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Background: Research shows that family involvement in psychosis treatment leads to better patient outcomes. Interventions that involve and counsel family members may improve patient outcomes by addressing barriers to treatment adherence and lowering family expressed emotion, thereby creating a less stressful and more supportive home environment. Learning to use motivational interviewing communication skills may help caregivers to decrease conflict and expressed emotion and improve treatment adherence.Methods: The current study is a pilot randomized controlled trial testing the impact of "Motivational Interviewing for Loved Ones" (MILO), a brief five-hour psychoeducational intervention for caregivers, in a sample of family members of individuals with early course psychosis (N = 40). Using a randomized crossover design, caregivers were randomized to either immediate MILO or a six-week waitlist control condition; all participants eventually received the intervention.Results: Caregiver participants experienced large (d = 1.08-1.43) and significant improvements in caregiver wellbeing, caregiver self-efficacy, family conflict, and expressed emotion. There was no change over time in caregiver-reported patient treatment adherence. Relative to waitlist, MILO had significant effects on family conflict and expressed emotion, a trending effect on perceived stress, and no effect on parenting self-efficacy or treatment adherence.Conclusions: MILO showed benefits for caregivers of FEP patients in this small, controlled trial. Further testing in a larger randomized controlled trial is warranted to better characterize MILO's effects for caregivers and patients across a range of diagnoses. [ABSTRACT FROM AUTHOR]

• Home-visiting interventions have positive effects on child cognitive development, parenting beliefs and parenting practices of caregivers in rural China. • Home-visiting interventions have null effects on child social-emotional development in rural China. • Three mechanisms are identified through which interventions are able to raise child cognitive development. • Shifting parenting beliefs; increasing parenting practices; and shifting parenting beliefs thus fostering better parenting practices of primary caregivers are the three mechanisms that are driving our overall results of the impact of home-visiting interventions on early child development. To better understand the impacts of parenting interventions (e.g., parental training of psychosocial stimulating activities) on child developmental outcomes and design effective policies to benefit young children, it is essential to identify the mechanisms through which the interventions work. To this end, this paper presents the results of two randomized controlled trials that offered home visitation, parenting trainings to 435 households (with 527 households as the control group) in 174 villages across three provinces in China. The findings from the randomized controlled trials showed that the interventions significantly improved child cognitive development and had a positive effect on the primary caregivers' parenting practices and their parenting beliefs. The analysis suggests three possible mechanisms through which the parenting interventions affected child cognitive development: changing the parenting beliefs of the primary caregivers, shifting the parenting practices of the primary caregivers, and improving the primary caregivers' parenting beliefs, thus fostering better parenting practices. [ABSTRACT FROM AUTHOR]

Most people with dementia live at home and depend on informal caregivers for care. Both caregivers and persons with dementia can experience negative psychological and behavioural effects as the disease progresses. Non-pharmacological interventions can alleviate these effects and dyadic interventions, involving both caregiver and person with dementia, may be particularly effective. In this systematic review, the effect of dyadic interventions involving community-dwelling persons with dementia and their informal caregivers was researched. This article is an update of a review of dyadic interventions up to 2012 (Van't Leven et al., 2013). Twenty-two randomized controlled trials published between January 2012 and March 2023 met eligibility criteria, representing 3857 dyads. Results of a meta-analysis showed no overall intervention effect. Thirteen studies reported positive intervention effects, 9 studies reported no intervention effects. Intervention content and participant characteristics and knowledge of the disease varied widely between the studies reviewed. Effective interventions were those that matched activities for the person with dementia to their interests and abilities and educating the caregiver about dementia and communication. Interventions of moderate length (3–4 months) tended to be more effective than longer or shorter interventions. Future studies should further explore the factors contributing to the effects of dyadic interventions. • Effective interventions adapt activities to preferences of the person with dementia. • Interventions most frequently improved quality of life and neuropsychiatric symptoms. • Interventions with a duration of 3–4 months were most effective. • Symptom severities and specific needs influence the efficacy of dyadic interventions. [ABSTRACT FROM AUTHOR]

