scholarly journals CovEMERALD: Assessing the feasibility and preliminary effectiveness of remotely delivered Eye Movement Desensitisation and Reprocessing following Covid-19 related critical illness: A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Andrew Bates ◽  
Sophie Rushbrook ◽  
Elan Shapiro ◽  
Michael Grocott ◽  
Rebecca Cusack
Keyword(s):  
United Kingdom ◽  
Critical Illness ◽  
Eye Movement ◽  
Hospital Discharge ◽  
Standard Care ◽  
Anxiety And Depression ◽  
Discharge Home ◽  
Full Protocol ◽  
Randomised Controlled ◽  
Group Allocation

Abstract Objectives Primary Objective: To determine the feasibility of delivering a protocolised, remote, online, Eye Movement Desensitisation and Reprocessing (EMDR) intervention, within 12-weeks of hospital discharge, for adult survivors of Covid-19 related critical illness. Secondary objectives: To investigate whether remotely delivered EMDR can improve psychological outcome following Covid-19 related critical illness, specifically Post-Traumatic Stress Disorder (PTSD), anxiety and depression. Trial design This is a single centre, randomised controlled cohort feasibility trial. Participants Participants will be recruited following discharge from the Intensive Care Unit at University Hospital Southampton, United Kingdom. Eligible patients will have received mechanical ventilation for a minimum of 24 hours, tested Covid-19 positive by polymerase chain reaction, will be over the age of 18 years and have the capacity to provide informed consent. Patients will be excluded if they have pre-existing cognitive impairment, pre-existing psychotic diagnosis or are not expected to survive post-hospital discharge. Intervention and comparator Group one: patients in the control arm will receive their standard package of prescribed care, following discharge home from hospital. If they experience any adverse physical or psychological health-conditions, they will access care through the usual available channels. Group two: patients randomly allocated to the intervention arm will receive their standard package of prescribed care, following discharge home from hospital. In addition, they will be referred to the Intensive Psychological Therapies Service in Poole, United Kingdom. They will receive an online appointment within 12-weeks of discharge home from hospital. They will receive a maximum of eight, weekly sessions of EMDR, delivered by a trained psychological therapist, following the Recent Traumatic Episode Protocol (R-TEP). Appendices 1 and 2 of the attached trial protocol contain a detailed description of the R-TEP intervention, written in accordance with the Template for Intervention Description and Replication (TIDieR) checklist and guide. Main outcomes The primary outcome from this trial will be feasibility. Feasibility will be determined by recruitment rates, expressed as a percentage of eligible patients approached, completion of the EMDR intervention, completion of final assessment at 6-months, incidence of attributable adverse events and protocol adherence by the psychological therapists. Secondary, exploratory outcomes will be assessed by comparison between the control and intervention groups at 6-months post-hospital discharge. Psychometric evaluation will consist of the PTSD Checklist-Civilian Version and Hospital Anxiety and Depression Scale. In addition, we will assess health-related quality of life using the EQ5D-5L, physical activity using wrist worn activity monitors and nutritional state using the Council of Nutrition Appetite Questionnaire. Randomisation Consenting participants will be randomly allocated to intervention or usual care using an internet-based system (ALEATM). Participants will be randomly assigned, on a 1:1 ratio, to receive either standard care (control) or the standard care plus online EMDR R-TEP (Intervention) Blinding (masking) Due to the nature of the intervention, participants cannot be blinded to group allocation. 6-month patient reported outcome measures will be completed using an online, electronic case report form. Group allocation will be masked during data analysis. Numbers to be randomised (sample size) This is a feasibility study, the results of which will be used to power a definitive study if appropriate. We anticipate a 25% mortality /loss to follow-up. A total of 26 patients will be recruited to this study, 13 patients in each arm. Trial Status CovEMERALD opened to recruitment on 23rd September 2020 with an anticipated recruitment period of 6-months. We are using protocol version number 1.2 (1st June 2020) Trial registration CovEMERALD was registered on clinicaltrials.gov NCT04455360 on 2nd July 2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

scholarly journals Supervised exercise rehabilitation in survivors of critical illness: A randomised controlled trial

