oh. Moh Chay, Kee Chong Ng

Published in: Trials | Issue 1/2021

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Abstract

Background

Enhanced parenting self-efficacy (PSE) contributes to positive parenting and future parental-child health. First-time parents, in particular, are in need of support since the pregnancy until post-delivery to strengthen their early PSE. However, there is a lack of effective and sustainable relevant programmes in the community. The Community-enabled Readiness for first 1000 Days Learning Ecosystem (CRADLE) aims to develop a self-learning eco-community throughout the pregnancy and early childhood to promote PSE among first-time parents. We apply choice architecture strategy using behavioural nudges and midwife-led continuity care during the first 1000 days, and test their effects on PSE and mother-child health for first-time families in Singapore.

Methods

This three-arm randomised controlled trial will recruit up to 750 pregnant women from the KK Women’s and Children’s Hospital, Singapore. Participants will be randomly assigned to receive: (1) standard routine care; (2) behavioural nudges (text messages) along with the use of a social media platform; or (3) midwife-led continuity care involving individualised teleconferencing sessions, during pregnancy and post-delivery. Using web-based questionnaires, participants will be assessed for baseline socio-demography and health status in the first visit, with follow-up assessments in the third trimester, at birth, 6-week (primary end-point), 6-, 12-, 18- and 24-month post-delivery. The primary outcome is PSE. Secondary outcomes include health and birth experience, mental wellness, feeding practice, maternal and child nutritional status. Intention-to-treat and per-protocol analyses will be performed using general linear models to test the effects of interventions across three arms. Recruitment has begun in June 2020 and is estimated to complete in September 2022.

Discussion

This study may identify a sustainable effective strategy in the community by helping first-time parents to have a positive experience during the pregnancy, childbirth and parenthood, leading to an enhanced PSE and health outcomes for both mother and child. Findings from this study will provide insight into the implementation of early parenting and mother-child care programmes.

