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

BMC Public Health

James Case¹  Terry Dobbs²  Christine McLean²  Karen B Eden⁶  Nancy E Glass³  Denise Wilson⁴  Shyamala Nada-Raja⁵  Alain C Vandal⁷  Jane Koziol-McLain² 

[1] James Reed Case Consulting, Oregon, USA;Centre for Interdisciplinary Trauma Research, Auckland University of Technology, Auckland 1142, New Zealand;School of Nursing, Johns Hopkins University, Maryland, USA;Taupua Waiora Centre for Maori Health Research, Auckland University of Technology, Auckland, New Zealand;Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand;Department of Medical Informatics & Clinical Epidemiology Department, Oregon Health & Science University, Oregon, USA;Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand and Ko Awatea, Auckland, New Zealand

关键词: Female;    Violence;    Mental health;    Safety;    Internet;    Computer-assisted decision making;    EHealth;    Protocol;    Randomized controlled trial;    Partner abuse;   

Others  :  1122805
DOI  :  10.1186/s12889-015-1395-0

 received in 2015-01-05, accepted in 2015-01-12,  发布年份 2015

【 摘 要 】

Background

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.

Methods/Design

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.

Discussion

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 registration

Trial registered on 03 July 2012 on the Australian New Zealand Clinical Trials Registry ACTRN12612000708853 webcite.

