scholarly journals Does mobilisation increase family engagement with an early childhood intervention programme? A randomised controlled trial

2013 ◽  
Vol 41 (2) ◽  
pp. 201-221
Author(s):  
Sarah Cotterill ◽  
Peter John ◽  
Alice Moseley
Keyword(s):  
Early Childhood ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Family Engagement ◽  
Early Childhood Intervention ◽  
Intervention Programme ◽  
Childhood Intervention ◽  
Randomised Controlled

scholarly journals Maternal sensitivity and mental health: does an early childhood intervention programme have an impact?

2015 ◽  
Vol 33 (3) ◽  
pp. 226-232 ◽  
Author(s):  
Paulina Brahm ◽  
Alejandra Cortázar ◽  
María Paz Fillol ◽  
María Verónica Mingo ◽  
Constanza Vielma ◽  
...  
Keyword(s):  
Mental Health ◽  
Early Childhood ◽  
Maternal Sensitivity ◽  
Early Childhood Intervention ◽  
Intervention Programme ◽  
Childhood Intervention

scholarly journals Targeted and tailored pharmacist-led intervention to improve adherence to antihypertensive drugs among patients with type 2 diabetes in Indonesia: study protocol of a cluster randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e034507 ◽  
Author(s):  
Sofa D Alfian ◽  
Rizky Abdulah ◽  
Petra Denig ◽  
Job F M van Boven ◽  
Eelko Hak
Keyword(s):  
Type 2 Diabetes ◽  
Randomised Controlled Trial ◽  
Antihypertensive Drugs ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Intervention Programme ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionCurrent intervention programme to improve drug adherence are either too complex or expensive for implementation and scale-up in low-middle-income countries. The aim of this study is to assess the process and effects of implementing a low-cost, targeted and tailored pharmacist intervention among patients with type 2 diabetes who are non-adherent to antihypertensive drugs in a real-world primary care Indonesian setting.Methods and analysisA cluster randomised controlled trial with a 3-month follow-up will be conducted in 10 community health centres (CHCs) in Indonesia. Type 2 diabetes patients aged 18 years and older who reported non-adherence to antihypertensive drugs according to the Medication Adherence Report Scale (MARS) are eligible to participate. Patients in CHCs randomised to the intervention group will receive a tailored intervention based on their personal adherence barriers. Interventions may include reminders, habit-based strategies, family support, counselling to educate and motivate patients, and strategies to address other drug-related problems. Interventions will be provided at baseline and at a 1-month follow-up. Simple question-based flowcharts and an innovative adherence intervention wheel are provided to support the pharmacy staff. Patients in CHCs randomised to the control group will receive usual care based on the Indonesian guideline. The primary outcome is the between-group difference in medication adherence change from baseline to 3-month follow-up assessed by MARS. Secondary outcomes include changes in patients’ blood pressure, their medication beliefs assessed by the Beliefs about Medicines Questionnaire (BMQ)-specific, as well as process characteristics of the intervention programme from a pharmacist and patient perspective.Ethics and disseminationEthical approval was obtained from the Ethical Committee of Universitas Padjadjaran, Indonesia (No. 859/UN6.KEP/EC/2019) and all patients will provide written informed consent prior to participation. The findings of the study will be disseminated through international conferences, one or more peer-reviewed journals and reports to key stakeholders.Trial registration numberNCT04023734.

scholarly journals Efficacy of a web-based self-help tool to reduce problem gambling in Switzerland: study protocol of a two-armed randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032110 ◽  
Author(s):  
Christian Baumgartner ◽  
Elena Bilevicius ◽  
Yasser Khazaal ◽  
Sophia Achab ◽  
Susanne Schaaf ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Problem Gambling ◽  
Medical Devices ◽  
Controlled Trial ◽  
Intervention Programme ◽  
Web Based ◽  
Related Disorder ◽  
Self Help ◽  
Study Results ◽  
Randomised Controlled