As the rates of vaccination decline in children with logistical barriers to vaccination, new strategies to increase vaccination are needed. The goal of this study was to develop and evaluate the effectiveness of the Vaccines For Babies (VFB) intervention, an automated reminder system with online resources to address logistical barriers to vaccination in caregivers of children enrolled in an integrated healthcare system. Effectiveness was evaluated in a randomized controlled trial. Qualitative interviews were conducted with parents of children less than two years old to identify logistical barriers to vaccination that were used to develop the VFB intervention. VFB included automated reminders to schedule the 6- and 12-month vaccine visit linking caregivers to resources to address logistic barriers, sent to the preferred mode of outreach (text, email, and/or phone). Parents of children between 3 and 10 months of age with indicators of logistical barriers to vaccination were randomized to receive VFB or usual well child care (UC). The primary outcome was percentage of days undervaccinated at 2 years of life. A difference in differences analysis was conducted. Qualitative interviews with 6 parents of children less than 2 years of age identified transportation, scheduling challenges, and knowledge of vaccine timing as logistical barriers to vaccination. We enrolled 250 participants in the trial, 45% were loss to follow-up. There were no significant differences in vaccination uptake between those enrolled in UC or the VFB intervention (0.51%, p = 0.86). In Medicaid enrolled participants, there was a modest decrease in percentage of days undervaccinated in the VFB intervention compared to UC (6.3%, p = 0.07). Automated Reminders and with links to heath system resources was not shown to increase infant vaccination uptake demonstrating additional resources are needed to address the needs of caregivers experiencing logistical barriers to vaccination. [ABSTRACT FROM AUTHOR]

Background: As recruitment and retention are often challenging in randomized controlled trials (RCTs), this study sought to identify predictors of participation (i.e., trial enrollment).Method: These analyses identified predictors of enrollment among 119 youth, ages 7-14, with a primary mood disorder, who screened eligible for the Omega-3 and Therapy pilot studies; 95 (79.8%) actually participated in the treatment.Results: Youth who received some form of travel assistance (16.0%) almost uniformly enrolled in the treatment portion of the RCT. Youth who lived further away from the study site (p = .047) or whose primary caregiver never married (p = .01) were less likely to enroll. Of note, socioeconomic status (SES) variables (parent education and child insurance status) did not significantly predict enrollment, suggesting that study incentives or accommodations may have adequately addressed barriers commonly associated with SES.Limitations: Due to the fairly high trial enrollment rate (approximately 80%), there likely was limited power to detect some differences between groups. Generalizability may be limited to youth with a primary mood disorder diagnosis.Conclusions: Despite retaining a large proportion of the youth who screened eligible, participant self-selection is a limitation of any RCT. A silent inclusion criterion of any RCT is willingness to be randomized. [ABSTRACT FROM AUTHOR]

This study will evaluate Functional Family Therapy-Gangs (FFT-G), an extension of a family-based therapeutic intervention—Functional Family Therapy (FFT)—designed to help troubled youth exhibiting mild to severe behavior problems overcome delinquency, substance abuse, and violence. FFT-G, however, addresses risk factors that are typically more salient among gang than delinquent populations. A randomized control trial with adjudicated youth in Philadelphia revealed reductions in recidivism over an 18-month period. The purposes of this paper are to outline the protocol for replicating FFT-G in the Denver metropolitan area, document the design and challenges of the prospective research, and promote transparency. As a condition of pre-trial or probation supervision, 400 youth/caregiver dyads will be randomly assigned to FFT-G or a treatment-as-usual control group. Preregistered confirmatory outcomes include recidivism (i.e., criminal/delinquent charges and adjudications/convictions) measured using official records (Open Science Framework: https://osf.io/abyfs). Secondary outcomes include measures of gang embeddedness, non-violent and violent recidivism, and substance use measured using interview-based surveys and arrest, revocation, incarceration, and crime type indicators of recidivism from official records. Exploratory mediation and moderation analyses are also planned. Intent-to-treat regression analyses will estimate intervention effects 18 months post-randomization. This study will contribute to advancing high-quality evidence-based knowledge on gang interventions for which there are few known effective responses. [ABSTRACT FROM AUTHOR]

