The effect of animated consent material on participants’ willingness to enrol in a placebo-controlled surgical trial: a protocol for a randomised feasibility study

Abstract Background Placebo-controlled surgical trials are recognised as the gold standard way to test the efficacy of a surgical procedure. Despite a rise in arthroscopic subacromial decompression (ASD) surgeries for the treatment of shoulder pain, only two placebo-controlled surgical trials have been conducted. These trials encountered significant recruitment challenges, threatening the external validity of findings. Difficulties with recruitment are common in clinical trials and likely to be amplified in placebo-controlled surgical trials. This mixed method feasibility trial aims to address the following questions: (i) Feasibility: What proportion of patients who have consented to undergo ASD report that they would be willing to enrol in a placebo-controlled trial for this procedure? (ii) Optimisation: Can patients’ willingness to enrol in, or understanding of, such a trial be improved by supplementing written consent materials with a brief visual animation that outlines the details of the trial? And (iii) exploration: What factors influence patients stated willingness to enrol in such a trial, and how do they believe the recruitment process could be improved? Methods This study aims to recruit 80 patients on the waiting list for ASD. Participants will be randomised (1:1) to either view a brief video animation explaining the hypothetical placebo-controlled trial in addition to written information or to written information only. Participants in both groups will be required to state if they would be willing to opt-in to the hypothetical ASD trial after immediately being presented with the consent material and again 1 week after completion of the consent process. Patients in both groups will also be required to complete a measure of trial literacy. Twenty participants will be purposively sampled to take part in an embedded qualitative study exploring understanding of trial concepts and factors contributing to willingness to opt-in. Discussion This feasibility study will provide evidence for optimising participant recruitment into a placebo-controlled trial of ASD by consenting patients using animated trial information in addition to written information. This pilot and feasibility data may also be relevant to placebo-controlled surgical trials more broadly, which are characterised by recruitment challenges. Trial registration ANZCTR, ACTRN12620001132932, date October 30, 2020

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Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA)

BMJ Open ◽

10.1136/bmjopen-2017-019142 ◽

2018 ◽

Vol 8 (1) ◽

pp. e019142 ◽

Cited By ~ 7

Author(s):

Kate Jolly ◽

Jenny Ingram ◽

Joanne Clarke ◽

Debbie Johnson ◽

Heather Trickey ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Infant Feeding ◽

Feasibility Study ◽

Breast Feeding ◽

Controlled Trial ◽

Feasibility Trial ◽

Study Results ◽

Service Staff ◽

Before And After ◽

Randomised Controlled

IntroductionBreast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman’s feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities.We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care.Methods and analysisA two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper–women interactions to assess intervention fidelity.Ethics and disseminationStudy results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN14760978; Pre-results.

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The Challenge of Equipoise: Qualitative Interviews Exploring the Views of Health Professionals and Women With Multiple Ipsilateral Breast Cancer in a Surgical Randomised Controlled Trial.

10.21203/rs.3.rs-386168/v2 ◽

2021 ◽

Author(s):

Jenny Ingram ◽

Lucy Beasant ◽

John Benson ◽

Adrian Murray Brunt ◽

Anthony Maxwell ◽

...

Keyword(s):

