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An equivalence evaluation of a nurse-moderated group-based internet support program for new mothers versus standard care: a pragmatic preference randomised controlled trial.

ABSTRACT: BACKGROUND: All mothers in South Australia are offered a clinic or home-visit by a Child and Family Health community nurse in the initial postnatal weeks. Subsequent support is available on request from staff in community clinics and from a telephone helpline. The aim of the present study is to compare equivalence of a single clinic-based appointment plus a nurse-moderated group-based internet intervention when infants were aged 0-6 months versus a single home-visit together with subsequent standard services (the latter support was available to mothers in both study groups). METHODS/DESIGN: The evaluation utilised a pragmatic preference randomised trial comparing the equivalence of outcomes for mothers and infants across the two study groups. Eligible mothers were those whose services were provided by nurses working in one of six community clinics in the metropolitan region of Adelaide. Mothers were excluded if they did not have internet access, required an interpreter, or their nurse clinician recommended that they not participate due to issues such as domestic violence or substance abuse. Randomisation was based on the service identification number sequentially assigned to infants when referred to the Child and Family Health Services from birthing units (this was done by administrative staff who had no involvement in recruiting mothers, delivering the intervention, or analyzing results for the study). Consistent with design and power calculations, 819 mothers were recruited to the trial. The primary outcomes for the trial are parents' sense of competence and self-efficacy measured using standard self-report questionnaires. Secondary outcomes include the quality of mother-infant relationships, maternal social support, role satisfaction and maternal mental health, infant social-emotional and language development, and patterns of service utilisation. Maternal and infant outcomes will be evaluated using age-appropriate questionnaires when infants are aged <2 months (pre-intervention), 9, 15, and 21 months. DISCUSSION: We know of no previous study that has evaluated an intervention that combines the capacity of nurse and internet-based services to improve outcomes for mothers and infants. The knowledge gained from this study will inform the design and conduct of community-based postnatal mother and child support programs. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613000204741.

SUBMITTER: Sawyer AC

PROVIDER: S-EPMC4108010 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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An equivalence evaluation of a nurse-moderated group-based internet support program for new mothers versus standard care: a pragmatic preference randomised controlled trial.

Sawyer Alyssa C P AC Lynch John J Bowering Kerrie K Jeffs Debra D Clark Jenny J Mpundu-Kaambwa Christine C Sawyer Michael G MG

BMC pediatrics 20140506

<h4>Background</h4>All mothers in South Australia are offered a clinic or home-visit by a Child and Family Health community nurse in the initial postnatal weeks. Subsequent support is available on request from staff in community clinics and from a telephone helpline. The aim of the present study is to compare equivalence of a single clinic-based appointment plus a nurse-moderated group-based internet intervention when infants were aged 0-6 months versus a single home-visit together with subseque ...[more]

PMID: 24886238

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Project description:BACKGROUND:Internet-based interventions moderated by community nurses have the potential to improve support offered to new mothers, many of whom now make extensive use of the Internet to obtain information about infant care. However, evidence from population-based randomized controlled trials is lacking. OBJECTIVE:The aim of this study was to test the non-inferiority of outcomes for mothers and infants who received a clinic-based postnatal health check plus nurse-moderated, Internet-based group support when infants were aged 1-7 months as compared with outcomes for those who received standard care consisting of postnatal home-based support provided by a community nurse. METHODS:The design of the study was a pragmatic, preference, non-inferiority randomized control trial. Participants were recruited from mothers contacted for their postnatal health check, which is offered to all mothers in South Australia. Mothers were assigned either (1) on the basis of their preference to clinic+Internet or home-based support groups (n=328), or (2) randomly assigned to clinic+Internet or home-based groups if they declared no strong preference (n=491). The overall response rate was 44.8% (819/1827). The primary outcome was parenting self-competence, as measured by the Parenting Stress Index (PSI) Competence subscale, and the Karitane Parenting Confidence Scale scores. Secondary outcome measures included PSI Isolation, Interpersonal Support Evaluation List-Short Form, Maternal Support Scale, Ages and Stages Questionnaire-Social-Emotional and MacArthur Communicative Development Inventory (MCDI) scores. Assessments were completed offline via self-assessment questionnaires at enrolment (mean child age=4.1 weeks, SD 1.3) and again when infants were aged 9, 15, and 21 months. RESULTS:Generalized estimating equations adjusting for post-randomization baseline imbalances showed that differences in outcomes between mothers in the clinic+Internet and home-based support groups did not exceed the pre-specified margin of inferiority (0.25 of a SD) on any outcome measure at any follow-up assessment, with the exception of MCDI scores assessing children's language development at 21 months for randomized mothers, and PSI Isolation scores at 9 months for preference mothers. CONCLUSION:Maternal and child outcomes from a clinic-based postnatal health check plus nurse-moderated Internet-based support were not inferior to those achieved by a universal home-based postnatal support program. Postnatal maternal and infant support using the Internet is a promising alternative to home-based universal support programs. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry Number (ANZCTR): ACTRN12613000204741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363712&isReview=true (Archived by WebCite at http://www.webcitation.org/6rZeCJ3k1).

