Dataset Information

The Baby Steps Web Program for the Well-Being of New Parents: Randomized Controlled Trial.

ABSTRACT:

Background

New parents face increased risks of emotional distress and relationship dissatisfaction. Digital interventions increase support access, but few preventive programs are optimized for both parents.

Objective

This study aims to conduct the first randomized controlled trial on universal self-guided digital programs to support positive perinatal adjustment of both mothers and fathers. Effects of childcare information (Baby Care) and information plus an interactive program (Baby Steps Wellbeing) were compared from the third trimester baseline to 3 and 6 months subsequently.

Methods

The study recruited 388 co-parenting male-female adult couples expecting their first single child (26-38 weeks' gestation), using web-based registration. Most (337/388, 86.8%) were obtained from prenatal hospital classes. Couples' randomization was automated and stratified by Edinburgh Postnatal Depression Scale (EPDS) scores (50% couples scored high if either mother >7, father >5). All assessments were web-based self-reports: the EPDS and psychosocial quality of life were primary outcomes; relationship satisfaction, social support, and self-efficacy for parenting and support provision were secondary. Linear mixed models provided intention-to-treat analyses, with linear and quadratic effects for time and random intercepts for participants and couples.

Results

Selection criteria were met by 63.9% (248/388) of couples, who were all randomized. Most participants were married (400/496, 80.6%), tertiary educated (324/496, 65.3%), employed full time (407/496, 82%), and born in Australia (337/496, 67.9%). Their mean age was 32.2 years, and average gestation was 30.8 weeks. Using an EPDS cutoff score of 13, 6.9% (18/248) of men, and 16.1% (40/248) of women screened positive for depression at some time during the 6 months. Retention of both partners was 80.6% (201/248) at the 6-month assessments, and satisfaction with both programs was strong (92% ≥50). Only 37.3% (185/496) of participants accessed their program more than once, with higher rates for mothers (133/248, 53.6%) than fathers (52/248, 20.9%; P<.001). The EPDS, quality of life, and social support did not show differential improvements between programs, but Baby Steps Wellbeing gave a greater linear increase in self-efficacy for support provision (P=.01; Cohen d=0.26) and lower reduction in relationship satisfaction (P=.03; Cohen d=0.20) than Baby Care alone. Mothers had greater linear benefits in parenting self-efficacy over time than fathers after receiving Baby Steps Wellbeing rather than Baby Care (P=.01; Cohen d=0.51). However, the inclusion of program type in analyses on parenting self-efficacy and relationship satisfaction did not improve model fit above analyses with only parent gender and time.

Conclusions

Three secondary outcomes showed differential benefits from Baby Steps Wellbeing, but for one (parenting self-efficacy), the effect only occurred for mothers, perhaps reflecting their greater program use. Increased engagement will be needed for more definitive testing of the potential benefits of Baby StepsWellbeing for perinatal adjustment.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12614001256662; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367277.

SUBMITTER: Kavanagh DJ

PROVIDER: S-EPMC8665385 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundMental health has come to be understood as not merely the absence of mental illness but also the presence of mental well-being, and recent interventions have sought to increase well-being in various populations. A population that deserves particular attention is that of health care workers, whose occupations entail high levels of stress, especially given the ongoing COVID-19 pandemic. A neuroscience-based web-based well-being program for health care workers-the Thrive program-has been newly developed to promote habits and activities that contribute to brain health and overall mental well-being.ObjectiveThis paper describes the protocol for a randomized controlled trial whose objective is to evaluate the Thrive program in comparison with an active control condition to measure whether the program is effective at increasing well-being and decreasing symptoms of psychological distress in health care workers at a designated Australian hospital.MethodsThe trial will comprise two groups (intervention vs active control) and 4 measurement occasions over a 12-week period. A survey will be administered in each of weeks 0, 4, 8, and 12, and the well-being program will be delivered in weeks 1-7 (via web-based video presentations or digital pamphlets). Each of the 4 surveys will comprise a range of questionnaires to measure well-being, psychological distress, and other key variables. The planned analyses will estimate group-by-time interaction effects to test the hypothesis that mental health will increase over time in the intervention condition relative to the active control condition.ResultsThe Thrive program was delivered to a small number of wards at the hospital between February 2021 and July 2021, and it will be delivered to the remaining wards from October 2021 to December 2021. A power calculation has recommended a sample size of at least 200 participants in total. A linear mixed model will be used to estimate the interaction effects.ConclusionsThis trial seeks to evaluate a new web-based well-being program for health care workers at a major public hospital. It will contribute to the growing body of research on mental well-being and ways to promote it.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12621000027819; https://tinyurl.com/58wwjut9.International registered report identifier (irrid)DERR1-10.2196/34005.

