scholarly journals The effectiveness of the Volunteer Family Connect Program in supporting vulnerable families: A randomised controlled trial intention-to-treat analysis of primary outcome variables (Preprint)

2018 ◽  
Author(s):  
Rebekah Grace ◽  
Kelly Baird ◽  
Emma Elcombe ◽  
Vana Webster ◽  
Jacqueline Barnes ◽  
...  
Keyword(s):  
Young Children ◽  
Home Visiting ◽  
Controlled Trial ◽  
Intervention Group ◽  
Parenting Competence ◽  
Community Connectedness ◽  
Intention To Treat ◽  
Vulnerable Families ◽  
Secondary Outcomes ◽  
Treat Analysis

BACKGROUND Volunteer home visiting is a widely adopted community-based approach to supporting families by linking isolated or vulnerable families with community volunteers. This study seeks to robustly evaluate the effectiveness of this model of support for families with young children. OBJECTIVE This paper reports the intention-to-treat analysis of primary and secondary outcomes for a pragmatic randomized controlled trial (RCT) of the Volunteer Family Connect intervention, a volunteer home visiting program designed to support families with young children who experience social isolation or a lack of parenting confidence and skills. METHODS The RCT was conducted across seven sites in Australia. Overall, 341 families were recruited: 169 intervention (services as usual + volunteer home visiting) and 172 control (services as usual) families. Intervention families received the program for 3-12 months. Participants were invited to complete six data collection points over a 15-month period. Primary outcomes were community connectedness and parenting competence. Secondary outcomes included parent physical and mental health, general parent wellbeing, parent empowerment, the sustainability of family routines, and the parent-child relationship. RESULTS The intervention group demonstrated significant improvement compared to the control group in both of the primary outcomes. They were significantly more like to report improvements in the guidance available to them as measured by the Social Provisions Scale, a key measure of community connectedness and scores on the Parenting Sense of Competence Scale were significantly in favour of the intervention group. Intervention families also reported significantly higher wellbeing, and were significantly more likely to feel that life was improving. A number of positive trends were also evident within the findings. CONCLUSIONS The Volunteer Family Connect intervention was considered to be an effective intervention for improving the community connectedness and parenting competence of families with young children. CLINICALTRIAL Australian New Zealand Clinical Trial Registry (Trial ID: ACTRN12616000396426).

scholarly journals Effectiveness of the Volunteer Family Connect Program in Reducing Isolation of Vulnerable Families and Supporting Their Parenting: Randomized Controlled Trial With Intention-To-Treat Analysis of Primary Outcome Variables

10.2196/13023 ◽  
2019 ◽  
Vol 2 (2) ◽  
pp. e13023
Author(s):  
Rebekah Grace ◽  
Kelly Baird ◽  
Emma Elcombe ◽  
Vana Webster ◽  
Jacqueline Barnes ◽  
...  
Keyword(s):  
Young Children ◽  
Home Visiting ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Outcome Variable ◽  
Control Group ◽  
Primary Outcome Variable ◽  
Community Connectedness ◽  
Vulnerable Families ◽  
Secondary Outcomes

