2-week Postintervention Research Articles

Effectiveness of an eHealth intervention for reducing psychological distress and increasing COVID-19 knowledge and protective behaviors among racialized sexual and gender minority adults: A quasi-experimental study (#SafeHandsSafeHearts).

Sexual and gender minority and racialized populations experienced heightened vulnerability during the Covid-19 pandemic. Marginalization due to structural homophobia, transphobia and racism, and resulting adverse social determinants of health that contribute to health disparities among these populations, were exacerbated by the Covid-19 pandemic and public health measures to control it. We developed and tested a tailored online intervention (#SafeHandsSafeHearts) to support racialized lesbian, gay, bisexual, transgender, queer, and other persons outside of heteronormative and cisgender identities (LGBTQ+) in Toronto, Canada during the pandemic. We used a quasi-experimental pre-test post-test design to evaluate the effectiveness of a 3-session, peer-delivered eHealth intervention in reducing psychological distress and increasing Covid-19 knowledge and protective behaviors. Individuals ≥18-years-old, resident in Toronto, and self-identified as sexual or gender minority were recruited online. Depressive and anxiety symptoms, and Covid-19 knowledge and protective behaviors were assessed at baseline, 2-weeks postintervention, and 2-months follow-up. We used generalized estimating equations and zero-truncated Poisson models to evaluate the effectiveness of the intervention on the four primary outcomes. From March to November 2021, 202 participants (median age, 27 years [Interquartile range: 23-32]) were enrolled in #SafeHandsSafeHearts. Over half (54.5%, n = 110) identified as cisgender lesbian or bisexual women or women who have sex with women, 26.2% (n = 53) cisgender gay or bisexual men or men who have sex with men, and 19.3% (n = 39) transgender or nonbinary individuals. The majority (75.7%, n = 143) were Black and other racialized individuals. The intervention led to statistically significant reductions in the prevalence of clinically significant depressive (25.4% reduction, p < .01) and anxiety symptoms (16.6% reduction, p < .05), and increases in Covid-19 protective behaviors (4.9% increase, p < .05), from baseline to postintervention. We demonstrated the effectiveness of a brief, peer-delivered eHealth intervention for racialized LGBTQ+ communities in reducing psychological distress and increasing protective behaviors amid the Covid-19 pandemic. Implementation through community-based organizations by trained peer counselors supports feasibility, acceptability, and the importance of engaging racialized LGBTQ+ communities in pandemic response preparedness. This trial is registered with ClinicalTrials.gov, number NCT04870723.

Effectiveness of a Digital Health Game Intervention on Early Adolescent Smoking Refusal Self-Efficacy.

Smoking poses a significant threat to adolescent health because of its immediate and long-term detrimental health effects. Smoking refusal self-efficacy predicts smoking behavior in adolescence. In adolescents' health education, digital interventions are potential tools to support smoking refusal self-efficacy. The aim of this two-arm cluster randomized controlled trial was to evaluate the effectiveness of a digital health game intervention compared with a no-intervention control group on smoking refusal self-efficacy in 10- to 13-year-old Finnish early adolescents. The early adolescents (n = 781) were randomized to the control group (n = 394) and the health game intervention group (n = 387). Smoking refusal self-efficacy, sources of smoking and snus refusal self-efficacy, and motivation to decline smoking and snus use in the future were measured at baseline, 2-week postintervention, and 3-month follow-up. Data were analyzed using linear mixed model and Wilcoxon rank-based test for clustered data. According to the results, the intervention group made improvements in sources of smoking and snus refusal self-efficacy between baseline and postintervention, and in sources of snus refusal self-efficacy between baseline and follow-up, compared with the control group. The intervention group showed improvements in smoking refusal self-efficacy among 12-year-olds between baseline and follow-up, and postintervention and follow-up compared with the control group. Similar improvements were also found among those with a smoking friend or a smoking parent between postintervention and follow-up. The results were promising for the use of digital health game interventions to promote early adolescent smoking refusal self-efficacy and preventing smoking experimentation. Further research can evaluate the long-term effects for adolescents.

An Open-Label Pilot Trial of a Brief, Parent-Based Sleep Intervention in Children With ADHD.

