scholarly journals Monitoring adverse social and medical events in public health trials: assessing predictors and interpretation against a proposed model of adverse event reporting

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Gwenllian Moody ◽  
Katy Addison ◽  
Rebecca Cannings-John ◽  
Julia Sanders ◽  
Carolyn Wallace ◽  
...  
Keyword(s):  
Adverse Event ◽  
Social Status ◽  
Home Visiting ◽  
Controlled Trial ◽  
Antisocial Behaviour ◽  
Well Being ◽  
Building Blocks ◽  
Good Clinical Practice ◽  
Adverse Event Reporting ◽  
Behaviour Score

Abstract Background Although adverse event (AE) monitoring in trials focusses on medical events, social outcomes may be important in public or social care trials. We describe our approach to reporting and categorising medical and other AE reports, using a case study trial. We explore predictors of medical and social AEs, and develop a model for conceptualising safety monitoring. Methods The Building Blocks randomised controlled trial of specialist home visiting recruited 1618 first-time mothers aged 19 years or under at 18 English sites. Event reports collected during follow-up were independently reviewed and categorised as either Medical (standard Good Clinical Practice definition), or Social (trial-specific definition). A retrospectively developed system was created to classify AEs. Univariate analyses explored the association between baseline participant and study characteristics and the subsequent reporting of events. Factors significantly associated at this stage were progressed to binary logistic regressions to assess independent predictors. Results A classification system was derived for reported AEs that distinguished between Medical or Social AEs. One thousand, three hundred and fifteen event reports were obtained for mothers or their babies (1033 Medical, 257 Social). Allocation to the trial intervention arm was associated with increased likelihood of Medical rather than Social AE reporting. Poorer baseline psycho-social status predicted both Medical and Social events, and poorer psycho-social status better predicted Social rather than Medical events. Baseline predictors of Social AEs included being younger at recruitment (OR = 0.78 (CI = 0.67 to 0.90), p = 0.001), receiving benefits (OR = 1.60 (CI = 1.09 to 2.35), p = 0.016), and having a higher antisocial behaviour score (OR = 1.22 (CI = 1.09 to 1.36), p < 0.001). Baseline predictors of Medical AEs included having a limiting long-term illness (OR = 1.37 (CI = 1.01 to 1.88), p = 0.046), poorer mental health (OR = 1.03 (CI = 1.01 to 1.05), p = 0.004), and being in the intervention arm of the trial (OR = 1.34 (CI = 1.07 to 1.70), p = 0.012). Conclusions Continuity between baseline and subsequent adverse experiences was expected despite potentially beneficial intervention impact. We hypothesise that excess events reported for intervention-arm participants is likely attributable to surveillance bias. We interpreted our findings against a new model that explicates processes that may drive event occurrence, presentation and reporting. Focussing only upon Medical events may miss the well-being and social circumstances that are important for interpreting intervention safety and participant management. Trial registration ISRCTN, ID: ISRCTN23019866. Registered on 20 April 2009.

scholarly journals Costs and consequences of the Family Nurse Partnership (FNP) programme in England: evidence from the Building Blocks trial

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 1640 ◽  
Author(s):  
Kerry Bell ◽  
Belen Corbacho ◽  
Sarah Ronaldson ◽  
Gerry Richardson ◽  
Kerry Hood ◽  
...  
Keyword(s):  
Home Visiting ◽  
Controlled Trial ◽  
Full Range ◽  
Building Blocks ◽  
Public Health Services ◽  
Intervention Programme ◽  
The Family ◽  
Cost Consequence ◽  
Implementation Costs ◽  
Family Nurse Partnership

