Assess Intervention Feasibility Research Articles

Leveraging Implementation Science at the Early-Stage Development of a Novel Telehealth-Delivered Fear of Exercise Program to Understand Intervention Feasibility and Implementation Potential: Feasibility Behavioral Intervention Study.

To increase real-world adoption of effective telehealth-delivered behavioral health interventions among midlife and older adults with cardiovascular disease, incorporating implementation science (IS) methods at earlier stages of intervention development may be needed. This study aims to describe how IS can be incorporated into the design and interpretation of a study assessing the feasibility and implementation potential of a technology-delivered behavioral health intervention. We assessed the feasibility and implementation potential of a 2-session, remotely delivered, home-based behavioral intervention composed of psychoeducation, interoceptive exposure through low-to-moderate intensity walking, interoceptive counseling, and homework (Reducing Exercise Sensitivity with Exposure Training; RESET) among patients with recent acute coronary syndrome (ACS) and some fear of exercise. To assess intervention feasibility, we measured patient protocol adherence, intervention delivery fidelity, and completion of intervention outcome assessments using direct observations, fidelity checklists, surveys, and device-measured physical activity. To assess implementation potential, we measured implementation outcomes (feasibility, acceptability, and appropriateness) using 4-item measures, each rated from the patient perspective on a 1 to 5 Likert scale (1=completely disagree and 5=completely agree; criteria: ≥4=agree or completely agree), and patient-perceived implementation determinants and design feedback using survey and interview data. Interview data underwent thematic analysis to identify implementation determinant themes, which were then categorized into Consolidated Framework for Implementation Research (CFIR) domains and constructs. Of 31 patients approached during recruitment, 3 (10%) were eligible, enrolled, and completed the study (mean age 46.3, SD 14.0 y; 2/3, 67% male; 1/3, 33% Black; and 1/3, 33% Asian). The intervention was delivered with fidelity for all participants, and all participants completed the entire intervention protocol and outcome assessments. On average, participants agreed that the RESET intervention was feasible and acceptable, while appropriateness ratings did not meet implementation criteria (feasibility: mean 4.2, SD 0.4; acceptability: mean 4.3, SD 0.7; and appropriateness: mean 3.7, SD 0.4). Key patient-perceived implementation determinants were related to constructs in the innovation (design, adaptability, and complexity), inner setting (available resources [physical space, funding, materials, and equipment] and access to knowledge and information), and innovation recipient characteristics (motivation, capability, opportunity, and need) domains of the CFIR, with key barriers related to innovation design. Design feedback indicated that the areas requiring the most revisions were the interoceptive exposure design and the virtual delivery modality, and reasons why included low dose and poor usability. The RESET intervention was feasible but not implementable in a small sample of patients with ACS. Our theory-informed, mixed methods approach aided our understanding of what, how, and why RESET was not perceived as implementable; this information will guide intervention refinement. This study demonstrated how integrating IS methods early in intervention development can guide decisions regarding readiness to advance interventions along the translational research pipeline.

Feasibility and Preliminary Effects of a Social Media-Based Peer-Group Mobile Messaging Smoking Cessation Intervention Among Chinese Immigrants who Smoke: Pilot Randomized Controlled Trial.

Chinese immigrants experience significant disparities in tobacco use. Culturally adapted tobacco treatments targeting this population are sparse and the use is low. The low use of these treatment programs is attributed to their exclusive focus on individuals who are ready to quit and the wide range of barriers that Chinese immigrants face to access these programs. To support Chinese immigrant smokers at all levels of readiness to quit and address their access barriers, we developed the WeChat Quit Coach, a culturally and linguistically appropriate WeChat (Tencent Holdings Limited)-based peer group mobile messaging smoking cessation intervention. This study aims to assess the feasibility, acceptability, and preliminary effects of WeChat Quit Coach. We enrolled a total of 60 Chinese immigrant smokers in 2022 in New York City for a pilot randomized controlled trial (RCT) and a single-arm pilot test. The first 40 participants were randomized to either the intervention arm (WeChat Quit Coach) or the control arm (self-help print material) using 1:1 block randomization stratified by sex. WeChat Quit Coach lasted 6 weeks, featuring small peer groups moderated by a coach, daily text messages with text questions, and chat-based instant messaging support from the coach in response to peer questions. The next 20 participants were enrolled in the single-arm pilot test to further assess intervention feasibility and acceptability. All 60 participants were offered a 4-week supply of complimentary nicotine replacement therapy. Surveys were administered at baseline and 6 weeks, with participants in the pilot RCT completing an additional survey at 6 months and biochemical verification of abstinence at both follow-ups. Of 74 individuals screened, 68 (92%) were eligible and 60 (88%) were enrolled. The majority of participants, with a mean age of 42.5 (SD 13.8) years, were male (49/60, 82%) and not ready to quit, with 70% (42/60) in the precontemplation or contemplation stage at the time of enrollment. The pilot RCT had follow-up rates of 98% (39/40) at 6 weeks and 93% (37/40) at 6 months, while the single-arm test achieved 100% follow-up at 6 weeks. On average, participants responded to daily text questions for 25.1 days over the 42-day intervention period and 23% (9/40) used the chat-based instant messaging support. Most participants were satisfied with WeChat Quit Coach (36/39, 92%) and would recommend it to others (32/39, 82%). At 6 months, self-reported 7-day point prevalence abstinence rates were 25% (5/20) in the intervention arm and 15% (3/20) in the control arm, with biochemically verified abstinence rates of 25% (5/20) and 5% (1/20), respectively. WeChat Quit Coach was feasible and well-received by Chinese immigrants who smoke and produced promising effects on abstinence. Large trials are warranted to assess its efficacy in promoting abstinence in this underserved population. ClinicalTrials.gov NCT05130788; https://clinicaltrials.gov/study/NCT05130788.