Project description:BackgroundResilience is a protective factor in healthy aging, helping to maintain and recover physical and mental functions. The Resilience in Illness Model has proven effective in fostering resilience and well-being. Physical activity is crucial for older adults' independence and well-being, even as aging causes a progressive decline. Additionally, older adults face challenges such as spousal loss and physical disability, making preventive intervention strategies necessary.ObjectiveThis study aims to develop and evaluate a web-based program to enhance resilience, physical activity, and well-being among community-dwelling older adults. Additionally, we aim to gather feedback on the program's strengths and limitations.MethodsA 4-week resilience-enhancing program was created, incorporating role-play and talk-in-interaction and focusing on 3 key skills: coping, control belief, and manageability. The program included scenarios such as becoming widowed and suffering a stroke, designed to engage older adults. A pilot test preceded the intervention. As a result of the COVID-19 pandemic, the program shifted from in-person to web-based sessions. A single-blind, parallel-group, randomized controlled trial was conducted. Participants aged over 65 years were recruited offline and randomly assigned to either an intervention or control group. A certified resilience practitioner delivered the program. Outcomes in resilience, physical activity, and well-being were self-assessed at baseline (T0), 4 weeks (T1), and 12 weeks (T2) after the program. A mixed methods approach was used to evaluate feedback.ResultsA web-based participatory program enhancing 3 skills-coping, control belief, and manageability for resilience-was well developed. Among 96 participants, 63 were randomized into the intervention group (n=31) and the control group (n=32). The mean age in the intervention group was 69.27 (SD 3.08) years and 74.84 (SD 6.23) years in the control group. Significant between-group differences at baseline were found in age (t45.6=-4.53, P<.001) and physical activity at baseline (t61=2.92, P=.005). No statistically significant between-group differences over time were observed in resilience (SE 7.49, 95% CI -10.74 to 18.61, P=.60), physical activity (SE 15.18, 95% CI -24.74 to 34.74, P=.74), and well-being (SE 3.74, 95% CI -2.68 to 11.98, P=.21) after controlling for baseline differences. The dropout rate was lower in the intervention group (2/31, 6%) compared with the control group (5/32, 16%). Moreover, 77% (24/31) of participants in the intervention group completed the entire program. Program feedback from the participants indicated high satisfaction with the web-based format and mentorship support.ConclusionsThis study demonstrated that a web-based resilience-enhancing program is appropriate, acceptable, feasible, and engaging for community-dwelling older adults. The program garnered enthusiasm for its potential to optimize resilience, physical activity, and well-being, with mentorship playing a crucial role in its success. Future studies should aim to refine program content, engagement, and delivery methods to effectively promote healthy aging in this population.Trial registrationClinicalTrials.gov NCT05808491; https://clinicaltrials.gov/ct2/show/NCT05808491.

