Ntombi Vimbela! Sexual violence risk reduction intervention: pre and one-year post assessments from a single arm pilot feasibility study among female students in South Africa.

BACKGROUND: The extremely high prevalence of sexual violence victimisation reported among female students in South African public higher education demands urgent action to develop, rigorously evaluate and scale effective prevention interventions. This article details findings from a pilot feasibility study of Ntombi Vimbela! a campus sexual violence risk reduction intervention developed to tackle the high burden of sexual violence in higher education institutions in South Africa. METHODS: Ntombi Vimbela! (NV!) is a sexual violence risk reduction intervention that comprises sexuality empowerment, gender and social norm change, early-risk identification, self-defence, resistance and mental wellbeing components. NV! is comprised of ten workshop sessions running for 3.5 h each. Workshops are co-delivered by two trained peer facilitators per group of at most 20 first-year female students. One-year post-intervention quantitative outcome assessments were remotely completed by 98 participants who participated in the NV! pilot workshops. Qualitative assessments were conducted with 35 participants through in-depth telephone interviews (IDTIs). FINDINGS: One year after attending NV! workshops, most participants reported improved awareness of sexual rights, assertive communication, shifts in gender equitable beliefs, reductions in rape myth acceptance, improved expressed sexual relationship power sexual decision-making, and improved negotiation within their intimate relationships. Participants' depressive symptoms also significantly decreased. Many participants improved awareness of sexual assault risk and vigilance, including using self-protection strategies such as removing themselves from environments where alcohol intoxication posed sexual assault risks. Some participants used assertive communication to withstand peer pressure to engage in risky sexual behaviours. Most participants scored highly on the self-defence efficacy scale. Some participants were exposed to and successful in using verbal and physical resistance strategies in potential sexual assault risky situations. CONCLUSION: These findings indicate the potential beneficial effects of NV! as a campus sexual violence risk reduction intervention at one-year post-intervention, which must be evaluated in a future rigorous randomised control trial. PILOT TRIAL REGISTERED AT: ClinicalTrials.gov NCT04607564 on 29/10/2020.

Piloting building early sentences therapy for pre-school children with low language abilities: An examination of efficacy and the role of sign as an active ingredient.

BACKGROUND: Early intervention is recommended for pre-school children with low language. However, few robustly evaluated language interventions for young children exist. Furthermore, in many interventions the theoretical underpinnings are underspecified and the 'active ingredients' of the interventions not tested. This paper presents a quasi-experimental study to test the efficacy and examine the active ingredients of Building Early Sentences Therapy (BEST): an intervention based on usage-based theory designed to support young children to understand and produce two-, three- and four-clause element sentences. BEST manipulates the input children hear to support them to harness the cognitive mechanisms hypothesized in usage-based theories to promote the development of abstract linguistic representations. One such input manipulation is the use of signing alongside verbal input signalling both content and morphology of target sentences. AIMS: To examine whether (1) BEST is more efficacious than treatment as usual (TAU); and (2) signing of content and morphology is an active ingredient of the intervention. METHODS & PROCEDURES: A quasi-experimental study recruited children aged 3;5-4;5 years from 13 schools. Schools were assigned to receive either BEST with sign, BEST without sign or TAU. The TAU group received their usual classroom provision. Across arms schools were matched with respect to classroom oral language environment and indices of deprivation. Participants were 48 children (28 boys) with expressive and/or receptive language abilities ≤ 16th centile measured using the New Reynell Developmental Language Scales (NRDLS). Outcomes gathered by researchers blind to treatment arm were NRDLS production and comprehension standard scores and measures of production of targeted sentence structures. OUTCOMES & RESULTS: Primary outcomes indicate that BEST with sign was significantly more efficacious than TAU with respect to NRDLS production standard score, but not comprehension. The advantage for production was maintained at follow-up. BEST without sign was significantly more efficacious than TAU on measures of targeted vocabulary, sentence structure and morphology. The results from this quasi-experimental study provide evidence for the efficacy of a usage-based intervention on expressive language outcomes for preschool children with low language abilities. There is also evidence to support the inclusion of sign as an active ingredient, and so efforts to train interventionists in its use are worthwhile. CONCLUSIONS & IMPLICATIONS: Patterns of findings across outcomes suggest signing of content and morphology may support the development of abstract linguistic representations and accelerate language learning. Given these positive results and the scale of this study, a fully powered randomized controlled trial is warranted. WHAT THIS PAPER ADDS: What is already known on the subject Robust language skills are crucial for positive social, emotional, academic and economic outcomes across the lifespan. There is a paucity of robustly evaluated interventions for preschool children with language difficulties. The development of such interventions is crucial for ameliorating language difficulties and promoting positive educational and psychosocial outcomes. What this study adds to the existing knowledge This paper evaluates BEST, a novel usage-based language intervention targeting children with language difficulties in the early years. Findings indicate that a usage-based intervention is efficacious for treating language difficulties. In particular, BEST benefited expressive language development, bringing benefits to both treated and untreated language structures and improving standard scores. The role of sign as an active ingredient is also supported. Further evaluation is warranted. What are the practical and clinical implications of this work? Findings suggest that BEST may be effective for targeting children who have been identified as having language difficulties. In particular, expressive language may be improved when the intervention is delivered as it was originally manualized, including a signing system to represent content and grammatical morphology. More broadly, these findings also provide preliminary evidence that the use of a signing system does not hinder oral language development in children with language difficulties and may conversely support their expressive language. Future research exploring the role and underpinning mechanisms of sign in language intervention is warranted.