Acceptability, feasibility and preliminary effects of an online group psychotherapy intervention for adolescents and young adults with cancer.

Adolescents and young adults (AYAs; ages 15-29years) diagnosed with cancer are increasingly recognized as an oncology population with distinct psychosocial needs. However, few specialized psychosocial interventions for AYAs currently exist. This study reports on the development of a novel group-based psychotherapy intervention to address the psychosocial needs of AYAs. The objective was to evaluate the acceptability, feasibility, and preliminary effects of the intervention. The manualized group psychotherapy program is delivered virtually over an 8-week period by registered psychologists. Four groups (n=5-11 AYAs per group) with a total of N=33 participants (Mage=20.97years, SD=3.68, range=15-29years, 76% women) were conducted. Recruitment and retention data assessed intervention feasibility. Patient-reported psychosocial outcomes were measured at baseline and immediately following the intervention to assess preliminary effects. Acceptability was assessed following the intervention using a self-report measure of participant satisfaction. Overall, the completion rate of the intervention was 85% (n=28). All participants "strongly agreed" (88%) or "agreed" (13%) that they were satisfied with the group. Meeting, sharing experiences, and expressing feelings with other AYAs were identified as the most helpful aspects. Participants reported significant improvements in emotional (p<0.05) and functional (p<0.01) quality of life from baseline to immediately post-intervention with medium effect sizes (d=0.58-0.70). Findings suggest that the intervention is feasible, acceptable, and shows promise for improving psychosocial outcomes for AYAs. Further research will refine the intervention and establish efficacy in a randomized trial.

Development of a psychological health promotion intervention for ultra-orthodox Jewish mothers of children with ADHD using the intervention mapping protocol

BackgroundAttention Deficit Hyperactivity Disorder (ADHD) is a common neuro-developmental health condition in children and adolescents, in which its associated behavior manifestations are known to negatively affect members of the family unit, especially mothers. Ultra-orthodox Jewish (UOJ) community is growing globally and mothers of children with ADHD in this community are potentially at risk for negative health outcomes. As the UOJ community is culturally conservative, maintaining a distinct separation from outside influences, they often avoid utilizing public mental health services due to stigma and a lack of culturally sensitive treatments. Thus, this study aimed to develop a theory-driven and culturally appropriate psychological health promotion intervention for these mothers using the Intervention Mapping protocol.MethodsA mixed-method design was used. Qualitative content analysis was performed on four focus groups (n=25). Additionally, descriptive statistics including the content validity index was used to measure feedback regarding the developed intervention protocol’s relevance, effectiveness, and appropriateness Theoretical models for behavior change, including the Behavior Change Wheel’s COM-B system and the Theoretical Domains Framework, and literature on ADHD in the general population and the ultra-orthodox community were integrated in the process. Intervention components were systematically derived from findings.ResultsKey determinants of health behavior change were identified, resulting in formulating intervention objectives addressing stigma reduction surrounding ADHD, increasing knowledge about the ADHD condition and treatment, awareness of the school systems’ capabilities in meeting the ADHD child’s needs, enhancing mothers’ advocacy skills, and maternal self-care. Intervention? strategies included a group setting, providing information on health consequences, social support, re-attribution, active learning, goal setting, and promoting an identity associated with the desired behavior change. Mothers’ quantitative feedback confirmed the overall relevance, effectiveness, and appropriateness of the interventions’ content (CVIavg= .86, .85, .87).ConclusionsIntervention Mapping facilitated the development of a culturally sensitive psychological health promotion intervention for ultra-orthodox Jewish mothers of children with ADHD. Further research is warranted to assess intervention feasibility and effectiveness.

