Dataset Information

Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial.

ABSTRACT: 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).

SUBMITTER: Sawyer MG

PROVIDER: S-EPMC5547246 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial.

Sawyer Michael G MG Reece Christy E CE Bowering Kerrie K Jeffs Debra D Sawyer Alyssa C P ACP Mittinty Murthy M Lynch John W JW

Journal of medical Internet research 20170724 7

<h4>Background</h4>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.<h4>Objective</h4>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, Intern ...[more]

PMID: 28739559

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Project description: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.

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:IntroductionTraining Basic Life Support saves lives. However, current BLS training approaches are time-consuming and costly. Alternative cost-efficient and effective training methods are highly needed. The present study evaluated whether a video-feedback supported peer-guided Basic Life Support training approach achieves similar practical performance as a standard instructor-guided training in laypersons.MethodsIn a randomized controlled non-inferiority trial, 288 first-year medical students were randomized to two study arms with different Basic Life Support training methods: 1) Standard Instructor Feedback (SIF) or 2) a Peer Video Feedback (PVF). Outcome parameters were objective data for Basic Life Support performance (compression depth and rate) from a resuscitation manikin with recording software as well as overall Basic Life Support performance and subjective confidence. Non-inferiority margins (Δ) for these outcome parameters and sample size calculation were based on previous studies with Standard Instructor Feedback. Two-sided 95% confidence intervals were employed to determine significance of non-inferiority.ResultsResults confirmed non-inferiority of Peer Video Feedback to Standard Instructor Feedback for compression depth (proportion difference PVF-SIF = 2.9%; 95% CI: -8.2% to 14.1%; Δ = -19%), overall Basic Life Support performance (proportion difference PVF-SIF = 6.7%; 95% CI: 0.0% to 14.3%; Δ = -27%) and subjective confidence for CPR performance (proportion difference PVF-SIF = -0.01; 95% CI: -0.18-0.17; Δ = -0.5) and emergency situations (proportion difference PVF-SIF = -0.02; 95% CI: -0.21-0.18; Δ = -0.5). Results for compression rate were inconclusive.DiscussionPeer Video Feedback achieves comparable results as standard instructor-based training methods. It is an easy-to-apply and cost-efficient alternative to standard Basic Life Support training methods. To improve performance with respect to compression rate, additional implementation of a metronome is recommended.

Project description:Background and aimsMost people with alcohol use disorder (AUD) are never treated. Internet-based interventions are effective in reducing alcohol consumption and could help to overcome some of the barriers to people not seeking or receiving treatment. The aim of the current study was to compare internet-delivered and face-to-face treatment among adult users with AUD.DesignRandomized controlled non-inferiority trial with a parallel design, comparing internet-delivered cognitive-behavioural therapy (ICBT) (n = 150) with face-to-face CBT (n = 151), at 3- and 6-month follow-ups.SettingA specialized clinic for people with AUD in Stockholm, Sweden. Participants were recruited between 8 December 2015 and 5 January 2018.ParticipantsA total of 301 patients [mean age 50 years, standard deviation (SD) = 12.3] with AUD, of whom 115 (38%) were female and 186 (62%) were male.Intervention and comparatorParticipants were randomized in blocks of 20 at a ratio of 1 : 1 to five modules of therapist-guided ICBT or to five modules of face-to-face CBT, delivered over a 3-month period. The same treatment material and the same therapists were used in both groups.MeasurementsThe primary outcome was standard drinks of alcohol consumed during the previous week at 6-month follow-up, analysed according to intention-to-treat. The pre-specified non-inferiority limit was five standard drinks of alcohol and d = 0.32 for secondary outcomes.ResultsThe difference in alcohol consumption between the internet and the face-to-face group was non-inferior in the intention-to-treat analysis of data from the 6-month follow-up [internet = 12.33 and face-to-face = 11.43, difference = 0.89, 95% confidence interval (CI) = -1.10 to 2.88]. The secondary outcome, Alcohol Use Disorder Identification Test score, failed to show non-inferiority of internet compared with face-to-face in the intention-to-treat analysis at 6-month follow-up (internet = 12.26 and face-to-face = 11.57, d = 0.11, 95% CI = -0.11 to 0.34).ConclusionsInternet-delivered treatment was non-inferior to face-to-face treatment in reducing alcohol consumption among help-seeking patients with alcohol use disorder but failed to show non-inferiority on some secondary outcomes.

