scholarly journals The Effect of Improved Access to Family Planning on Postpartum Women: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Mahesh Karra ◽  
David Canning
Keyword(s):  
Randomized Controlled Trial ◽  
Family Planning ◽  
Data Collection ◽  
Contraceptive Use ◽  
Controlled Trial ◽  
Well Being ◽  
Birth Spacing ◽  
Randomized Controlled ◽  
Causal Impact

BACKGROUND The World Health Organization recommends that a woman waits at least 24 months after a live birth before getting pregnant again; however, an estimated 25% of birth intervals in low-income countries do not meet this recommendation for adequate birth spacing, and the unmet need for postpartum family planning (PPFP) services is high. Few randomized controlled trials have assessed the causal impact of access to PPFP services, and even fewer evaluations have investigated how such interventions may affect postpartum contraceptive use, birth spacing, and measures of health and well-being. OBJECTIVE This protocol paper aims to describe a randomized controlled trial that is being conducted to identify the causal impact of an intervention to improve access to PPFP services on contraceptive use, pregnancy, and birth spacing in urban Malawi. The causal effect of the intervention will be determined by comparing outcomes for respondents who are randomly assigned to an intervention arm against outcomes for respondents who are randomly assigned to a control arm. METHODS Married women aged 18-35 years who were either pregnant or had recently given birth were randomly assigned to either the intervention arm or control arm. Women assigned to the intervention arm received a package of services over a 2-year intervention period. Services included a brochure and up to 6 home visits from trained family planning counselors; free transportation to a high-quality family planning clinic; and financial reimbursement for family planning services, consultations, and referrals for services. Two follow-up surveys were conducted 1 and 2 years after the baseline survey. RESULTS A total of 2143 women were randomly assigned to either the intervention arm (n=1026) or the control arm (n=1117). Data collection for the first follow-up survey began in August 2017 and was completed in February 2018. A total of 1773 women, or 82.73% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the first follow-up. Data collection for the second follow-up survey began in August 2018 and was completed in February 2019. A total of 1669 women, or 77.88% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the second follow-up. The analysis of the primary outcomes is ongoing and is expected to be completed in 2021. CONCLUSIONS The results of this trial seek to fill the current knowledge gaps in the effectiveness of family planning interventions on improving fertility and health outcomes. The findings also show that the benefits of improving access to family planning are likely to extend beyond the fertility and health domain by improving other measures of women’s well-being. CLINICALTRIAL American Economics Association Registry Trial Number AEARCTR-0000697; https://www.socialscienceregistry.org/trials/697 Registry for International Development Impact Evaluations (RIDIE) Trial Number RIDIE-STUDY-ID-556784ed86956; https://ridie.3ieimpact.org/index.php?r=search/detailView&id=320 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/16697

scholarly journals The Effect of Improved Access to Family Planning on Postpartum Women: Protocol for a Randomized Controlled Trial

10.2196/16697 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e16697
Author(s):  
Mahesh Karra ◽  
David Canning
Keyword(s):  
Randomized Controlled Trial ◽  
Family Planning ◽  
Data Collection ◽  
Contraceptive Use ◽  
Controlled Trial ◽  
Well Being ◽  
Birth Spacing ◽  
Randomized Controlled ◽  
Causal Impact

Background The World Health Organization recommends that a woman waits at least 24 months after a live birth before getting pregnant again; however, an estimated 25% of birth intervals in low-income countries do not meet this recommendation for adequate birth spacing, and the unmet need for postpartum family planning (PPFP) services is high. Few randomized controlled trials have assessed the causal impact of access to PPFP services, and even fewer evaluations have investigated how such interventions may affect postpartum contraceptive use, birth spacing, and measures of health and well-being. Objective This protocol paper aims to describe a randomized controlled trial that is being conducted to identify the causal impact of an intervention to improve access to PPFP services on contraceptive use, pregnancy, and birth spacing in urban Malawi. The causal effect of the intervention will be determined by comparing outcomes for respondents who are randomly assigned to an intervention arm against outcomes for respondents who are randomly assigned to a control arm. Methods Married women aged 18-35 years who were either pregnant or had recently given birth were randomly assigned to either the intervention arm or control arm. Women assigned to the intervention arm received a package of services over a 2-year intervention period. Services included a brochure and up to 6 home visits from trained family planning counselors; free transportation to a high-quality family planning clinic; and financial reimbursement for family planning services, consultations, and referrals for services. Two follow-up surveys were conducted 1 and 2 years after the baseline survey. Results A total of 2143 women were randomly assigned to either the intervention arm (n=1026) or the control arm (n=1117). Data collection for the first follow-up survey began in August 2017 and was completed in February 2018. A total of 1773 women, or 82.73% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the first follow-up. Data collection for the second follow-up survey began in August 2018 and was completed in February 2019. A total of 1669 women, or 77.88% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the second follow-up. The analysis of the primary outcomes is ongoing and is expected to be completed in 2021. Conclusions The results of this trial seek to fill the current knowledge gaps in the effectiveness of family planning interventions on improving fertility and health outcomes. The findings also show that the benefits of improving access to family planning are likely to extend beyond the fertility and health domain by improving other measures of women’s well-being. Trial Registration American Economics Association Registry Trial Number AEARCTR-0000697; https://www.socialscienceregistry.org/trials/697 Registry for International Development Impact Evaluations (RIDIE) Trial Number RIDIE-STUDY-ID-556784ed86956; https://ridie.3ieimpact.org/index.php?r=search/detailView&id=320 International Registered Report Identifier (IRRID) DERR1-10.2196/16697

