scholarly journals Pilot Randomized Controlled Trial Protocol Evaluating an Evidence-based Parenting Intervention among Filipino Parents (Preprint)

2021 ◽  
Author(s):  
Samantha Macam ◽  
Wendy Jean Mack ◽  
Lawrence Palinkas ◽  
Michele D. Kipke ◽  
Joyce Rivera Javier
Keyword(s):  
Randomized Controlled Trial ◽  
Parenting Stress ◽  
Parenting Practices ◽  
Controlled Trial ◽  
Evidence Based ◽  
Filipino Americans ◽  
Incredible Years ◽  
Randomized Controlled ◽  
To Receive ◽  
Internalizing And Externalizing

BACKGROUND Filipino Americans underutilize mental health and preventive care services even though studies have indicated that Filipino youth experience high rates of suicidal ideation, substance abuse and teen pregnancy, while adults experience immigration stress, discrimination, and depression. Evidence-based parenting interventions provided in early childhood have proven to be effective in preventing the onset and escalation of child mental health disorders. In a pilot randomized controlled trial, we found that participation in the Incredible Years® (IY) Parent Training Program improved parenting stress and positive parenting practices and decreased child internalizing and externalizing symptoms among Filipino families. A fully powered trial is needed to determine the efficacy of IY as a prevention program among Filipino families. OBJECTIVE The aims of this manuscript are to 1) describe the design and rationale of a randomized controlled trial evaluating the effects of the on-line IY program among parents recruited from multiple community-based settings and its impact on parenting practices, parenting stress, and child problem behavior among Filipino Americans and 2) describe the impact of COVID-19 on our study protocols. METHODS This study uses a randomized controlled two-arm individually randomized group treatment pretest posttest design for 180 parent-child dyads. Individuals are eligible if they are 18 years or older, live in California, and have at least one Filipino child aged 8-12 years old. Consenting participants are randomly allocated to receive: (1) the 12-week Incredible Years parenting intervention (intervention arm), or (2) American Academy of Pediatrics’ Bright Future handouts and placed on a waitlist to receive IY post-trial (waitlist control arm). Primary outcomes include the Parent Practices Interview (PPI) and Parenting Stress Index (PSI). Secondary outcomes will be measured by the Child Behavior Checklist (CBCL, completed by Parent and Child) and will include child externalizing and externalizing behaviors, and total problems. Data is collected at baseline, 3-month and 6-month follow-ups. RESULTS Recruitment is currently ongoing. Changes made to the protocol due to COVID-19 include administration of surveys remotely and implementation of the intervention online. The pandemic has provided an opportunity to evaluate the effectiveness of an online version of IY that may improve access and increase use of the intervention. Recruitment and data collection procedures are still ongoing and are expected to be completed in one year. CONCLUSIONS Our research will determine whether IY promotes positive parenting practices and prevents child internalizing and externalizing behaviors among Filipino families with children ages 8-12 years old. It will also uplift cultural narratives and add to the evidence based supporting online parenting programs and their implementation in real-world settings. If found efficacious, IY has the potential to prevent behavioral health disparities in this understudied and high-risk Filipino population and can be scaled, adapted, and implemented in other at-risk ethnic minority communities. CLINICALTRIAL ClinicalTrials.gov NCT04031170; https://clinicaltrials.gov/ct2/show/NCT04031170

Effectiveness of Parenting Program for Macau Shift Work Parents: Randomized Controlled Trial

2020 ◽  
Vol 30 (6) ◽  
pp. 612-622
Author(s):  
Cynthia Leung ◽  
Stanley Chan ◽  
H. L. Ip ◽  
Heidi Szeto ◽  
Miki Lee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Parenting Stress ◽  
Shift Work ◽  
Parenting Practices ◽  
Controlled Trial ◽  
Intervention Group ◽  
Parenting Program ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Before And After

Purpose: This study aimed to evaluate the effectiveness of the Happy Parenting: Round-the-Clock Parenting (HPRCP) program for Macau parents on shift work, using randomized controlled trial design. Methods: The participants included 154 parents on shift work who were randomized into the intervention ( n = 78) and waitlist control ( n = 76) groups. Participants were requested to complete a set of questionnaires on their children’s behavior, their own parenting stress, parenting practices, and emotion-focused parenting style both before and after the completion of the program by the intervention group. Results: Analysis was by intention-to-treat. The results indicated significant reduction in child behavior problems, parenting stress, and dysfunctional parenting practices in the intervention group after intervention. Conclusions: The results provided promising evidence on the effectiveness of the HPRCP program for parents on shift work.

