Dataset Information

A web-based intervention for abused women: the New Zealand isafe randomised controlled trial protocol.

ABSTRACT: Intimate partner violence (IPV) and its associated negative mental health consequences are significant for women in New Zealand and internationally. One of the most widely recommended interventions is safety planning. However, few women experiencing violence access specialist services for safety planning. A safety decision aid, weighing the dangers of leaving or staying in an abusive relationship, gives women the opportunity to prioritise, plan and take action to increase safety for themselves and their children. This randomised controlled trial is testing the effectiveness of an innovative, interactive web-based safety decision aid. The trial is an international collaborative concurrent replication of a USA trial (IRIS study NCT01312103), regionalised for the Aotearoa New Zealand culture and offers fully automated online trial recruitment, eligibility screening and consent.In a fully automated web-based trial (isafe) 340 abused women will be randomly assigned in equal numbers to a safety decision aid intervention or usual safety planning control website. Intervention components include: (a) safety priority setting, (b) danger assessment and (c) an individually tailored safety action plan. Self-reported outcome measures are collected at baseline and 3, 6, and 12-months post-baseline. Primary outcomes are depression (measured by Center for Epidemiologic Studies Depression Scale, Revised) and IPV exposure (measured by Severity Violence Against Women Scale) at 12 months post-baseline. Secondary outcomes include PTSD, psychological abuse, decisional conflict, safety behaviors and danger in the relationship.This trial will provide much-needed information on the potential relationships among safety planning, improved mental health, reduced violence as well as decreased decisional conflict related to safety in the abusive relationship. The novel web-based safety decision aid intervention may provide a cost-effective, easily accessed safety-planning resource that can be translated into clinical and community practice by multiple health disciplines and advocates. The trial will also provide information about how women in abusive relationships safely access safety information and resources through the Internet. Finally, the trial will inform other research teams on the feasibility and acceptability of fully automated recruitment, eligibility screening, consent and retention procedures.Trial registered on 03 July 2012 on the Australian New Zealand Clinical Trials Registry ACTRN12612000708853 .

SUBMITTER: Koziol-McLain J

PROVIDER: S-EPMC4314812 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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A web-based intervention for abused women: the New Zealand isafe randomised controlled trial protocol.

Koziol-McLain Jane J Vandal Alain C AC Nada-Raja Shyamala S Wilson Denise D Glass Nancy E NE Eden Karen B KB McLean Christine C Dobbs Terry T Case James J

BMC public health 20150131

<h4>Background</h4>Intimate partner violence (IPV) and its associated negative mental health consequences are significant for women in New Zealand and internationally. One of the most widely recommended interventions is safety planning. However, few women experiencing violence access specialist services for safety planning. A safety decision aid, weighing the dangers of leaving or staying in an abusive relationship, gives women the opportunity to prioritise, plan and take action to increase safe ...[more]

PMID: 25637195

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Project description:OBJECTIVES:Delivery of interventions via smartphone is a relatively new initiative in public health, and limited evidence exists regarding optimal strategies for recruitment. We describe the effectiveness of approaches used to recruit participants to a smartphone-enabled nutrition intervention trial. METHODS:Internet and social media advertising, mainstream media advertising and research team networks were used to recruit New Zealand adults to a fully automated smartphone-delivered nutrition labelling trial (no face-to-face visits were required). Recruitment of M?ori and Pacific participants was a key focus and ethically relevant recruitment materials and approaches were used where possible. The effectiveness of recruitment strategies was evaluated using Google Analytics, monitoring of study website registrations and randomisations, and self-reported participant data. The cost of the various strategies and associations with participant demographics were assessed. RESULTS:Over a period of 13 months, there were 2448 registrations on the study website, and 1357 eligible individuals were randomised into the study (55%). Facebook campaigns were the most successful recruitment strategy overall (43% of all randomised participants) and for all ethnic groups (M?ori 44%, Pacific 44% and other 43%). Significant associations were observed between recruitment strategy and age (p<0.001), household size (p<0.001), ethnicity (p<0.001), gender (p=0.005) and interest in healthy eating (p=0.022). Facebook campaigns resulted in the highest absolute numbers of study registrations and randomisations (966 and 584, respectively). Network strategies and Facebook campaigns cost least per randomised participant (NZ$4 and NZ$5, respectively), whereas radio advertising costs most (NZ$179 per participant). CONCLUSION:Internet and social media advertising were the most effective and least costly approaches to recruiting participants to a smartphone-delivered trial. These approaches also reached diverse ethnic groups. However, more culturally appropriate recruitment strategies are likely to be necessary in studies where large numbers of participants from specific ethnic groups are sought. TRIAL REGISTRATION:ACTRN12614000644662; Post-results.