To assess the effects of a brief parent-based behavioral sleep intervention in children with ADHD. Families with a child with ADHD and parent-reported sleep problems received a brief parent-based sleep intervention, which involved two one-to-one consultation sessions and one telephone follow-up with the parent/caregiver. Child's sleep and clinical symptoms, and parental sleep and daytime functioning were assessed at baseline, 2-week post-intervention, and 3-month follow-up. Sixty eligible families (mean age of the child: 9.4 ± 1.5 years; boys: 75%) were recruited, and 43 (72%) completed the whole intervention. The intervention resulted in significant improvements in the child's sleep, clinical symptoms, and parental sleep and parenting stress, and these improvements were generally maintained at 3-month follow-up. The findings supported the promising effects of a brief parent-based sleep intervention on improving sleep and clinical symptoms in children with ADHD and parental sleep and parenting stress. Further randomized clinical trials with long-term follow-up are needed to test the robustness of the effectiveness of the intervention.

P079 Shifting the Paradigm: Implementation Science in Enhancing Sleep Health among Shiftworkers

Abstract Introduction Addressing the urgent public health concern of sleep health among shiftworkers, our study examined the application and effectiveness of a tailored sleep intervention, the Sleepfit app. We assessed reach, effectiveness, adoption, and maintenance, while identifying potential implementation barriers across diverse shiftwork industries. Methods The two-phase study commenced with the Sleepfit app's optimisation, originally developed for day workers, by integrating sleep improvement strategies specifically for shiftworkers. The feasibility of large-scale implementation was then evaluated based on the RE-AIM framework, considering reach, effectiveness, adoption, implementation, and maintenance. The study involved existing shiftworkers (current sample, n=29; anticipated final sample n=90). Validated sleep health measures and RE-AIM metrics were used, with data analysed through a mixed-methods approach. Results Preliminary results indicate significant improvement in sleep satisfaction and reduction in insomnia severity, indicating the potential of the intervention in enhancing sleep outcomes. We also observed increased engagement with healthy sleep practices, demonstrated by a significant decrease in poor sleep behaviours. Interestingly, our preliminary findings propose specific benefits for younger shiftworkers who typically engage in problematic sleep practices. Preliminary data suggests 71% of shiftworkers engaged with the app at 2-weeks post intervention, with 23% continuing to use the app during long-term maintenance evaluation. As data collection is ongoing, a detailed analysis incorporating feasibility and all RE-AIM dimensions will be subsequently presented. Conclusion Preliminary findings suggest the Sleepfit app may serve as an effective sleep health intervention among shiftworkers, with further analyses needed to fully understand its feasibility and long-term adoption.

HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients with Cancer.

Psilocybin-assisted psychotherapy shows promise in treating depression and existential distress in people with serious medical illness. However, its individual-based methodology poses challenges for scaling and resource availability. The HOPE trial (A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients with Cancer) is an IRB-approved open-label feasibility and safety pilot study examining psilocybin-assisted group therapy in cancer patients with a DSM-5 depressive disorder (including major depressive disorder as well as adjustment disorder with depressed mood). We report here the safety and clinical outcome measures including 6-month follow up data. Outcome measures were collected at baseline, 2-week and 26-weeks post intervention. The study involved three group preparatory sessions, one high-dose (25mg) group psilocybin session, and three group integration sessions with cohorts of four participants over a three week intervention. 12 participants completed the trial. No serious adverse events attributed to psilocybin occurred. The primary clinical outcome measures of change in symptoms of depression on the clinician administered 17-item-HAM-D showed clinically substantial decrease in HAM-D scores from baseline to the 2-week timepoint (21.5 to 10.09, p<0.001) and the 26-week timepoint (21.5 to 14.83, p=0.006). Six out of twelve participants met criteria for remission at 2 weeks, as defined by HAM-D < 7, three out twelve demonstrated a clinically significant change (4-6 points), and eight out of twelve demonstrated a clinically substantial change (7-12 points). This pilot study demonstrated the safety, feasibility, and possible efficacy of psilocybin-assisted group therapy for cancer patients dealing with depressive symptoms. Based on demonstrated efficacy and significant reductions in therapist time, future investigations with the group therapy model are warranted. This article describes a single-arm, open-label pilot study of psilocybin-assisted group therapy for patients dealing with symptoms of depression associated with a cancer diagnosis. Results indicate that this intervention was safe and feasible with a suggestion of efficacy. Group-format psilocybin-assisted therapy is a promising methodology that addresses challenges of scalability.

School-based universal mental health promotion intervention for adolescents in Vietnam: Two-arm, parallel, controlled trial.