Conducting a Pilot Randomized Controlled Trial on a Medical Inpatient Unit Utilizing Cognitive Remediation Therapy for Adolescents with Restrictive Eating Disorders: Protocol Updates and Reflections on Feasibility.

We conducted a pilot randomized control trial (RCT) to simultaneously examine the feasibility of effectively implementing Cognitive Remediation Therapy (CRT) for adolescents with anorexia nervosa (AN) during medical hospitalization at a single-site hospital center. Employment of this protocol occurred on a general medical unit with diverse medical admitting diagnoses, not an eating disorder floor of a hospital and not part of a structured inpatient anorexia nervosa treatment program. This was the first time an RCT for a psychosocial intervention was implemented on this unit with patients with eating disorders. Here, we describe the process of piloting the study, including modifications that needed to be made to the original protocol. We also describe the feedback from major stakeholders regarding the process of conducting the pilot study. We summarize lessons learned and steps to take for smooth integration of an RCT of a therapeutic intervention on medical unit.Trial registration: ClinicalTrials.gov Identifier NCT02883413.

An application of PRECIS-2 to evaluate trial design in a pilot cluster randomised controlled trial of a community-based smoking cessation intervention for women living in disadvantaged areas of Ireland.

BACKGROUND: "We Can Quit2" (WCQ2) was a pilot cluster randomised controlled trial with an embedded process evaluation assessing the feasibility and acceptability of 'We Can Quit' (WCQ, a peer-delivered community-based stop-smoking programme for women in disadvantaged communities. The control group comprised 'enhanced usual care' offered by the Irish Health Service Executive (HSE). The PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) is a tool to assess whether a trial design is more explanatory (working under ideal conditions) or pragmatic (working under 'real-world' conditions). The aim of this paper was to retrospectively evaluate the WCQ2 pilot trial using PRECIS-2 to inform the decision-making process on progression to a future definitive trial (DT). METHODS: The WCQ2 trial protocol and HSE standard stop-smoking service were described across the nine PRECIS-2 domains: eligibility, recruitment, setting, organisation, flexibility-delivery, flexibility-adherence, follow-up and primary outcome. Team members scored the domains as pragmatic or explanatory for each arm in a half-day workshop. RESULTS: Seven team members (practitioners and researchers) assessed the overall trial design as more explanatory than pragmatic. Important differences emerged between the two arms. WCQ targeted adult women from disadvantaged communities whereas HSE run a limited enhanced service for all quitters. Trial recruitment was challenging, intense efforts were needed as the trial proceeded. WCQ was delivered in a non-clinical community setting, HSE services in a clinical setting. WCQ organisation was co-designed with community partners and comprises peer-to-peer group support delivered by trained lay community facilitators, whereas HSE one-to-one support is delivered by Smoking Cessation Officers with a clinical background. Only WCQ allowed flexibility in delivery and adherence. Follow-up was more intensive in WCQ. Greater efforts to improve participant retention will be required in a future DT. CONCLUSIONS: PRECIS-2 allowed the reflection of practitioners and researchers on similarities and differences between intervention and control arms. Results will inform the decision on progression to an effectiveness DT, which will require more a pragmatic and less explanatory design. This novel use of PRECIS-2 to retrospectively evaluate a complex community-based pilot trial in advance of a full DT will also support learning for those undertaking hybrid trials of implementation and effectiveness. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry ( No. 74721694 ).