Background: The Family Nurse Partnership (FNP) is a licensed intensive home visiting intervention programme delivered to teenage mothers which was originally introduced in England in 2006 by the Department of Health and is now provided through local commissioning of public health services and supported by a national unit led by a consortium of partners. The Building Blocks (BB) trial aimed to explore the effectiveness and cost-effectiveness of this programme. This paper reports the results of an economic evaluation of the Building Blocks randomised controlled trial (RCT) based on a cost-consequence approach. Methods: A large sample of 1618 families was followed-up at various intervals during pregnancy and for two years after birth. A cost-consequence approach was taken to appraise the full range of costs arising from the intervention including both health and social measures of cost alongside the consequences of the trial, specifically, the primary outcomes. Results: A large number of potential factors were identified that are likely to attract additional costs beyond the implementation costs of the intervention including both health and non-health outcomes. Conclusion: Given the extensive costs and only small beneficial consequences observed within the two year follow-up period, the cost-consequence model suggests that the FNP intervention is unlikely to be worth the substantial costs and policy makers may wish to consider other options for investment. Trial registration: ISRCTN23019866 (20/04/2009)

scholarly journals Maternal Parenting Electronic Diary in the Context of a Home Visit Intervention for Adolescent Mothers in an Urban Deprived Area of São Paulo, Brazil: Randomized Controlled Trial

10.2196/13686 ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. e13686
Author(s):  
Daniel Fatori ◽  
Adriana Argeu ◽  
Helena Brentani ◽  
Anna Chiesa ◽  
Lislaine Fracolli ◽  
...  
Keyword(s):  
Adolescent Mothers ◽  
Home Visiting ◽  
Controlled Trial ◽  
Compliance Rate ◽  
Well Being ◽  
Control Group ◽  
Pregnant Adolescents ◽  
Maternal Parenting ◽  
Randomized Controlled ◽  
Nurse Home Visiting

Background Pregnancy during adolescence is prevalent in low- and middle-income countries (LMICs), which is associated with various adverse outcomes that can be prevented with home visiting programs. However, testing these interventions in LMICs can be challenging due to limited resources. The use of electronic data collection via smartphones can be an alternative and ideal low-cost method to measure outcomes in an environment with adverse conditions. Objective Our study had two objectives: to test the efficacy of a nurse home visiting intervention on maternal parenting and well-being measured by an electronic daily diary (eDiary), and to investigate the compliance rate of the eDiary measurement method. Methods We conducted a randomized controlled trial to test the efficacy of Primeiros Laços, a nurse home visiting program, for adolescent mothers living in an urban deprived area of São Paulo, Brazil. A total of 169 pregnant adolescents were assessed for eligibility criteria, 80 of whom were included and randomized to the intervention (n=40) and control group (care as usual, n=40). Primeiros Laços is a home visiting intervention delivered by trained nurses tailored to first-time pregnant adolescents and their children, starting during the first 16 weeks of pregnancy until the child reaches 24 months of age. Participants were assessed by blind interviewers at 8-16 weeks of pregnancy (baseline), 30 weeks of pregnancy, and when the child was 3, 6, and 12 months of age. At 18 months, participants were assessed regarding maternal parenting and parental well-being using a 7-consecutive-day eDiary. The smartphone app was programmed to notify participants every day at 9:00 PM over a period of seven days. Results We were able to contact 57/80 (71%) participants (29 from the intervention group and 28 from the control group) when the child was 18 months of age. Forty-eight of the 57 participants (84%) completed at least one day of the eDiary protocol. The daily compliance rate ranged from 49% to 70%. Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, 95% CI [0.06, 0.58], P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, 95% CI [1.20, 4.50], P=.01).Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, P=.01). Conclusions The Primeiros Laços intervention improved maternal parenting and parental well-being, demonstrating its promise for low-income adolescent mothers. The compliance rate of the eDiary assessment showed that it was generally accepted by adolescent mothers with limited resources. Future studies can implement ambulatory assessment in LMICs via smartphones to measure mother and child behaviors. Trial Registration ClinicalTrials.gov NCT02807818; https://clinicaltrials.gov/ct2/show/NCT02807818

scholarly journals A Trauma-Informed, Family-Centered, Virtual Home Visiting Program for Young Children: One-Year Outcomes

2021 ◽  
Author(s):  
Catherine Mogil ◽  
Nastassia Hajal ◽  
Hilary Aralis ◽  
Blair Paley ◽  
Norweeta G. Milburn ◽  
...  
Keyword(s):  
Online Education ◽  
Child Behavior ◽  
Psychological Health ◽  
Home Visiting ◽  
Preventive Intervention ◽  
Controlled Trial ◽  
Well Being ◽  
Trauma Informed ◽  
Family Centered ◽  
Parent Child