"ReachOut": Pilot Evaluation of a Help-Seeking Intervention for Common Mental Health Concerns Among Distressed Non-Treatment-Seeking Young Adults.

Purpose There is a pressing need for interventions with the potential for scalability to enhance help-seeking inclination and behavior among individuals experiencing common mental health concerns. These interventions are important for addressing the widespread treatment gap. This study aimed to test the effectiveness, feasibility, and acceptability of a newly developed simple technology-based multi-component help-seeking intervention ("ReachOut") for common mental health concerns among distressed, non-treatment-seeking young adults. Methods "ReachOut" was delivered to 172 young adults aged 20-35 years, scoring above the cut-off on the Kessler Psychological Distress scale. Effectiveness was studied using a single-group short-term prospective study design to examine changes in help-seeking barriers, inclination, and behavior. We assessed intervention feasibility in terms of demand, implementation, practicality, and limited efficacyand acceptability was determinedbased on the rate of participation consent, the extent of pro-active initiation of contact with the facilitatorduring the intervention, feedback obtained on various "ReachOut" componentsand ratings on the likelihood of recommendingthe interventiontoa person in distress. Results Significant reductions in the mean barriers and improvement in mean help-seeking inclination from mental health professionals (MHPs) were observed on the Friedman test from baseline to the two-month follow-up period after the intervention. Thirty-eight percent of participants (N=41) reported seeking help from MHPs by two-month follow-up. Feedback from participants, assessments, and observations indicated that "ReachOut" was feasible and acceptable among the target sample. Conclusions The study provides preliminary evidence of the effectiveness, feasibility, and acceptability of the help-seeking intervention "ReachOut" in reducing barriers and improving help-seeking inclination and behavior for common mental health concerns among distressed non-treatment-seeking young adults.

Assessing the feasibility of an intervention for adolescents and parents transitioning out of paediatric eating disorder services: A mixed methods study.

To assess the feasibility of a new intervention designed to support adolescents and parents in the transition from paediatric eating disorder (ED) treatment to adult mental health services. Pre-transition adolescents with EDs, and their parents, were invited to complete up to five transition intervention components over 3months. A mixed methods design was used to assess intervention feasibility, comprised of acceptability and preliminary effectiveness. A single-arm pre-post design was used to collect and analyse quantitative survey and feasibility data. Individual qualitative interviews and written reflections were collected and analysed using content analysis. This study yielded a 33% (10/31) recruitment rate and 68% (13/19) retention rate. On average, participants completed 75% of the expected components in under 3months, with varied completion of each expected intervention component (40%-100%). Participants found the intervention convenient and helpful. Parents reported a significant decrease in guilt (Z=-2.02, p=0.04, d=-0.83). By 1-month post-transition, three adolescents transitioned to interim supports and none started specialist adult treatment. Although this transition intervention did not demonstrate adequate feasibility, its acceptability and effectiveness should be evaluated after an update based on participant feedback. Other solutions to bridge the transition gap for adolescents with EDs should continue to be identified. NCT04888273.

Virtual parent-led peer support groups for parents of children with eating disorders: A mixed methods feasibility study.

To examine the feasibility of a virtual parent-led peer support group (vPLPSG) intervention for parents of children with eating disorders (EDs). Forty-four parents were invited to attend 2-h-long vPLPSG sessions every other week for 6 months. A convergent mixed methods design was used to integrate quantitative survey data (collected at three timepoints and analyzed using repeated measures ANOVA) and qualitative interview data (collected at 6 months and analyzed using content analysis) to assess intervention feasibility. Feasibility was comprised of acceptability (e.g., recruitment and retention rates, desire to continue attending the groups) and preliminary effectiveness (e.g., change in parents' self-reported burden). The recruitment rate (67%), retention rate (77%), and attendance rate (60%) demonstrated adequate acceptability. All parents expressed their recommendation of this group to other parents, and most wanted to continue attending vPLPSG sessions. Participants qualitatively reported less isolation and burden as well as improvements in skills and confidence to manage their child's symptoms. These preliminary effectiveness findings were corroborated by quantitative data, with participants reporting a significant decrease in burden [mean difference (MD) = 6.61; p < .004], increase in confidence (MD = 11.17; p < .001), and decrease in unmet needs (MD = 5.03; p < .001) from baseline to 6-months. The vPLPSG intervention demonstrated feasibility with respect to acceptability and improvements in preliminary parental outcomes. Future research should evaluate the effectiveness of this intervention using a larger, more diverse sample. Dedicated efforts to support caregivers, such as through virtual parent-led peer support groups, have the potential to increase confidence and decrease burden for parents managing their child's eating disorder.