Trial registration

ClinicalTrials.gov NCT04275765. Registered on 19 February 2020.
Appendix
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Literature
1.
Bateson P, Barker D, Clutton-Brock T, Deb D, D’Udine B, Foley RA, et al. Developmental plasticity and human health. Nature. 2004;430:419–21.PubMedCrossRef
2.
Hanson M, Godfrey KM, Lillycrop KA, Burdge GC, Gluckman PD. Developmental plasticity and developmental origins of non-communicable disease: theoretical considerations and epigenetic mechanisms. Prog Biophys Mol Biol. 2011;106:272–80.PubMedCrossRef
3.
Suzuki K. The developing world of DOHaD. J Dev Orig Health Dis. 2018;3:266–9.CrossRef
4.
Koletzko B, Godfrey KM, Poston L, Szajewska H, Van Goudoever JB, de Waard M, et al. Nutrition during pregnancy, lactation and early childhood and its implications for maternal and long-term child health: the early nutrition project recommendations. Ann Nutr Metab. 2019;2:93–106.CrossRef
5.
6.
Borrelli SE, Walsh D, Spiby H. First-time mothers’ expectations of the unknown territory of childbirth: uncertainties, coping strategies and ‘going with the flow’. Midwifery. 2018;63:39–45.PubMedCrossRef
7.
Wernand JJ, Kunseler FC, Oosterman M, Beekman AT, Schuengel C. Prenatal changes in parenting self-efficacy: linkages with anxiety and depressive symptoms in primiparous women. Infant Ment Health J. 2014;35:42–50.PubMedCrossRef
8.
Wittkowski A, Garrett C, Calam R, Weisberg D. Self-report measures of parental self-efficacy: a systematic review of the current literature. J Child Fam Stud. 2017;26:2960–78.PubMedPubMedCentralCrossRef
9.
Albanese AM, Russo GR, Geller PA. The role of parental self-efficacy in parent and child well-being: a systematic review of associated outcomes. Child Care Health Dev. 2019;45:333–63.PubMedCrossRef
10.
Glatz T, Buchanan CM. Over-time associations among parental self-efficacy, promotive parenting practices, and adolescents’ externalizing behaviors. J Fam Psychol. 2015;29:427.PubMedCrossRef
11.
Jones TL, Prinz RJ. Potential roles of parental self-efficacy in parent and child adjustment: a review. Clin Psychol Rev. 2005;25:341–63.PubMedCrossRef
12.
Abdollahi F, Agajani-Delavar M, Zarghami M, Lye MS. Postpartum mental health in first-time mothers: a cohort study. Iran J Psychiatry Behav Sci. 2016;10:e426.PubMedPubMedCentral
13.
Gross CL, Marcussen K. Postpartum depression in mothers and fathers: the role of parenting efficacy expectations during the transition to parenthood. Sex Roles. 2017;76:290–305.CrossRef
14.
Secer Z, Ogelman G. Analysing Mothers’ self-efficacy perception towards parenting in relation to peer relationships of 5-6 year-old preschool children. Educ Sci Theory Pract. 2012;12:2001–8.
15.
Ahun MN, Consoli A, Pingault JB, Falissard B, Battaglia M, Boivin M, et al. Maternal depression symptoms and internalising problems in the offspring: the role of maternal and family factors. Eur Child Adolesc Psychiatry. 2018;27:921–32.PubMedCrossRef
16.
Heerman WJ, Taylor JL, Wallston KA, Barkin SL. Parenting self-efficacy, parent depression, and healthy childhood behaviors in a low-income minority population: a cross-sectional analysis. Matern Child Health J. 2017;21:1156–65.PubMedPubMedCentralCrossRef
17.
Bandura A. The nature and structure of self-efficacy. In: Self-efficacy: the exercise of control. New York: WH Freeman and Company; 1997. p. 37–78.
18.
Bryanton J, Gagnon AJ, Hatem M, Johnston C. Predictors of early parenting self-efficacy: results of a prospective cohort study. Nurs Res. 2008;57:252–9.PubMedCrossRef
19.
Morse CA, Buist A, Durkin S. First-time parenthood: influences on pre-and postnatal adjustment in fathers and mothers. J Psychosom Obstet Gynaecol. 2000;21:109–20.PubMedCrossRef
20.
Mihelic M, Filus A, Morawaska A. Correlates of prenatal parenting expectations in new mothers: is better self-efficacy a potential target for preventing postnatal adjustment difficulties? Prev Sci. 2016;17:949–59.PubMedCrossRef
21.
Soltani F, Maleki A, Shobeiri F, Shamsaei F, Ahmadi F, Roshanaei G. The limbo of motherhood: women’s experiences of major challenges to cope with the first pregnancy. Midwifery. 2017;55:38–44.PubMedCrossRef
22.
Ong SF, Chan WC, Shorey S, Chong YS, Klainin-Yobas P, He HG. Postnatal experiences and support needs of first-time mothers in Singapore: a descriptive qualitative study. Midwifery. 2014;30:772–8.PubMedCrossRef
23.
Nakamura Y, Takeishi Y, Ito N, Ito M, Atogami F, Yoshizawa T. Comfort with motherhood in late pregnancy facilitates maternal role attainment in early postpartum. Tohoku J Exp Med. 2015;235:53–9.PubMedCrossRef
24.
Norling-Gustafsson A, Skaghammar K, Adolfsson A. Expectant parents’ experiences of parental education within the antenatal health service. Psychol Res Behav Manag. 2011;4:159.PubMedPubMedCentral
25.
Dahlen HG, Barclay LM, Homer CS. The novice birthing: theorising first-time mothers’ experiences of birth at home and in hospital in Australia. Midwifery. 2010;26:53–63.PubMedCrossRef
26.
Barimani M, Frykedal KF, Rosander M, Berlin A. Childbirth and parenting preparation in antenatal classes. Midwifery. 2018;57:1–7.PubMedCrossRef
27.