Background: Although self-efficacy is a potential determinant of feeding and care behaviors, there is limited empirical analysis of the role of maternal self-efficacy in low- and middle-income countries. In the context of behavior change interventions (BCIs) addressing complementary feeding (CF), it is possible that maternal self-efficacy can mediate or enhance intervention impacts.Objective: In the context of a BCI in Bangladesh, we studied the role of maternal self-efficacy for CF (MSE-CF) for 2 CF behaviors with the use of a theoretically grounded empirical model of determinants to illustrate the potential roles of MSE-CF.Methods: We developed and tested a locally relevant scale for MSE-CF and included it in a survey (n = 457 mothers of children aged 6-24 mo) conducted as part of a cluster-randomized evaluation. Qualitative research was used to inform the selection of 2 intervention-targeted behaviors: feeding green leafy vegetables in the last 24 h (GLV) and on-time introduction of egg (EGG) between 6 and 8 mo of age. We then examined direct, mediated, and potentiated paths of MSE-CF in relation to the impacts of the BCI on these behaviors with the use of regression and structural equation modeling.Results: GLV and EGG were higher in the intensive group than in the nonintensive control group (16.0 percentage points for GLV; P < 0.001; 11.2 percentage points for EGG; P = 0.037). For GLV, MSE-CF mediated (β = 0.345, P = 0.010) and potentiated (β = 0.390, P = 0.038) the effect of the intensive group. In contrast, MSE-CF did not mediate or potentiate the effect of the intervention on EGG.Conclusions: MSE-CF was a significant mediator and potentiator for GLV but not for EGG. The divergent findings highlight the complex determinants of individual specific infant and young child feeding behaviors. The study shows the value of measuring behavioral determinants, such as MSE-CF, that affect a caregiver's capability to adopt intervention-targeted behaviors. [ABSTRACT FROM AUTHOR]

Caregivers of adults with cancer often provide prolonged demanding assistance (e.g., physical, emotional) to their loved ones, resulting in caregiver burden. This meta-analytic review examined the efficacy of psychosocial interventions in reducing caregiver burden in caregivers of adults with cancer. Randomized controlled trials (RCTs) were identified from six electronic databases and clinical trial registries. Random-effects meta-analyses were conducted for subgroups of interventions and control conditions. Overall, 90 records describing 50 RCTs showed that psychosocial interventions reduced caregiver burden compared to passive controls (e.g. wait-list) at post-intervention (g = 0.26, 95%CI [0.12, 0.40]), but not at the first follow-up (g = 0.10, 95%CI [−0.05, 0.24]). Subgroup analyses showed that compared to passive controls, therapeutic counseling and skills training interventions significantly reduced caregiver burden at post-intervention, whereas psycho-education/support interventions did not significantly reduce burden. Very few RCTs examined intervention efficacy compared to active controls (e.g., psycho-education/support). The evidence grade ranged from very low to moderate due to inconsistency and imprecision of the results. Therapeutic counseling and skills training interventions appear efficacious in improving caregiver burden at post-intervention, although these improvements attenuate over time. Rigorous trials examining intervention effects on long-term outcomes are needed to better understand the effective mechanisms to sustain reduction in caregiver burden. • A meta-analytic review of psychosocial interventions for cancer caregiver burden. • Results revealed small significant intervention effects at post-intervention. • Therapeutic counseling and skills training interventions showed greater promise. • Carer age, gender, race, and relationship were significant moderators. • Clinical implications and future directions for research are discussed. [ABSTRACT FROM AUTHOR]

Background Child-to-parent violence is an often hidden serious problem for parental caregivers of mentally ill adult children who experience violence toward them. To date, the comprehensive dyadic parent-adult child intervention to manage child-to-parent violence is scarce. Objective To evaluate the effect of Child- and Parent-focused Violence Program, an adjunctive intervention involved with both violent adult children with mental illness and their victimized biological parent (parent–adult child dyads) on violence management. Design Open-label randomized controlled trial. Setting A psychiatric ward in a teaching hospital and two mental hospitals in Southern Taiwan. Participants Sixty-nine patients aged ≥20 years, with thought or mood disorders, having violent behavior in the past 6 months toward their biological parent of either gender were recruited. The violent patients’ victimized biological parents who had a major and ongoing role in provision of care to these patients, living together with and being assaulted by their violent children were also recruited. The parent–adult child dyads were selected. Methods The intervention was carried out from 2011 to 2013. The parent–adult child dyads were randomly assigned to either the experimental group (36 dyads), which received Child- and Parent-focused Violence Intervention Program, or to the control group (33 dyads), which received only routine psychiatric care. The intervention included two individualized sessions for each patient and parent, separately, and 2 conjoint sessions for each parental-child dyad for a total of 6 sessions. Each session lasted for at least 60-min. Data collection was conducted at 3 different time frames: pre-treatment, post-treatment, and treatment follow-up (one month after the completion of the intervention). Results Occurrence of violence prior to intervention was comparable between two groups: 88.9% ( n = 32) parents in the experimental group versus 93.9% ( n = 31) in the control group experienced verbal attack, and 50% ( n = 18) versus 48.5% ( n = 16) received body attack and were injured. The intervention significantly reduced violence, improved impulsivity, changed patients’ and parents’ violence attributions, and fostering active coping processes in the experimental group as compared to the control group ( p < 0.05). No significant reductions were found in verbal aggression, cognitive and social reactions in the parent's reactions to assault, attentional subscale of impulsivity and wishful thinking ( p > 0.05). Conclusions Child- and Parent-focused Violence Intervention Program is effective on child-to-parent violence management in parent–adult child dyads. Thus, the intervention can be helpful for patients who have just been diagnosed with mental illness and had an episode of violence toward their parents within a narrow time frame. [ABSTRACT FROM AUTHOR]