2018 ◽  
Vol 20 (1) ◽  
pp. 18-26 ◽  
Author(s):  
Ceri Battle ◽  
Karen James ◽  
Paul Temblett ◽  
Hayley Hutchings
Keyword(s):  
Hospital Discharge ◽  
Controlled Trial ◽  
Unit Length ◽  
Exercise Programme ◽  
Anxiety And Depression ◽  
Six Minute Walk Test ◽  
Supervised Exercise ◽  
Randomised Controlled ◽  
Minute Walk

Objectives To investigate the impact of a six-week supervised exercise programme on cardiopulmonary fitness, balance, muscle strength and anxiety and depression in patients who have been discharged home from hospital following an intensive care unit length of stay of greater than 48 h. To investigate patients' perceptions of a six-week supervised exercise programme delivered at three months post hospital discharge. Design A single centre parallel, randomised controlled trial. Setting Outpatient department of a university teaching hospital in the UK. Participants Sixty adult survivors of critical illness, at three months post-hospital discharge. Intervention A six-week individually prescribed and supervised exercise program, with associated advice to home exercise modification. Twice weekly exercise sessions were individualised to participant's functional status and included cardiopulmonary, balance and strengthening exercises. Follow up at seven weeks, six months and 12 months. Outcome measures Six-Minute Walk Test, BERG balance test, grip strength and Hospital Anxiety and Depression Scale. A pre-designed survey was used to explore patient perceptions of the programme. Results Sixty participants ( n = 30 received allocated programme in both control and treatment groups) were randomised. Loss to follow up resulted in n = 34 participants for intention to treat analysis at 12 months follow up (leaving n = 19 in control group, n = 15 in treatment group). Median participant age at enrolment was 62 years (interquartile range: 49–72), with a median intensive care unit length of stay of nine days (interquartile range: 4–17). No significant differences were found for the Six-Minute Walk Test at any time point ( p > 0.05). Anxiety levels and balance were significantly improved in the treatment group at 12 months ( p = 0.006 and p = 0.040, respectively). Conclusions Further research is needed into appropriate interventions and outcome measures, target patient populations and timing of such intervention post-hospital discharge.

scholarly journals Safety and Feasibility of an Exercise Prescription Approach to Rehabilitation Across the Continuum of Care for Survivors of Critical Illness

2012 ◽  
Vol 92 (12) ◽  
pp. 1524-1535 ◽  
Author(s):  
Sue Berney ◽  
Kimberley Haines ◽  
Elizabeth H. Skinner ◽  
Linda Denehy
Keyword(s):  
Critical Illness ◽  
Exercise Training ◽  
Hospital Discharge ◽  
Standard Care ◽  
Controlled Trial ◽  
Functional Limitations ◽  
Continuum Of Care ◽  
Rehabilitation Program ◽  
Outpatient Program ◽  
The Continuum

Background Survivors of critical illness can experience long-standing functional limitations that negatively affect their health-related quality of life. To date, no model of rehabilitation has demonstrated sustained improvements in physical function for survivors of critical illness beyond hospital discharge. Objective The aims of this study were: (1) to describe a model of rehabilitation for survivors of critical illness, (2) to compare the model to local standard care, and (3) to report the safety and feasibility of the program. Design This was a cohort study. Methods As part of a larger randomized controlled trial, 74 participants were randomly assigned, 5 days following admission to the intensive care unit (ICU), to a protocolized rehabilitation program that commenced in the ICU and continued on the acute care ward and for a further 8 weeks following hospital discharge as an outpatient program. Exercise training was prescribed based on quantitative outcome measures to achieve a physiological training response. Results During acute hospitalization, 60% of exercise sessions were able to be delivered. The most frequently occurring barriers to exercise were patient safety and patient refusal due to fatigue. Point prevalence data showed patients were mobilized more often and for longer periods compared with standard care. Outpatient classes were poorly attended, with only 41% of the patients completing more than 70% of outpatient classes. No adverse events occurred. Limitations Limitations included patient heterogeneity and delayed commencement of exercise in the ICU due to issues of consent and recruitment. Conclusions Exercise training that commences in the ICU and continues through to an outpatient program is safe and feasible for survivors of critical illness. Models of care that maximize patient participation across the continuum of care warrant further investigation.