Breast Cancer ◽

Controlled Trial ◽

Feasibility Trial ◽

Randomised Control Trial ◽

Trial Participation ◽

Multidisciplinary Teams ◽

Ipsilateral Breast ◽

Surgical Interventions ◽

Surgical Trial ◽

Breast Care

Abstract BackgroundA multicentre feasibility trial (MIAMI), comparing outcomes and quality of life of women with multiple ipsilateral breast cancer randomised to therapeutic mammoplasty or mastectomy, was conducted from September 2018 to March 2020. The MIAMI surgical trial aimed to investigate recruitment of sufficient numbers of women. Multidisciplinary teams at 10 breast care centres in the UK identified 190 with MIBC diagnosis; 20 were eligible for trial participation but after being approached only four patients were recruited. A nested qualitative study sought to understand the reasons for this lack of recruitment.MethodsInterviews were conducted from November 2019 to September 2020 with 17 staff from eight hospital-based breast care centres that recruited and attempted to recruit to MIAMI; and seven patients from four centres, comprising all patients who were recruited to the trial and some who declined to take part. Interviews were audio-recorded, anonymised and analysed using thematic methods of building codes into themes and sub-themes using the process of constant comparison.ResultsOverarching themes of 1) influences on equipoise and recruitment and 2) effects of a lack of equipoise were generated. Within these themes health professional themes described the barriers to recruitment as ‘the treatment landscape has changed’; staff preferences and beliefs’ which influenced equipoise and patient advice; and how different the treatments were for patients. Patient themes of ‘altruism and timing of trial approach’; ‘influences from consultants and others’; and ‘diagnostic journey doubts’ all played a part in whether patients agreed to take part in the trial.ConclusionsBarriers to recruiting to breast cancer surgical trials can be significant, especially where there are substantial differences between the treatments being offered and a lack of equipoise communicated by healthcare professionals to patients. Patients can become overwhelmed by numerous requests for participation in research trials and inappropriate timing of trial discussions. Alternative study designs to the gold standard randomised control trial for surgical interventions may be required to provide the high-quality evidence on which to base practice.Trial registration numbers: ISRCTN (ISRCTN17987569) registered 20/04/2018, https://www.isrctn.com/ISRCTN17987569; and ClinicalTrials.gov (NCT03514654).

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The challenge of equipoise: qualitative interviews exploring the views of health professionals and women with multiple ipsilateral breast cancer in a surgical randomised controlled trial

10.21203/rs.3.rs-386168/v1 ◽

2021 ◽

Author(s):

Jenny Ingram ◽

Lucy Beasant ◽

John Benson ◽

Adrian Murray Brunt ◽

Anthony Maxwell ◽

...

Keyword(s):

Breast Cancer ◽

Controlled Trial ◽

Qualitative Interviews ◽

Feasibility Trial ◽

Randomised Control Trial ◽

Ipsilateral Breast ◽

Surgical Interventions ◽

Surgical Trial ◽

Patient Advice ◽

Randomised Controlled

Abstract Background. A multicentre feasibility trial (MIAMI), comparing outcomes and quality of life of women with multiple ipsilateral breast cancer (MIBC) randomised to therapeutic mammoplasty or mastectomy, has been conducted. The MIAMI feasibility trial aimed to investigate recruitment of sufficient numbers of women to this surgical trial, however only four patients were recruited. A nested qualitative study sought to understand the reasons for this lack of recruitment.Methods. Interviews were conducted from November 2019 to September 2020 with 17 staff from eight hospital-based breast care centres that recruited and attempted to recruit to MIAMI; and seven patients from four centres, comprising all patients who were recruited to the trial and some who declined to take part. Interviews were audio-recorded, anonymised and analysed using thematic methods of building codes into themes and sub-themes using the process of constant comparison.Results. Overarching themes of 1) influences on equipoise and recruitment and 2) effects of a lack of equipoise were generated. Within these themes health professional themes described the barriers to recruitment in ‘the treatment landscape has changed’; staff preferences and beliefs’ which influenced equipoise and patient advice; and how different the treatments were for patients. Patient themes of ‘altruism and timing of trial approach’; ‘influences from consultants and others’; and ‘diagnostic journey doubts’ played a part in whether patients agreed to take part in the trial.Conclusions. Barriers to recruiting to breast cancer surgical trials can be significant, especially where there are substantial differences between the treatments being offered and a lack of equipoise communicated by healthcare professionals to patients. Patients can become overwhelmed by numerous requests for participation in research trials and inappropriate timing of trial discussions. Alternative study designs to the gold standard randomised control trial for surgical interventions may be required to provide the high-quality evidence on which to base practice.Trial registration numbers: ISRCTN (ISRCTN17987569) and ClinicalTrials.gov (NCT03514654).