We report the challenges of the Working to Improve Discussions About Defibrillator Management trial, our novel, multicenter trial aimed at improving communication between cardiology clinicians and their patients with advanced heart failure (HF) who have implantable cardioverter defibrillators (ICDs). The study objectives are (1) to increase ICD deactivation conversations, (2) to increase the number of ICDs deactivated, and (3) to improve psychological outcomes in bereaved caregivers. The unit of randomization is the hospital, the intervention is aimed at HF clinicians, and the patient and caregiver are the units of analysis. Three hospitals were randomized to usual care and three to intervention. The intervention consists of an interactive educational session, clinician reminders, and individualized feedback. We enroll patients with advanced HF and their caregivers, and then we regularly survey them to evaluate whether the intervention has improved communication between them and their HF providers. We encountered three implementation barriers. First, there were institutional review board concerns at two sites because of the palliative nature of the study. Second, we had difficulty in creating entry criteria that accurately identified an HF population at high risk of dying. Third, we had to adapt our entry criteria to the changing landscape of ventricular assist devices and cardiac transplant eligibility. Here we present our novel solutions to the difficulties we encountered. Our work has the ability to enhance conduct of future studies focusing on improving care for patients with advanced illness. [ABSTRACT FROM AUTHOR]

Randomized controlled trials (RCTs) are the gold standard for generating evidence to inform clinical oncology practice. Knowledge gained through qualitative research methodologies can be complementary to that gained through RCTs. How qualitative research has been combined with RCTs in oncology has not been previously characterized. This scoping review was conducted to summarize how qualitative research associated with RCTs in the oncology setting has been conducted and examine the quality of reporting. Manuscripts reporting on qualitative research linked with RCTs in the cancer context that involved patients (both adult and pediatric) and/or informal caregiver (friends/family) were included. Peer-reviewed manuscripts indexed in MEDLINE (OVID) and CINAHL, published in English between 2008 and January 2019. Formal scoping review methods were followed. A data extraction tool informed by the research questions as well as the COnsolidated criteria for REporting Qualitative research (COREQ) was utilized. Extraction was conducted independently by two authors, with disagreements resolved by a third. Fifty-four articles were included. Assessing information sharing, diet/exercise, and psychotherapeutic interventions were the most common focuses of the RCTs. The most common focus of the qualitative component was on gaining insight into the experience of receiving the intervention or participating in RCT procedures. How the intervention impacted the cancer experience was not a common focus of the qualitative components. Some reports provided insufficient information to understand how the qualitative components aligned with the RCT components. The results of the qualitative and RCT components were not integrated to draw meaningful conclusions about the efficacy of the intervention under study in most cases. Reports focusing on only qualitative methods had higher median (Mdn) reporting of COREQ items compared to reports that included both the qualitative and RCT components (Mdn = 18 vs. Mdn = 14, respectively; p <0.001). This review identified that qualitative research has been combined with RCTs in the cancer context in a number of ways, most commonly to understand the experience of receiving study interventions or participating in trial procedures. Exploring how interventions impact other aspects of the cancer experience is an approach that should be considered in future work. Formalized guidelines for the design and reporting of investigations that combine qualitative and RCT approaches in the cancer context are expected to be of value. Tweetable abstract: Combining qualitative research with randomized controlled trials in oncology: an impornt opportunity for discovery. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Group-based Parent Management Training, the Oregon model (PMTO, 12 sessions) was delivered by the regular staff of municipal child and family services. PMTO is based on social interaction learning theory and promotes positive parenting skills in parents of children with conduct problems. This study examined the effectiveness of the group-based training intervention in real world settings both immediately following and six months after termination of the intervention. Methods: One hundred thirty-seven children (3–12 years) and their parents participated in this study. The families were randomly assigned to group-based training or a comparison group. Data were collected from parents and teachers. Results: The caregiver assessments of parenting practices and child conduct problems and caregiver and teacher reported social competence revealed immediate and significant intervention effects. Short- and long-term beneficial effects were reported from parents, although no follow-up effects were evident on teacher reports. Conclusions: These effectiveness findings and the potential for increasing the number of families served to support the further dissemination and implementation of group-based parent training. [Copyright &y& Elsevier]