【 授权许可】

   
2015 Koziol-McLain et al.; licensee BioMed Central.

【 参考文献 】

• [1]World Health Organization: Global and regional estimates of violence against women: Prevalence and health effects of intimate partner violence and non-partner sexual violence. World Health Organization Press, Geneva; 2013.
• [2]Fanslow J, Robinson E: Violence against women in New Zealand: prevalence and health consequences. N Z Med J 2004, 117(1206):U1173.
• [3]Campbell JC: Health consequences of intimate partner violence. Lancet 2002, 359(9314):1331-6.
• [4]Devries KM, Mak JY, Bacchus LJ, Child JC, Falder G, Petzold M, et al.: Intimate partner violence and incident depressive symptoms and suicide attempts: a systematic review of longitudinal studies. PLoS Med 2013, 10(5):e1001439.
• [5]Beydoun HA, Beydoun MA, Kaufman JS, Lo B, Zonderman AB: Intimate partner violence against adult women and its association with major depressive disorder, depressive symptoms and postpartum depression: a systematic review and meta-analysis. Soc Sci Med 2012, 75(6):959-75.
• [6]Rees S, Silove D, Chey T, Ivancic L, Steel Z, Creamer M, et al.: Lifetime prevalence of gender-based violence in women and the relationship with mental disorders and psychosocial function. JAMA 2011, 306(5):513-21.
• [7]Dutton MA: Complexity of Women’s response to violence: response to Briere and Jordan. J Interpers Violence 2004, 19(11):1277-82.
• [8]Hardesty JL, Campbell JC: Safety planning for abused women and their children. In Protecting children from domestic violence: strategies for community intervention. Edited by Jaffe PG, Baker LL, Cunningham AJ. Guilford Press, New York; 2004:89-100.
• [9]Zink T, Elder N, Jacobson J, Klostermann B: Medical management of intimate partner violence considering the stages of change: precontemplation and contemplation. Ann Fam Med 2004, 2(3):231-9.
• [10]Glass N, Eden KB, Bloom T, Perrin N: Computerized Aid improves safety decision process for survivors of intimate partner violence. J Interpers Violence 2010, 25(11):1947-64.
• [11]Eden KB, Perrin N, Hanson G, Messing J, Bloom T, Campbell JC, Gielen AC, Clough A, Barnes-Hoyt J, Glass N: Use of online safety decision aid by abused women: Effect on decisional conflict in a randomized controlled trial. Am J Prevent Med. 2014. doi:10.1016/j.amepre.2014.09.027.
• [12]Stacey D, Légaré F, Col Nananda F, Bennett Carol L, Barry Michael J, Eden Karen B et al.: Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2014. doi:10.1002/14651858.CD001431.pub4.
• [13]Young-Hauser AM, Eden KB, Wilson D, Koziol-Mclain J: Intimate partner violence: modifying an internet-based safety decision aid to a New Zealand context. J Technol Hum Serv 2014, 32(4):297-311.
• [14]Kreuter MW, Lukwago SN, Bucholtz RD, Clark EM, Sanders-Thompson V: Achieving cultural appropriateness in health promotion programs: targeted and tailored approaches. Health Educ Behav 2003, 30(2):133-46.
• [15]World Wide Web Consortium: Web Content Accessibility Guidelines 2.0. 2008.
• [16]Eysenbach G: CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res 2011, 13(4):e126.
• [17]Ministry of Social Development: The Social Report 2010. Ministry of Social Development, Wellington NZ; 2010.
• [18]New Zealand Family Violence Clearinghouse: NZFVC fact sheet - Family violence statistics Christchurch; December 2009.
• [19]Koziol-McLain J, Garrett N, Fanslow J, Hassall I, Dobbs T, Henare-Toka TA, et al.: A randomized controlled trial of a brief emergency department intimate partner violence screening intervention. Ann Emerg Med 2010, 56(4):413-23.
• [20]Dutton MA, Holtzworth-Munroe A, Jouriles E, McDonald R, Krishnana S, McFarlane J, et al.: Recruitment and retention in intimate partner violence research. Department of Justice, Rockville, MD U.S; 2003.
• [21]Campbell JC, Dienemann JD: Ethical issues in research on violence against women. In Sourcebook on Violence Against Women. Edited by Renzetti CM, Edelson JL, Bergen RL. Sage Publications, Thousand Oaks: CA; 2001:57-72.
• [22]Campbell JC, Webster DW, Glass N: The danger assessment: validation of a lethality risk assessment instrument for intimate partner femicide. J Interpers Violence 2009, 24(4):653-74.
• [23]Campbell JC, Webster D, Koziol-McLain J, Block C, Campbell D, Curry MA, et al.: Risk factors for femicide in abusive relationships: results from a multisite case control study. Am J Public Health 2003, 93(7):1089-97.
• [24]Nicolaidis C, Curry MA, Ulrich Y, Sharps P, McFarlane J, Campbell D, et al.: Could we have known? A qualitative analysis of data from women who survived an attempted homicide by an intimate partner. J Gen Intern Med 2003, 18(10):788-94.
• [25]Sharps PW, Koziol-McLain J, Campbell J, McFarlane J, Sachs C, Xu X: Health care providers' missed opportunities for preventing femicide. Prev Med 2001, 33(5):373-80.