Project description:IntroductionThe strong correlation between domestic and family violence (DFV) and mental health has been well documented in studies. Pregnancy is a period when both DFV and mental distress tend to occur and/or accentuate. Although limited, available evidence from developed countries has shown continual support and education as psychological first aid that can reduce DFV and improve mental health. However, there is significantly less number of studies from resource-constrained countries; thus, there continues to be a substantial gap in knowledge and awareness regarding effective interventions for DFV.Methods and analysisA two-arm randomised trial with a nested qualitative study has been planned to assess feasibility and treatment effect estimates of a counselling-based psychosocial intervention among pregnant women with a history of abuse. A total of 140 pregnant women who meet the inclusion criteria will be recruited into the study. Block randomisation will be used to allocate women equally into two groups. The intervention group will receive a counselling session, an information booklet and continuous support by a researcher, while women in the control group will receive contact information of local support services. Feasibility measures, such as rates of recruitment, consent and retention, will be calculated. Qualitative interviews with participants and healthcare providers will explore the acceptability and usability of the intervention. Outcome measures, such as psychological distress, quality of life, social support and self-efficacy, will be measured at baseline, 4 weeks postintervention and 6 weeks postpartum.Ethics and disseminationThis study has obtained ethical approval from the Griffith University Human Research Ethics Committee, the Nepal Health Research Council and the Institutional Review Board of a tertiary hospital in Dharan, Nepal. The findings will be disseminated via peer-reviewed publications and conference presentations and will be used to inform a future multicentre trial.Trial registration number12618000307202; Pre-results.

Project description:IntroductionApproximately 35% of patients with cancer experience clinically significant distress, and unmet psychological supportive care needs are prevalent. This study describes the protocol for a randomised controlled trial (RCT) to assess the efficacy and cost-effectiveness of an internet-based psychological intervention for distressed patients with cancer.Methods and analysisIn phase I, the intervention was developed on an interactive web platform and pilot tested for acceptability using a qualitative methodology with 21 patients with cancer. Phase II is an RCT underway with patients with or at risk of elevated psychological distress comparing: (1) static patient education website with (2) individualised web-delivered cognitive behavioural intervention (CancerCope). Participants were recruited through the Queensland Cancer Registry and Cancer Council Helpline and met the following inclusion criteria: (1) recently diagnosed with cancer; (2) able to read and speak English; (3) no previous history of head injury, dementia or psychiatric illness; (4) no other concurrent cancer; (5) phone and internet access; (5) scored ≥4 on the Distress Thermometer. Participants are assessed at four time points: baseline/recruitment and 2, 6 and 12 months after recruitment and intervention commencement. Of the 163 participants recruited, 50% met caseness for distress. The area of highest unmet supportive care needs were psychological followed by physical and daily living needs. Primary outcomes are psychological and cancer-specific distress and unmet psychological supportive care needs. Secondary outcomes are positive adjustment, quality of life and cost-effectiveness.Ethics and disseminationEthical approval was obtained from the Griffith University Human Research Ethics Committee (Approval: PSY/70/13/HREC) and the Metro South Human Research Ethics Committee (HREC/13/QPAH/601). All participants provide informed consent prior to taking part in the study. Once completed, this study will provide recommendations about the efficacy of web-based cognitive behavioural interventions to facilitate better psychosocial adjustment for people with cancer.Trial registration numberANZCTR (ACTRN12613001026718).

Project description:The majority of the older Singaporean women aged 50 years and above are physically inactive and have unhealthy dietary habits, placing them at 'high risk' of non-communicable diseases (NCDs). The adoption of regular physical activity (PA) and a healthy diet are essential lifestyle behaviours to reduce this risk. This randomised controlled trial (RCT) involves the development, implementation and evaluation of a PA and nutrition programme for community-dwelling Singaporean women who currently attend recreational centres (RCs are public facilities supporting social leisure activities) in their local area. The intervention will be developed after conducting formative evaluation with RC attendees and managers through focus group discussions and pilot testing of resources (i.e. surveys, accelerometers, and health booklets). Programme ambassadors (trained, certified fitness instructors and nutritionists) will deliver all sessions in English and Mandarin; implement classes to meet participants' varying needs; and conduct sessions at different times at convenient venues. Social Cognitive Theory (SCT) has been selected as the theoretical framework to inform intervention strategies as it explores the interactions of human behaviour with the environment and has been found to be valuable when developing behavioural change interventions particularly in older adults (J Gerontol B Psychol Sci Soc Sci 67B(1):18-26, 2012; Obesity Reviews 15(12):983-95, 2014). Its major construct, self-efficacy, is invaluable in achieving successful behaviour change, such as increasing levels of PA or improving dietary intake (Trials. 2017; https://doi.org/10.1186/s13063-016-1771-9 ; Psychol Health Med 18(6):714-24, 2013).The development and implementation of the PA and nutrition intervention strategies will be guided by SCT and Motivational interviewing (MI) and implemented by trained programme ambassadors at the RCs. Sixty RCs located in Singapore will be selected from five major geographical districts and randomly allocated to the intervention (n = 30) or control (n = 30) cluster. A sample of 600 (intervention n = 300; control n = 300) women aged 50 years and above will then be recruited from these 60 centres and only the intervention group will be enrolled into the PA and nutrition intervention. It is hypothesised that by the end of the intervention, the intervention group participants compared to the control group will show significantly greater improvements in the following outcome variables: PA and dietary behaviours, health-related quality of life, objective measures of PA, anthropometric, lipid and glucose profiles. Data will be collected at baseline and 6 months and analysed using mixed regression models.It is anticipated that recruitment, retention and compliance of participants will be challenging due to the target group being unfamiliar with such community-based research programmes.Australian and New Zealand Clinical Trials Registry, ACTRN12617001022358. Registered on 14 July 2017. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372984&isReview=true.