Background Volunteer home visiting is a widely adopted community-based approach to support families by linking isolated or vulnerable families with community volunteers who visit their homes weekly over approximately 12 months. This study seeks to robustly evaluate the effectiveness of this model of support for families with young children. Objective This paper reports the intention-to-treat analysis of primary and secondary outcomes for a pragmatic randomized controlled trial (RCT) of the Volunteer Family Connect intervention, a volunteer home-visiting program designed to support families with young children who experience social isolation or a lack of parenting confidence and skills. Methods The RCT was conducted across seven sites in Australia. Overall, 341 families were recruited: 169 intervention (services as usual+volunteer home visits) and 172 control (services as usual) families. Intervention families received the program for 3-12 months. Participants were invited to complete six data collection points over a 15-month period. Primary outcomes were community connectedness and parenting competence. Secondary outcomes included parent physical and mental health, general parent wellbeing, parent empowerment, the sustainability of family routines, and the parent-child relationship. According to the protocol, the program would be judged to be effective if at least one of the primary outcomes was significantly positive and the other was neutral (ie, intervention families did not demonstrate positive or negative outcomes compared to the control group). Results The intervention group demonstrated significant improvement in the primary outcome variable parenting sense of competence as compared to the control group. Overall, there was no significant difference between the intervention and control groups with regard to the primary outcome variable community connectedness, other than on the “Guidance” subscale of the Social Provisions Scale. Because there were statistically significant findings for the total score of one primary outcome variable “parenting sense of competence” and largely neutral findings for the primary outcome variable “community connectedness,” the program met the previously defined criteria for program effectiveness. In relation to secondary outcomes, intervention families reported significantly higher wellbeing and were significantly more likely to feel that life was improving. Conclusions The Volunteer Family Connect intervention was considered an effective intervention, with a role to play on the landscape of services available to support vulnerable families with young children. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12616000396426; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370304

OS10.4.A The effects of SmartCare on neuro-oncology family caregivers’ distress: a randomized controlled trial

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii13-ii13
Author(s):  
F W Boele ◽  
J M Weimer ◽  
J Proudfoot ◽  
A L Marsland ◽  
T S Armstrong ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Family Caregivers ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Symptom Burden ◽  
Significant Group ◽  
Intention To Treat ◽  
Secondary Outcomes ◽  
Physical Consequences

Abstract BACKGROUND Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. MATERIAL AND METHODS Family caregivers with depressive symptoms were randomized to three groups: SmartCare© plus/minus self-guided CBT, or ECAU. Primary outcomes (depressive symptoms (CES-D); caregiving-specific distress (Caregiver Needs Screen)) and secondary outcomes (anxiety (POMS-A), caregiver mastery (Caregiver Mastery Scale), and caregiver burden (Caregiver Reactions Assessment)) were assessed online. Intention to treat analyses of covariance corrected for baseline scores were performed for outcomes at four months. RESULTS In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n=80) and compared to ECAU (n=40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (p=0.01, partial ɳ 2=0.08). Among secondary outcomes, there was a trend towards improvement in mastery for the intervention group compared with ECAU (p=0.08, partial ɳ 2=0.04). CONCLUSION SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis.

QOLP-29. THE EFFECTS OF AN ONLINE, NURSE-LED NEEDS-BASED SUPPORT PROGRAM ON NEURO-ONCOLOGY FAMILY CAREGIVERS' DISTRESS: A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi189-vi189
Author(s):  
Florien Boele ◽  
Paula Sherwood ◽  
Jason Weimer ◽  
Judith Proudfoot ◽  
Anna Marsland ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Family Caregivers ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Symptom Burden ◽  
Support Program ◽  
Significant Group ◽  
Intention To Treat ◽  
Secondary Outcomes

Abstract BACKGROUND Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. METHODS Family caregivers with depressive symptoms were randomized to three groups: SmartCare© plus/minus self-guided CBT, or ECAU. Primary outcomes (depressive symptoms (CES-D); caregiving-specific distress (Caregiver Needs Screen)) and secondary outcomes (anxiety (POMS-A), caregiver mastery (Caregiver Mastery Scale), and caregiver burden (Caregiver Reactions Assessment)) were assessed online. Intention to treat analyses of covariance corrected for baseline scores were performed for outcomes at four months. RESULTS In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n=80) and compared to ECAU (n=40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (p=0.01, partial ɳ 2=0.08). Among secondary outcomes, there was a trend towards improvement in mastery for the intervention group compared with ECAU (p=0.08, partial ɳ 2=0.04). CONCLUSION SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis.