scholarly journals A Digital Program (Hope) for People Living With Cancer During the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial

10.2196/24264 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e24264
Author(s):  
Hayley Wright ◽  
Faith Martin ◽  
Wendy Clyne ◽  
Cain C T Clark ◽  
Michael McGillion ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Wait List ◽  
Care Providers ◽  
Randomized Controlled ◽  
Cancer Support

Background During the COVID-19 lockdown period in the United Kingdom that began on March 23, 2020, more than a quarter of a million people with cancer reported worsening mental health. Help to Overcome Problems Effectively (Hope) is a self-management program for people with cancer, designed to provide support for distress, unmet needs, and poor psychological health. In light of social distancing during the COVID-19 pandemic, digital delivery of the Hope Programme has become ever more vital for people with cancer. Previous pre-post studies of the digital Hope Programme have found reduced anxiety and depression and improved well-being for people with cancer. However, evaluation of this evidence has been limited by the lack of a control group in these previous studies. Objective We now present a protocol for a feasibility randomized controlled trial of the digital Hope Programme for people with cancer during the COVID-19 pandemic. Primary outcomes will be recruitment, dropout, and adherence rates, and estimations of sample and effect size. To detect signals of efficacy, secondary outcomes will be participant mental health and well-being. Methods Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks. The study will employ a feasibility wait-list randomized controlled trial (RCT) design, with people with cancer being randomized to join the digital Hope Programme immediately (intervention group [IG]) or join a 6-week waiting list (wait-list control group [WLCG]) with a 1:1 allocation ratio. Participants will complete digital measures of depression, anxiety, mental well-being, and confidence in managing their own health. Online questionnaires will be administered preprogram and 6 weeks postprogram. Results All people who had requested access to the Hope Programme from MCS (N=61) will be invited to participate in the trial. Baseline data collection commenced in April 2020, and the Hope Programme began for the IG in May 2020 and for the WLCG in June 2020. Postprogram data collection was completed by the end of August 2020. Conclusions This feasibility study will provide data to inform the design of a future definitive trial. Wider-scale provision of the digital Hope Programme has potential to improve the lives of thousands of people with cancer and reduce the burden on health care providers during these unprecedented times. Trial Registration ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250 International Registered Report Identifier (IRRID) DERR1-10.2196/24264

scholarly journals Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery: Protocol for a Feasibility Cluster Randomized Controlled Trial Harnessing Mobile Phone Technology Blended With Peer Support

10.2196/15058 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e15058 ◽  
Author(s):  
Andrew Gumley ◽  
Simon Bradstreet ◽  
John Ainsworth ◽  
Stephanie Allan ◽  
Mario Alvarez-Jimenez ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Digital Health ◽  
Controlled Trial ◽  
Well Being ◽  
Service Users ◽  
Main Trial ◽  
Definitive Trial ◽  
Randomized Controlled ◽  
Cluster Randomized

Background Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. Objective This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. Methods We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. Results Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. Conclusions The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262 International Registered Report Identifier (IRRID) DERR1-10.2196/15058

scholarly journals Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery: Protocol for a Feasibility Cluster Randomized Controlled Trial Harnessing Mobile Phone Technology Blended With Peer Support (Preprint)

2019 ◽  
Author(s):  
Andrew Gumley ◽  
Simon Bradstreet ◽  
John Ainsworth ◽  
Stephanie Allan ◽  
Mario Alvarez-Jimenez ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Digital Health ◽  
Controlled Trial ◽  
Well Being ◽  
Service Users ◽  
Main Trial ◽  
Definitive Trial ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. OBJECTIVE This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. METHODS We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. RESULTS Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. CONCLUSIONS The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262