IntroductionThe past-year prevalence of problem gambling worldwide averages 2.3%. Switzerland exhibits a slightly lower past-year prevalence rate, of 1.1%, among adults. Only a minority of these adults attend outpatient treatment. Surveyed problem gamblers have explained that they wanted to handle the problem on their own. The option of a web-based self-help programme could potentially reach those users who hesitate to approach treatment centres and help them to reduce or stop their problem gambling. The effectiveness of such web-based interventions has been shown in other countries.Methods and analysisThis two-armed randomised controlled trial (RCT) will examine the efficacy of a web-based self-help intervention, relative to an active control condition with a self-help manual, at reducing problem gambling. The active intervention programme, spanning 8 weeks, consists of nine modules developed to reduce gambling and attenuate psychopathological comorbidity, including depression, anxiety and stress-related disorder symptoms, relying on motivational interviewing and cognitive behavioural therapy. With a target sample size of 352, questionnaire data will be collected at baseline, and at 8 and 24 weeks after baseline. Primary outcomes will be the number of days one has gambled in the last 30 days. Secondary outcomes will include money and time spent on gambling activities, changes in gambling-related problems (Problem Gambling Severity Index, Gambling Symptom Assessment Scale), use of alcohol and cigarettes, and psychopathological comorbidity. All data analysis will comply with the intention-to-treat principle.Ethics and disseminationThe RCT will be conducted in accordance with the Declaration of Helsinki; the consort eHealth Guidelines for studies on medical devices; the European Directive on medical devices 93/42/EEC, Swiss Law and Swiss Regulatory Authority requirements. The study was approved by the ethics committee of the Canton of Zurich. Results will be published in a scientific peer-reviewed journal. Participants will be informed via e-mail about study results via a lay-person-friendly summary of trial findings.Trial registration numberCurrent Controlled Trials registry (ISRCTN16339434).

scholarly journals Addressing multiple modifiable risks through structured community-based Learning Clubs to improve maternal and infant health and infant development in rural Vietnam: protocol for a parallel group cluster randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e023539 ◽  
Author(s):  
Jane Fisher ◽  
Tuan Tran ◽  
Stanley Luchters ◽  
Thach D Tran ◽  
David B Hipgrave ◽  
...  
Keyword(s):  
Early Childhood ◽  
Randomised Controlled Trial ◽  
Infant Health ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Childhood Development ◽  
Specific Information ◽  
Cluster Randomised ◽  
Parallel Group ◽  
Randomised Controlled

IntroductionOptimal early childhood development is an international priority. Risks during pregnancy and early childhood have lasting effects because growth is rapid. We will test whether a complex intervention addressing multiple modifiable risks: maternal nutrition, mental health, parenting capabilities, infant health and development and gender-based violence, is effective in reducing deficient cognitive development among children aged two in rural Vietnam.Methods and analysisThe Learning Clubs intervention is a structured programme combining perinatal stage-specific information, learning activities and social support. It comprises 20 modules, in 19 accessible, facilitated groups for women at a community centre and one home visit. Evidence-informed content is from interventions to address each risk tested in randomised controlled trials in other resource-constrained settings. Content has been translated and culturally adapted for Vietnam and acceptability and feasibility established in pilot testing.We will conduct a two-arm parallel-group cluster-randomised controlled trial, with the commune as clustering unit. An independent statistician will select 84/112 communes in Ha Nam Province and randomly assign 42 to the control arm providing usual care and 42 to the intervention arm. In total, 1008 pregnant women (12 per commune) from 84 clusters are needed to detect a difference in the primary outcome (Bayley Scales of Infant and Toddler Development Cognitive Score <1 SD below standardised norm for 2 years of age) of 15% in the control and 8% in the intervention arms, with 80% power, significance 0.05 and intracluster correlation coefficient 0.03.Ethics and disseminationMonash University Human Research Ethics Committee (Certificate Number 20160683), Melbourne, Victoria, Australia and the Institutional Review Board of the Hanoi School of Public Health (Certificate Number 017-377IDD- YTCC), Hanoi, Vietnam have approved the trial. Results will be disseminated through a comprehensive multistranded dissemination strategy including peer-reviewed publications, national and international conference presentations, seminars and technical and lay language reports.Trial registration numberACTRN12617000442303; Pre-results.

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