The aim of this study was to evaluate the effects of Happy House, a universal school-based programme, in reducing adolescents' depressive symptoms and improving their mental well-being, coping self-efficacy and school connectedness. This was a school-based, two-arm parallel controlled trial. Depressive symptoms were measured using the Centre for Epidemiologic Studies Depression Scale. Data were collected at recruitment, and at 2 weeks and 6 months post-intervention. Mixed-effect models were conducted to estimate the effects of the intervention on the outcomes. A total of 1,084 students were recruited. At 2 weeks post-intervention, the effect size on depressive symptoms was 0.11 (p=0.011) and the odds of having clinically significant depressive symptoms were lower in the intervention compared to the control (0.56, p=0.027). Both of these were no longer significant at 6 months post-intervention. Psychological well-being mean scores in the intervention were significantly higher than in the control at 2 weeks post-intervention (effect size 0.13). Coping self-efficacy mean scores were significantly higher in the intervention group at both 2-week and 6-month post-intervention (effect sizes from 0.17 to 0.26). Data support the potential of Happy House to reduce the prevalence of adolescent mental health problems and to promote positive mental health in the school context in Vietnam.

Effect of photodynamic therapy as an adjunctive to mechanical debridement on the nonsurgical treatment of peri-implant mucositis: A randomized controlled clinical trial

The use of photodynamic therapy (PDT) has been evaluated as an adjunctive technique for bacterial decontamination of implants with peri-implantitis. Given the controversies over the efficacy of the application of PDT to treat peri-implant diseases, the present clinical study aimed to evaluate the posttherapeutic clinical parameters and cytokine levels in peri-implant crevicular fluid in patients with peri-implant mucosal inflammation, receiving mechanical debridement (MD) alone or in association with PDT. In this double-blinded randomized clinical trial, 52 patients with peri-implant mucosal inflammation were selected and they were randomly assigned to 2 treatment groups: a MD group and an MD + PDT group using an 805 nm laser and indocyanine green (ICG). Although the decrease in bleeding on probing was the primary outcome, pocket depth, PUS, pain on probing, clinical attachment level, gingival recession, tumor necrosis factor-α, interleukin (IL)-1β, IL-6 and matrix metalloproteinase-8 were also evaluated at baseline, 2-week, and 3-month postintervention. Repeated measure analysis of variance was used to analyze inter-group differences and a P ≤ 0.05 was considered for significant differences between tested parameters. Statistically significant improvements (P < 0.001) were detected for all variables after comparison of baseline data with those collected at each time interval of the study. Nevertheless, the inter-group comparisons of these variables between the baseline, 2-week, and 3-month intervals did not reveal any significant decrease in sites treated with either MD alone or MD + PDT. The application of PDT using 805-nm laser and ICG as an adjunct therapy to MD did not provide any additional improvements in the clinical or biologic parameters of peri-implant mucosal inflammation.

Reducing Ageism in an Undergraduate Nutrition Class Using an Online Educational Intervention

ObjectivesAgeism is prevalent in healthcare and can lead to negative health outcomes. The aim of our study is to determine the effectiveness of an online educational intervention to reduce ageism among students in an undergraduate nutrition class. MethodsVolunteers in an entry-level nutrition course were randomized into an intervention (INT) (n = 30) and a control (CON) (n = 29) group. Participants were asked to watch 6 videos (∼20 minutes total) and describe what they learned. The INT group learned about ageism and myths on aging, while the CON group learned about cultural competency. Ageism was measured at pre (T1), immediate-post (T2), and 2-weeks post-intervention (T3) using the Fraboni Scale of Ageism (FSA), the Ambivalent Ageism Scale (AAS) which provides a total score, benevolent (AAS-Ben) and hostile (AAS-hostile) ageism sub scores, and the age Implicit Association Test (IAT) (D-score). Participants were categorized based on D score as higher (≤.15) or lower preference for older adults (>.15). Also, perceived old age cutoff was asked. Mixed model analysis with repeated measures and binomial logistic regression analysis were performed. Results93% and 63% were female and non-Hispanic white, respectively. Group-by-time interactions for ageism indicators were not statistically significant (p > .05). Significant changes in estimated mean and standard error with simple effect analyses in the INT group includes decrease of FSA from 55.5 (1.4) at T1 to 49.9 (1.9) and 50.0 (2.0) at T2 and T3 respectively; decrease of total AAS from 41.2 (1.6) at T1 to 35.5 (1.8) and 35.7 (1.8) at T2 and T3, respectively; and decrease of AAS Hostile from 12.2 (0.6) at T1 to 9.5 (0.7) and 9.0 (0.7) at T2 and T3, respectively. Perceived old age cutoff increased from 59 (2) to 71 (2) and 72 (2) years by T2 and T3, respectively. Thus, ageism was significantly reduced up to 2 weeks only in the INT group after the educational intervention (p < .05). No significant changes in IAT. Qualitative data analysis of written answers provided by INT group also supported these findings. ConclusionsFindings from our study suggest that an online educational intervention may be useful in reducing ageism among undergraduate nutrition and dietetic students. Funding SourcesUniversity of Mississippi Startup funds; School of Applied Sciences - Dean’s office funds.