Extended Family Outreach in Hereditary Cancer Using Web-Based Genealogy, Direct-to-Consumer Ancestry Genetics, and Social Media: Mixed Methods Process Evaluation of the ConnectMyVariant Intervention

Cascade screening, defined as helping at-risk relatives get targeted genetic testing of familial variants for dominant hereditary cancer syndromes, is a proven component of cancer prevention; however, its uptake is low. We developed and conducted a pilot study of the ConnectMyVariant intervention, in which participants received support to contact at-risk relatives that extended beyond first-degree relatives and encourage relatives to obtain genetic testing and connect with others having the same variant through email and social media. The support that participants received included listening to participants' needs, assisting with documentary genealogy to find common ancestors, facilitating direct-to-consumer DNA testing and interpretation, and assisting with database searches. We aimed to assess intervention feasibility, motivations for participating, and engagement among ConnectMyVariant participants and their families. We used a mixed methods design including both quantitative and qualitative evaluation methods. First, we considered intervention feasibility by characterizing recruitment and retention using multiple recruitment mechanisms, including web-based advertising, dissemination of invitations with positive test results, provider recruitment, snowball sampling, and recruitment through web-based social networks and research studies. Second, we characterized participants' motivations, concerns, and engagement through project documentation of participant engagement in outreach activities and qualitative analysis of participant communications. We used an inductive qualitative data analysis approach to analyze emails, free-text notes, and other communications generated with participants as part of the ConnectMyVariant intervention. We identified 84 prospective participants using different recruitment mechanisms; 57 participants were ultimately enrolled in the study for varying lengths of time. With respect to motivations for engaging in the intervention, participants were most interested in activities relating to genealogy and communication with others who had their specific variants. Although there was a desire to find others with the same variant and prevent cancer, more participants expressed an interest in learning about their genealogy and family health history, with prevention in relatives considered a natural side effect of outreach. Concerns about participation included whether relatives would be open to communication, how to go about it, and whether others with a specific variant would be motivated to help find common ancestors. We observed that ConnectMyVariant participants engaged in 6 primary activities to identify and communicate with at-risk relatives: sharing family history, family member testing, direct-to-consumer genealogy genetic testing analysis, contacting (distant) relatives, documentary genealogy, and expanding variant groups or outreach. Participants who connected with others who had the same variant were more likely to engage with several extended family outreach activities. This study demonstrated that there is an interest in extended family outreach as a mechanism to improve cascade screening for hereditary cancer prevention. Additional research to systematically evaluate the outcomes of such outreach may be challenging but is warranted.

Expanding Contraceptive Access for Teens—Leveraging the Pediatric Emergency Department

Adolescents have limited access to sexual healthcare services, and the emergency department (ED) may be the only place some will seek care. We implemented an ED-based contraception counseling intervention to assess intervention feasibility, and adolescent intention to initiate contraception, contraception initiation, and follow-up visit completion. This prospective cohort study trained advanced practice providers in the EDs of two pediatric urban academic medical centers to deliver brief contraception counseling. A convenience sample of patients enrolled from 2019 to 2021 included females aged 15-18 not pregnant/desiring pregnancy and/or using hormonal contraception/an intrauterine device. Participants completed surveys to assess demographics and intention to initiate contraception (yes/no). Sessions were audiotaped and reviewed for fidelity. We ascertained contraception initiation and follow-up visit completion via medical record review and participant survey at 8weeks. Twenty-seven advanced practice providers were trained, and 96 adolescents were counseled/responded to surveys (mean age 16.7years; 19% non-Hispanic White, 56% non-Hispanic Black; 18% Hispanic). Mean counseling duration was 12minutes and >90% of reviewed sessions maintained fidelity to content/style. Most participants (61%) reported intention to initiate contraception, and these participants were older and more likely to report prior contraceptive use, compared to those without intention. One-third (33%) initiated contraception in the ED or after the follow-up visit. Contraceptive counseling was feasible to integrate in the ED visit. Intention to initiate contraception was common and many adolescents initiated contraception. Future work should increase the pool of trained providers and supports for same-day contraception initiation for those desiring in this novel setting.

