scholarly journals Adult and adolescent livestock productive asset transfer programmes to improve mental health, economic stability and family and community relationships in rural South Kivu Province, Democratic Republic of Congo: a protocol of a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (3) ◽  
pp. e013612 ◽  
Author(s):  
Anjalee Kohli ◽  
Nancy A Perrin ◽  
Mitima Mpanano Remy ◽  
Mirindi Bacikenge Alfred ◽  
Kajabika Binkurhorhwa Arsene ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Economic ◽  
Democratic Republic ◽  
Democratic Republic Of Congo ◽  
Controlled Trial ◽  
Economic Stability ◽  
Rural South ◽  
Asset Transfer ◽  
Productive Asset ◽  
Randomised Controlled

scholarly journals Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a community-based individually randomised controlled trial in Kasaï, Democratic Republic of Congo

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041213
Author(s):  
Cécile Cazes ◽  
Kevin Phelan ◽  
Victoire Hubert ◽  
Rodrigue Alitanou ◽  
Harouna Boubacar ◽  
...  
Keyword(s):  
Democratic Republic ◽  
Democratic Republic Of Congo ◽  
Controlled Trial ◽  
Acute Malnutrition ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Medical Complication ◽  
Republic Of Congo ◽  
Link Type ◽  
Randomised Controlled

IntroductionAcute malnutrition (AM) is a continuum condition, arbitrarily divided into moderate and severe AM (SAM) categories, funded and managed in separate programmes under different protocols. Optimising acute MAlnutrition (OptiMA) treatment aims to simplify and optimise AM management by treating children with mid-upper arm circumference (MUAC) <125 mm or oedema with one product—ready-to-use therapeutic food—at a gradually tapered dose. Our main objective was to compare the OptiMA strategy with the standard nutritional protocol in children 6–59 months presenting with MUAC <125 mm or oedema without additional complications, as well as in children classified as uncomplicated SAM (ie, MUAC <115 mm or weight-for-height Z-score (WHZ) <−3 or with oedema).Methods and analysisThis study was a non-inferiority, individually randomised controlled clinical trial conducted at community level in the Democratic Republic of Congo. Children 6–59 months presenting with MUAC <125 mm or WHZ <−3 or with bipedal oedema and without medical complication were included after signed informed consent in outpatient health facilities. All participants were followed for 6 months. Success in both arms was defined at 6 months post inclusion as being alive, not acutely malnourished per the definition applied at inclusion and without an additional episode of AM throughout the 6-month observation period. Recovery among children with uncomplicated SAM was the main secondary outcome. For the primary objective, 890 participants were needed, and 480 children with SAM were needed for the main secondary objective. We will perform non-inferiority analyses in per-protocol and intention-to-treat basis for both outcomes.Ethics and disseminationEthics approvals were obtained from the National Health Ethics Committee of the Democratic Republic of Congo and from the Ethics Evaluation Committee of Inserm, the French National Institute for Health and Medical Research (Paris, France). We will submit results for publication to a peer-reviewed journal and disseminate findings in international and national conferences and meetings.Trial registration numberNCT03751475. Registered 19 September 2018, https://clinicaltrials.gov/ct2/show/NCT03751475.

scholarly journals Building caregivers’ emotional, parental and social support skills to prevent violence against adolescent girls: findings from a cluster randomised controlled trial in Democratic Republic of Congo

2018 ◽  
Vol 3 (5) ◽  
pp. e000824 ◽  
Author(s):  
Lindsay Stark ◽  
Ilana Seff ◽  
Khudejha Asghar ◽  
Danielle Roth ◽  
Theresita Bakamore ◽  
...  
Keyword(s):  
Sexual Violence ◽  
Adolescent Girls ◽  
Democratic Republic ◽  
Democratic Republic Of Congo ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
Parenting Behaviours

IntroductionParenting programmes are increasingly popular for reducing children’s exposure to interpersonal violence in low/middle-income countries, but there is limited evidence on their effectiveness. We investigated the incremental impact of adding a caregiver component to a life skills programme for adolescent girls, assessing girls’ exposure to violence (sexual and others) and caregivers’ gender attitudes and parenting behaviours.MethodsIn this two-arm, single-blinded, cluster randomised controlled trial, we recruited 869 adolescent girls aged 10–14 and 764 caregivers in South Kivu, Democratic Republic of Congo. Following a baseline survey, participants were divided into 35 clusters based on age, language and location. Eighteen clusters were randomised to the treatment arm and 17 clusters to the wait-list control arm. Adolescent girls in both arms received 32 life skills sessions; caregivers in the treatment arm received 13 complementary caregiver sessions. The primary outcome was girls’ self-reported exposure to sexual violence in the last 12 months; secondary outcomes included self-reports of specific forms of sexual violence, physical and emotional violence, transactional sex, child marriage for girls and parenting behaviours for caregivers. Intent-to-treat and per-protocol analyses were conducted.ResultsAt 12 months of follow-up, the intervention showed no impact on sexual violence (adjusted OR=0.95; 95% CI 0.65 to 1.37) or any secondary outcomes for girls. The intervention was associated with improved supportive parenting behaviours. Protocol adherence was also associated with improvements in these outcomes.ConclusionWhile the caregiver curriculum improved some parenting outcomes, additional programmatic adaptations may be needed to reduce adolescent girls’ violence exposure in humanitarian settings.Trial registration numberNCT02384642.