Abstract: People with advanced pulmonary disease (APD), such as those with chronic obstructive pulmonary disease, have markedly impaired quality of life. Home Oxygen Therapy (HOT) itself is burdensome, although it often improves survival duration and quality of life in these patients. The exact burdens on informal caregivers of these patients are unknown. The central purpose of the pragmatic randomized controlled study described in this protocol is to determine the effectiveness of improving the skills and knowledge of carers of patients with APD who use HOT. Specifically we aimed to estimate the incremental impact of this carer intervention above usual care on health, economic, psychological and social domains for patient and carer dyads relative to the level of current burden. Eligible patients and their carers were recruited through three major hospitals, and randomized to an intervention or control group. The carers in the intervention group received two home-delivered education sessions based on the principles of academic detailing. Participants are currently being followed over 12months. The primary outcome will be the proportion of patients surviving without a chronic obstructive pulmonary disease-related readmission / residential (non respite) care over 12months. Carer secondary outcomes include perceived caregiver burden, level of expected and received social support, perceived level of mastery, self esteem, health related quality of life and disability, and ability to conduct domestic chores and household maintenance, social activities and provide service to others, and fatigue. Secondary patient outcomes include health related quality of life and disability, and current respiratory health status. [Copyright &y& Elsevier]

Objective: To assess whether a multifactorial fall prevention program was more effective than usual geriatric care in preventing falls and reducing fear of falling in frail community-dwelling older fallers, with and without cognitive impairment, and in alleviating subjective caregiver burden in caregivers. Design, Setting, and Participants: A randomized, 2 parallel-group, single-blind, multicenter trial conducted in 36 pairs of frail fallers, who were referred to a geriatric outpatient clinic after at least 1 fall in the past 6 months, and their informal caregivers. Intervention: Groups of 5 pairs of patients and caregivers received 10 twice-weekly, 2-hour sessions with physical and psychological components and a booster session. Measurements: The primary outcome was the fall rate during a 6-month follow-up. Additionally, we measured fear of falling and subjective caregiver burden. Data on the secondary outcome measures were collected at baseline, directly after, and at 3 and 6 months after the last session of the intervention. Results: Directly after the intervention and at the long-term evaluation, the rate of falls in the intervention group was higher than in the control group, although these differences were not statistically significant (RR = 7.97, P = .07 and RR = 2.12, P = .25, respectively). Fear of falling was higher in the intervention group, and subjective caregiver burden did not differ between groups. Conclusion: Although we meticulously developed this pairwise multifactorial fall prevention program, it was not effective in reducing the fall rate or fear of falling and was not feasible for caregivers, as compared with regular geriatric care. Future research initiatives should be aimed at how to implement the evidence-based principles of geriatric fall prevention for all frail fallers rather than developing more complex interventions for the frailest. [Copyright &y& Elsevier]