Project description:BACKGROUND:Parents of children with chronic kidney disease (CKD) experience high levels of stress in the daily management of their child's illness. Parents need continuously available support and information, yet online support programs are lacking. e-Powered Parents was developed to fill this gap; it is an online program consisting of (1) medical information, (2) an interactive part, and (3) four training modules (stress management, setting limits, communication, and coping). Prior to a large-scale evaluation, we conducted a feasibility study that consisted of an effect study and a process evaluation. OBJECTIVE:The objectives of our study were to (1) identify the outcome measures that are most likely to capture the potential benefit, (2) evaluate the potential effectiveness and effect size, and (3) evaluate recruitment, reach, the dose received, and context. METHODS:We conducted a feasibility study with a two-armed, wait-list randomized controlled trial (RCT). Prior to baseline, parents (n=146) were randomly allocated to group 1 or group 2. After completing the baseline questionnaire, parents in group 1 were given access to e-Powered Parents, while those in group 2 received usual care. At the 6-month follow-up (T1), all parents received a questionnaire and parents in group 2 were given access to e-Powered Parents as well. After 1.5 years, through an extra measurement (T2), we evaluated the effect of long-term exposure. Outcomes were the child's quality of life (Child Vulnerability Scale), parental stress (Pediatric Inventory for Parents) and fatigue (Multidimensional Fatigue Inventory), self-efficacy in communication with health care professionals (Perceived Efficacy in Patient-Physician Interactions, PEPPI-5), and parental perceptions of family management (Family Management Measure). Floor and ceiling effects and percentage of parents showing no change in scores were calculated. We used linear mixed models to evaluate the potential effectiveness and effect sizes using the intention-to-treat and per-protocol analyses. In the process evaluation, we evaluated recruitment, reach, the dose received, and context using a questionnaire sent to the parents, log-in data, and a focus group interview with health care professionals. RESULTS:At T1 (n=86) and T2 (n=51), no significant effects were found on any of the five outcomes. The PEPPI-5 showed ceiling effects and high percentages of parents showing no change between the measurement times. The information and interactive part of the intervention were used by 84% (57/68) of the parents in group 1 and 49% (32/65) of the parents in group 2. The information pages were visited most often. Overall, 64% (85/133) of the parents logged in to the training platform and 31% (26/85) actually used the training modules. CONCLUSIONS:We did not observe any significant effect on any of the outcomes. This could possibly be explained by the minimal use of the intervention and by parents' heterogeneity. For continued participation, we recommend a tailored intervention and further studies to find out whether and how online programs could be used to support parents in the management of their child's CKD. TRIAL REGISTRATION:Netherlands Trial Registry NTR4808; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4808 (Archived by WebCite at http://www.webcitation.org/719rCicvW).

Project description:BackgroundMindfulness can improve overall well-being by training individuals to focus on the present moment without judging their thoughts. However, it is unknown how much mindfulness practice and training are necessary to improve well-being.ObjectiveThe primary aim of this study was to determine whether a standard 8-session web-based mindfulness-based cognitive therapy (MBCT) program, compared with a brief 3-session mindfulness intervention, improved overall participant well-being. In addition, we sought to explore whether the treatment effects differed based on the baseline characteristics of the participants (ie, moderators).MethodsParticipants were recruited from 17 patient-powered research networks, web-based communities of stakeholders interested in a common research area. Participants were randomized to either a standard 8-session MBCT or a brief 3-session mindfulness training intervention accessed on the web. The participants were followed for 12 weeks. The primary outcome of the study was well-being, as measured by the World Health Organization-Five Well-Being Index. We hypothesized that MBCT would be superior to a brief mindfulness training.ResultsWe randomized 4411 participants, 3873 (87.80%) of whom were White and 3547 (80.41%) of female sex assigned at birth. The mean baseline World Health Organization-Five Well-Being Index score was 50.3 (SD 20.7). The average self-reported well-being in each group increased over the intervention period (baseline to 8 weeks; model-based slope for the MBCT group: 0.78, 95% CI 0.63-0.93, and brief mindfulness group: 0.76, 95% CI 0.60-0.91) as well as the full study period (ie, intervention plus follow-up; baseline to 20 weeks; model-based slope for MBCT group: 0.41, 95% CI 0.34-0.48; and brief mindfulness group: 0.33, 95% CI 0.26-0.40). Changes in self-reported well-being were not significantly different between MBCT and brief mindfulness during the intervention period (model-based difference in slopes: -0.02, 95% CI -0.24 to 0.19; P=.80) or during the intervention period plus 12-week follow-up (-0.08, 95% CI -0.18 to 0.02; P=.10). During the intervention period, younger participants (P=.05) and participants who completed a higher percentage of intervention sessions (P=.005) experienced greater improvements in well-being across both interventions, with effects that were stronger for participants in the MBCT condition. Attrition was high (ie, 2142/4411, 48.56%), which is an important limitation of this study.ConclusionsStandard MBCT improved well-being but was not superior to a brief mindfulness intervention. This finding suggests that shorter mindfulness programs could yield important benefits across the general population of individuals with various medical conditions. Younger people and participants who completed more intervention sessions reported greater improvements in well-being, an effect that was more pronounced for participants in the MBCT condition. This finding suggests that standard MBCT may be a better choice for younger people as well as treatment-adherent individuals.Trial registrationClinicalTrials.gov NCT03844321; https://clinicaltrials.gov/ct2/show/NCT03844321.