scholarly journals Effects of a community-driven water, sanitation and hygiene intervention on water and sanitation infrastructure, access, behaviour, and governance: a cluster-randomised controlled trial in rural Democratic Republic of Congo

2021 ◽  
Vol 6 (5) ◽  
pp. e005030
Author(s):  
John Paul Quattrochi ◽  
Aidan Coville ◽  
Eric Mvukiyehe ◽  
Caleb Jeremie Dohou ◽  
Federica Esu ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Democratic Republic ◽  
Democratic Republic Of Congo ◽  
School Attendance ◽  
Water Governance ◽  
Controlled Trial ◽  
Water Storage ◽  
Financial Cost ◽  
Water And Sanitation ◽  
Randomised Controlled

IntroductionInadequate water and sanitation is a central challenge in global health. Since 2008, the Democratic Republic of Congo government has implemented a national programme, Healthy Villages and Schools (Villages et Ecoles Assainis (VEA), with support from UNICEF, financed by UK’s Foreign, Commonwealth and Development Office.MethodsA cluster-level randomised controlled trial of VEA was implemented throughout 2019 across 332 rural villages, grouped into 50 treatment and 71 control clusters. Primary outcomes included time spent collecting water; quantity of water collected; prevalence of improved primary source of drinking water; and prevalence of improved primary defecation site. Secondary outcomes included child health, water governance, water satisfaction, handwashing practices, sanitation practices, financial cost of water, school attendance and water storage practices. All outcomes were self-reported. The primary analysis was on an intention-to-treat basis, using linear models. Outcomes were measured October–December 2019, median 5 months post-intervention.ResultsThe programme increased access to improved water sources by 33 percentage points (pp) (95% CI 22 to 45), to improved sanitation facilities by 26 pp (95% CI 14 to 37), and improved water governance by 1.3 SDs (95% CI 1.1 to 1.5), water satisfaction by 0.6 SD (95% CI 0.4 to 0.9), handwashing practices by 0.5 SD (95% CI 0.3 to 0.7) and sanitation practices by 0.3 SD (95% CI 0.1 to 0.4). There was no significant difference in financial cost of water, school attendance, child health or water storage practices.ConclusionVEA produced large increases in access to and satisfaction with water and sanitation services, in self-reported hygiene and sanitation behaviour, and in measures of water governance.Trial registration numberAEARCTR-0004648; American Economic Association RCT registry.

scholarly journals Increasing demand for school counselling through a lay counsellor-delivered classroom sensitisation intervention: a stepped-wedge cluster randomised controlled trial in New Delhi, India

2021 ◽  
Vol 6 (6) ◽  
pp. e003902
Author(s):  
Rachana Parikh ◽  
Adriaan Hoogendoorn ◽  
Daniel Michelson ◽  
Jeroen Ruwaard ◽  
Rhea Sharma ◽  
...  
Keyword(s):  
Mental Health ◽  
Low Income ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
New Delhi ◽  
Stepped Wedge ◽  
Whole School ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionWe evaluated a classroom-based sensitisation intervention that was designed to reduce demand-side barriers affecting referrals to a school counselling programme. The sensitisation intervention was offered in the context of a host trial evaluating a low-intensity problem-solving treatment for common adolescent mental health problems.MethodsWe conducted a stepped-wedge, cluster randomised controlled trial with 70 classes in 6 secondary schools serving low-income communities in New Delhi, India.The classes were randomised to receive a classroom sensitisation session involving a brief video presentation and moderated group discussion, delivered by a lay counsellor over one class period (intervention condition, IC), in two steps of 4 weeks each. The control condition (CC) was whole-school sensitisation (teacher-meetings and whole-school activities such as poster displays). The primary outcome was the proportion of students referred into the host trial. Secondary outcomes were the proportion of students who met mental health caseness criteria and the proportion of self-referred adolescents.ResultsBetween 20 August 2018 and 9 December 2018, 835 students (23.3% of all students) were referred into the host trial. The referred sample included 591 boys (70.8%), and had a mean age of 15.8 years, SD=0.06; 194 students (31.8% of 610 with complete data) met mental health caseness criteria. The proportion of students referred in each trial conditionwas significantly higher in the IC (IC=21.7%, CC=1.5%, OR=111.36, 95% CI 35.56 to 348.77, p<0.001). The proportion of self-referred participants was also higher in the IC (IC=98.1%, CC=89.1%, Pearson χ2 (1)=16.92, p<0.001). Although the proportion of referred students meeting caseness criteria was similar in both conditions (IC=32.0% vs CC=28.1%), the proportion weighted for the total student population was substantially higher in the IC (IC=5.2%, CC=0.3%, OR=52.39, 95% CI 12.49 to 219.66,p<0.001).ConclusionA single, lay counsellor-delivered, classroom sensitisation session increased psychological help-seeking for common mental health problems among secondary school pupils from urban, low-income communities in India.Trial registration numberNCT03633916.

scholarly journals Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050661
Author(s):  
Håvard Kallestad ◽  
Simen Saksvik ◽  
Øystein Vedaa ◽  
Knut Langsrud ◽  
Gunnar Morken ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Patient Education ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Group Differences ◽  
Post Intervention ◽  
Cognitive Behavioural ◽  
Randomised Controlled

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.

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