scholarly journals Diaphragm Used with Replens Gel and Risk of Bacterial Vaginosis: Results from a Randomized Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Craig R. Cohen ◽  
Su-Chun Cheng ◽  
Stephen Shiboski ◽  
Tsungai Chipato ◽  
Martin Matu ◽  
...  
Keyword(s):  
Bacterial Vaginosis ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Vaginal Swab ◽  
Intention To Treat ◽  
Hiv Acquisition ◽  
And Control ◽  
Treat Analysis

Background. Bacterial vaginosis (BV) has been linked to female HIV acquisition and transmission. We investigated the effect of providing a latex diaphragm with Replens and condoms compared to condom only on BV prevalence among participants enrolled in an HIV prevention trial.Methods. We enrolled HIV-seronegative women and obtained a vaginal swab for diagnosis of BV using Nugent’s criteria; women with BV (score 7–10) were compared to those with intermediate (score 4–6) and normal flora (score 0–3). During quarterly follow-up visits over 12–24 months a vaginal Gram stain was obtained. The primary outcome was serial point prevalence of BV during followup.Results. 528 participants were enrolled; 213 (40%) had BV at enrollment. Overall, BV prevalence declined after enrollment in women with BV at baseline (OR=0.4, 95% CI 0.29–.56) but did not differ by intervention group. In the intention-to-treat analysis BV prevalence did not differ between the intervention and control groups for women who had BV (OR=1.01, 95% CI 0.52–1.94) or for those who did not have BV (OR=1.21, 95% CI 0.65–2.27) at enrollment. Only 2.1% of participants were treated for symptomatic BV and few women (5–16%) were reported using anything else but water to cleanse the vagina over the course of the trial.Conclusions. Provision of the diaphragm, Replens, and condoms did not change the risk of BV in comparison to the provision of condoms alone.

scholarly journals A Home Visiting Parenting Program and Child Obesity: A Randomized Trial

2018 ◽  
pp. 117-126
Author(s):  
Monica Roosa Ordway ◽  
Lois S. Sadler ◽  
Margaret L. Holland ◽  
Arietta Slade ◽  
Nancy Close ◽  
...  
Keyword(s):  
Young Children ◽  
Low Socioeconomic Status ◽  
Home Visiting ◽  
Maternal Mental Health ◽  
Controlled Trial ◽  
Intervention Group ◽  
Overweight And Obesity ◽  
Control Group ◽  
Home Visiting Program ◽  
Overweight Or Obesity

BACKGROUND Young children living in historically marginalized families are at risk for becoming adolescents with obesity and subsequently adults with increased obesity-related morbidities. These risks are particularly acute for Hispanic children. We hypothesized that the prevention-focused, socioecological approach of the “Minding the Baby” (MTB) home visiting program might decrease the rate of childhood overweight and obesity early in life. METHODS This study is a prospective longitudinal cohort study in which we include data collected during 2 phases of the MTB randomized controlled trial. First-time, young mothers who lived in medically underserved communities were invited to participate in the MTB program. Data were collected on demographics, maternal mental health, and anthropometrics of 158 children from birth to 2 years. RESULTS More children in the intervention group had a healthy BMI at 2 years. The rate of obesity was significantly higher (P < .01) in the control group (19.7%) compared with the intervention group (3.3%) at this age. Among Hispanic families, children in the MTB intervention were less likely to have overweight or obesity (odds ratio = 0.32; 95% confidence interval: 0.13–0.78). CONCLUSIONS Using the MTB program, we significantly lowered the rate of obesity among 2-year-old children living in low-socioeconomic-status communities. In addition, children of Hispanic mothers were less likely to have overweight or obesity at 2 years. Given the high and disproportionate national prevalence of Hispanic young children with overweight and obesity and the increased costs of obesity-related morbidities, these findings have important clinical, research, and policy implications.