Project description:BackgroundUp to one-third of young people live with chronic physical conditions (eg, diabetes, asthma, and autoimmune disease) that frequently involve recurrent pain, fatigue, activity limitations, stigma, and isolation. These issues may be exacerbated as young people transition through adolescence. Accordingly, young people with chronic illness are at a high risk of psychological distress. Accessible, evidence-based interventions for young people with chronic illnesses are urgently needed to improve well-being, support adaptation, and enhance daily functioning. Self-compassion, which is an adaptive means of relating to oneself during times of difficulty, is a promising intervention target for this population.ObjectiveThis study aims to test the efficacy of a 4-week, self-guided, web-based self-compassion training program for improving well-being among young Australians (aged 16-25 years) living with a chronic medical condition. The primary outcomes were self-compassion, emotion regulation difficulties, and coping; the secondary outcomes were well-being, distress, and quality of life. We also sought to test whether changes in primary outcomes mediated changes in secondary outcomes and gather feedback about the strengths and limitations of the program.MethodsWe conducted a single-blind, parallel-group, randomized controlled trial comparing a 4-week, fully automated, web-based self-compassion training program with a waitlist control. Participants were recruited via the internet, and outcomes were self-assessed at 4 (T1) and 12 weeks (T2) after the baseline time point via a web-based survey. A mixed methods approach was used to evaluate the program feedback.ResultsOverall, 151 patients (age: mean 21.15, SD 2.77 years; female patients: n=132, 87.4%) were randomized to the intervention (n=76, 50.3%) and control (n=75, 49.7%) groups. The loss-to-follow-up rate was 47.4%, and program use statistics indicated that only 29% (22/76) of young people in the experimental group completed 100% of the program. The main reported barrier to completion was a lack of time. As anticipated, treatment effects were observed for self-compassion (P=.01; partial η2=0.05; small effect); well-being (P≤.001; partial η2=0.07; medium effect); and distress (P=.003; partial η2=0.054; small-medium effect) at the posttest time point and maintained at follow-up. Contrary to our hypotheses, no intervention effects were observed for emotion regulation difficulties or maladaptive coping strategies. Improvements in adaptive coping were observed at the posttest time point but were not maintained at follow-up. Self-compassion, but not emotion regulation difficulties or coping, mediated the improvements in well-being.ConclusionsMinimal-contact, web-based self-compassion training can confer mental health benefits on young people with chronic conditions. This group experiences substantial challenges to participation in mental health supports, and program engagement and retention in this trial were suboptimal. Future work should focus on refining the program content, engagement, and delivery to optimize engagement and treatment outcomes for the target group.Trial registrationAustralian New Zealand Clinical Trials Registry 12619000572167; https://tinyurl.com/5n6hevt.International registered report identifier (irrid)RR2-10.1186/s12889-020-8226-7.

