|- candidate number||12866|
|- NTR Number||NTR3463|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-jun-2012|
|- Secondary IDs||60-60110-97-008 / 2010/038; ZonMw project number / METC (region Arnhem - Nijmegen)|
|- Public Title||EffeCTIve: Study of the effectiveness of Critical Time Intervention after residence in Dutch women’s shelters.|
|- Scientific Title||Critical Time Intervention for abused women after leaving Dutch women’s shelters: A Randomized Controlled Trial.|
|- ACRONYM||Not applicable|
|- hypothesis||One of the main priorities of Dutch women’s shelters is to professionalize working methods in the care for abused women. Moreover, shelters are focused on evaluating outcomes of women’s trajectories. Until now most Dutch women’s shelters have not adhered to specific intervention methods and there rarely is an empirical and theoretical foundation for the interventions used. A systematic literature review showed Critical Time Intervention is an appropriate intervention method for socially vulnerable people (De Vet et al., in preparation). In the current study we investigate whether Critical Time Intervention (CTI) is more effective than care as usual for women who make the transition from a second-stage shelter to supported or independent living.|
Our hypothesis is that, for women who are moving from a women’s shelter to independent or supported housing, Critical Time Intervention will be more effective than care as usual with regard to:
1. improving quality of life and;
2. preventing re-abuse.
|- Healt Condition(s) or Problem(s) studied||Abused women, Shelter|
|- Inclusion criteria||Women are eligible for the study when:|
1. They are staying in the shelter due to partner violence or honor-related violence;
2. They are staying in one of the participating shelters;
3. They are about to make the transition from a shelter residence to independent or supported housing;
4. The date of their departure from the shelter is known or they have received a declaration of urgency;
5. They are 18 years of age or older.
|- Exclusion criteria||Women are not eligible to participate in the study when:|
1. They have stayed in the shelter for less than six weeks on the date of their departure from the shelter;
2. They are going to live outside the region in which the shelter or one of the other participating shelter organizations provides services.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2009|
|- planned closingdate||1-okt-2013|
|- Target number of participants||166|
|- Interventions||CTI is a time-limited, structured and problem directed approach (Valencia, Van Hemert, Van Hoeken & Van der Plas, 2006) which is applied during critical moments in the life of socially vulnerable people. Acute incidents or crisis situations are examples of critical moments by which problems of these persons attract attention of care providers. These periods are characterized by a lot of stress. Most of the time there is no continuity of care which is of great importance for people to stabilize in their environment. At the same time there could be a great readiness to change. CTI prepares for this and has the purpose to set up care efficiently and to give clients the opportunity to optimize their quality of life. CTI supports clients during the transition period when clients are restoring their balance and self efficacy and works together with clients to approach their desired quality of life.
1. A defined time span (time-limited);
2. A strong accent on creating links with the social and professional network (early linking);
3. A problem directed method with the focus on up to three selected areas of attention. CTI makes active use of the diverse supply of care that is available in the community and builds in nine months towards a structure which gives the clients enough support from their social and professional network to maintain in society. CTI is pro-active and outreaching.
The intervention is being applied and tested widely in the US, Europe and South America. It has been shown that CTI is effective and cost effective for homeless people with schizophrenia (Jones, Colson, Valencia & Susser, 1994; Susser et al., 1997; Herman et al., 2000; Jones et al., 2003; Kasprow & Rosenheck, 2007). There is no research available on the effectiveness of CTI related to abused women; however, a study with homeless families (mainly young mothers with children) was carried out in 2007. The results of this study showed CTI to reduce homelessness among families and improve school and mental health outcomes among children (Samuels, 2012). The hypothesis is that CTI is also applicable and effective for abused women. For this group, the transition from a women’s shelter to independent or supported housing is a critical moment during which the risk of re-victimization is heightened. CTI can be adjusted for the prevention of re-abuse and focuses on linking the women to a social and professional network.