Pilot study of a well-being app to support New Zealand young people during the COVID-19 pandemic

BackgroundWell-being apps represent a promising and scalable approach for improving mental health outcomes in youth, especially during a global pandemic when access to face-to-face interventions may be limited. Whitu (meaning 7 in the New Zealand Māori language Te Reo) is a newly developed well-being app with 7 modules that support young people to learn and practice evidence-based coping skills, including relaxation, mindfulness, self-compassion, and goal-setting. ObjectiveDuring this pilot, we explored the acceptability, usability, and preliminary efficacy of Whitu before refining the app for a randomized controlled trial (RCT). MethodsWe recruited 20 New Zealand young people aged 16-25 years via social media to trial the first prototype of the Whitu app over 6 weeks. Within-group differences from baseline to 2- and 6-weeks post intervention in self-reported well-being, depression, anxiety, stress, self-compassion, optimism and sleep quality were evaluated using repeated-measures ANOVA. A further 21 participants aged 16-30 years were recruited to participate in 4 focus groups to give feedback on the app's usability and cultural acceptability. Feedback was analysed using directed content analysis. ResultsStatistically significant improvements in anxiety (p = 0.024) and stress (p = 0.017) were observed from baseline to 2-weeks post intervention. Improvements in well-being (p = 0.021), depression (p = 0.031), anxiety (p = 0.005), and stress (p = 0.004) were also observed from baseline to 6-weeks. No statistically significant changes were seen in self-compassion, optimism, or sleep quality. Effect sizes (partial η2s) ranged from 0.25 (depression) to 0.42 (stress). Qualitative feedback comprised of five key themes, namely: factors affecting engagement, issues with functionality, preferences regarding aesthetics, effectiveness and adverse effects, and cultural acceptability. ConclusionsOur preliminary results suggest that Whitu may be an effective app for improving multiple dimensions of young people's well-being. Modifications to the look and feel, cultural content, and onboarding have been undertaken based on the qualitative feedback, and an RCT is currently underway.

Impact of COVID-19 pandemic on people with epilepsy: An interventional study using early physical consultation

BackgroundTelehealth use is limited in developing countries. Therefore, a modified approach with early physical consultation was designed and applied in our hospital. This study aimed to determine the efficacy of this early physical consultation in reducing the clinical and psychological impacts of coronavirus disease-19 (COVID-19), which enabled insight into its global feasibility. MethodParticipants were contacted and offered early physical consultation with a neurologist. Patients who participated in the Phase 1 study on the impacts of the COVID-19 pandemic on people with epilepsy and treated in our hospital were recruited. Clinical and psychological outcomes of COVID-19 were assessed with the Hospital Anxiety Depression Scale (HADS) and Quality of Life in Epilepsy Inventory (QOLIE-31). ResultA total of 312 patients completed this study with a mean age of 39.13 ± 16.13 years, majority female (51.0%), and experienced seizures at least once yearly (64.7%). There was 12.6% who experienced seizure worsening related to the COVID-19 pandemic. After receiving early clinical intervention, 30.8% achieved better seizure control with another 51.1% had no seizure occurrence. The mean HADS anxiety score improved immediately post-intervention (5.27 ± 4.32 vs. 4.79 ± 4.26, p < 0.01), and at 2-week post-intervention (5.58 ± 4.46 vs. 4.73 ± 3.95, p < 0.01). The mean HADS depression score also improved immediately post-intervention (4.12 ± 3.69 vs. 3.84 ± 3.76, p < 0.05) and at 2-week post-intervention (4.38 ± 3.81 vs. 3.73 ± 3.63, p < 0.05). The intervention resulted in significant improvement in energy-fatigue and social function subscales in QOLIE-31 but a reduction in cognitive and medication effects subscales. ConclusionEarly physical consultation with stringent precautionary measures is feasible and effective in improving the psychological outcome during COVID-19 pandemic.