Project description:BackgroundThe transition to motherhood is characterized by physical, psychological, social, and relational changes. Quality of life (QoL) changes substantially during this transition. Higher QoL is associated with social support, essential for coping with the challenges and changes of becoming a mother. An early universal home visiting program (New Families) is developed to strengthen and support families. The study aims to evaluate the impact of New Families on first-time mothers' QoL and to investigate the association between their QoL, social support, and selected possible predictive factors.MethodsA prospective non-randomized controlled study with parallel group design. Child Health Services in five city districts of Oslo were matched in intervention and control groups. First-time mothers were allocated based on the residential area and assessed at pregnancy week 28 (N = 228), six weeks postpartum (N = 184), and three months postpartum (N = 167). Measures of the World Health Organization Quality of Life brief, Perinatal Infant Care Social Support Scale, and background variables were collected from October 2018 to June 2020. Multivariate linear regression models were applied to examine intervention impact and assess associations.ResultsOur data did not reveal a significant association between New Families intervention and the QoL levels of first-time mothers at three months postpartum. Thus, we analyzed the whole sample together. Emotional support was significantly associated with higher QoL levels in the physical health (B = 0.19, 95%CI [0.04 to 0.34]) and social relationships (B = 0.40, 95%CI [0.20 to 0.60]) domains. Appraisal support was significantly associated with higher QoL levels in the psychological (B = 0.34, 95%CI [0.18 to 0.50]) and environment (B = 0.33, 95%CI [0.19 to 0.48]) domains. QoL levels in pregnancy were significantly associated with QoL levels postpartum, showing small to medium effect size (ES = 0.30 to 0.55), depending on the domain.ConclusionsFurther research, including qualitative interviews, could provide more insights into the impact of New Families on QoL. A positive association between QoL levels in pregnancy and postpartum suggests that postnatal interventions targeting improved QoL could potentially improve postpartum QoL. Emotional and appraisal support seems beneficial for first-time mothers' QoL and could be provided and facilitated by public health nurses.Trial registrationclinicaltrial.gov NCT04162626.

Project description:BackgroundAcademic procrastination is widespread among college students. Procrastination is strongly negatively correlated with psychological well-being, thus early interventions are needed. Internet- and mobile-based cognitive behavioral therapy (iCBT) could provide a low-threshold treatment option. Human guidance seems to be a decisive mechanism of change in iCBT. Persuasive design optimization of iCBT and guidance by a digital coach might represent a resource-saving alternative. The study evaluated the non-inferiority of a digital coach in comparison to human guidance with regard to the primary outcome procrastination.MethodsThe iCBT StudiCare procrastination was optimized by principles of the Persuasive System Design (PSD). A total of 233 college students were randomly assigned to either StudiCare procrastination guided by a digital coach (intervention group, IG) or by a human eCoach (control group, CG). All participants were assessed at baseline, 4-, 8- and 12-weeks post-randomization. Symptom change and between-group differences were assessed with latent growth curve models and supported by effect size levels. The non-inferiority margin was set at Cohen's d = - 0.3.ResultsThe primary outcome procrastination measured by the Irrational Procrastination scale (IPS) significantly decreased across groups (γ = - 0.79, p < .001, Cohen's d = -0.43 to -0.89) from baseline to 12-weeks post-randomization. There were no significant differences between groups (γ = -0.03, p = .84, Cohen's d = -0.03 to 0.08). Regarding symptoms of depression, no significant time x group effect was found (γ = 0.26, p = .09; Cohen's d = -0.15 to 0.21). There was also no significant time x group effect on the improvement of symptoms of anxiety (γ = 0.25, p = .09). However, Cohen's ds were above the non-inferiority margin 8-weeks (Cohen's d = 0.51) and 12-weeks post-randomization (Cohen's d = 0.37), preferring the CG. Of the IG, 34% and of the CG, 36% completed 80% of the modules.ConclusionsThe PSD optimized version of StudiCare procrastination is effective in reducing procrastination. The digital coach was not inferior to human guidance. Guidance by a digital coach in iCBT against procrastination for college students could be a resource-saving alternative to human guidance.Trial registrationThe trial was registered at the WHO International Clinical Trials Registry Platform via the German Clinical Trial Register (ID: DRKS00025209, 30/04/2021).

Dataset Information

Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial.

Publications

Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial.

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