AbstractMilitary-connected families face many challenges associated with military life transitions, including deployment separations. We report on a randomized controlled trial to evaluate the efficacy of Families OverComing Under Stress-Early Childhood (FOCUS-EC) delivered through an in-home, virtual telehealth platform. FOCUS-EC is a trauma-informed, family-centered preventive intervention designed to promote family resilience and well-being. Military-connected families with 3- to 6-year-old children (194 mothers; 155 fathers; 199 children) were randomized to FOCUS-EC or an online education condition. Parent psychological health symptoms, child behavior, parenting, and parent–child relationships were examined by parent-report and observed interaction tasks for up to 12 months. Longitudinal regression models indicated that FOCUS-EC families demonstrated significantly greater improvements than online education families in parent-reported and observational measures of child behavior, parenting practices, and parent–child interaction, as well as greater reductions in parent posttraumatic stress symptoms. Findings provide support for the benefit of a virtually-delivered preventive intervention for military-connected families.

scholarly journals Bad Blood or My Blood: A Qualitative Study into the Dimensions of Interventions for Mothers with Children Born of Sexual Violence

2019 ◽  
Vol 16 (23) ◽  
pp. 4810
Author(s):  
van Ee ◽  
Blokland
Keyword(s):  
Clinical Practice ◽  
Qualitative Study ◽  
Sexual Violence ◽  
Therapeutic Relationship ◽  
Expert Knowledge ◽  
Well Being ◽  
Building Blocks ◽  
Good Clinical Practice ◽  
Traumatic Experience ◽  
Secure Attachment

Research has shown that there is a negative relation between the experience of sexual violence of mothers and the well-being of their children. When a child is born out of sexual violence, the origin of the child is connected to the traumatic experience. Despite the difficult maternal task of navigating this relationship, research on interventions for mothers with a child born of sexual violence is absent. The current qualitative study was designed to gather expert knowledge of twelve clinicians on the dimensions of interventions for these mothers and their children as a first step in the development of good clinical practice for interventions. Using thematic analysis, the interviews were transcribed, coded and analyzed. Three building blocks for interventions for mothers and their children born of sexual violence were identified: building a secure attachment, reduction of trauma-related symptomatology, and addressing stigmatization. Clinicians describe many factors that need to be taken into account in treatment but emphasize the importance of the therapeutic relationship to be efficacious. The foundation of a strong therapeutic relationship together with the building blocks are the elements for good clinical practice on interventions for mothers with a child born of sexual violence.

scholarly journals Maternal Parenting Electronic Diary in the Context of a Home Visit Intervention for Adolescent Mothers in an Urban Deprived Area of São Paulo, Brazil: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Daniel Fatori ◽  
Adriana Argeu ◽  
Helena Brentani ◽  
Anna Chiesa ◽  
Lislaine Fracolli ◽  
...  
Keyword(s):  
Adolescent Mothers ◽  
Home Visiting ◽  
Controlled Trial ◽  
Compliance Rate ◽  
Well Being ◽  
Control Group ◽  
Pregnant Adolescents ◽  
Maternal Parenting ◽  
Randomized Controlled ◽  
Nurse Home Visiting