Effect of preoperative education and ICU tour on patient and family satisfaction and anxiety in the intensive care unit after elective cardiac surgery: a randomised controlled trial

2020 ◽  
pp. bmjqs-2019-010667
Author(s):  
Veronica Ka Wai Lai ◽  
Ka Man Ho ◽  
Wai Tat Wong ◽  
Patricia Leung ◽  
Charles David Gomersall ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Standard Care ◽  
Controlled Trial ◽  
Family Members ◽  
Family Satisfaction ◽  
Anxiety And Depression ◽  
Preoperative Education ◽  
Randomised Controlled ◽  
Control Family ◽  
Over Time

BackgroundPreoperative education may help participants to psychologically prepare themselves for surgery, but the outcomes of such preparation have rarely been assessed in patients requiring postoperative care in the intensive care unit (ICU) as well as in family members.ObjectiveTo assess the effect of a preoperative multifaceted education intervention on patient and family satisfaction levels in the ICU and measures of perioperative patients’ anxiety and depression.Trial designSingle-centre, two-armed, parallel, superiority, randomised controlled trial. Healthcare professionals in ICU and outcome assessor were blinded to treatment allocation.Participants100 elective coronary artery bypass grafting±valve surgery patients and their family members.InterventionsPreoperative education comprising of a video and ICU tour in addition to standard care (treatment), versus standard care (control).OutcomesPatient and family satisfaction levels with ICU using validated PS-ICU23 and FS-ICU24 questionnaires (0–100), respectively; change in perioperative anxiety and depression scores between 1 day presurgery and 3 days postsurgery.ResultsAmong 100 (50 treatment, 50 control) patients and 98 (49 treatment, 49 control) family members, 94 (48 treatment, 46 control) patients and 94 (47 treatment, 47 control) family members completed the trial. Preoperative education was associated with higher overall patient (mean difference (MD) 6.7, 95% CI 0.2 to 13.2) and family (MD 10.0, 95% CI 3.8 to 16.3) satisfaction scores. There was a weak association between preoperative education and a reduction in patient’s anxiety scores over time (MD −1.7, 95% CI −3.5 to 0.0). However, there was no evidence of a treatment effect on patient’s depression scores over time (MD −0.6, 95% CI −2.3 to 1.2).ConclusionProviding comprehensive preoperative information about ICU to elective cardiac surgical patients improved patient and family satisfaction levels and may decrease patients’ anxiety levels.Trial registration numberChiCTR-IOR-15006971.

scholarly journals Critical Care Cycling Study (CYCLIST) trial protocol: a randomised controlled trial of usual care plus additional in-bed cycling sessions versus usual care in the critically ill

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017393 ◽  
Author(s):  
Marc R Nickels ◽  
Leanne M Aitken ◽  
James Walsham ◽  
Adrian G Barnett ◽  
Steven M McPhail
Keyword(s):  
Quality Of Life ◽  
Critical Illness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Hospital Discharge ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Surgical Intensive Care Unit ◽  
Randomised Controlled