Project description:BackgroundPostnatal depression and caregiving difficulties adversely affect mothers, infants, and later childhood development. In many countries, resources to help mothers and infants are limited. Online group-based nurse-led interventions have the potential to help address this problem by providing large numbers of mothers with access to professional and peer support during the postnatal period.ObjectiveThis study tested the effectiveness of a 4-month online group-based nurse-led intervention delivered when infants were aged 2 to 6 months as compared with standard care outcomes.MethodsThe study was a block randomized control trial. Mothers were recruited at the time they were contacted for the postnatal health check offered to all mothers in South Australia. Those who agreed to participate were randomly assigned to the intervention or standard care. The overall response rate was 63.3% (133/210). Primary outcomes were the level of maternal depressive symptoms assessed with the Edinburgh Postnatal Depression Scale (EPDS) and quality of maternal caregiving assessed using the Parenting Stress Index (PSI; competence and attachment subscales), the Parenting Sense of Competence Scale (PSCS), and the Nursing Child Assessment Satellite Training Scale. Assessments were completed at baseline (mean child age 4.9 weeks [SD 1.4]) and again when infants were aged 8 and 12 months.ResultsOutcomes were evaluated using linear generalized estimating equations adjusting for postrandomization group differences in demographic characteristics and the outcome score at baseline. There were no significant differences in the intervention and standard care groups in scores on the PSI competence subscale (P=.69) nor in the PSCS (P=.11). Although the group by time interaction suggested there were differences over time between the EPDS and PSI attachment subscale scores in the intervention and standard care groups (P=.001 and P=.04, respectively), these arose largely because the intervention group had stable scores over time whereas the standard care group showed some improvements between baseline and 12 months. Mothers engaged well with the intervention with at least 60% (43/72) of mothers logging-in once per week during the first 11 weeks of the intervention. The majority of mothers also rated the intervention as helpful and user-friendly.ConclusionsMothers reported that the intervention was helpful, and the app was described as easy to use. As such, it appears that support for mothers during the postnatal period, provided using mobile phone technology, has the potential to be an important addition to existing services. Possible explanations for the lack of differences in outcomes for the 2 groups in this study are the failure of many mothers to use key components of the intervention and residual differences between the intervention and standard care groups post randomization.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12616001732471; http://www.ANZCTR.org.au/ACTRN12616001732471.aspx (archived on WebCite as http://www.webcitation.org/77zo30GDw).

