scholarly journals Multisite randomized efficacy trial of educational materials for young children with incarcerated parents

2020 ◽  
pp. 1-17 ◽  
Author(s):  
Julie Poehlmann-Tynan ◽  
Hilary Cuthrell ◽  
Lindsay Weymouth ◽  
Cynthia Burnson ◽  
Lexi Frerks ◽  
...  

Abstract Although children with incarcerated parents exhibit more behavior problems, health concerns, and academic difficulties than their peers, few interventions or resources are available to support affected children. This randomized, controlled, multisite efficacy trial evaluated Sesame Street’s "Little Children, Big Challenges: Incarceration" initiative with children aged 3 to 8 years with a jailed father. Seventy-one diverse children and their caregivers were randomized to an educational outreach group (n = 32) or wait list control group (n = 39). Researchers observed children during jail visits and interviewed caregivers by phone 2 and 4 weeks later. The effects of the intervention on children’s behavior and emotions occurring during a jail visit depended on what children had been told about the father’s incarceration. Children who were told honest, developmentally appropriate explanations showed less negative affect at entry, an increase in negative affect when the intervention was administered, and a decrease in negative affect during the visit. Intervention group children who were told distortions, nothing, or explanations that were not developmentally appropriate showed more negative affect initially, and their negative affect remained relatively stable during their time in the jail. In addition, children who were told the simple, honest truth about the parent’s incarceration (a recommendation in the educational materials) exhibited more positive affect during the visit, with a medium effect size. Caregivers in the educational outreach group reported more positive change in how they talked to children about the incarceration over time compared to the control group.

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Nicole C. Gavin ◽  
Tricia M. Kleidon ◽  
Emily Larsen ◽  
Catherine O’Brien ◽  
Amanda Ullman ◽  
...  

Abstract Background To evaluate the feasibility of an efficacy trial comparing a hydrophobic polyurethane peripherally inserted central catheter (PICC) with a standard polyurethane PICC. Methods This pilot randomised controlled trial (RCT) was conducted between May 2017 and February 2018. Adult participants (n = 111) were assigned to hydrophobic polyurethane PICC with proximal valve (intervention) or a polyurethane PICC with external clamp (standard care). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were central line-associated bloodstream infection, local infection, occlusion, thrombosis, fracture and dislodgement, phlebitis, local or systemic allergic reaction, and PICC dwell time. Results All feasibility outcomes were achieved, apart from eligibility criteria. In total, 338 patients were screened, 138 were eligible (41%), and of these 111 were randomised (80%). Patients received the allocated PICC in 106 (95%) insertions. No patients withdrew from the study and there was no missing data. PICC failure was 24% (13/55) in the intervention group and 22% (12/55) in the standard care group (p = 0.820). PICC failure per 1000 PICC days was 16.3 in the intervention group and 18.4 in the control group (p = 0.755). The average dwell time was 12 days in the intervention and 8 days in the control group. Conclusions This study demonstrates the feasibility of an efficacy trial of PICC materials in an adult population, once adjustments were made to include not only in-patients, but also patients being discharged to the Hospital in the Home service. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12616001578493. Prospectively registered on 16 November 2016. The trial protocol was published a priori (Kleidon et al., Vasc Access 3:15–21, 2017).


2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Elizabeth W. Gonzalez ◽  
Marcia Polansky ◽  
Carol F. Lippa ◽  
Laura N. Gitlin ◽  
Jaclene A. Zauszniewski

This pilot randomized trial tested an intervention aimed at enhancing resourcefulness in family caregivers of persons with dementia, postulating that caregivers’ emotional outcomes (anxiety and depression) and role outcomes (reward, strain, mutuality, and preparedness) would be improved, and problem behaviors in the care recipients (persons with dementia) would be reduced as a result of the intervention. Subjects were stratified by race (white or African American) and by baseline resourcefulness (high or low). Family caregivers were randomly assigned to an intervention group in which subjects attended six resourcefulness training sessions, meeting for 2 hours weekly over 6 weeks, or to a control group that received no treatment. Small to medium effects were shown for the intervention program on resourcefulness, anxiety, and preparedness of the caregivers and on frequency of behavior problems in the care recipients. Caregivers in the intervention group reported significantly more resourcefulness skills, with a medium effect at week 6 and a small effect 12 weeks later, compared with the control group. Persons with dementia had fewer behavior problems in the intervention group compared with control, although the difference was not significant. Caregivers’ anxiety was reduced in the intervention group at 12 weeks.