"Strong Teeth": an early-phase study to assess the feasibility of an oral health intervention delivered by dental teams to parents of young children

BackgroundTooth decay (caries) is a significant health burden in young children. There is strong evidence for the benefits of establishing appropriate home-based oral health behaviours in early childhood. Dental teams are well placed to provide this information and there is clear advice on what oral health information should be given to parents. However, research has shown that there is limited guidance, training and resources on how dental teams should deliver this advice. "Strong Teeth" is a complex oral health intervention, using evidence-based resources and training underpinned by behaviour change psychology, to support behaviour change conversations in dental practice. This early phase evaluation aims to assess the feasibility of this intervention, prior to a full-scale trial.MethodsThe study recruited 15 parents of children aged 0–2-years-old and 21 parents of children aged 3–5 years old, from five NHS dental practices across West Yorkshire. Participant demographics, self-reported brushing behaviours, dietary habits, a dental examination and three objective measures of toothbrushing were collected in a home-setting at baseline, then at 2-weeks and 2-months post-intervention. Recruitment, retention and intervention delivery were analysed as key process outcomes. Brushing habits were compared to national toothbrushing guidelines – the Delivering Better Oral Health toolkit (Public Health England).ResultsStrong Teeth was feasible to deliver in a General Dental Practice setting in 94% of cases. Feasibility of recruitment (37%) exceeded progression criterion, however retention of participants (75%) was below the progression criterion for the 0–2 age group. More than half of children recruited aged 3–5-years had caries experience (52%). Total compliance to toothbrushing guidance at baseline was low (28%) and increased after the intervention (52%), an improvement that was statistically significant. Dietary habits remained largely unchanged. Plaque scores significantly decreased in the 3–5-year-olds and toothbrushing duration increased in all age groups.Conclusion"Strong Teeth" intervention delivery and data collection in the home setting was feasible. There was a positive indication of impact on reported toothbrushing behaviours. Some amendments to study design, particularly relating to the inclusion of the 0–2-year-old group, should be considered before progression to a full trial.Trial registration ISRCTN Register: ISRCTN10709150. Registered retrospectively 24/7/2019.

Efficacy of two vertically integrated teaching–learning methods – The ocular basic science workshop versus lecture in enhancing knowledge and skills of ocular examination techniques and underlying principles in second clinical year medical students: A prospective interventional study

Purpose: The purpose of the study was to compare the efficacy of two vertically integrated teaching–learning methods, a peer-led ocular basic science workshop (OBSW) versus lecture by ophthalmology faculty, in enhancing the underlying basic science knowledge and examination skills of ophthalmic clinical tests among second clinical year medical students. Design: This was a prospective, interventional comparative study. Students were randomly assigned to peer-led OBSW and interactive lecture-based method of teaching by a faculty. Change in knowledge was assessed using pre and post multiple-choice question test score. Quantitative assessment of clinical examination skills between the two groups was done using objective structured clinical examination (OSCE) at 2-week postintervention. All assessors were blinded. Student's attitude toward the teaching–learning methods was assessed using a 5-point Likert scale. Setting: This study was conducted in the departments of ophthalmology, anatomy, and physiology of a tertiary care medical college in southern India. Participants: Second clinical year students starting their ophthalmology rotation, 5 peer teachers, and 47 students were recruited. All completed the study. Results: Post intervention, there was a significant change in basic science knowledge from baseline among both the arms. Mean improvement in posttest score immediately following the OBSW was 9.25 (standard deviation [SD]: 3.34, 95% confidence interval (CI): 7.84–10.66, t = 13.57, P = 0.00) and 7.83 (SD: 3.66), 95% CI: 6.24–9.41, t = 10.24, P = 0.00) after the lecture. The improvement in scores continued in the 2-week posttest scores. There was no statistically significant difference in the OSCE scores between the two groups. Conclusions: The vertically integrated OBSW and lecture methods were equally effective in improving knowledge and clinical skills of basic ocular examination skills among the second clinical year medical students.