Project description:BackgroundMany countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children. The Family Nurse Partnership (FNP) is a licensed intensive home-visiting intervention developed in the USA and introduced into practice in England that involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained family nurses. We aimed to assess the effectiveness of giving the programme to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth.MethodsWe did a pragmatic, non-blinded, randomised controlled, parallel-group trial in community midwifery settings at 18 partnerships between local authorities and primary and secondary care organisations in England. Eligible participants were nulliparous and aged 19 years or younger, and were recruited at less than 25 weeks' gestation. Field-based researchers randomly allocated mothers (1:1) via remote randomisation (telephone and web) to FNP plus usual care (publicly funded health and social care) or to usual care alone. Allocation was stratified by site and minimised by gestation (<16 weeks vs ≥16 weeks), smoking status (yes vs no), and preferred language of data collection (English vs non-English). Mothers and assessors (local researchers at baseline and 24 months' follow-up) were not masked to group allocation, but telephone interviewers were blinded. Primary endpoints were biomarker-calibrated self-reported tobacco use by the mother at late pregnancy, birthweight of the baby, the proportion of women with a second pregnancy within 24 months post-partum, and emergency attendances and hospital admissions for the child within 24 months post-partum. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN23019866.FindingsBetween June 16, 2009, and July 28, 2010, we screened 3251 women. After enrolment, 823 women were randomly assigned to receive FNP and 822 to usual care. All follow-up data were retrieved by April 25, 2014. 304 (56%) of 547 women assigned to FNP and 306 (56%) of 545 assigned to usual care smoked at late pregnancy (adjusted odds ratio [AOR] 0·90, 97·5% CI 0·64-1·28). Mean birthweight of 742 babies with mothers assigned to FNP was 3217·4 g (SD 618·0), whereas birthweight of 768 babies assigned to usual care was 3197·5 g (SD 581·5; adjusted mean difference 20·75 g, 97·5% CI -47·73 to 89·23. 587 (81%) of 725 assessed children with mothers assigned to FNP and 577 (77%) of 753 assessed children assigned to usual care attended an emergency department or were admitted to hospital at least once before their second birthday (AOR 1·32, 97·5% CI 0·99-1·76). 426 (66%) of 643 assessed women assigned to FNP and 427 (66%) 646 assigned to usual care had a second pregnancy within 2 years (AOR 1·01, 0·77-1·33). At least one serious adverse event (mainly clinical events associated with pregnancy and infancy period) was reported for 310 (38%) of 808 participants (mother-child) in the usual care group and 357 (44%) of 810 in the FNP group, none of which were considered related to the intervention.InterpretationAdding FNP to the usually provided health and social care provided no additional short-term benefit to our primary outcomes. Programme continuation is not justified on the basis of available evidence, but could be reconsidered should supportive longer-term evidence emerge.FundingDepartment of Health Policy Research Programme.

Project description:BackgroundWhen complex health services interventions are implemented in real-world settings, adaptations are inevitable. Adaptations are changes made to an intervention, implementation strategy, or context prior to, during, and after implementation to improve uptake and fit. There is a growing interest in systematically documenting and understanding adaptations including what is changed, why, when, by whom, and with what impact. The rural Transitions Nurse Program (TNP) is a program in the Veterans Health Administration (VHA), designed to safely transition a rural veteran from a tertiary hospital back home. TNP has been implemented in multiple cohorts across 11 sites nationwide over 4 years. In this paper, we describe adaptations in five TNP sites from the first cohort of sites and implications for the scale-up of TNP and discuss lessons learned for the systematic documentation and analysis of adaptations.MethodsWe used the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) expanded version of the original Stirman framework to guide the rapid qualitative matrix analysis of adaptations. Adaptations were documented using multiple approaches: real-time database, semi-structured midpoint and exit interviews with implementors, and member checking with the implementation team. Interviews were recorded and transcribed. To combine multiple sources of adaptations, we used key domains from our framework and organized adaptations by time when the adaptation occurred (pre-, early, mid-, late implementation; sustainment) and categorized them as proactive or reactive.ResultsForty-one unique adaptations were reported during the study period. The most common type of adaptation was changes in target populations (patient enrollment criteria) followed by personnel changes (staff turnover). Most adaptations occurred during the mid-implementation time period and varied in number and type of adaptation. The reasons for this are discussed, and suggestions for future adaptation protocols are included.ConclusionsThis study demonstrates the feasibility of systematically documenting adaptations using multiple methods across time points. Implementors were able to track adaptations in real time across the course of an intervention, which provided timely and actionable feedback to the implementation team overseeing the national roll-out of the program. Longitudinal semi-structured interviews can complement the real-time database and elicit reflective adaptations.