A 16-week aerobic exercise and mindfulness-based intervention on chronic psychosocial stress: a pilot and feasibility study.

OBJECTIVES: Researchers have begun delivering mindfulness and aerobic exercise training concurrently on the premise that a combination intervention will yield salutary outcomes over and above each intervention alone. An estimate of the effect of combination training on chronic psychosocial stress in a nonclinical population has not been established. The objective of this study was to establish protocol feasibility in preparation of a definitive RCT targeting healthy individuals, and to explore the preliminary effect of combination training on reducing chronic psychosocial stress in this population. METHODS: Twenty-four participants were allocated to a single-arm pre-post study and subjected to 16 weeks of concurrent mindfulness psychoeducation and aerobic exercise training. Feasibility criteria were collected and evaluated. Within-group changes in chronic psychosocial stress, mindfulness, emotion regulation, and cardiorespiratory fitness were also assessed. Primary analyses were based on 17 participants. RESULTS: Retention rate, response rate, recruitment rate, and sample size analyses indicate a definitive trial is feasible for detecting most effects with precision. There was also a decline in our primary dependent measure of chronic psychosocial stress (dpretest = -0.56, 95% CI [ -1.14,-0.06]). With regard to secondary measures, there was an increase in the use of cognitive reappraisal, and a reduction in use of maladaptive emotion regulation strategies. We are insufficiently confident to comment on changes in mindfulness and aerobic capacity [Formula: see text]. However, there were subgroup improvements in aerobic economy at submaximal exercise intensities. CONCLUSIONS: We recommend a definitive trial is feasible and should proceed. TRIAL REGISTRATION: ANZCTR (ID: ACTRN12619001726145 ). Retrospectively registered December 9, 2019.

Promoting Exercise and Healthy Diet Among Primary Care Patients: Feasibility, Preliminary Outcomes, and Lessons Learned From a Pilot Trial With High Intensity Interval Exercise.

Physical activity and healthy diet are recognized as effective approaches for disease prevention. Controlled laboratory clinical trials support these approaches, yet minimal data exists supporting implementation of exercise as medicine within a healthcare setting. Objectives: To understand perception and barriers to exercise and nutrition from patients and physicians from a family medicine clinic (FMC) to inform the implementation of a laboratory-based exercise and nutrition lifestyle intervention (Phase I), and to determine the feasibility, adherence, and preliminary outcomes of implementing this lifestyle intervention into a FMC (Phase II). Methods: In phase I 10 patients and 5 physicians were interviewed regarding perceptions of exercise and nutrition practices. In phase II patients at risk for cardiovascular disease were enrolled into a lifestyle intervention (n = 16), within a FMC, manipulating diet and exercise. Cardiorespiratory fitness (CRF), body composition, and metabolic blood markers were completed at baseline, after the 12-week intervention, and at 24 weeks. Feasibility was defined by patients who completed the intervention and number of sessions vs. total available. Results: Prescribing high-intensity interval training and a meal replacement for 12 weeks in patients with at least one risk factor for cardiovascular disease, was shown to have moderate feasibility with 62.5% (n = 10) for patients completing the 12 week intervention, and poor feasibility for assessing effects 12 weeks after cessation of the intervention, with 50% (n = 5) participants returning. Tracking exercise electronically via FitBit had moderate fidelity (n = 9), with hardcopy logs yielding poor compliance (n = 6). This pilot study demonstrated preliminary effectiveness of this home-based approach for improving cardiorespiratory fitness with an average 4.31 ± 5.67 ml·kg·min-1 increase in peak oxygen consumption. Blood triglycerides and insulin were improved in 70% and 60% of the patients, respectively. Conclusions: Despite moderate feasibility, a home-based exercise and nutrition has the potential to be used as an effective approach for managing and mitigating cardiovascular disease risk factors. There were key lessons learned which will help to develop and adapt a larger scale lifestyle intervention into a clinical setting. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/study/NCT02482922, identifier NCT02482922.