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Protocol for a two-arm feasibility RCT to support postnatal maternal weight management and positive lifestyle behaviour in women from an ethnically diverse inner city population: the SWAN feasibility trial

Pilot and Feasibility Studies ◽

10.1186/s40814-019-0497-3 ◽

2019 ◽

Vol 5 (1) ◽

Author(s):

Debra Bick ◽

Cath Taylor ◽

Amanda Avery ◽

Vanita Bhavnani ◽

Victoria Craig ◽

...

Keyword(s):

Inner City ◽

Weight Management ◽

Standard Care ◽

Retention Rate ◽

Controlled Trial ◽

Ethnically Diverse ◽

Trial Registration ◽

Feasibility Trial ◽

Maternal Weight ◽

City Population

Abstract Introduction A high BMI during and after pregnancy is linked to poor pregnancy outcomes and contributes to long-term maternal obesity, hypertension, and diabetes. Evidence of feasible, effective postnatal interventions is lacking. This randomised controlled trial will assess the feasibility of conducting a future definitive trial to determine effectiveness and cost-effectiveness of lifestyle information and access to Slimming World® (Alfreton, UK) groups for 12 weeks commencing from 8 to 16 weeks postnatally, in relation to supporting longer-term postnatal weight management in women in an ethnically diverse inner city population. Methods/analysis Women will be recruited from one maternity unit in London. To be eligible, women will be overweight (BMI 25–29.9 kg/m2) or obese (BMI ≥ 30 kg/m2) as identified at their first antenatal contact, or have a normal BMI (18.5–24.9 kg/m2) at booking but gain excessive gestational weight as assessed at 36 weeks gestation. Women will be aged 18 and over, can speak and read English, expecting a single baby, and will not have accessed weight management groups in this pregnancy. Women will be randomly allocated to standard care plus lifestyle information and access to Slimming World® (Alfreton, UK) groups or standard care only. A sample of 130 women is required. Feasibility trial objectives reflect those considered most important inform a decision about undertaking a definitive future trial. These include estimation of impact of lifestyle information and postnatal access to Slimming World® (Alfreton, UK) on maternal weight change between antenatal booking weight and weight at 12 months postbirth, recruitment rate and time to recruitment, retention rate, influence of lifestyle information and Slimming World® (Alfreton, UK) groups on weight management, diet, physical activity, breastfeeding, smoking cessation, alcohol intake, physical and mental health, infant health, and health-related quality of life 6 and 12 months postnatally. An embedded process evaluation will assess acceptability of study processes and procedures to women. Ethics/dissemination London–Camberwell St Giles Research Ethics Committee, reference: 16/LO/1422. Outcomes will be disseminated in peer-reviewed journals and presentations at national and international conferences. Trial registration Trial registration number: ISRCTN 39186148. Protocol version number: v7, 13 August 17. Trial sponsor: King’s College London.

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PREBIOTIC: A Study Protocol of a Randomised Controlled Trial to Assess Prebiotic Supplementation in Kidney Transplant Recipients for Preventing Infections and Gastrointestinal Upset: A Feasibility Study

10.21203/rs.3.rs-149396/v1 ◽

2021 ◽

Author(s):

Samuel Chan ◽

Carmel M Hawley ◽

Elaine M Pascoe ◽

Christopher Cao ◽

Katrina L Campbell ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Kidney Transplant ◽

Controlled Trial ◽

Gastrointestinal Symptoms ◽

Trial Registration ◽

Feasibility Trial ◽

Transplant Recipients ◽

Kidney Transplant Recipients ◽

Double Blind ◽

Randomised Controlled

Abstract BackgroundModulating the microbiota in the large intestine of kidney transplant recipients through prebiotic supplementation may prevent infectious complications from occurring. To date, there have been no interventional trials which have investigated this novel treatment in kidney transplantation. The aim of PREBIOTIC is to assess the feasibility of performing a randomised controlled trial of prebiotics in reducing infections and gastrointestinal symptoms in kidney transplant recipients.MethodsSixty kidney transplant patients will be recruited to a double-blind, placebo-controlled, randomised feasibility trial. Patients will be provided with prebiotic therapy or placebo for four to six weeks. Outcomes will include recruitment, adherence, tolerance, retention, laboratory parameters (including serum indoxyl sulphate, ρ-cresyl sulphate and stool collection), patients’ self-assessed quality of life, gastrointestinal symptoms and clinical outcomes.DiscussionThis trial will assess the feasibility of prebiotic supplementation in kidney transplant recipients. Prebiotics may not only alter the gut microbiota and their inherent metabolism and production of uraemic toxins, but may also prevent infections from occurring in kidney transplant recipients.Trial RegistrationAustralian New Zealand Clinical Trials Registry number ACTRN12618001057279p. The date of registration was 25th June 2018, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375370&isReview=true.