Project description:BackgroundAlthough breastfeeding guidelines for infants admitted to the neonatal intensive care unit (NICU) have been introduced in Japan, these guidelines have not been reflected in practice. To improve this situation, it is important for nurses and nurse-midwives to acquire knowledge of appropriate care. This study examined changes in nurse-midwives' knowledge, attitude, and implementation of appropriate care after implementing an education program focused on early essential care for breast milk expression among mothers of preterm infants.MethodsThis pre- and post-intervention study using a single group was conducted from June 2018 to May 2019 and enrolled 36 nurse-midwives in one perinatal medical center. The education program content included nurses' roles in early essential care for milk expression and the necessary care to promoting breast milk production among mothers of preterm infants. The nurse-midwives' knowledge and attitude on care were investigated 3 months before (pre-1), just before (pre-2), just after (post-1), and 3 months after (post-2) the program. The nurse-midwives' care implementation was investigated at pre-1, pre-2, and post-2. During this time, 11 mothers (before: 7, after: 4) reported the status of milk expression for 10 days after birth.ResultsThe mean knowledge scores of the nurse-midwives at post-1 and post-2 were significantly higher than that at pre-2 (post-1: p < 0.001, post-2: p < 0.001). The attitude on care scores at post-1 and post-2 were significantly higher than that at pre-2 (post-1: p < 0.001, post-2: p = 0.010). The care implementation score at post-2 was significantly higher than that at pre-2 in eight items (e.g., Q7 Explain about the effect of initiating milk expression early and assist mothers in it). However, the education program did not cause any changes in the mothers' initiation and frequency of milk expression, and breast milk volume after birth.ConclusionsThe significant increases in the knowledge, attitude on care, and care implementation scores of the nurse-midwives suggest the beneficial effects of the education program. The small number of mothers in the survey on the practice of breast milk expression limited the full determination of the benefits of the education program for nurse-midwives.

Project description:BackgroundMembers of families headed by single mothers are at increased risk of psychosocial disadvantage and mental health problems. We assessed the effect of a community-based program of social support and education groups for single mothers of young children on maternal well-being and parenting.MethodsWe recruited 116 single mothers of children 3 to 9 years old through community advertisements. Eligible mothers were randomly assigned either to participate in a 10-week program of group sessions (1.5 hours per week) offering social support and education, with a parallel children's activity group, or to receive a standard list of community resources and the option to participate in group sessions at the end of the follow-up period. Interviewers blinded to the randomization collected assessment data from all mothers at baseline and at 3 follow-up visits (immediately after the intervention and at 3 and 6 months after the intervention). Outcome measures were self-reported mood, self-esteem, social support and parenting.ResultsBetween February 2000 and April 2003, the program was offered to 9 groups of single mothers. Most of the mothers in the trial reported high levels of financial and mental health problems. In the short term (after the intervention), mothers in the intervention group had improved scores for mood (p < 0.01, standardized effect = 0.55) and self-esteem (p < 0.05, standardized effect = 0.29) compared with mothers in the control group; scores for the other 2 measures did not differ between the groups. Growth curve analysis of program effects over the follow-up period showed improvement in all 4 outcomes, with no significant difference between the intervention and control groups.InterpretationThis community-based program of group sessions offering social support and education to low-income single mothers had positive short-term effects on mood and self-esteem but not on social support and parenting. Longer follow-up showed attenuation of these effects.

Dataset Information

An equivalence evaluation of a nurse-moderated group-based internet support program for new mothers versus standard care: a pragmatic preference randomised controlled trial.

Publications

An equivalence evaluation of a nurse-moderated group-based internet support program for new mothers versus standard care: a pragmatic preference randomised controlled trial.

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