Music therapy as social skill intervention for children with comorbid ASD and ID: study protocol for a randomized controlled trial

BackgroundAutism spectrum disorder (ASD) is a developmental impairment characterized by persistent deficits in social communication and interactions, and over half of children with ASD possess below average intellectual ability (IQ < 85). The social development and response to social skill interventions among children with ASD and comorbid intellectual disability (ID) is not well understood. Music therapy is a systematic process of intervention, wherein a therapist may help clients promote their social skills by using musical experience. The proposed study will address limited research evidence on music therapy as an intervention for social functioning in children with ASD with mild to borderline ID.MethodA randomized controlled trial (RCT) with two parallel groups of 40 children each (1:1 allocation ratio) is planned. Participants will receive 45 min of music therapy or non-musical intervention targeting social skills once a week for 12 weeks. Primary outcome measures will be independent ratings on the Childhood Autism Rating Scale and parent ratings on the Social Responsiveness Scale-2. Linear mixed-effects models for these two outcome measures will be created for data collected at 2-week pre-intervention, 2-week post-intervention, and 4-month post-intervention sessions. In-session behaviors at the first and last intervention will be videotaped and coded offline and compared. Pretreatment neural response of quantitative electroencephalograms (qEEG) to social scenes will be used to predict the outcomes of musical and non-musical social skill interventions, whereas qEEG responses to music will be used to predict the effectiveness of musical social skill intervention.DiscussionIf neural markers of social skill development are found, then the long-term goal is to develop individualized intervention based on pre-treatment markers to maximize treatment efficacy. The proposed study’s results may also suggest directions to development and provision of music therapy services in Hong Kong.Trial registrationClinicalTrials.gov (NCT04557488). Registered September 21, 2020.

S0385 Implementation of a Deprescribing Tool to Reduce Inappropriate Proton Pump Inhibitor Use

INTRODUCTION: Recent perceptions of inappropriate PPI use have led to an increased interest in deprescribing; however, evaluation of different PPI deprescribing methods have been inconsistent. Inappropriate use of a PPI usually occurs either in the absence of an absolute indication or for non-absolute indications without considering or attempting PPI cessation. The purpose of this project was to study the effectiveness of a deprescribing algorithm to reduce inappropriate use of PPIs in an outpatient gastroenterology clinic. METHODS: This project recruited adult patients seen in the outpatient gastroenterology clinic that were on PPI therapy for more than 8 weeks. Patient’s eligible for study completed an initial GerdQ and were contacted at 2-week and 4-week post intervention for follow up. The primary outcome measure was symptom control, defined as a change in positive predictor GerdQ difference of ≤ 2 at 4 weeks. Baseline variables were assessed with descriptive statistics for analysis and project evaluation. RESULTS: The baseline (week 0) mean GerdQ (1.6 ± 2.09762) was marginally increased at week 2 (1.6667 ± 2.19306) and remained stable at week 4 (1.6667 ± 2.25726). A paired-samples t tests was calculated to compare the mean GerdQ score at baseline to the mean change in GerdQ score at 4 weeks. A significant change from baseline to week 4 was found (t(14) = 2.860, P < 0.05). Of the 15 participants, 13 (87%) had a score change ≤2. CONCLUSION: Overall, most participants (87%) had a statistically significant stability in their GerdQ scores at 4 weeks after having their PPIs deprescribed. These results are considerably higher than the predetermined goal of at least 25% participants with symptom control used to evaluate project effectiveness. It has been widely accepted in the medical community that PPIs are often prescribed inappropriately. The appeal for evidence-based guidelines has been expressed among many medical practitioners to improve their deprescribing capabilities. The potential reduction in health care expenditures, adverse effects, and pill burden strengthens the need to deprescribe PPIs used inappropriately. Results from this study will hopefully encourage clinicians to routinely evaluate use of ongoing medications and deprescribe where appropriate.Figure 1.: PPI deprescribing algorithm. Please note that participants were monitored at 2 and 4 weeks rather than 4 and 12 weeks. Reprinted with permission.Table 1.: GerdQ tool used to measure clinical data at baseline (Week 0), Week 2, and Week 4Table 2.: Comparison of outcome measures assessed by GerdQ score at baseline (week 0), week 2, and week 4. (a) Total of difference in GerdQ scores. Negative values indicate increase in positive predictors in GERD symptoms while positive values indicate decrease in positive predictors in GERD symptoms

Effects of the ACT OUT! Social Issue Theater Program on Social-Emotional Competence and Bullying in Youth and Adolescents: Protocol for a Cluster Randomized Controlled Trial.