Caregivers of patients with chronic conditions or disability experience fatigue, burden and poor health-related quality of life. There is evidence of the effectiveness of support interventions for decreasing this impact. However, little is known about the benefits of home-based nursing intervention in primary health care. To evaluate the effectiveness of a home-based, nurse-led-intervention (CuidaCare) on the quality of life of caregivers of individuals with disabilities or chronic conditions living in the community, measured at 12-month follow-up. A pragmatic, two-arm, cluster-randomized controlled trial with a 1-year follow-up period was performed between June 2013 and December 2015. Consecutive caregivers aged 65 years or older, all of whom assumed the primary responsibility of caring for people with disabling conditions for at least 6 months a year, were recruited from 22 primary health care centers. Subsequently, 11 centers were randomly assigned to usual care group, and 11 were assigned to the intervention group. The caregivers in the intervention group received the usual care and additional support (cognitive restructuring, health education and emotional support). The primary outcome was quality of life, assessed with the EQ-5D instrument (visual analog scale and utility index score); the secondary outcome variables were perception of burden, anxiety, and depression. Data were collected at baseline, at the end of the intervention, and at the 6- and 12-month follow-up visits. We analyzed the primary outcome as intention-to-treat, and missing data were added using the conditional mean single imputation method. A total of 224 caregivers were included in the study (102 in the intervention group and 122 in the usual care group). Generalized Estimating Equation models showed that the CuidaCare intervention was associated with a 5.46 point (95% CI: 2.57; 8.35) change in the quality of life, as measured with the visual analog scale adjusted for the rest of the variables at 12 months. It also produced an increase of 0.04 point (95% CI: 0.01; 0.07) in the utilities. No statistically significant differences were found between the two groups at 12 months with respect to the secondary outcomes. The findings suggest that incorporating a home-based, nurse-led-intervention for caregivers into primary care can improve the health-related quality of life of caregivers of patients with chronic or disabling conditions. [ABSTRACT FROM AUTHOR]

Abstract: This study describes an evaluation of a psycho-educational intervention for family caregivers of patients dying of cancer at home. In a randomized controlled trial, participants (n = 106) received standard home-based palliative care services (n = 52) or these services plus the new intervention (n = 54). Data were collected at three time points: upon commencement of home-based palliative care (Time 1), five weeks later (Time 2), and then eight weeks following patient death (Time 3). No intervention effects were identified with respect to preparedness to care, self-efficacy, competence, and anxiety. However, participants who received the intervention reported a significantly more positive caregiver experience than those who received standard care at both Times 2 and 3. The findings indicate that it is possible to increase caregiver rewards despite being immersed in challenging circumstances that often yield considerable negative psychosocial sequelae. Furthermore, it is feasible for health professionals to discuss emotive topics, such as impending death, with caregivers without adverse effects. [Copyright &y& Elsevier]

Physical activity in people with dementia (PwD) may enhance physical and mental functioning. Exergaming, which combines physical exercise with cognitive stimulation in a gaming environment, was developed to overcome barriers in performing physical activities. We evaluated the effects of exergaming in day care centers (DCCs) for PwD and informal caregivers (ICs). A randomized controlled trial among 23 DCCs across the Netherlands randomized to exergaming (interactive cycling during 6 months) or a care-as-usual control group. A total of 112 (73 exergaming, 39 control) community-dwelling dyads (PwD, IC), with the PwD visiting a DCC at least twice per week. All outcomes were assessed using structured questionnaires during interviews with PwD and ICs at baseline (T0), 3 months (T1), and 6 months (T2). Primary outcomes: physical activity and mobility of the PwD. Secondary outcomes: physical, cognitive, emotional and social functioning, and quality of life for PwD. For ICs: experienced burden, quality of life, and positive care experiences. Mixed-model analyses showed no statistically significant effects on primary outcomes. There were statistically significant positive effects on PwD's secondary outcomes at T2 on cognition [Mini-Mental State Examination (MMSE): r = 2.30, 95% confidence interval (CI): 0.65, 3.96, P =.007; and Trail Making Test part A (TMT-A): r = −28.98, 95% CI: −54.89, −3.08, P =.029], social functioning (Behavior Observation Scale for Intramural Psychogeriatrics subscale 1 (GIP): r = −1.86, 95% CI: −3.56, −0.17, P =.031), and positive post-test effects in ICs on distress caused by the PwD's neuropsychiatric symptoms (NPI-Q total distress: r = −3.30, 95% CI: −6.57, −0.03, P =.048) and on sense of competence (SSCQ: r = 2.78, 95% CI: 0.85, 4.71, P =.005). Exergaming appeared not effective on the primary outcomes. Despite the study being underpowered, we found positive effects on secondary outcomes for PwD and ICs, and no negative effects. We therefore recommend further study, dissemination, and implementation. [ABSTRACT FROM AUTHOR]