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

scholarly journals Effect of Inquiry-Based Stress Reduction (IBSR) Intervention on Well-Being, Resilience and Burnout of Teachers during the COVID-19 Pandemic

2021 ◽  
Vol 18 (7) ◽  
pp. 3689
Author(s):  
Tzofnat Zadok-Gurman ◽  
Ronit Jakobovich ◽  
Eti Dvash ◽  
Keren Zafrani ◽  
Benjamin Rolnik ◽  
...  
Keyword(s):  
Stress Reduction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Stressful Events ◽  
Control Group ◽  
Subjective Well Being ◽  
Intention To Treat ◽  
School Year ◽  
Blended Intervention

Objective: The COVID-19 pandemic has had a major impact on teachers professional and personal lives. Our primary aim was to assess the effect of a blended Inquiry-Based Stress Reduction (IBSR), an emerging mindfulness and cognitive reframing intervention on teacher’s well-being. Our secondary aims were to assess the effect of IBSR on resilience, burnout, mindfulness, and stress among teachers during the COVID-19 pandemic. Methods: The study was a prospective controlled trial with an intervention group (N = 35) and a comparison control group (N = 32). The intervention took place in the Jerusalem District throughout the school year from November 2019 to May 2020. The sessions were conducted in blended learning that included traditional learning (face-to-face) and online learning. Data was analyzed on an intention-to-treat basis. Results: IBSR blended intervention enhanced the resilience and improved the subjective and psychological well-being of teachers in spite of the breakout of the COVID-19 pandemic and the first lockdown in Israel. Simultaneously the control group suffered from enhanced burnout levels and a decline in psychological and subjective well-being. Conclusions: Implementation of IBSR blended intervention during the school year may benefit teachers’ well-being and ability to flourish, even during stressful events such as the COVID-19 pandemic.

scholarly journals Hybrid Tele and In-Clinic Occupation Based Intervention to Improve Women’s Daily Participation after Breast Cancer: A Pilot Randomized Controlled Trial

2021 ◽  
Vol 18 (11) ◽  
pp. 5966
Author(s):  
Khawla Loubani ◽  
Rachel Kizony ◽  
Uzi Milman ◽  
Naomi Schreuer
Keyword(s):  
Breast Cancer ◽  
Cognitive Abilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Performance Measure ◽  
Control Group ◽  
Activity Levels ◽  
Emotional Symptoms ◽  
Short Period ◽  
Secondary Outcomes

Background: Women after breast cancer (BC) cope with decreased daily participation and quality of life (QOL) due to physical, cognitive, and emotional symptoms. This study examined a hybrid occupation-based intervention, Managing Participation with Breast Cancer (MaP-BC), to improve daily participation in their meaningful activities. Methods: Thirty-five women after BC phase were randomly allocated to the MaP-BC intervention (n = 18) or control (n = 17) group (standard care only). Assessments were administered at baseline (T1), 6-week (T2), and 12-week (T3) post-T1. Main outcome: perceived performance and performance-satisfaction with meaningful activities according to the Canadian Occupational Performance Measure. Secondary outcomes: retained activity levels (Activity Card Sort), QOL (Functional Assessment of Cancer Therapy-Breast), cognitive abilities (Montreal Cognitive Assessment and Behavior Rating Inventory of Executive Function), and upper-extremity functioning (Disability of Arm, Shoulder, Hand). Results showed significant interaction (group x time) effects for the primary outcome in performance, F(2,66) = 29.54, p = 0.001, ɳP2 = 0.472, and satisfaction, F(2,66) = 37.15, p = 0.000, ɳP2 = 0.530. The intervention group improved more in performance, t = 5.51, p = 0.0001, d = 1.298, and satisfaction, t = −5.32, p = 0.0001, d = 1.254, than the control group between T1 and T2. Secondary outcomes demonstrated within-group improvements. Conclusion: MaP-BC, a comprehensive occupation-based hybrid intervention tailored to women’s functional daily needs after BC, improved participation in meaningful activities within a short period.

scholarly journals Effectiveness of one-to-one peer support for patients with severe mental illness – a randomised controlled trial