Project description:BACKGROUND:Although the availability and use of mobile mental health apps has grown exponentially in recent years, little data are available regarding their efficacy. OBJECTIVE:This study aimed to evaluate the effectiveness of an app developed to promote stress management and well-being among working women compared with a control app. METHODS:Female employees at a private hospital were invited to participate in the study via mailing lists and intranet ads. A total of 653 individuals self-enrolled through the website. Eligible participants were randomized between control (n=240) and intervention (n=250) groups. The well-being mobile app provides an 8-week program with 4 classes per week (including a brief theoretical portion and a 15-min guided practice). The active control app also provided 4 assessments per week that encouraged participants to self-observe how they were feeling for 20 min. We also used the app to conduct Web-based questionnaires (10-item Perceived Stress Scale and 5-item World Health Organization Well-Being Index) and ask specific questions to assess subjective levels of stress and well-being at baseline (t1), midintervention (t4=4 weeks after t1) and postintervention (t8=8 weeks after t1). Both apps were fully automated without any human involvement. Outcomes from the control and intervention conditions at the 3 time points were analyzed using a repeated measures analysis of variance. RESULTS:Among the randomized participants (n=490), 185 participants were excluded at the 4-week follow-up and another 79 at the 8-week follow-up because of noncompliance with the experimental protocol. Participants who did not complete t4 and t8 assessments were equally distributed between groups (t4: control group=34.6% [83/240] and intervention group=40.8% [102/250]; P=.16; t8: control group=29.9% [47/157] and intervention group=21.6% [32/148]; P=.10). Both groups showed a significant increase in general well-being as a function of time (F2,426=5.27; P=.006), but only the intervention group presented a significant increase in work-related well-being (F2,426=8.92; P<.001), as well as a significant reduction in work-related and overall stress (F2,426=5.50; P=.004 and F2,426=8.59; P<.001, respectively). CONCLUSIONS:The well-being mobile app was effective in reducing employee stress and improving well-being. TRIAL REGISTRATION:Clinicaltrials.gov NCT02637414; https://clinicaltrials.gov/ct2/show/NCT02637414.

Project description:ImportancePhysician burnout disproportionately affects women physicians and begins in training. Professional coaching may improve well-being, but generalizable evidence is lacking.ObjectiveTo assess the generalizability of a coaching program (Better Together Physician Coaching) in a national sample of women physician trainees.Design, setting, and participantsA randomized clinical trial involving trainees in 26 graduate medical education institutions in 19 states was conducted between September 1, 2022, and December 31, 2022. Eligible participants included physician trainees at included sites who self-identified as a woman (ie, self-reported their gender identity as woman, including those who reported woman if multiple genders were reported).InterventionA 4-month, web-based, group coaching program.Main outcomes and measuresThe primary outcomes were change in burnout (measured using subscales for emotional exhaustion, depersonalization, and personal achievement from the Maslach Burnout Inventory). Secondary outcomes included changes in impostor syndrome, moral injury, self-compassion, and flourishing, which were assessed using standardized measures. A linear mixed model analysis was performed on an intent-to-treat basis. A sensitivity analysis was performed to account for the missing outcomes.ResultsAmong the 1017 women trainees in the study (mean [SD] age, 30.8 [4.0] years; 540 White participants [53.1%]; 186 surgical trainees [18.6%]), 502 were randomized to the intervention group and 515 were randomized to the control group. Emotional exhaustion decreased by an estimated mean (SE) -3.81 (0.73) points in the intervention group compared with a mean (SE) increase of 0.32 (0.57) points in the control group (absolute difference [SE], -4.13 [0.92] points; 95% CI, -5.94 to -2.32 points; P < .001). Depersonalization decreased by a mean (SE) of -1.66 (0.42) points in the intervention group compared with a mean (SE) increase of 0.20 (0.32) points in the control group (absolute difference [SE], -1.87 [0.53] points; 95%CI, -2.91 to -0.82 points; P < .001). Impostor syndrome decreased by a mean (SE) of -1.43 (0.14) points in the intervention group compared with -0.15 (0.11) points in the control group (absolute difference [SE], -1.28 (0.18) points; 95% CI -1.63 to -0.93 points; P < .001). Moral injury decreased by a mean (SE) of -5.60 (0.92) points in the intervention group compared with -0.92 (0.71) points in the control group (absolute difference [SE], -4.68 [1.16] points; 95% CI, -6.95 to -2.41 points; P < .001). Self-compassion increased by a mean (SE) of 5.27 (0.47) points in the intervention group and by 1.36 (0.36) points in the control group (absolute difference [SE], 3.91 [0.60] points; 95% CI, 2.73 to 5.08 points; P < .001). Flourishing improved by a mean (SE) of 0.48 (0.09) points in the intervention group vs 0.09 (0.07) points in the control group (absolute difference [SE], 0.38 [0.11] points; 95% CI, 0.17 to 0.60 points; P < .001). The sensitivity analysis found similar findings.Conclusions and relevanceThe findings of this randomized clinical trial suggest that web-based professional group-coaching can improve outcomes of well-being and mitigate symptoms of burnout for women physician trainees.Trial registrationClinicalTrials.gov Identifier: NCT05222685.