2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Alexandra Elissavet Bakou ◽  
Ruichong Shuai ◽  
Lee Hogarth

Introduction. Imagery-based stress management therapies are effective at reducing alcohol use. To explore the therapeutic mechanism, the current study tested whether brief functional imagery training linked to personal negative affect drinking triggers would attenuate sensitivity to noise stress-induced alcohol seeking behaviour in a laboratory model. Methods. Participants were UK-based hazardous student drinkers (N = 61, 80.3% women, aged 18–25) who reported drinking to cope with negative affect. Participants in the active intervention group (n = 31) were briefly trained to respond to personal negative drinking triggers by retrieving an adaptive strategy to mitigate negative affect, whereas participants in the control group (n = 30) received risk information about binge drinking at university. The relative value of alcohol was then measured by preference to view alcohol versus food pictures in two-alternative choice trials, before (baseline) and during noise stress induction. Results. There was a significant two-way interaction p < .04 where the control group increased their alcohol picture choice from baseline to the noise stress test p < .001 , whereas the active intervention group did not p = .33 , and the control group chose alcohol more frequently than the active group in the stress test p = .03 , but not at baseline p = .16 . Conclusions. These findings indicate that imagery-based mood management can protect against the increase in the relative value of alcohol motivated by acute stress in hazardous negative affect drinkers, suggesting this mechanism could underpin the therapeutic effect of mood management on drinking outcomes.


Author(s):  
Gesche Janzarik ◽  
Daniel Wollschläger ◽  
Michèle Wessa ◽  
Klaus Lieb

In this study, a new group intervention program to foster resilience in nursing professionals was tested for efficacy. In total, 72 nurses were recruited and randomised to either an intervention condition or to a wait list control condition. The study had a pre-test, post-test, follow-up design. The eight-week program targeted six resilience factors: cognitive flexibility, coping, self-efficacy, self-esteem, self-care, and mindfulness. Compared to the control group, the intervention group reported a significant improvement in the primary outcome mental health (measured with the General Health Questionnaire) from pre-test (M = 20.79; SD = 9.85) to post-test (M = 15.81; SD = 7.13) with an estimated medium effect size (p = 0.03, η2 = 0.08) at post-test. Further significant improvements were found for resilience and other resilience related outcomes measures. The individual stressor load of the subjects was queried retrospectively in each measurement. Stress levels had a significant influence on mental health. The intervention effect was evident even though the stress level in both groups did not change significantly between the measurements. Follow-up data suggest that the effects were sustained for up to six months after intervention. The resilience intervention reduced mental burden in nurses and also positively affected several additional psychological outcomes.


2018 ◽  
Vol 36 (7_suppl) ◽  
pp. 102-102
Author(s):  
Carrie R Howell ◽  
Kevin R. Krull ◽  
Robyn Partin, MS ◽  
Nina S. Kadan-Lottick ◽  
Leslie L. Robison ◽  
...  

102 Background: This study of adolescent survivors of childhood cancer evaluated the initial efficacy of a web-delivered, interactive, rewards-based physical activity intervention that aimed to increase moderate to vigorous physical activity (MVPA) and improve fitness, neurocognitive and health-related quality of life (HRQoL) outcomes over 24 weeks. Methods: Survivors (aged ≥ 11 to < 15 years) who were not undergoing active cancer treatment, were physically active < 60 minutes/day and were treated at a single institution were randomized (2:1) to a rewards-based physical activity intervention delivered via the internet or a control group. The intervention group received educational materials, an activity monitor, and access to an interactive website designed to motivate increased physical activity via rewards (e.g. t-shirts, stickers, gift cards) and the control group received only the activity monitor and educational materials. Physical activity, fitness, neurocognitive and HRQoL outcomes were assessed at baseline and 24-weeks. Mean changes in outcomes were compared between groups using paired t-tests. Results: Of 97 survivors enrolled, 78 completed the study (53 in the intervention group, 25 in the control group), the mean age was 12.7 (SD 1.1), 80% were white, and 55.1% were female. The intervention group increased their MVPA over time (mean change in weekly MVPA: 4.7 minutes [SD 119.9]), while the control group steadily decreased their weekly MVPA (-24.3 minutes [SD 89.7]) (p = 0.30). In the intervention group, mean change in hand grip strength (p = 0.01), number of sit-ups (p < 0.01) and push-ups (p < 0.01), neurocognitive measures (e.g. verbal executive function, p < 0.01), and HRQoL outcomes (e.g. overall HRQoL, p = 0.01; physical function, p = 0.01) improved over time; no change was observed in the control group. Conclusions: These preliminary findings indicate that increasing MVPA via an intervention designed to increase motivation to exercise may have positive effects on fitness, neurocognitive and HRQoL outcomes in adolescent survivors of childhood cancer. Clinical trial information: NCT01778127.