IntroductionIn-bed cycling with patients with critical illness has been shown to be safe and feasible, and improves physical function outcomes at hospital discharge. The effects of early in-bed cycling on reducing the rate of skeletal muscle atrophy, and associations with physical and cognitive function are unknown.Methods and analysisA single-centre randomised controlled trial in a mixed medical-surgical intensive care unit (ICU) will be conducted. Adult patients (n=68) who are expected to be mechanically ventilated for more than 48 hours and remain in ICU for a further 48 hours from recruitment will be randomly allocated into either (1) a usual care group or (2) a group that receives usual care and additional in-bed cycling sessions. The primary outcome is change in rectus femoris cross-sectional area at day 10 in comparison to baseline measured by blinded assessors. Secondary outcome measures include muscle strength, incidence of ICU-acquired weakness, handgrip strength, time to achieve functional milestones (sitting out of bed, walking), Functional Status Score in ICU, ICU Mobility Scale, 6 min walk test 1 week post-ICU discharge, incidence of delirium and quality of life (EuroQol Five Dimensions questionnaire Five Levels scale). Quality of life assessments will be conducted post-ICU admission at day 10, 3 and 6 months after acute hospital discharge. Participants in the intervention group will complete an acceptability of intervention questionnaire.Ethics and disseminationAppropriate ethical approval from Metro South Health Human Research Ethics Committee has been attained. Results will be published in peer-reviewed publications and presented at scientific conferences to assist planning of future multicentre randomised controlled trials (if indicated) that will test in-bed cycling as an intervention to improve the physical, cognitive and health-related quality of life outcomes of patients with critical illness.Trial registration numberThis trial has been prospectively registered on the Australian and New Zealand Clinical Trial Registry (ACTRN12616000948493); Pre-results.

scholarly journals Hyperimmune anti-COVID-19 IVIG (C-IVIG) Therapy for Passive Immunization of Severe and Critically Ill COVID-19 Patients: A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Shaukat Ali ◽  
Shobha Luxmi ◽  
Fatima Anjum ◽  
Sheikh Muhammad Muhaymin ◽  
Syed Muneeb Uddin ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Critically Ill ◽  
Hospital Care ◽  
Standard Care ◽  
Passive Immunization ◽  
University Hospital ◽  
Dosage Group ◽  
Full Protocol ◽  
Randomised Controlled ◽  
Group 1

Abstract Objectives The aim of this trial is to investigate the safety and clinical efficacy of passive immunization therapy through Hyperimmune anti-COVID-19 Intravenous Immunoglobulin (C-IVIG: 5% liquid formulation), on severe and critically ill patients with COVID-19. Trial design This is a phase I/II single centre, randomised controlled, single-blinded, superiority trial, through parallel-group design with sequential assignment. Participants will be randomised either to receive both C-IVIG and standard care or only standard care (4:1). Participants The study is mono-centric with the participants including COVID19 infected individuals (positive SARS-CoV-2 PCR on nasopharyngeal and/or oropharyngeal swabs) admitted in institute affiliated with Dow University Hospital, Dow University of Health Sciences, Karachi, Pakistan. Consenting patients above 18 years that are classified by the treating physician as severely ill i.e. showing symptoms of COVID-19 pneumonia; dyspnea, respiratory rate ≥30/min, blood oxygen saturation ≤93%, PaO2/FiO2 <300, and lung infiltrates >50% on CXR; or critically ill i.e. respiratory failure, septic shock, and multiple organ dysfunction or failure. Patients with reported IgA deficiency, autoimmune disorder, thromboembolic disorder, and allergic reaction to immunoglobulin treatment were excluded from study. Similarly, pregnant females, patients requiring two or more inotropic agents to maintain blood pressure and patients with acute or chronic kidney injury/failure, were also excluded from the study. Intervention and comparator The study consists of four interventions and one comparator arm. All participants receive standard hospital care which includes airway support, anti-viral medication, antibiotics, fluid resuscitation, hemodynamic support, steroids, painkillers, and anti-pyretics. Randomised test patients will receive single dose of C-IVIG in following four dosage groups: Group 1: 0.15g/Kg with standard hospital care Group 2: 0.2g/Kg with standard hospital care Group 3: 0.25g/Kg with standard hospital care Group 4: 0.3g/Kg with standard hospital care Group 5 (comparator) will receive standard hospital care only Main outcomes The primary outcomes are assessment and follow-up of participants to observe 28-day mortality and, • the level and duration of assisted ventilation during hospital stay, • number of days to step down (shifting from ICU to isolation ward), • number of days to hospital discharge, • adverse events (Kidney failure, hypersensitivity with cutaneous or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, transfusion related acute lung injury (TRALI)) during hospital stay, • change in C-Reactive Protein (CRP) levels, • change in neutrophil lymphocyte ratio to monitor inflammation. Randomisation Consenting participants who fulfill the criteria are allocated to either intervention or comparator arm with a ratio of 4:1, using sequentially numbered opaque sealed envelope simple randomization method. The participant allocated for intervention will be sequentially assigned dosage group 1-4 in ascending order. Participants will not be recruited in the next dosage group before a set number of participants in one group (10) are achieved. Blinding (masking) Single blinded study, with participants blinded to allocation. Numbers to be randomised (sample size) Total 50 patients are randomised. The intervention arms consist of 40 participants divided in four groups of 10 participants while the comparator group consists of 10 patients. Trial Status Current version of the protocol is “Version 2” dated 29th September, 2020. Participants are being recruited. Recruitment started on June, 2020 and is estimated to primarily end on January, 2021. Trial registration This trial was registered at ClinicalTrials.gov, NCT04521309 on 20 August 2020 and is retrospectively registered. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).