Stressor-Oriented MUlticomponent Intervention and the WeLl-Being of Patients with Alzheimer’s Disease: A Randomized Controlled Trial (SOUL-P)

2021 ◽  
Vol 79 (1) ◽  
pp. 141-152
Author(s):  
Bing Yang ◽  
Siyuan Yang ◽  
Yunmei Zhang ◽  
Wentao Liu ◽  
Yao Gan ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Randomized Controlled Trial ◽  
Perceived Stress ◽  
Family Conflict ◽  
Multidisciplinary Team ◽  
Controlled Trial ◽  
Well Being ◽  
Randomized Controlled

Background: Patients with Alzheimer’s disease (AD) experience various stressors that negatively impact well-being. Most studies have, however, small effect size and are limited by the experiences of severe patients. Therefore, we conducted a single-blind, randomized controlled trial, which has included patients at different stages. Objective: The stressor-oriented multicomponent program was designed as an intervention for AD patients to enhance well-being. Methods: Patients were randomly assigned to control or SOUL-P conditions according to disease severity. The SOUL-P group received 15 intensive sessions over 6 months and 6 maintenance sessions over a 6-month follow-up by a multidisciplinary team comprising psychologists, occupational therapists, and community nurses. The control group received a similar number of sessions by community nurses. Stress-related outcomes (primary stressors and well-being outcomes) were obtained from in-person baseline and follow-up interviews conducted at 6- and 12-months post-baseline. A treatment compliance survey was conducted at the intervention endpoint for patients. Results: Of the 863 patients screened, 218 (25.3%) were eligible. At 6 months, compared to controls, SOUL-P patients had improved quality of life (QoL) (p < 0.001; Cohen d = 0.56), depression (p = 0.020; Cohen d = –0.33), neurobehavioral symptoms (p = 0.034; Cohen d = –0.30), perceived stress (p = 0.030; Cohen d = –0.31), and family conflict (p = 0.026; Cohen d = –0.32). QoL, depression, perceived stress, and family conflict were still significantly different at 12 months. Most patients were satisfied with SOUL-P, while caregivers in the SOUL-P group reported overloading tasks. Conclusion: SOUL-P may reduce perceived stress and improve psychological outcomes in AD patients. Stressor-based interventions, patient-oriented goals, and a multidisciplinary team are essential features for a successful SOUL-P.

scholarly journals Reducing physical and emotional violence by teachers using the intervention Interaction Competencies with Children – for Teachers (ICC-T): study protocol of a multi-country cluster randomized controlled trial in Ghana, Tanzania, and Uganda

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Florian Scharpf ◽  
Anette Kirika ◽  
Faustine Bwire Masath ◽  
Getrude Mkinga ◽  
Joseph Ssenyonga ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Academic Performance ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Well Being ◽  
Cluster Randomized Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Violence has severe and long-lasting negative consequences for children’s and adolescents’ well-being and psychosocial functioning, thereby also hampering communities’ and societies’ economic growth. Positive attitudes towards violence and the lack of access to alternative non-violent strategies are likely to contribute to the high levels of teachers’ ongoing use of violence against children in sub-Saharan African countries. Notwithstanding, there are currently very few school-level interventions to reduce violence by teachers that a) have been scientifically evaluated and b) that focus both on changing attitudes towards violence and on equipping teachers with non-violent discipline strategies. Thus, the present study tests the effectiveness of the preventative intervention Interaction Competencies with Children – for Teachers (ICC-T) in primary and secondary schools in Tanzania, Uganda, and Ghana. Methods The study is a multi-site cluster randomized controlled trial with schools (clusters) as level of randomization and three data assessment points: baseline assessment prior to the intervention, the first follow-up assessment 6 months after the intervention and the second follow-up assessment 18 months after the intervention. Multi-stage random sampling will be applied to select a total number of 72 schools (24 per country). Schools will be randomly allocated to the intervention and the control condition after baseline. At each school, 40 students (stratified by gender) in the third year of primary school or in the first year of secondary/junior high school and all teachers (expected average number: 20) will be recruited. Thus, the final sample will comprise 2880 students and at least 1440 teachers. Data will be collected using structured clinical interviews. Primary outcome measures are student- and teacher-reported physical and emotional violence by teachers in the past week. Secondary outcome measures include children’s emotional and behavioral problems, quality of life, cognitive functioning, academic performance, school attendance and social competence. Data will be analyzed using multilevel analyses. Discussion This study aims to provide further evidence for the effectiveness of ICC-T to reduce teacher violence and to improve children’s functioning (i.e., mental health, well-being, academic performance) across educational settings, societies and cultures. Trial registration The trial was registered at clinicaltrials.org under the ClinicalTrials.gov identifier NCT04948580 on July 2, 2021.