BACKGROUND Pregnancy during adolescence is prevalent in low- and middle-income countries (LMICs), which is associated with various adverse outcomes that can be prevented with home visiting programs. However, testing these interventions in LMICs can be challenging due to limited resources. The use of electronic data collection via smartphones can be an alternative and ideal low-cost method to measure outcomes in an environment with adverse conditions. OBJECTIVE Our study had two objectives: to test the efficacy of a nurse home visiting intervention on maternal parenting and well-being measured by an electronic daily diary (eDiary), and to investigate the compliance rate of the eDiary measurement method. METHODS We conducted a randomized controlled trial to test the efficacy of Primeiros Laços, a nurse home visiting program, for adolescent mothers living in an urban deprived area of São Paulo, Brazil. A total of 169 pregnant adolescents were assessed for eligibility criteria, 80 of whom were included and randomized to the intervention (n=40) and control group (care as usual, n=40). Primeiros Laços is a home visiting intervention delivered by trained nurses tailored to first-time pregnant adolescents and their children, starting during the first 16 weeks of pregnancy until the child reaches 24 months of age. Participants were assessed by blind interviewers at 8-16 weeks of pregnancy (baseline), 30 weeks of pregnancy, and when the child was 3, 6, and 12 months of age. At 18 months, participants were assessed regarding maternal parenting and parental well-being using a 7-consecutive-day eDiary. The smartphone app was programmed to notify participants every day at 9:00 PM over a period of seven days. RESULTS We were able to contact 57/80 (71%) participants (29 from the intervention group and 28 from the control group) when the child was 18 months of age. Forty-eight of the 57 participants (84%) completed at least one day of the eDiary protocol. The daily compliance rate ranged from 49% to 70%. Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, 95% CI [0.06, 0.58], <i>P</i>=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, 95% CI [1.20, 4.50], <i>P</i>=.01).Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, <i>P</i>=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, <i>P</i>=.01). CONCLUSIONS The Primeiros Laços intervention improved maternal parenting and parental well-being, demonstrating its promise for low-income adolescent mothers. The compliance rate of the eDiary assessment showed that it was generally accepted by adolescent mothers with limited resources. Future studies can implement ambulatory assessment in LMICs via smartphones to measure mother and child behaviors. CLINICALTRIAL ClinicalTrials.gov NCT02807818; https://clinicaltrials.gov/ct2/show/NCT02807818

scholarly journals Community Volunteer Support for Families With Young Children: Protocol for the Volunteer Family Connect Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Rebekah Grace ◽  
Lynn Kemp ◽  
Jacqueline Barnes ◽  
Emma Elcombe ◽  
Jennifer Knight ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Data Collection ◽  
Young Children ◽  
Home Visiting ◽  
Controlled Trial ◽  
Well Being ◽  
The Body ◽  
Community Connectedness ◽  
Randomized Controlled ◽  
Home Visiting Program

BACKGROUND Use of community volunteers to support vulnerable families is a widely employed strategy with a long history. However, there has been minimal formal scientific investigation into the effectiveness of volunteer home visiting programs for families. There is also a need for research examining whether volunteer home visiting leads to improved outcomes for volunteers. OBJECTIVE The objective of this paper is to describe the research protocol for a pragmatic randomized controlled trial (RCT) of the Volunteer Family Connect intervention, a volunteer home visiting program designed to support families of young children who experience social isolation or a lack of parenting confidence and skills. The project is being conducted in partnership with 3 leading not-for-profit organizations, designed to contribute to the body of evidence that informs decisions about appropriate family support services according to the level of need. It is the first study to examine outcomes for both the families and the volunteers who deliver the service. METHODS The RCT is being conducted in 7 sites across Australia. We aim to recruit 300 families to the study: 150 control (services as usual) and 150 intervention (services as usual + volunteer home visiting) families. Intervention families will receive the service for 3-12 months according to their needs, and all participants will complete 6 data collection points over 15 months. A minimum of 80 volunteers will also be recruited, along with a matched community comparison group. The volunteers will complete 3 data collection points over 12 months. Primary outcomes include community connectedness and parenting competence. Secondary outcomes include parent physical and mental health; general parent well-being; parent empowerment; the child-parent relationship; sustainability of family routines; child immunization; child nutrition or breastfeeding; number of accidental injury reports; and volunteer health, well-being, and community connectedness. RESULTS This effectiveness trial was funded in 2016, and we aim to complete data collection by the end of 2018. The first results are expected to be submitted early in 2019. CONCLUSIONS There is a need to rigorously assess volunteer home visiting and whether it has a unique and important role on the service landscape, complementary to professional services. This research is the first trial of a volunteer home visiting program to be conducted in Australia and one of the largest of its kind worldwide. CLINICALTRIAL Australian New Zealand Clinical Trial Registry ACTRN12616000396426; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370304 (Archived by WebCite athttp://www.webcitation.org/70q42fU7V) REGISTERED REPORT IDENTIFIER RR1-10.2196/1000

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