A simulation and experiential learning intervention for labor and delivery providers to address HIV stigma during childbirth in Tanzania: study protocol for the evaluation of the MAMA intervention

BackgroundThe experience of HIV stigma during intrapartum care can impact women’s trust in the health care system and undermine their long-term commitment to HIV care engagement. Delivery of respectful maternity care (RMC) to women living with HIV (WLHIV) can improve quality of life and clinical outcomes. The goal of this study is to conduct an evaluation of MAMA (Mradi wa Afya ya Mama Mzazi, Project to Support the Health of Women Giving Birth), a simulation team-training curriculum for labor and delivery providers that addresses providers’ instrumental and attitudinal stigma toward WLHIV and promotes the delivery of evidence-based RMC for WLHIV.MethodsThe MAMA intervention will be evaluated among healthcare providers across six clinics in the Kilimanjaro Region of Tanzania. To evaluate the impact of MAMA, we will enroll WLHIV who give birth in the facilities before (n = 103 WLHIV) and after (n = 103 WLHIV) the intervention. We will examine differences in the primary outcome (perceptions of RMC) and secondary outcomes (postpartum HIV care engagement; perceptions of HIV stigma in the facility; internal HIV stigma; clinical outcomes and evidence-based practices) between women enrolled in the two time periods. Will also assess participating providers (n = 60) at baseline, immediate post, 1-month post training, and 2-month post training. We will examine longitudinal changes in the primary outcome (practices of RMC) and secondary outcomes (stigma toward WLHIV; self-efficacy in delivery intrapartum care). Quality assurance data will be collected to assess intervention feasibility and acceptability.DiscussionThe implementation findings will be used to finalize the intervention for a train-the-trainer model that is scalable, and the outcomes data will be used to power a multi-site study to detect significant differences in HIV care engagement.Trial RegistrationThe trial is registered at clinicaltrials.gov, NCT05271903.

Development and Feasibility Testing of a Multilevel Intervention to Increase Hepatitis C Virus Screening Among Baby Boomers in Primary Care

Chronic infection with hepatitis C virus (HCV) results in an increased risk of cirrhosis and hepatocellular carcinoma (HCC). Only 15% of baby boomers (born 1945–1965) have ever been screened. We aimed to develop a multilevel intervention to increase HCV screening for baby boomers in a primary care setting. This study included two phases: intervention development (phase 1) and feasibility testing (phase 2). In phase 1, we partnered with a Community Advisory Board and a Provider Advisory Board to develop a multilevel intervention to increase HCV screening to be delivered to both providers and patients in primary care. Phase 2 assessed intervention feasibility, acceptability, and usability by conducting Concurrent Think Aloud (CTA) interviews and surveys using previously validated scales with patients (n = 8) and providers (n = 7). Phase 1 results: The patient-level intervention included a mailed reminder letter and CDC pamphlet and a 7-min in-clinic educational video. The provider-level intervention included a 30-min educational session and monthly performance feedback e-mails. Phase 2 results: Qualitatively, both the patient and provider-level intervention were feasible, acceptable, and usable by the target audiences. Quantitatively, on a 1–4 scale, the range of patient-level scores was 3.00–4.00 and provider level was 3.50–4.00 for feasibility, acceptability, and usability. This intervention could improve HCV screening among a high-risk population and therefore reduce HCV-related morbidity and mortality. This project developed a feasible, acceptable, and usable multilevel intervention aimed at increasing HCV screening in primary care.

Community pharmacist intervention to close statin gaps in diabetes care: The GuIDE-S study

Statin therapy is recommended for people with type 2 diabetes (T2D) to lower cardiovascular risk; however, evidence suggests that significant gaps in statin therapy exist. To evaluate (1) the impact of a community pharmacist-led model for initiating statin therapy in people with type 2 diabetes (T2D) on statin initiation and (2) pharmacists' self-reported perceptions of the intervention feasibility and fidelity to the intervention. This was a type 1 hybrid effectiveness-implementation study of 9 intervention and 18 control pharmacies within a community pharmacy chain. Pharmacy staff proactively identified patients with T2D not taking a statin and prescribed a statin via a collaborative practice agreement or facilitated acquisition of a prescription from the patient's preferred prescriber. The eligible population included patients aged 18-84 years with T2D, who had filled ≥60 days' supply of one, noninsulin, diabetes medication in a rolling 6-month period, and who had not filled a statin during the same period. A Cox proportional hazards model was used to compare time to statin initiation. Pharmacists at intervention pharmacies completed a survey at 6 and 12 months after implementation (March and August 2019, respectively) to assess intervention feasibility and fidelity. For the statin initiation analysis, 1670 intervention patients were matched to 3358 control patients. Overall, 26.3% (n=442) of intervention patients and 25.4% (n=854) of control patients initiated a statin within 12 months of their index date. There was no difference in statin initiation likelihood between intervention and control patients (hazard ratio: 1.00; 95% CI: 0.83, 1.21). Fifteen pharmacists completed the 6-month survey (33% response rate), and 12 completed the 12-month survey (26%). The intervention's feasibility score was 4.0 at 6 months and 4.2 at 12 months, indicating an increase in perceived feasibility. Fidelity decreased from 6 to 12 months. The community pharmacist-led intervention resulted in more patients initiating statin therapy as compared to usual care; however, the differences were not statistically significant. Pharmacists perceived the intervention to be feasible; however, fidelity decreased over time.