2020 ◽  
Vol 8 ◽  
pp. 205031212090782
Author(s):  
Xiaoming Li ◽  
Shan Qiao ◽  
Yuejiao Zhou

Objectives: Parents living with HIV who disclose their HIV status to their children could benefit from the parental HIV disclosure. However, it is also very challenging because of persistent stigma and discrimination against HIV. This report describes the study design and protocol of the “Interactive Communication with Openness, Passion, and Empowerment (iCOPE)” randomized controlled trial aimed at assisting parents living with HIV in conducting culturally and developmentally appropriate disclosure to their uninfected children in China through trainings among both parents living with HIV and healthcare providers. Methods: A total of 791 parents living with HIV with children aged between 6 and 15 years and 357 healthcare providers were randomized into either the intervention group or control group. Intervention package for parents consisted of five 2-h sessions focusing on positive coping, disclosure decision making, developing a developmentally appropriate disclosure plan, and accessing social support and post-disclosure counseling. The intervention for healthcare providers was made up of two 45-min sessions organized around two primary themes: knowledge of child cognitive development and effective parent–child communication skills in the context of parental disclosure. The control group received nutritional education of either five 2-h sessions (parents) or two 45-min sessions (healthcare providers). The outcome assessments were conducted at baseline, 6, 12, 18, 24, 30, and 36 months. Conclusion: The iCOPE study is among the first efforts to develop and evaluate a theory-based and multi-level intervention to promote culturally and developmentally appropriate parental HIV disclosure in China. It has implications for healthcare providers, social workers, and policy makers as it will provide efficacy data on how to enhance appropriate parental HIV disclosure and will shed light on developing a clinical guideline regarding parental HIV disclosure in China and other low- and middle-income countries.


2020 ◽  
pp. 1014-1026
Author(s):  
Nicole M. Alberts ◽  
Wendy M. Leisenring ◽  
Jessica S. Flynn ◽  
Jillian Whitton ◽  
Todd M. Gibson ◽  
...  

PURPOSE Approximately 40% of childhood cancer survivors experience chronic pain, with many also reporting pain-related disability. Given associations established in the general population among respiration, anxiety, and pain, continuous tracking and feedback of respiration may help survivors manage pain. METHODS A feasibility, nonblinded, randomized controlled trial (RCT) comparing wearable respiratory monitoring with a control group examined feasibility, acceptability, and preliminary efficacy among survivors of childhood cancer with chronic pain who were ≥ 18 years of age, able to speak and read English, lived in the United States, and had access to a smartphone and the Internet. The primary outcomes were pain interference, pain severity, anxiety, negative affect, and perceived stress. The intervention group (n = 32) received a wearable respiratory monitor, used the device, and completed an in-application breathing exercise daily for 30 days. The control group (n = 33) received psychoeducation after completion of the study. RESULTS Almost all participants in the intervention group (n = 31 of 32) and control group (n = 32 of 33) completed the study. Of those who completed the intervention, 90.3% wore the device for ≥ 50% of the trial. Posttreatment improvement for negative affect (Cohen d = 0.59; 95% CI, 0.09 to 1.10) was significantly greater in the intervention group compared with the control group. A follow-up study (n = 24) examined acceptability and feasibility of a second-generation device among those who completed the RCT. Most survivors (81.0%) wore the device daily during the trial and 85.7% reported satisfaction with the device and the application. CONCLUSION The results of this pilot study support the acceptability and feasibility of wearable respiratory monitoring among survivors of childhood cancer. Larger randomized trials are needed to assess efficacy and maintenance of this intervention for chronic pain.