BackgroundStudents in the United States spend a meaningful portion of their developmental lives in school. In recent years, researchers and educators have begun to focus explicitly on social and emotional learning (SEL) in the school setting. Initial evidence from meta-analyses suggests that curricula designed to promote SEL likely produce benefits in terms of social-emotional competence (SEC) and numerous related behavioral and affective outcomes. At the same time, there are often barriers to implementing such curricula as intended, and some researchers have questioned the strength of the evaluation data from SEL programs. As part of the effort to improve programming in SEL, this paper describes the protocol for a cluster randomized trial of the ACT OUT! Social Issue Theater program, a brief psychodramatic intervention to build SEC and reduce bullying behavior in students.ObjectiveThe objective of this trial is to examine if a short dose of interactive psychodrama can affect SEC metrics and bullying experiences in schoolchildren in either the short (2-week) or medium (6-month) term.MethodsThe ACT OUT! trial is a cluster randomized superiority trial with 2 parallel groups. The unit of measurement is the student, and the unit of randomization is the classroom. For each grade (fourth, seventh, and 10th), an even number of classrooms will be selected from each school—half will be assigned to the intervention arm and half will be assigned to the control arm. The intervention will consist of 3 moderated psychodramatic performances by trained actors, and the control condition will be the usual school day. Outcome data will be collected at baseline (preintervention), 2-week postintervention (short term), and 6-month postintervention (medium term). Outcomes will include social-emotional competency; self-reported bullying and experiences of being bullied; receptivity to the program; and school-level data on truancy, absenteeism, and referrals to school displinary action for bullying. A power analysis adjusted for clustering effect, design effect, and potential attrition yielded a need for approximately 1594 students, consisting of an estimated 80 classrooms split evenly into intervention and control arms.ResultsThis study was funded in June 2019; approved by the Indiana University Institutional review board on September 17, 2019; began subject recruitment on November 5, 2019; and prospectively registered with ClinicalTrials.gov.ConclusionsMany states have issued recommendations for the integration of SEL into schools. The proposed study uses a rigorous methodology to determine if the ACT OUT! psychodramatic intervention is a cost-effective means of bolstering SEC and reducing bullying incidence in schools.Trial RegistrationClinicalTrials.gov NCT04097496; https://clinicaltrials.gov/ct2/show/NCT04097496International Registered Report Identifier (IRRID)PRR1-10.2196/17900

Family caregivers of children and adolescents with rare diseases: a novel palliative care intervention

ObjectiveTo develop and pilot test a palliative care intervention for family caregivers of children with rare diseases (FAmily-CEntered pediatric Advance Care Planning-Rare (FACE-Rare)).MethodsFACE-Rare development involved an iterative, family-guided process including...

800-P: A Comparative Effectiveness Trial for Youth with Type 1 Diabetes to Reduce Alcohol Use in College

Youth with type 1 diabetes (T1D) use alcohol similar to their healthy peers; prevention is needed. We sought to develop and test competing versions of an intervention targeting alcohol avoidance for youth with T1D in a comparative effectiveness pilot trial. We recruited 138 college students (ages 17-25) with T1D via social media and delivered a brief electronic intervention, with participants randomly assigned to receive identical content narrated either by a peer or provider and evaluated effects on behavior at 2-weeks post-intervention. Of 138 enrolled, 122 completed follow-up; youth were 20.5 years, 80.3% female, 82.8% used a pump, 60.7% a CGM, mean last HbA1c of 7.7, with 85.2% lifetime alcohol use. Both arms saw gains in knowledge, attitudes, and concerns at follow-up (see Table) but those delivered the provider intervention rated their spokesperson as more knowledgeable and trustworthy. All youth reported decreases in binge drinking post intervention (21.3%) compared to prior (35.2%, OR 0.49, 95% CI 0.33-0.73). Changes in binge drinking were partially mediated by concerns about alcohol and T1D. This scalable intervention was successful at affecting knowledge, attitudes/concerns, and binge drinking and could be implemented broadly. Disclosure L.E. Wisk: None. E. Nelson: None. K.M. Magane: None. E.R. Weitzman: None. Funding Boston Children’s Hospital (FP01017994 to L.E.W., E.R.W.); Agency for Healthcare Research and Quality (K12HS022986); Conrad N. Hilton Foundation (20140273 to E.R.W.)

2076-P: Time Restricted Eating (TRE) Promotes Weight Loss, Alters Body Composition, and Improves Metabolic Parameters in Overweight Humans