A Mobile Education and Social Support Group Intervention for Improving Postpartum Health in Northern India: Development and Usability Study.

BackgroundStructural and cultural barriers limit Indian women’s access to adequate postnatal care and support despite their importance for maternal and neonatal health. Targeted postnatal education and support through a mobile health intervention may improve postnatal recovery, neonatal care practices, nutritional status, knowledge and care seeking, and mental health.ObjectiveWe sought to understand the feasibility and acceptability of our first pilot phase, a flexible 6-week postnatal mobile health intervention delivered to 3 groups of women in Punjab, India, and adapt our intervention for our next pilot phase, which will formally assess intervention feasibility, acceptability, and preliminary efficacy.MethodsOur intervention prototype was designed to deliver culturally tailored educational programming via a provider-moderated, voice- and text-based group approach to connect new mothers with a social support group of other new mothers, increase their health-related communication with providers, and refer them to care needed. We targeted deployment using feature phones to include participants from diverse socioeconomic groups. We held moderated group calls weekly, disseminated educational audios, and created SMS text messaging groups. We varied content delivery, group discussion participation, and chat moderation. Three groups of postpartum women from Punjab were recruited for the pilot through community health workers. Sociodemographic data were collected at baseline. Intervention feasibility and acceptability were assessed through weekly participant check-ins (N=29), weekly moderator reports, structured end-line in-depth interviews among a subgroup of participants (15/29, 52%), and back-end technology data.ResultsThe participants were aged 24 to 28 years and 1 to 3 months postpartum. Of the 29 participants, 17 (59%) had their own phones. Half of the participants (14/29, 48%) attended ≥3 of the 6 calls; the main barriers were childcare and household responsibilities and network or phone issues. Most participants were very satisfied with the intervention (16/19, 84%) and found the educational content (20/20, 100%) and group discussions (17/20, 85%) very useful. The participants used the SMS text messaging chat, particularly when facilitator-moderated. Sustaining participation and fostering group interactions was limited by technological and sociocultural challenges.ConclusionsThe intervention was considered generally feasible and acceptable, and protocol adjustments were identified to improve intervention delivery and engagement. To address technological issues, we engaged a cloud-based service provider for group calls and an interactive voice response service provider for educational recordings and developed a smartphone app for the participants. We seek to overcome sociocultural challenges through new strategies for increasing group engagement, including targeting midlevel female community health care providers as moderators. Our second pilot will assess intervention feasibility, acceptability, and preliminary effectiveness at 6 months. Ultimately, we seek to support the health and well-being of postpartum women and their infants in South Asia and beyond through the development of efficient, acceptable, and effective intervention strategies.

Parallel Parent–Child Mindfulness Intervention Among Chinese Migrant Families: A Mixed-Methods Feasibility Study

Purpose This study examines the feasibility and effects of a parallel parent–child mindfulness intervention on parenting stress, child behavior, and parent–child relationship among low-income migrant families. Methods Using a quasi-experimental design, 21 Chinese migrant parents and one child of each parent were assigned to an 8-week intervention ( n = 11 pairs) or waitlist control ( n = 10 pairs). Semi-structured qualitative interviews and pre–post quantitative measures were used to assess intervention feasibility and effects. Results Qualitative interviews suggest mindfulness training promotes family well-being through enhanced parental and child emotional regulation. Quantitative results suggest within-group parenting stress significantly decreased in the intervention group (partial η 2 = .423) but not in controls (partial η 2 = .000); between-group analyses showed a nonsignificant, medium effect size on parenting stress (partial η 2 = .069). Conclusions The intervention shows good feasibility and initial support for reducing parenting stress. Future research requires a larger randomized controlled trial among high-stress populations such as migrant families.

Managing Obesity in Young Children: A Multiple Methods Study Assessing Feasibility, Acceptability, and Implementation of a Multicomponent, Family-Based Intervention.