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Social Stories™ to alleviate challenging behaviour and social difficulties exhibited by children with autism spectrum disorder in mainstream schools: design of a manualised training toolkit and feasibility study for a cluster randomised controlled trial with nested qualitative and cost-effectiveness components

Health Technology Assessment ◽

10.3310/hta20060 ◽

2016 ◽

Vol 20 (6) ◽

pp. 1-258 ◽

Cited By ~ 6

Author(s):

Barry Wright ◽

David Marshall ◽

Joy Adamson ◽

Hannah Ainsworth ◽

Shehzad Ali ◽

...

Keyword(s):

Outcome Measures ◽

Feasibility Study ◽

Single Case ◽

Controlled Trial ◽

Social Stories ◽

Autism Spectrum ◽

Feasibility Trial ◽

Social Difficulties ◽

Single Case Designs ◽

Randomised Controlled

BackgroundA Social Story™ (Carol Gray) is a child-friendly intervention that is used to give children with autism spectrum disorders (ASDs) social information in situations where they have social difficulties. Limited evidence mainly using single-case designs suggests that they can reduce anxiety and challenging behaviour.ObjectivesThe objectives were to conduct a systematic review, use this to develop a manualised intervention and run a feasibility trial to inform a fully powered randomised controlled trial (RCT) on their clinical effectiveness and cost-effectiveness in schools.DesignThis is a three-stage study following the Medical Research Council framework for complex interventions. Specifically, it involved a theoretical phase, a qualitative stage and a feasibility trial stage.SettingQualitative interviews and focus groups took place in Child and Adolescent Mental Health Service and primary care settings. The feasibility study took place in 37 local mainstream schools.ParticipantsFifty children (aged 5–15 years) in mainstream school settings with a diagnosis of ASD were entered into the trial. For each child, an associated teacher and parent was also recruited.InterventionsThe intervention was a goal-setting session followed by a manualised toolkit (including a training session) for creating Social Stories™ for use with school-aged children. The comparator treatment was a goal-setting session followed by an attention control. Both arms received treatment as usual.Main outcome measuresOutcomes tested as part of the feasibility study included child- and proxy-completed questionnaires for mental health, quality of life and goal-based outcome measures. Adults additionally completed behaviour diaries and the parental stress index.ResultsThe review found that the research into social stories is predominantly based in the USA, carried out in under-12-year-olds and using single-case designs. Most studies either did not follow established Social Story criteria or did not report if they did. The assessment of effectiveness presents a largely positive picture but is limited by methodological issues. There were no adequate RCTs and insufficient information to assess a number of important sources of potential bias in most studies. A manualised intervention was produced using an iterative process between user focus groups and a writing team, and assessed in the feasibility study. All 50 participant groups were recruited within the study time frame. Two outcome measures, the Social Responsiveness Scale-2 and the custom-made goal-based measure, showed high levels of completion rates and appeared to be capturing social and behaviour skills targeted by the use of Social Stories. Detailed recommendations for a full trial are provided.LimitationsBlinding of participants was not feasible. Treatment fidelity was not assessed because of low levels of story return rates.ConclusionsThe study showed that a fully powered RCT is feasible with an extended geographical footprint. A large amount of data and information has helped to inform the design of this RCT, which will be the subject of a future research grant application. Future work could focus on developing an appropriate blinded outcome measure for this population.Study registrationThis study is registered as PROSPERO CRD42011001440.Trial registrationCurrent Controlled Trials ISRCTN96286707.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 6. See the NIHR Journals Library website for further project information.