Svensson J, Barclay L, Cooke M. Randomised-controlled trial of two antenatal education programmes. Midwifery. 2009;25:114–25.PubMedCrossRef
28.
Sandall J, Soltani H, Gates S, Shennan A, Devane D. Midwife-led continuity models versus other models of care for childbearing women. Cochrane Database Syst Rev. 2016;4:CD004667.PubMed
29.
Toohill J, Callander E, Gamble J, Creedy DK, Fenwick J. A cost effectiveness analysis of midwife psycho-education for fearful pregnant women–a health system perspective for the antenatal period. BMC Pregnancy Childbirth. 2017;17:217.PubMedPubMedCentralCrossRef
30.
Jiao N, Zhu L, Chong YS, Chan WC, Luo N, Wang W, et al. Web-based versus home-based postnatal psychoeducational interventions for first-time mothers: a randomised controlled trial. Int J Nurs Stud. 2019;99:103385.PubMedCrossRef
31.
32.
Blumenthal-Barby J, Opel DJ. Nudge or grudge? Choice architecture and parental decision-making. Hast Cent Rep. 2018;48:33–9.CrossRef
33.
34.
35.
Hansen PG, Jespersen AM. Nudge and the manipulation of choice: a framework for the responsible use of the nudge approach to behaviour change in public policy. Euro J Risk Regul. 2013;4:3–28.CrossRef
36.
Bandura A. Regulation of cognitive processes through perceived self-efficacy. Dev Psychol. 1989;25:729–35.CrossRef
37.
Kendall S, Bloomfield L. Developing and validating a tool to measure parenting self-efficacy. J Adv Nurs. 2005;51:174–81.PubMedCrossRef
38.
Bloomfield L, Kendall S. Parenting self-efficacy, parenting stress and child behaviour before and after a parenting programme. Prim Health Care Res. 2012;13:364–72.CrossRef
39.
Bandura A. Self-efficacy mechanism in human agency. Am Psychol. 1982;37:122–47.CrossRef
40.
Johnston C, Mash EJ. A measure of parenting satisfaction and efficacy. J Clin Child Psychol. 1989;18:167–75.CrossRef
41.
Chung FF, Wan GH, Kuo SC, Lin KC, Liu HE. Mother-infant interaction quality and sense of parenting competence at six months postpartum for first-time mothers in Taiwan: a multiple time series design. BMC Pregnancy Childbirth. 2018;18:365.PubMedPubMedCentralCrossRef
42.
Gilmore L, Cuskelly M. Factor structure of the parenting sense of competence scale using a normative sample. Child Care Health Dev. 2009;35:48–55.PubMedCrossRef
43.
44.
45.
Slavin V, Gamble J, Creedy DK, Fenwick J, Pallant J. Measuring physical and mental health during pregnancy and postpartum in an Australian childbearing population - validation of the PROMIS Global Short Form. BMC Pregnancy Childbirth. 2019;19:370.PubMedPubMedCentralCrossRef
46.
Hollins Martin CJ, Martin CR. Development and psychometric properties of the birth satisfaction scale-revised (BSS-R). Midwifery. 2014;30:610–9.PubMedCrossRef
47.
Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003;41:1284–94.PubMedCrossRef
48.
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987;150:782–6.PubMedCrossRef
49.
Kozinszky Z, Dudas RB. Validation studies of the Edinburgh Postnatal Depression Scale for the antenatal period. J Affect Disord. 2015;176:95–105.PubMedCrossRef
50.
Nijagal MA, Wissig S, Stowell C, Olson E, Amer-Wahlin I, Bonsel G, et al. Standardized outcome measures for pregnancy and childbirth, an ICHOM proposal. BMC Health Serv Res. 2018;18:953.PubMedPubMedCentralCrossRef
51.
Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003;32:734–44.PubMedCrossRef
52.
Baughcum AE, Powers SW, Johnson SB, Chamberlin LA, Deeks CM, Jain A, et al. Maternal feeding practices and beliefs and their relationships to overweight in early childhood. J Dev Behav Pediatr. 2001;22:391–408.PubMedCrossRef
53.
Quah PL, Cheng TS, Cheung YB, Yap F, Saw SM, Godfrey KM, et al. Maternal and infant correlates of maternal feeding beliefs and practices in a multi-ethnic Asian population: the GUSTO (Growing Up in Singapore Towards healthy Outcomes) study. Public Health Nutr. 2016;19:2789–98.PubMedCrossRef
54.
Ulfsdotter M, Enebrink P, Lindberg L. Effectiveness of a universal health-promoting parenting program: a randomized waitlist controlled trial of All Children in Focus. BMC Public Health. 2014;14:1083.PubMedPubMedCentralCrossRef
55.
56.
Kristensen IH, Kronborg H. What are the effects of supporting early parenting by enhancing parents’ understanding of the infant? Study protocol for a cluster-randomized community-based trial of the Newborn Behavioral Observation (NBO) method. BMC Public Health. 2018;18:832.PubMedPubMedCentralCrossRef
57.
Soh SE, Tint MT, Gluckman PD, Godfrey KM, Rifkin-Graboi A, Chan YH, et al. Cohort profile: Growing Up in Singapore Towards healthy Outcomes (GUSTO) birth cohort study. Int J Epidemiol. 2014;43:1401–9.PubMedCrossRef
Metadata
Title
A Community-enabled Readiness for first 1000 Days Learning Ecosystem (CRADLE) for first-time families: study protocol of a three-arm randomised controlled trial
Authors
See Ling Loy
Thilagamangai
Joyce Teo
Sze Wern Chan
Nurul Khairani Abdul Razak
Oh. Moh Chay
Kee Chong Ng
Publication date
01-12-2021
Publisher
BioMed Central
Published in
Trials / Issue 1/2021
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-021-05144-5

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