scholarly journals Cognitive–behaviour therapy for health anxiety in medical patients (CHAMP): a randomised controlled trial with outcomes to 5 years

2017 ◽  
Vol 21 (50) ◽  
pp. 1-58 ◽  
Author(s):  
Peter Tyrer ◽  
Paul Salkovskis ◽  
Helen Tyrer ◽  
Duolao Wang ◽  
Michael J Crawford ◽  
...  
Keyword(s):  
Cognitive Behaviour Therapy ◽  
Standard Care ◽  
Controlled Trial ◽  
Health Anxiety ◽  
Cost Effective ◽  
Health Technology ◽  
Anxiety And Depression ◽  
Behaviour Therapy ◽  
Cognitive Behaviour ◽  
Randomised Controlled

BackgroundHealth anxiety is an under-recognised but frequent cause of distress that is potentially treatable, but there are few studies in secondary care.ObjectiveTo determine the clinical effectiveness and cost-effectiveness of a modified form of cognitive–behaviour therapy (CBT) for health anxiety (CBT-HA) compared with standard care in medical outpatients.DesignRandomised controlled trial.SettingFive general hospitals in London, Middlesex and Nottinghamshire.ParticipantsA total of 444 patients aged 16–75 years seen in cardiology, endocrinology, gastroenterology, neurology and respiratory medicine clinics who scored ≥ 20 points on the Health Anxiety Inventory (HAI) and satisfied diagnostic requirements for hypochondriasis. Those with current psychiatric disorders were excluded, but those with concurrent medical illnesses were not.InterventionsCognitive–behaviour therapy for health anxiety – between 4 and 10 1-hour sessions of CBT-HA from a health professional or psychologist trained in the treatment. Standard care was normal practice in primary and secondary care.Main outcome measuresPrimary – researchers masked to allocation assessed patients at baseline, 3, 6, 12, 24 months and 5 years. The primary outcome was change in the HAI score between baseline and 12 months. Main secondary outcomes – costs of care in the two groups after 24 and 60 months, change in health anxiety (HAI), generalised anxiety and depression [Hospital Anxiety and Depression Scale (HADS)] scores, social functioning using the Social Functioning Questionnaire and quality of life using the EuroQol-5 Dimensions (EQ-5D), at 6, 12, 24 and 60 months, and deaths over 5 years.ResultsOf the 28,991 patients screened over 21 months, 5769 had HAI scores of ≥ 20 points. Improvement in HAI scores at 3 months was significantly greater in the CBT-HA group (mean number of sessions = 6) than in the standard care, and this was maintained over the 5-year period (overallp < 0.0001), with no loss of efficacy between 2 and 5 years. Differences in the generalised anxiety (p = 0.0018) and depression scores (p = 0.0065) on the HADS were similar in both groups over the 5-year period. Gastroenterology and cardiology patients showed the greatest CBT gains. The outcomes for nurses were superior to those of other therapists. Deaths (n = 24) were similar in both groups; those in standard care died earlier than those in CBT-HA. Patients with mild personality disturbance and higher dependence levels had the best outcome with CBT-HA. Total costs were similar in both groups over the 5-year period (£12,590.58 for CBT-HA; £13,334.94 for standard care). CBT-HA was not cost-effective in terms of quality-adjusted life-years, as measured using the EQ-5D, but was cost-effective in terms of HAI outcomes, and offset the cost of treatment.LimitationsMany eligible patients were not randomised and the population treated may not be representative.ConclusionsCBT-HA is a highly effective treatment for pathological health anxiety with lasting benefit over 5 years. It also improves generalised anxiety and depressive symptoms more than standard care. The presence of personality abnormality is not a bar to successful outcome. CBT-HA may also be cost-effective, but the high costs of concurrent medical illnesses obscure potential savings. This treatment deserves further research in medical settings.Trial registrationCurrent Controlled Trials ISRCTN14565822.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 50. See the NIHR Journals Library website for further project information.