2017 ◽  
Vol 42 ◽  
pp. 103-110 ◽  
Author(s):  
C.I. Mahlke ◽  
S. Priebe ◽  
K. Heumann ◽  
A. Daubmann ◽  
K. Wegscheider ◽  
...  
Keyword(s):  
Mental Illness ◽  
Peer Support ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Treatment As Usual ◽  
Secondary Outcomes ◽  
One To One ◽  
Randomised Controlled

AbstractBackgroundOne-to-one peer support is a resource-oriented approach for patients with severe mental illness. Existing trials provided inconsistent results and commonly have methodological shortcomings, such as poor training and role definition of peer supporters, small sample sizes, and lack of blinded outcome assessments.MethodsThis is a randomised controlled trial comparing one-to-one peer support with treatment as usual. Eligible were patients with severe mental illnesses: psychosis, major depression, bipolar disorder or borderline personality disorder of more than two years’ duration. A total of 216 patients were recruited through in- and out-patient services from four hospitals in Hamburg, Germany, with 114 allocated to the intervention group and 102 to the control group. The intervention was one-to-one peer support, delivered by trained peers and according to a defined role specification, in addition to treatment as usual over the course of six months, as compared to treatment as usual alone. Primary outcome was self-efficacy measured on the General Self-Efficacy Scale at six-month follow-up. Secondary outcomes included quality of life, social functioning, and hospitalisations.ResultsPatients in the intervention group had significantly higher scores of self-efficacy at the six-month follow-up. There were no statistically significant differences on secondary outcomes in the intention to treat analyses.ConclusionsThe findings suggest that one-to-one peer support delivered by trained peer supporters can improve self-efficacy of patients with severe mental disorders over a one-year period. One-to-one peer support may be regarded as an effective intervention. Future research should explore the impact of improved self-efficacy on clinical and social outcomes.

scholarly journals Mindfulness-Based Cognitive Therapy as Migraine Intervention: a Randomized Waitlist Controlled Trial

2021 ◽  
Author(s):  
K. Simshäuser ◽  
R. Pohl ◽  
P. Behrens ◽  
C. Schultz ◽  
C. Lahmann ◽  
...  
Keyword(s):  
Cognitive Therapy ◽  
Psychological Functioning ◽  
Controlled Trial ◽  
Intervention Group ◽  
Medium Effect ◽  
Headache Frequency ◽  
Post Intervention ◽  
Significant Group ◽  
Secondary Outcomes ◽  
And Coping

Abstract Background Based on promising effects seen in a pilot study evaluating a generic mindfulness-based program for migraine, we developed a migraine-specific adaptation of the Mindfulness-Based Cognitive Therapy (MBCT) program. The aim of this study was to evaluate this program for feasibility and effectiveness in a randomized controlled trial. Method Fifty-four patients suffering from migraine were randomly allocated to either waitlist or the adapted MBCT. Outcomes were migraine-related parameters as well as variables of psychological functioning and coping. Assessment took place at baseline and post-intervention, for the intervention group also at follow-up (7 months). The effects of the intervention were analyzed by the use of ANCOVAs and linear mixed models. Results With respect to migraine parameters we did not find a significant group difference in the primary outcome (headache-related impairment), but the intervention resulted in a significant reduction of headache frequency (p = .04). In the analysis of secondary outcomes, MBCT showed superiority in four out of eight psychological parameters (perceived stress, anxiety, rumination, catastrophizing) with small to medium effect sizes. The intervention proved to be feasible and participants reported high degrees of contentment and achievement of personal goals. Conclusions The migraine-specific MBCT program did not result in improvements with regard to headache-related impairment but showed a reduction in headache frequency as well as improved psychological functioning in secondary outcomes. Trial Registration This trial was registered in the German Trial Registry “Deutsches Register Klinischer Studien” (ID: DRKS00007477), which is a WHO-listed primary trial register.

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