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71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial

Emergency Medicine Journal ◽

10.1136/emj-2020-rcemabstracts.21 ◽

2020 ◽

Vol 37 (12) ◽

pp. 835.3-836

Author(s):

Hamza Malik ◽

Andrew Appelboam ◽

Gordon Taylor ◽

Daryl Wood ◽

Karen Knapp

Keyword(s):

Data Collection ◽

Controlled Trial ◽

Wrist Fracture ◽

Recruitment Rate ◽

Feasibility Trial ◽

Point Of Care Ultrasound ◽

Distal Radial Fractures ◽

Definitive Trial ◽

Randomised Controlled

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.

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Nutrigenetics-based intervention approach for adults with non-alcoholic fatty liver disease (NAFLD): study protocol for a randomised controlled feasibility trial

BMJ Open ◽

10.1136/bmjopen-2020-045922 ◽

2021 ◽

Vol 11 (4) ◽

pp. e045922

Author(s):

Laura Haigh ◽

Stuart McPherson ◽

John C Mathers ◽

Quentin M Anstee

Keyword(s):

Liver Disease ◽

Fatty Liver ◽

Fatty Liver Disease ◽

Controlled Trial ◽

Phase 1 ◽

Feasibility Trial ◽

Alcoholic Fatty Liver ◽

Intervention Protocol ◽

Randomised Controlled ◽

Alcoholic Fatty Liver Disease

IntroductionLifestyle interventions targeting weight loss and improved dietary patterns are the recommended treatment for non-alcoholic fatty liver disease (NAFLD). However, the effectiveness of current established diet therapies is suboptimal. The patatin‐like phospholipase domain containing 3 (PNPLA3) gene modifies disease outcome and hepatic lipid handling, but the role of PNPLA3 variants in modulating responsiveness to different diet therapies is unknown.Methods and analysisThis project aims to assess the feasibility of conducting a genotype-driven randomised controlled trial (RCT) investigating the differential response to a Mediterranean diet (MD) intervention of NAFLD patients according to genotype for the rs738409 (I148M) variant of PNPLA3. A single-centre randomised controlled feasibility trial will be undertaken. We will recruit 60 adults with NAFLD from a tertiary hepatology centre in England. In a cross-over design, participants will undertake Diet 1 (MD) and Diet 2 (control) for 4 weeks, in random order (1:1 allocation), separated by a 4 weeks washout period. Participants will complete one-to-one diet and lifestyle consultations at baseline, end of diet phase 1, end of washout and end of diet phase 2. Participants will be advised to maintain baseline levels of physical activity and body weight. The primary outcome is the acceptability and feasibility of the intervention protocol. Secondary outcomes include exploratory assessment of liver fibrosis biomarkers and lipid biomarkers.Ethics and disseminationEthical approval was granted by East of Scotland Research Ethics Service REC 1 (19/ES/0112). Results will be disseminated through peer-reviewed journals and presented at local, national and international meetings and conferences. The findings of this trial will lay the foundation for a future definitive RCT by informing trial design and optimising the intervention diets, instruments and procedures.Trial registration numberISRCTN93410321.

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Impact of Polyvalent Mechanical Bacterial Lysate on lymphocyte number and activity in asthmatic children: a randomized controlled trial

Allergy Asthma & Clinical Immunology ◽

10.1186/s13223-020-00503-4 ◽

2021 ◽

Vol 17 (1) ◽

Author(s):

Małgorzata Bartkowiak-Emeryk ◽

Andrzej Emeryk ◽

Jacek Roliński ◽

Ewelina Wawryk-Gawda ◽

Ewa Markut-Miotła

Keyword(s):