scholarly journals Ambulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX trial): a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040798
Author(s):  
Anne E Holland ◽  
Tamera Corte ◽  
Daniel C Chambers ◽  
Andrew J Palmer ◽  
Magnus Per Ekström ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Interstitial Lung Disease ◽  
Randomised Controlled Trial ◽  
Lung Disease ◽  
Oxygen Therapy ◽  
Controlled Trial ◽  
Activity Level ◽  
Anxiety And Depression ◽  
Randomised Controlled

IntroductionInterstitial lung diseases are characterised by scarring of lung tissue that leads to reduced transfer of oxygen into the blood, decreased exercise capacity and premature death. Ambulatory oxygen therapy may be used to treat exertional oxyhaemoglobin desaturation, but there is little evidence to support its efficacy and there is wide variation in clinical practice. This study aims to compare the clinical efficacy and cost-effectiveness of ambulatory oxygen versus ambulatory air in people with fibrotic interstitial lung disease and exertional desaturation.Methods and analysisA randomised, controlled trial with blinding of participants, clinicians and researchers will be conducted at trial sites in Australia and Sweden. Eligible participants will be randomised 1:1 into two groups. Intervention participants will receive ambulatory oxygen therapy using a portable oxygen concentrator (POC) during daily activities and control participants will use an identical POC modified to deliver air. Outcomes will be assessed at baseline, 3 months and 6 months. The primary outcome is change in physical activity measured by number of steps per day using a physical activity monitor (StepWatch). Secondary outcomes are functional capacity (6-minute walk distance), health-related quality of life (St George Respiratory Questionnaire, EQ-5D-5L and King’s Brief Interstitial Lung Disease Questionnaire), breathlessness (Dyspnoea-12), fatigue (Fatigue Severity Scale), anxiety and depression (Hospital Anxiety and Depression Scale), physical activity level (GENEActive), oxygen saturation in daily life, POC usage, and plasma markers of skeletal muscle metabolism, systematic inflammation and oxidative stress. A cost-effectiveness evaluation will also be undertaken.Ethics and disseminationEthical approval has been granted in Australia by Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/42) with governance approval at all Australian sites, and in Sweden (Lund Dnr: 2019-02963). The results will be published in peer-reviewed scientific journals, presented at conferences and disseminated to consumers in publications for lay audiences.Trial registration numberClinicalTrials.gov Registry (NCT03737409).

scholarly journals Supporting Parents & Kids Through Lockdown Experiences (SPARKLE): A digital parenting support app implemented in an ongoing general population cohort study during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Katarzyna Kostyrka-Allchorne ◽  
Cathy Creswell ◽  
Sarah Byford ◽  
Crispin Day ◽  
Kimberley Goldsmith ◽  
...  
Keyword(s):  
Cohort Study ◽  
Conduct Problems ◽  
Controlled Trial ◽  
Child Conduct Problems ◽  
Parenting Support ◽  
Parent Outcomes ◽  
Full Protocol ◽  
Children’S Behaviour ◽  
Randomised Controlled