TRE, restriction of the eating window, reduces weight in animals and humans. We performed a randomized clinical trial examining the effect of TRE on body composition and glycemic measures in overweight humans without diabetes. We hypothesized that TRE will reduce weight and alter body composition compared with unrestricted feeding (non-TRE). 21 overweight subjects [18F/3M, mean(SE), age: 44.7 years (2.7), BMI:34.6 kg/m2(1.7) with a prolonged eating window:15.6 hours (0.2)] were randomized to either 12 weeks of TRE [n=11 (goal 8 hours)] or non-TRE [n=10]. All oral intake was logged using the myCircadianClock smart phone application to remotely monitor TRE adherence. Subjects also underwent: 2-hour oral glucose tolerance test, 2-week continuous glucose monitoring (Freestyle Libre), and 2-week activity tracking (Actigraph Link) pre and post intervention. Compared with the non-TRE group [eating window 15.2 hours (0.3)] post-intervention, the TRE group [eating window 10.4 hours (0.6)] decreased weight [-3.6 kg(0.6) vs. -1.4 kg(0.7)], visceral fat [-260 g(110) vs. 38 g(56)], lean mass [-1450 g(389) vs. -95.5 g(351)] and triglycerides [-23.6%(6.8) vs. -0.57%(7.6)] (all p≤0.05). Relative to baseline, the TRE group decreased: weight, fasting glucose, fat mass, lean mass, visceral fat, and fasting triglyceride levels (all p&amp;lt;0.05). This was not observed in the non-TRE group. TRE-related weight loss was associated with lower: fat mass [-4%(0.9)], visceral fat [-11%(4.0)], and lean mass [-3%(0.8)] relative to baseline (all p&amp;lt;0.05). All TRE-related effects were not significant after adjusting for weight loss. Neither intervention significantly altered physical activity. In overweight subjects, TRE reduced weight and improved metabolic parameters (triglycerides, fasting glucose). However, the TRE-related weight loss included both lean and fat mass loss. Further investigation into the translational aspects of TRE to treat obesity-related disorders is warranted. Disclosure L.S. Chow: Research Support; Self; Eli Lilly and Company. E. Manoogian: None. A.C. Alvear: None. Q. Wang: None. S. Panda: Other Relationship; Self; PenguinRandomHouse. D.G. Mashek: Consultant; Self; Eli Lilly and Company. Research Support; Self; Eli Lilly and Company. Funding University of Minnesota Healthy Foods Healthy Lives (17SFR-2YR50LC)

Effectiveness of the “living successfully with low vision” self-management program: Results from a randomized controlled trial in Singaporeans with low vision

ObjectiveTo determine the effectiveness of the “Living Successfully with Low Vision” (LSLV) self-management program to improve patient-reported outcomes in Singaporeans. MethodsIn this randomized controlled trial, 165 participants with low vision (LV) were recruited and assigned to usual care (LV aid training only; N = 82) or LSLV program (N = 83). The LSLV program focuses on problem solving, coping mechanism and anticipation/preparation for future needs. The primary outcome was vision-related quality of life (VRQoL; measured using the Impact of Vision Impairment [IVI] questionnaire), while secondary outcomes included health-related quality of life; mental health; and self-efficacy, assessed at baseline, 2-weeks and 6-months post-intervention. Within- and between-group comparisons were conducted using paired t-tests and repeated measures analysis of covariance, respectively. ResultsA total of 128 individuals (77.6%) completed all assessments. At 2 weeks, LSLV participants alone experienced a significant within-group improvement in the mean IVI Emotional score (P = 0.05) but not at 6 months. No other within- or between-group effects were observed. ConclusionWhile SM programs have shown promising results in the management of many chronic diseases, our findings suggest that the LVSM program was not an effective approach for LV rehabilitation in Singapore. Practice implicationOther evidence-based strategies to improve QoL in patients with LV may be warranted.

Effects of the Use of Self-Directed Video on Knowledge of Malang city's Volunteer communities in conducting cPR Actions

Cardiac arrest is a cardiovascular emergency which is the highest cause of death in the world, both in developing and developed countries. The occurrence of Out-of-Hospital Cardiac Arrest (OHCA) is commonly encountered by lay people. Therefore, everyone actually has an important role in increasing the survival rate of cardiac arrest patients, especially in the implementation of CPR. One way to improve the ability of lay people to do CPR is to use the learning method of self-directed video. However, several studies have suggested that the self-directed video media is less effective than ordinary knowledge improvement methods. In this regard, the researcher conducted this study with the aim to identify the effects of selfdirected video on volunteer knowledge in conducting CPR. This study used a queasy experiment design with a pretest-posttest approach. Knowledge was measured at pre-intervention, immediate post-intervention, 1-week post-intervention, and 2-week post-intervention using questionnaires. Data were analyzed using Friedman and Wilcoxon tests. The results showed a change in knowledge between pre-intervention and immediate post-intervention, between pre-intervention and 1-week post-intervention, and between pre intervention and 2-week post-intervention (p=0.001). Thus, self-directed videos are considered able to improve volunteer knowledge in conducting CPR.