Radiofrequency ablation for markedly incompetent perforators versus compression therapy in the management of post-phelebtic venous ulcers: A randomized controlled trial

Vascular ◽  
2021 ◽  
pp. 170853812110100
Author(s):  
Mohamed Shukri Abdelgawad ◽  
Amr M El-Shafei ◽  
Hesham A Sharaf El-Din ◽  
Ehab M Saad ◽  
Tamer A Khafagy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Radiofrequency Ablation ◽  
Controlled Trial ◽  
Compression Therapy ◽  
Randomized Controlled ◽  
Venous Ulcers ◽  
Group A ◽  
Group B ◽  
To Receive

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p  = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.

scholarly journals Smartphone Cardiac Rehabilitation, Assisted Self-Management Versus Usual Care: Protocol for a Multicenter Randomized Controlled Trial to Compare Effects and Costs Among People With Coronary Heart Disease (Preprint)

2019 ◽  
Author(s):  
Jonathan Charles Rawstorn ◽  
Kylie Ball ◽  
Brian Oldenburg ◽  
Clara K Chow ◽  
Sarah A McNaughton ◽  
...  
Keyword(s):  
Health Care ◽  
Coronary Heart Disease ◽  
Randomized Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Management ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Delivery Models

BACKGROUND Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. OBJECTIVE The aim of this study is to compare the effects and costs of the innovative <i>Smartphone Cardiac Rehabilitation, Assisted self-Management</i> (SCRAM) intervention with usual care CR. METHODS In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. RESULTS The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. CONCLUSIONS The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15022

scholarly journals A Randomized Controlled Trial of Attentional Control Training for Treating Alcohol Use Disorder

2021 ◽  
Vol 12 ◽  
Author(s):  
Angelina Isabella Mellentin ◽  
W. Miles Cox ◽  
Javad S. Fadardi ◽  
Laila Martinussen ◽  
Nicolaj Mistarz ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Attentional Control ◽  
Alcohol Use Disorder ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Alcohol Cues ◽  
Group A ◽  
Group B

Background: There is consistent evidence that community and clinical samples of individuals with an alcohol use disorder (AUD) have attentional biases toward alcohol cues. The alcohol attentional control training program (AACTP) has shown promise for retraining these biases and decreasing alcohol consumption in community samples of excessive drinkers. However, there is a lack of evidence regarding the effectiveness of ACTP in clinical AUD samples. The main aim of the present study is to investigate whether primary pharmacological and psychological, evidence-based alcohol treatment can be enhanced by the addition of a gamified AACTP smartphone application for patients with an AUD.Design and Methods: The study will be implemented as a randomized controlled trial. A total of 317 consecutively enrolled patients with AUD will be recruited from alcohol outpatient clinics in Denmark. Patients will be randomized to one of three groups upon initiation of primary alcohol treatment: Group A: a gamified AACTP smartphone application + treatment as usual (TAU); Group B: a gamified AACTP sham-control application + TAU; or Group C: only TAU. Treatment outcomes will be assessed at baseline, post-treatment, and at 3- and 6-month follow-ups. Repeated measures MANOVA will be used to compare the trajectories of the groups over time on alcohol attentional bias, alcohol craving, and drinking reductions. It is hypothesized that Group A will achieve better treatment outcomes than either Group B or Group C.Perspectives: Because attentional bias for alcohol cues is proportional to the amount of alcohol consumed, and these biases are not addressed within current evidence-based treatment programs, this study is expected to provide new evidence regarding the effectiveness of the gamified AACTP in a clinical population. Furthermore, due to promising results found using AACTP in community samples of excessive drinkers, there is a high probability that the AACTP treatment in this study will also be effective, thereby allowing AACTP to be readily implemented in clinical settings. Finally, we expect that this study will increase the effectiveness of evidence-based AUD treatment and introduce a new, low-cost gamified treatment targeting patients with an AUD. Overall, this study is likely to have an impact at the scientific, clinical, and societal levels.Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT05102942?term=NCT05102942&amp;draw=2&amp;rank=1, identifier: NCT05102942.

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