Abstract Objectives The COVID-19 related lockdowns and distancing measures have presented families with unprecedented challenges. A UK-wide cohort study tracking changes in families’ mental health since early lockdown (Co-SPACE) found a significant rise in primary school-aged children’s behaviour problems and associated family-related stress. Three-quarters of parents in Co-SPACE also reported wanting extra support. In SPARKLE, we will examine whether providing Co-SPACE families with a smartphone application delivering information and parenting support, Parent Positive, can reverse the negative effects of the pandemic on children and parents. The efficacy on child and parent outcomes and cost-effectiveness of Parent Positive will be examined. We will also test whether the effects are moderated by pre-existing levels of child conduct problems and usage of Parent Positive. Exploratory analyses will examine whether other baseline characteristics or lockdown circumstances moderate the effects of Parent Positive. Trial design SPARKLE is a two-arm superiority parallel group randomised controlled trial embedded in an existing large UK-wide self-selected community cohort – Co-SPACE. Those who consent to SPARKLE will be randomised 1:1 to either Parent Positive or Follow-up As Usual (FAU). Participants Co-SPACE (a UK-wide longitudinal cohort study) parents aged ≥18 who have children aged 4-10 years will be eligible for SPARKLE. Intervention and comparator Parent Positive: is a digital public health intervention that can be delivered rapidly at scale to support parents in managing their children’s behaviour to reduce conduct problems and levels of family conflict, which were exacerbated during the first lockdown, and which may increase further in future months as families need to cope with continuous uncertainty and further disruption to their daily lives. Co-designed with parents and based on decades of parenting research, Parent Positive consists of three elements: (i) Parenting Boosters: where advice, delivered in the form of narrated animations, videos, graphics and text is provided to help parents with eight common parenting challenges; (ii) Parenting Exchange: a facilitated parent-to-parent communication and peer support platform and; (iii) Parent Resources: giving access to carefully selected high-quality, evidence-based online parenting resources. Follow-up as Usual: FAU was selected as a comparator because the public health nature meant that an active comparator was not appropriate due to the pragmatic, rapid implementation of the trial. Individuals randomised to FAU will receive no intervention for the first two months while the data for baseline (T1), T2 and T3 are collected. They will then be given full access to the app until 30th November 2021. Main outcomes Outcome measures will be collected remotely through Qualtrics according to the Co-SPACE schedule at baseline (T1), which will be the Co-SPACE survey data obtained immediately prior to randomisation, and then at one month (T2) and two months (T3) post-randomisation. Measures will be collected to assess group differences in child and parent outcomes, costs and service utilisation, and adverse events. Usage of Parent Positive will also be tracked. The primary outcome is parent-reported child conduct problems at one-month post-randomisation measured using the Strengths and Difficulties Questionnaire conduct problems subscale. Randomisation Enrolled participants will be allocated to Parent Positive or FAU at the ratio of 1:1 by simple randomisation using the Randomizer function within the Qualtrics programme. Neither blocking nor stratification will be used. Blinding (masking) It is not possible to blind parents enrolled in the study and Qualtrics will automatically inform parents of their group allocation. Blinded members of the research team and the senior statistician will not be given access to the Qualtrics system or the data in order to remain blinded until after the analysis is complete. We do not anticipate any serious harms associated with taking part in the intervention, therefore there will be no need to unblind any blinded staff during the study. The junior statistician will be unblinded throughout. Numbers to be randomised (sample size) A total of 616 will be recruited into the trial with 308 consenting parents randomised to each treatment arm. Trial status V1.0; 15.03.2021. Not yet recruiting. Anticipated start date: 1st April 2021. Anticipated end date for recruitment: 31st July 2021. Trial registration Clinicaltrial.gov: NCT04786080. The trial was prospectively registered on 8 March 2021. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

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