Project description:INTRODUCTION:Incidence of autistic traits, mental health problems, stress and poor coping is high among family members of children with autism. These problems are coupled with challenging behaviour among children with autism. Current treatment for these families is disjointed and costly. The need for whole family support is supported by the National Institute for Health and Care Excellence recommendations, developments regarding children's service provision, research and requests by families of children with autism. Despite evidence that family therapies can provide benefits to these families, efficacy has not been subject to a randomised controlled trial. Systemic Autism-related Family Enabling (SAFE) is a new family therapy intervention designed specifically for families of children with autism. We aim to establish the feasibility of running a fully powered randomised controlled trial to evaluate SAFE. METHODS AND ANALYSIS:Families of children with autism aged 3-16 years will be invited to participate. Consenting participants will be randomised 2:1 to either SAFE+support as usual or support as usual alone. The proposed primary outcome measure for the main trial will be the Systemic CORE 15. Participants will also complete proposed secondary outcome measures, indexing changes in child behaviour, child-parent attachment, anxiety and depression. Generic health economic outcome measures (EuroQol 5 dimensions and Child Health Utility 9 Dimensions) will also provide data on the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline and 32 weeks post-allocation. Data on ability to identify, recruit, randomise, retain and collect data from families, acceptability of outcome measures, adherence of therapists and families to the intervention, appropriateness of resource use questionnaires and effectiveness of training will be collected for feasibility analysis. Qualitative data will also explore acceptability of SAFE and reasons for declining and withdrawing from the study. ETHICS AND DISSEMINATION:The current trial protocol received ethical approval from the South West-Exeter Research Ethics Committee (Ref: 17/SW/0192). The findings of the trial will be disseminated in collaboration with our Family Consultation Group and other partners. Findings will be shared locally, nationally and internationally through events, conferences and published papers. TRIAL REGISTRATION NUMBER:ISCTRN83964946 (Pre-results) IRAS 213527.

Project description:BACKGROUND:The primary objective of this randomised controlled trial (RCT) is to establish the effectiveness of a novel online quality of life (QoL) intervention tailored for people with late stage (? 10 episodes) bipolar disorder (BD) compared with psychoeducation. Relative to early stage individuals, this late stage group may not benefit as much from existing psychosocial treatments. The intervention is a guided self-help, mindfulness based intervention (MBI) developed in consultation with consumers, designed specifically for web-based delivery, with email coaching support. METHODS/DESIGN:This international RCT will involve a comparison of the effectiveness and cost-effectiveness of two 5-week adjunctive online self-management interventions: Mindfulness for Bipolar 2.0 and an active control (Psychoeducation for Bipolar). A total of 300 participants will be recruited primarily via social media channels. Main inclusion criteria are: a diagnosis of BD (confirmed via a phone-administered structured diagnostic interview), no current mood episode, history of 10 or more mood episodes, no current psychotic features or active suicidality, under the care of a medical practitioner. Block randomisation will be used for allocation to the interventions, and participants will retain access to the program for 6 months. Evaluations will be conducted at pre- and post- treatment, and at 3- and 6- months follow-up. The primary outcome measure will be the Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD), collected immediately post-intervention at 5 weeks (T1). Secondary measures include BD-related symptoms (mania, depression, anxiety, stress), time to first relapse, functioning, sleep quality, social rhythm stability and resource use. Measurements will be collected online and via telephone assessments at baseline (T0), 5 weeks (T1), three months (T2) and six months (T3). Candidate moderators (diagnosis, anxiety or substance comorbidities, demographics and current treatments) will be investigated as will putative therapeutic mechanisms including mindfulness, emotion regulation and self-compassion. A cost-effectiveness analysis will be conducted. Acceptability and any unwanted events (including adverse treatment reactions) will be documented and explored. DISCUSSION:This definitive trial will test the effectiveness and cost-effectiveness of a novel QoL focused, mindfulness based, online guided self-help intervention for late stage BD, and investigate its putative mechanisms of therapeutic action. TRIAL REGISTRATION:ClinicalTrials.gov : NCT03197974 . Registered 23 June 2017.

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Dataset Information

A web-based intervention for abused women: the New Zealand isafe randomised controlled trial protocol.

Publications

A web-based intervention for abused women: the New Zealand isafe randomised controlled trial protocol.

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