2021 ◽  
Author(s):  
Francesco Bossi ◽  
Francesca Zaninotto ◽  
Sonia D’Arcangelo ◽  
Nicola Lattanzi ◽  
Andrea Patricelli Malizia ◽  
...  

BACKGROUND Mindfulness practice consists of “paying attention on purpose, in the present moment, and nonjudgmentally to the unfolding of experience moment by moment”. Mindfulness training was shown to be effective in improving well-being and reducing perceived stress in several conditions. These effects were also found in online mindfulness-based training, especially on employees in organizational environments. OBJECTIVE The aim of this study was to test the effectiveness of online mindfulness training on healthy employees especially after the first Italian Covid-19 lockdown, when the measures to prevent contagion were loosened, but the second wave was starting again to emerge. METHODS Participants in the training group underwent an 8-week mindfulness training based on the Mindfulness-Based Stress Reduction (MBSR) protocol compared to a control (no-intervention) group. A new practice was presented each week by two trainers, who were also available for Q&A on a weekly basis. All participants filled in weekly surveys for the whole training duration via online questionnaires to measure their habits, mindfulness (FFMQ-15), emotion regulation (ERQ), positive and negative affect (PANAS), depression, anxiety and stress (DASS-21), resilience (RSA) and insomnia (ISI). 46 participants in the training group and 54 in the control group completed at least half of the weekly questionnaires and were considered in the longitudinal analyses. RESULTS We found significant differences between the training and control groups over time in the measures of mindfulness (in particular the nonreactivity subscale), positive affect, depression, and insomnia. Moreover, we found that the frequency of practice and ease perceived in practicing were positively correlated to several indices of well-being (mindfulness, positive affect, cognitive reappraisal) and negatively correlated to several indices of stress (negative affect, depression, anxiety, stress, insomnia, expressive suppression). CONCLUSIONS These results show the importance and effectiveness of online mindfulness training to cope with stress among employees, especially after the Covid-19 lockdown, a period of great uncertainties and psychological tension.


2021 ◽  
Vol 49 (11) ◽  
pp. 1-16
Author(s):  
Shuman Wu

The "Three Good Things" is a self-administered positive psychological intervention that is effective in reducing depressive symptoms and improving well-being; however, there is still little known about its possible underlying mechanisms. I examined the efficacy of the Three Good Things intervention and investigated the mediating role of positive and negative affect in the intervention's effect on depressive symptoms and subjective well-being. Participants were undergraduate students randomly assigned to either the intervention group ( n = 128), who participated in a 16-week trial of the intervention and completed assessment measures, or to the control group (n = 121), who completed assessment measures but not the intervention. The three time points for assessment were Week 1 (baseline), Week 8 (Time 1), and Week 16 (Time 2). The results show that levels of depression and negative affect were lower in the intervention group than in the control group at Time 2, whereas positive affect and subjective well-being were higher. Thus, the intervention can reduce depression and promote well-being by reducing negative affect and improving positive affect.


2021 ◽  
Vol 45 (5) ◽  
pp. 902-915
Author(s):  
Mohammad S. Alyahya ◽  
Nihaya A. Al-Sheyab ◽  
Jumana A. Alqudah ◽  
Othman Beni Younis ◽  
Yousef S. Khader

Objectives: To increase patients' self-efficacy for initiation of physical activity, there is a need to include physical activity into patient education in clinic settings. In this study, we aimed to assess the effectiveness of multimedia messaging service (MMS) education on exercise self-efficacy in patients with type 2 diabetes mellitus (T2DM). Methods: We used a quasi-experimental, pretest-posttest design to study 98 patients with T2DM. The intervention group received MMS education targeting exercise self-efficacy for 2 months, and the control group received routine care only. Patients in both groups completed the Exercise Self-efficacy scale at 3 stages (at baseline, at 4 weeks, and at 8 weeks post-intervention). Results: We found a slight increase between baseline, first follow-up, and second follow-up in interpersonal and competing demands factors in the intervention group (p = .002, p = .001, respectively), but no improvement in the control group in any of the 3 factors over time (p > .05). Also, Cohen's d values indicated a medium effect size in all exercise self-efficacy subscales (interpersonal [0.734], competing demands [0.665], and internal feelings [0.696]). Conclusions: Health education using theoretically-based MMS targeting exercise self-efficacy was effective and affordable in promoting and changing patients' beliefs and physical activity behaviors.


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