scholarly journals Feasibility randomized controlled trial of a one-day CBT workshop (‘DISCOVER’) for 15- to 18-year-olds with anxiety and/or depression in clinic settings

2019 ◽  
Vol 48 (2) ◽  
pp. 142-159
Author(s):  
Christina E. Loucas ◽  
Irene Sclare ◽  
Daniel Stahl ◽  
Daniel Michelson
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Well Being ◽  
Small Sample ◽  
Effect Estimate ◽  
Emotional Difficulties ◽  
Randomized Controlled ◽  
Clinically Referred

AbstractBackground:‘DISCOVER’ one-day cognitive behavioural therapy (CBT) workshops have been developed to provide accessible, developmentally sensitive psychological support for older adolescents experiencing emotional difficulties. Previous school-based evaluations of the DISCOVER model have shown positive outcomes.Aims:The current study aimed to test the model for clinically referred adolescents, in real-world settings.Method:A randomized controlled trial (RCT) assessed feasibility, acceptability and preliminary outcomes of the DISCOVER intervention, in comparison with usual care, for 15- to 18-year-olds with emotional difficulties. Participants were recruited from outpatient clinic waiting lists in UK child and adolescent mental health services (CAMHS). Research feasibility indicators included rates of recruitment, randomization, intervention participation (group workshops and individualized follow-up telephone calls), and data collection (at baseline and 8-week follow-up). Intervention acceptability was assessed using a structured service satisfaction questionnaire and semi-structured qualitative interviews with intervention participants. Preliminary clinical outcomes were explored using adolescent-reported validated measures of depression, anxiety and well-being.Results:n = 24 participants were randomized to intervention and usual care groups. Workshop attendance was good and high levels of treatment satisfaction were reported, although feasibility challenges emerged in recruitment and randomization. Trends were found towards potential improvements in anxiety and well-being for the intervention group, but the effect estimate for depression was imprecise; interpretability was also limited due to the small sample size.Conclusions:DISCOVER appears to be a feasible and acceptable intervention model for clinically referred 15- to 18-year-olds with emotional difficulties. A full-scale RCT is warranted to evaluate effectiveness; protocol modifications may be necessary to ensure feasible recruitment and randomization procedures.

Resilience, Insight, Self-Compassion, and Empowerment (RISE): A Randomized Controlled Trial of a Psychoeducational Group Program for Nurses

2021 ◽  
pp. 107839032110333
Author(s):  
Amanda T. Sawyer ◽  
Amanda K. Bailey ◽  
Jeanette F. Green ◽  
Jingwei Sun ◽  
Patricia Stearnes Robinson
Keyword(s):  
Randomized Controlled Trial ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Psychoeducational Group ◽  
Randomized Controlled ◽  
Self Compassion ◽  
Mind Set

Background: Nurses tend to be vulnerable to burnout and compassion fatigue due to constant workplace stressors. There is a need to provide advocacy, education, programming, and resources in the areas of positive coping and self-care to reduce burnout symptoms and promote well-being. RISE is an 8-week psychoeducational group intervention for nurses with four themes: resilience, insight, self-compassion, and empowerment. Objectives: This randomized controlled trial examined the effects of RISE on mental well-being. Methods: The sample included 75 registered nurses who work in a hospital-based setting. Outcomes included resilience, insight, self-compassion, empowerment, stress mind-set, perceived stress, and burnout. Independent-samples t tests were conducted to compare outcomes between intervention and wait-list control groups at baseline and 1-month follow-up, as well as at 3-month follow-up. Supplemental analyses included paired-samples t tests and linear mixed models to compare the outcomes of the intervention group participants at baseline to 1-month follow-up, as well as at 3-month and 6-month follow-ups. Results: Participants in the intervention group showed improved levels of insight (i.e., engagement in self-reflection), perceived stress, and burnout (i.e., emotional exhaustion) when compared with the control group and improved levels of resilience, self-compassion, stress mind-set, and perceived stress when compared with their baseline. Conclusions: This study informs how RISE affects nurse well-being and may be an effective intervention for reducing burnout and stress. This type of whole-person intervention can support nurses to improve their well-being and ability to cope amid the complex interplay of factors at the individual, unit, and organizational levels.

Sign in / Sign up

Export Citation Format

Share Document