T Lymphocytes ◽

Allergic Asthma ◽

Respiratory Infections ◽

Controlled Trial ◽

Trial Registration ◽

House Dust Mites ◽

Dust Mites ◽

Bacterial Lysate ◽

Clinical Trial Registration ◽

Asthmatic Children

Abstract Background Polyvalent Mechanical Bacterial Lysate (PMBL®) contains antigens of bacteria responsible for respiratory infections. PMBL® has been proven to reduce the number of respiratory infections, and in its use, immunological benefits have been seen in allergic patients. PMBL® activates both innate and specific immune responses. The lysate induces dendritic cells, T and B lymphocytes and IgA secretion, as well as the production of antibodies directed against administered bacterial antigens. Moreover, it increases the response against other bacteria and viruses. The immunologic mechanism of lysate’s action is not yet clearly determined. The objective of this study was to assess the effect of PMBL® on T cells in children with allergic asthma. Methods This study was a part of the EOLIA study. Herein, 49 children with allergic asthma and house dust mites allergy were included: 21 in PMBL® and 28 in the Placebo group, both, drug and placebo were administered sublingually. The tests were done at baseline and 12 weeks after the last tablet intake. The lymphocytes CD45+, lymphocytes T CD3+, CD3+CD25+, CD3+CD69+, Th CD3+CD4+, CD4+CD25+, CD4+CD25+ high, CD4+CD69+, Treg CD4+CD25+FOXP3, Tc CD3+CD8+, CD8+CD25+, CD8+CD69+, NK-like T CD3+CD16+CD56+ and NK cells CD3−CD16+CD56+ were described. Results At baseline, no significant differences between groups relative to blood count cells were observed, except for eosinophils. After 12 weeks, we observed an increase of T lymphocytes count. In addition, CD4+CD25+FOXP3+, CD8+ and CD3−CD16+CD56+ and (insignificantly) Th count increased. However, CD69+ and CD25+ subset of CD3+ significantly decreased. Conclusions The EOLIA study demonstrated that PMBL® administration 10 days per month for 3 months changed the panel of T lymphocytes. Trial registration Clinical Trial Registration: This study was a part of the EOLIA (Efficacy Of mechanical bacterial Lysate In Allergic children), a clinical study NCT02541331. Frederic Durmont, MD Lallemand Pharma International AG. Date of registration 09/08/2013. URL of trial registry record: https://clinicaltrials.gov/ct2/show/study/NCT02541331.

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Addressing the mental health needs of adolescents in South African communities: a protocol for a feasibility randomized controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00803-5 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

K. Sorsdahl ◽

C. van der Westhuizen ◽

M. Neuman ◽

H. A. Weiss ◽

B. Myers

Keyword(s):

Mental Health ◽

At Risk ◽

South African ◽

Mental Health Problems ◽

Age Of Onset ◽

Common Mental Disorders ◽

Controlled Trial ◽

Feasibility Trial ◽

Counselling Intervention ◽

Health Counselling

Abstract Background Like many low- and middle-income countries, almost half of the proportion of the South African population is under the age of 25. Given the peak age of onset for most mental health problems is in adolescence, it is vital that adolescents have access to mental health counselling. There are several initiatives to increase access to mental health counselling in South Africa, primarily through the integration of counselling for common mental disorders (CMD) into primary health care services, but adolescents (15–18 years of age) generally do not utilize these services. To address this gap, we will undertake a study to explore the feasibility of conducting a trial of the effectiveness of a community-based mental health counselling intervention for adolescents at-risk for a CMD. Methods The study is a feasibility trial of the ASPIRE intervention, a four-session blended multi-component counselling intervention adapted for South African adolescents at risk for depression and alcohol use disorders. We will enrol 100 adolescents from community settings and randomly assign them to the ASPIRE intervention or a comparison condition. Feasibility measures, such as rates of recruitment, consent to participate in the trial and retention, will be calculated. Qualitative interviews with participants and counsellors will explore the acceptability of the intervention. The primary outcomes for a subsequent trial would be reductions in symptoms of depression and days of heavy drinking which will be measured at baseline, 6 weeks, and 3 months post-randomization. Discussion This feasibility trial using a mixed-methods design will allow us to determine whether we can move forward to a larger effectiveness trial of the ASPIRE intervention. Trial registration The trial is registered with the Pan African Clinical Trials Registry (PACTR20200352214510). Registered 28 February 2020—retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9795

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