• [26]Campbell JC: Helping women understand their risk in situations of intimate partner violence. J Interpers Violence 2004, 19(12):1464-77.
• [27]Glass N, Perrin N, Hanson G, Bloom T, Gardner E, Campbell JC: Risk for reassault in abusive female same-sex relationships. Am J Public Health 2008, 98(6):1021-7.
• [28]Radloff LS: The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas 1977, 1(3):385-401.
• [29]Eaton WW: Center for epidemiologic studies depression scale: review and revision. In The use of psychological tesing for treatment planning and utcomesassessment. 3rd edition. Edited by Maruish ME. Lawrence Erlbaum Associates, Mahwah, NJ; 2004.
• [30]Van Dam NT, Earleywine M: Validation of the center for epidemiologic studies depression scale–revised (CESD-R): pragmatic depression assessment in the general population. Psychiatry Res 2011, 186(1):128-32.
• [31]Marshall LL: Development of the severity of violence against women scales. J Fam Violence 1992, 7(2):103-21.
• [32]McFarlane J, Nava A, Gilroy H, Paulson R, Maddoux J: Testing two global models to prevent violence against women and children: methods and baseline data analysis of a seven-year prospective study. Issues Ment Health Nurs 2012, 33(12):871-81.
• [33]Haggerty LA, Kelly U, Hawkins J, Pearce C, Kearney MH: Pregnant women's perceptions of abuse. J Obstet Gynecol Neonatal Nurs 2001, 30(3):283-90.
• [34]Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA: Psychometric properties of the PTSD Checklist (PCL). Behav Res Ther 1996, 34(8):669-73.
• [35]Norris FH, Hamblen JL: Standardized self-report measures of civilian trauma and PTSD. In Assessing psychological trauma and PTSD. Edited by Wilson JP, Keane TM, Martin T. Guilford Press, New York; 2004:63-102.
• [36]Reinert DF, Allen JP: The alcohol use disorders identification test: an update of research findings. Alcohol Clin Exp Res 2007, 31(2):185-99.
• [37]Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M: Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO collaborative project on early detection of persons with harmful alcohol consumption–II. Addiction 1993, 88(6):791-804.
• [38]Yudko E, Lozhkina O, Fouts A: A comprehensive review of the psychometric properties of the drug abuse screening test. J Subst Abus Treat 2007, 32(2):189-98.
• [39]Smith PH, Earp JA, DeVellis R: Measuring battering: development of the Women's Experience with Battering (WEB) scale. Women's Health 1995, 1(4):273-88.
• [40]O'Connor AM: Validation of a decisional conflict scale. Med Decis Mak 1995, 15(1):25-30.
• [41]Sullivan CM, Bybee DI: Reducing violence using community-based advocacy for women with abusive partners. J Consult Clin Psychol 1999, 67(1):43-53.
• [42]Parker B, McFarlane J, Soeken K, Silva C, Reel S: Testing an intervention to prevent further abuse to pregnant women. Res Nurs Health 1999, 22(1):59-66.
• [43]Johnson EE, Hamer R, Nora RM, Tan B, Eisenstein N, Engelhart C: The Lie/Bet questionnaire for screening pathological gamblers. Psychol Rep 1997, 80(1):83-8.
• [44]Johnson EE, Hamer RM, Nora RM: The Lie/Bet questionnaire for screening pathological gamblers: a follow-up study. Psychol Rep 1998, 83(3 Pt 2):1219-24.
• [45]D'Agostino RB, Belanger A, D'Agostino RB Jr: A suggestion for using powerful and informative tests of normality. Am Stat 1990, 44(4):316-21.
• [46]Bauer DJ, Preacher KJ, Gil KM: Conceptualizing and testing random indirect effects and moderated mediation in multilevel models: new procedures and recommendations. Psychol Methods 2006, 11(2):142-63.
• [47]Diggle P, Kenward MG: Informative drop-out in longitudinal data analysis. J R Stat Soc: Ser C: Appl Stat 1994, 43(1):49-93.
• [48]Little RJA: Modeling the drop-out mechanism in repeated-measures studies. J Am Stat Assoc 1995, 90(431):1112.
• [49]Roy J: Latent class models and their application to missing-data patterns in longitudinal studies. Stat Methods Med Res 2007, 16(5):441-56.
• [50]Beunckens C, Molenberghs G, Verbeke G, Mallinckrodt C: A latent-class mixture model for incomplete longitudinal Gaussian data. Biometrics 2008, 64(1):96-105.
• [51]Roy J: Modeling longitudinal data with nonignorable dropouts using a latent dropout class model. Biometrics 2003, 59(4):829-36.
• [52]Andresen EM, Malmgren JA, Carter WB, Patrick DL: Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med 1994, 10(2):77-84.
• [53]McFarlane JM, Groff JY, O'Brien JA, Watson K: Secondary prevention of intimate partner violence: a randomized controlled trial. Nurs Res 2006, 55(1):52-61.
• [54]McFarlane J, Malecha A, Gist J, Watson K, Batten E, Hall I, et al.: Protection orders and intimate partner violence: an 18-month study of 150 black, Hispanic, and white women. Am J Public Health 2004, 94(4):613-8.