Background:We developed a multicomponent, family-based intervention for young children with obesity consisting of parent group sessions, home nursing visits, and multidisciplinary clinical encounters. Our objective was to assess intervention feasibility, acceptability, and implementation.Methods:From 2017 to 2020, we conducted a multiple methods study in the obesity management clinic at a tertiary children's hospital (Toronto, Canada). We included 1–6 year olds with a body mass index ≥97th percentile and their parents; we also included health care providers (HCPs) who delivered the intervention. To assess feasibility, we performed a pilot randomized controlled trial (RCT) comparing the intervention to usual care. To explore acceptability, we conducted parent focus groups. To explore implementation, we examined contextual factors with HCPs using the Consolidated Framework for Implementation Research.Results:There was a high level of ineligibility (n = 34/61) for the pilot RCT. Over 21 months, 11 parent-child dyads were recruited; of 6 randomized to the intervention, 3 did not participate in group sessions or home visits. In focus groups, themes identified by parents (n = 8) related to information provided at referral; fit between the intervention and patient needs; parental gains from participating in the intervention; and feasibility of group sessions. HCPs (n = 10) identified contextual factors that were positively and negatively associated with intervention implementation.Conclusions:We encountered challenges related to intervention feasibility, acceptability, and implementation. Lessons learned from this study will inform the next iteration of our intervention and are relevant to intervention development and implementation for young children with obesity.Clinical Trial Registration number: NCT03219658.

The Development and Pilot of a Technology-Based Intervention in the United States for Father's Mental Health in the Perinatal Period.

Paternal mental health is increasingly recognized as an important public health issue, with about 10% of men experiencing depression perinatally. Paternal depression is associated with less responsive parenting, greater parenting stress, and suboptimal child development. In response to a lack of existing interventions that directly focus on fathers’ mental health in the United States, we developed and pilot tested the Fathers and Babies (FAB) intervention for use with partners of women enrolled in home visiting (HV) programs.After a review of the extant literature, FAB was developed with input from HV stakeholders and infant mental health consultants. FAB was subsequently pilot tested with 30 father-mother dyads, with mixed-method data collected from a subset of intervention participants to assess intervention feasibility and acceptability and guide intervention refinement.Five themes related to FAB content and delivery considerations emerged from the initial focus groups that were used to guide FAB development. Mixed-method data collected during the pilot study established that fathers receiving FAB reported its content appropriate and thought it was feasible to receive the intervention. Several recommendations for FAB revisions were also provided.FAB is an innovative intervention developed for fathers from contemporary family structures that was well-received during its pilot testing. Feasibility and acceptability data suggest that fathers have favorable opinions about intervention content and delivery, while also highlighting areas for future revisions of FAB.

Feasibility, acceptability, and effectiveness of a decision aid versus an informational website to promote clinical trial decision-making among cancer patients: A pilot randomized controlled trial

To assess intervention feasibility and acceptability, and compare the effectiveness of the CHOICES Decision Aid (DA) versus the National Cancer Institute (NCI) Cancer Clinical Trials (CCT) website to improve knowledge about CCTs and preparedness to make an informed decision. Oncology patients (n=101) with a scheduled clinic visit were enrolled and randomized. Decision-making variables were collected at two timepoints. Post-intervention scores were examined via paired t-tests and multivariate regression analyses. Predictors of the magnitudes of the change in scores were examined in multivariable regression analyses. The interventions were feasible to implement and acceptable to participants. Both interventions increased objective and subjective knowledge, improved clarity of opinions, and reduced decisional conflict (p-values<0.01). Improvements in the belief that one could find out about CCTs were observed in the CHOICES DA arm (p<0.001). Multivariable analyses controlling for educational attainment showed no significant differences in the magnitude of change in outcome variables between intervention arms, but did find that improvements in some variables in the NCI arm - but not CHOICES DA arm - were associated with previous educational attainment. Interventions were feasible to implement and acceptable. Improvements in knowledge and decision-making outcomes were observed in both arms, supporting the view that interventions to improve CCT decision making are effective and feasible. Our results suggest that the CHOICES DA may be more effective than an informational website in improving decision-making outcomes regardless of participants' educational attainment. CCT resources should support informed decision-making among all cancer survivors, regardless of educational attainment.

Implementation of START (STrAtegies for RelaTives) for dementia carers in the third sector: Widening access to evidence-based interventions.