In this study the women in the control group will receive care as usual as provided by women’s shelters (if offered).
|- Primary outcome||The primary outcome measure is quality of life.|
|- Secondary outcome||Secondary outcome measures are:|
1. Re-occurrence of violence;
2. Care needs;
4. Social support;
5. Psychological distress, including:
B. Post Traumatic Stress Symptoms.
7. Substance use;
8. Care use;
9. Parenting stress;
10. Working alliance between client and professional;
11. Experiences with shelter and care.
|- Timepoints||Each participant will be interviewed four times in a 9-month period:|
1. Immediately before shelter exit (T0, face-to-face);
2. 3 months later (T3, by phone);
3. 6 months later (T6, by phone);
4. 9 months later (T9, face-to-face);
5. Quality of life will be assessed with the brief version of Lehman’s Quality of Life Interview (Lehman, 1988; Wolf, 2007): all subjective indicators will be measured at T0, T6 and T9 and all objective items at T0 and T9;
6. Re-occurence of violence will be examined with questions of the ‘Refuge facilities for women: Availability and effectiveness: A study of supply and demand’ (Wolf, Jonker, Nicolas, Meertens & Te Pas, 2006) study at every time point;
7. Care needs will be assessed with part 1 of the Quality of Life and Care questionnaire (Wennink & Wijngaarden, 2004) at T0 and T9;
8. Self-esteem will be evaluated with the Rosenberg Self-Esteem scale (Rosenberg, 1965) at T0 and T9;
9. Social support will be examined with questions from the Lehman Quality of Life Interview (Lehman, 1988) and questions from the Course of Homelessness study (COH) at T0 and T9;
10. Psychological distress will be examined at T0 and T9 with the Brief Symptom Inventory (Derogatis, 1975a; De Beurs & Zitman, 2006);
11. Depression will be measured with the Center for Epidemiological Studies Depression Scale (CES-D) (Radloff, 1977; Hanewald, 1987) at T0 and T9;
12. Post Traumatic Stress Symptoms will be examined with the Dutch version of the Impact of Event Scale– Revised (IESR) (SVL) (Olde, Kleber, van der Hart & Pop, 2006) at T0 and T9;
13. Loneliness will be measured with the De Jong-Gierveld & Kamphuis Loneliness Scale (De Jong- Gierveld & Kamphuis, 1985) at T0 and T9;
14. Substance use will be assessed with the European Addiction Severity Index III (McLellan et al., 1980; Hendriks, 1994) at T0 and T9;
15. Care use will be evaluated with a self-constructed questionnaire (applied in several studies of the Netherlands Centre for Social Care Research) at T0 and T9;
16. Parenting stress will be measured with questions of the Parenting Stress Questionnaire (Vermulst et al. 2011) at T0 and T9;
17. Working alliance between client and professional will be assessed with the short version of the Working Alliance Inventory (Vervaeke & Vertommen, 1996) at T0, T6 and T9;
18. Experiences with shelter and community care services will be evaluated with the Consumer Quality Index for Shelter and Community Care Services (CQI-SCCS) (Beijersbergen & Wolf, 2010) at T0 and T9.
|- Trial web site||http://www.werkplaatsoxo.nl/|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MSc. D.A.M. Lako|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Mariëlle Beijersbergen|
|- Sponsor/Initiator ||Radboud University Nijmegen Medical Centre, Department of Primary and Community Care (huispost 117)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Academic Collaborative Centre for Shelters and Public Mental Health|
|- Brief summary||This study primarily aims to professionalize working methods in shelter services and determine the effects thereof. In this multicentered randomized controlled trial we will investigate whether Critical Time Intervention is more effective than care as usual for abused women making the transition from second-stage shelters to independent or supported housing in improving quality of life (primary outcome measure). Furthermore, we will investigate what the effectiveness of Critical Time Intervention (CTI) is with regard to preventing re-abuse, care needs, self esteem, social support, psychological health, substance use, parenting stress and use of care. The 166 participants for this study will be recruited from 9 shelters for abused women across the Netherlands who have joined the Academic Collaborative Centre for Shelters and Public Mental Health. Participants will be interviewed four times in nine months: before leaving the shelter and at 3, 6 and 9 months after leaving the shelter. Additionally, the position and model integrity of CTI will be investigated during the study period.|
|- Main changes (audit trail)||- The number of participants holds 136;|
- The failure rate at T9 (6%);
- The number of interviews conducted (509).
|- RECORD||5-jun-2012 - 6-nov-2013|