Family members remain the main care providers for the increasing numbers of people with dementia, and often become depressed or anxious. In an implementation research project, we aimed to widen access to Strategies for RelaTives (START), a clinically and cost-effective intervention for the mental health of family carers, by laying the foundations for its implementation in the third sector. We used the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to guide implementation of START, a manual-based, individually-delivered, multicomponent eight-session coping strategy intervention. We interviewed a maximum variation sample of twenty-seven stakeholders from the English Alzheimer’s Society (AS), about possible difficulties in management, training, and delivery of START. We trained and supervised three AS dementia support workers in different locations, to each deliver START to three family carers. Two researchers independently coded pre-intervention interviews for themes. We assessed intervention feasibility through monitoring delivery fidelity, rating audio-recordings from 1–5 (5 being high) and interviewing facilitators, family carers and AS managers about their experiences. We assessed effectiveness on family carers’ mental health using the Hospital Anxiety and Depression Scale (HADS) before and after receiving START (scores 0–42). We changed START’s format by reflecting carer diversity more and increasing carer stories prominence, but core content or delivery processes were unchanged. All carers received START and attended every session. The mean fidelity score was 4.2. Mean HADS-total score reduced from baseline 18.4 (standard deviation 7.4) to follow-up 15.8 (9.7). Six (67%) carers scored as clinically depressed on baseline HADS and 2 (22%) at follow-up. Facilitators and carers rated START positively. Appropriately experienced third sector workers can be trained and supervised to deliver START and it remains effective. This has the potential for widened access at scale.

Abstract 14540: Preliminary Efficacy and Feasibility of an Emotion Regulation Intervention on Physical Activity and Depressive and Anxious Symptoms in Individuals in Cardiac Rehabilitation

Cardiac rehabilitation (CR) is an important part of overcoming an acute cardiac event, but can be undermined by debilitating levels of depression and anxiety, which can leave cardiac patients at risk for diminished functional capacity. The purpose of this randomized control trial was to evaluate the development and early efficacy testing of a theoretically based emotion regulation treatment (RENEwS) designed to assist people in CR to optimize recovery following acute cardiac events. CR participants (n=30, 83% men) were randomized to 5 one-hour, in-person group sessions of RENEwS or a phone-based active-control group. Participants completed measures of depression and anxiety symptoms at three timepoints. PA was objectively measured for 7 days at each time point using waist-worn actigraphy monitors. Between-group differences were calculated using linear mixed models to evaluate initial efficacy. Qualitative data were collected during RENEwS sessions and analyzed using content analysis with a directed approach to assess intervention feasibility and acceptability. Compared to active-control participants, RENEwS participants showed greater reductions in depression (Cohen’s f = .34) and anxiety symptoms (Cohen’s f = .40) but only modest improvements in PA from baseline to 5 months (Cohen’s f = .08). Descriptive exploratory analysis of within-group changes in the RENEwS group reveals individuals with above mean depressive symptoms and individuals with above mean anxiety symptoms experienced clinically meaningful decreases in psychological symptoms and increases in PA at 5 months. Qualitative analysis of feasibility indicated strengths in acceptability, demand, adaptation, integration, and implementation. Findings show that RENEwS is a promising emotion regulation intervention for CR patients, though revisions are needed to address practicality, expansion, and efficacy.

Work2Prevent, an Employment Intervention Program as HIV Prevention for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 3): Protocol for a Single-Arm Community-Based Trial to Assess Feasibility and Acceptability in a Real-World Setting.

BackgroundIn the United States, young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth face elevated rates of HIV infection. However, racial and ethnic disparities in adolescent HIV infection cannot be attributed to individual-level factors alone and are situated within larger social and structural contexts that marginalize and predispose sexual and gender minority youth of color to HIV. Addressing broader ecological factors that drive transmission requires interventions that focus on the distal drivers of HIV infection, including violence exposure, housing, food insecurity, educational attainment, and employment. Given the ways that economic instability may make YMSM, YTW, and GNC youth of color vulnerable to HIV exposure, this study focuses on employment as an HIV prevention intervention. More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness. The intervention was adapted from iFOUR, an evidence-based employment program for HIV-positive adults in phase 1 of this study, and pilot tested in a university-based setting in phase 2.ObjectiveThis paper aims to describe the protocol for the community-based test phase of W2P. The purpose of this phase was to pilot test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color within a lesbian, gay, bisexual, transgender, and queer (LGBTQ) community setting.MethodsThe employment intervention was pilot tested using a single-arm pretest-posttest trial design implemented among a sample of vulnerable YMSM, YTW, and GNC youth of color using services within a community-based LGBTQ center. Assessments will examine intervention feasibility, acceptability, and preliminary estimates of efficacy.ResultsPhase 3 of W2P research activities began in May 2019 and was completed in December 2019. Overall, 41 participants were enrolled in the community-based pilot.ConclusionsThis study will assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce vulnerability to HIV when implemented in a community-based setting serving LGBTQ youth of color. Testing the intervention in a community setting is an opportunity to evaluate how recruitment, retention, and other outcomes are impacted by delivery in a venue akin to where this intervention could eventually be used by nonresearchers. If W2P demonstrates feasibility and acceptability, a larger multisite trial implemented in multiple community settings serving YMSM, YTW, and GNC youth of color is planned.Trial RegistrationClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310International Registered Report Identifier (IRRID)DERR1-10.2196/18051