|- candidate number||12350|
|- NTR Number||NTR3425|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-mei-2012|
|- Secondary IDs||60-60110-97-009 / 2010/247; ZonMw project number / MEC (region Arnhem - Nijmegen) registration number|
|- Public Title||EffeCTIve: Study of the effectiveness of Critical Time Intervention in Dutch services for homeless people.|
|- Scientific Title||EffeCTIve: Study of the effectiveness of Critical Time Intervention in Dutch services for homeless people.|
|- hypothesis||One of the main priorities of Dutch homeless shelter services is to professionalize working methods. Moreover, shelters are focused on evaluating outcomes of clientsf trajectories. Until now most Dutch shelter providers havenft 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 homeless 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 clients who make the transition from a shelter to supported or independent living.|
Our hypothesis is that for people who are moving from a shelter for homeless people to independent or supported housing, Critical Time Intervention will be more effective than care as usual, with regard to:
1. Decreasing the number of days of homelessness, as found by Susser et al. (1997);
2. Improving quality of life.
|- Healt Condition(s) or Problem(s) studied||Homeless persons, Critical Time Intervention|
|- Inclusion criteria||People can participate in this study when:|
1. They are staying in one of the participating shelters;
2. They are about to depart from the shelter to move into independent or supported housing;
3. The date of their departure from the shelter is known or they have received a declaration of urgency;
4. They are 18 years of age or older.
|- Exclusion criteria||People cannot participate in this study when:|
1. They have stayed in the shelter for longer than fourteen months 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 organisations provides service.
|- 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||274|
|- 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 and the risk of relapse into homelessness. 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 give clients the opportunity to optimize their quality of life. CTI supports clients during the transition period and during 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 a selection of areas of attention. CTI makes active use of the variety of supply of care that is available in the community and builds in nine months towards a structure which gives the clients enough support from his social and professional network to maintain in society. CTI is pro-active and outreaching.
The intervention is widely applied and tested in the US, Europe and South America. It has been showed 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).
In this study the control group will receive care as usual by shelter services (if offered).
|- Primary outcome||The primary outcome measure is reoccurrence of homelessness (in days).|
|- Secondary outcome||1. Quality of life;|
2. Care needs;
4. Social support;
5. Psychological distress;
6. Substance use;
7. Care use;
9. Working alliance between client and professional;
10. Experiences with shelter and care;
11. Physical health problems.
|- Timepoints||Each participant will be interviewed at four time points in a 9-month period:|
1. Immediately before discharge from shelter facility (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. Reoccurrence of homelessness will be measured with an adapted version of the Residential Timeline Follow-Back Calendar (New Hampshire Dartmouth Psychiatric Research Center, 2000) at every time point;
6. Quality of life will be assessed with the brief version of Lehmans 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;
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. Loneliness will be measured with the De Jong-Gierveld & Kamphuis Loneliness Scale (De Jong- Gierveld & Kamphuis, 1985) at T0 and T9;
12. Substance use will be assessed with the European Addiction Severity Index III (McLellan et al., 1980; Hendriks, 1994) at T0 and T9;
13. 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;
14. 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;
15. 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;
16. Physical health problems will be examined with questions of the brief version of Lehmans Quality of Life Interview (Lehman, 1988; Wolf, 2007) at T0 and T9 and the International Classification of Diseases (ICD) (Reinking et al., 1998) at T0.
|- Trial web site||http://www.werkplaatsoxo.nl |
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MSc. Renée Vet, de|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Mariëlle Beijersbergen|
|- Sponsor/Initiator ||Radboud University Nijmegen Medical Centre|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||This study primarily aims to professionalize working methods in shelter services and determine the effects of it. In this multicentered randomized controlled trial we will investigate whether Critical Time Intervention is more effective than care as usual for adults making the transition from crisis shelters to independent or supported housing in reducing days of homelessness (primary outcome measure). Furthermore, we will investigate what the effectiveness of Critical Time Intervention (CTI) is concerning quality of life, care needs, self esteem, social support, psychological health, substance use and use of care. The 274 participants for this study will be recruited from 9 shelter facilities for homeless 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, 3 months after, 6 months after 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)||12-7-2013:|
- The number of participants (183);
- The failure rate at T6 (13%);
- The failure rate at T9 at this time (6%). The last interviews of the results will be completed in late August. The expected failure rate at T9 is 5%.
- The number of interviews conducted at this time (663).
The primary outcome is recurrent loss of housing, as measured by the number of days participants do not live in conventional independent housing (property or legal (sub)tenancy) or accommodation permanently provided by friends, relatives or acquaintances without legal (sub)tenancy during follow up.
Remove 11. Physical health problems from the secundary outcomes.
Timepoints: 5. Recurrent loss of housing will be measured with an adapted version of the Residential Timeline Follow-Back Calendar (New Hampshire Dartmouth Psychiatric Research Center, 2000) at every time point
Remove 16. Physical health problems will be examined with questions of the brief version of Lehmans Quality of Life Interview (Lehman, 1988; Wolf, 2007) at T0 and T9 and the International Classification of Diseases (ICD) (Reinking et al., 1998) at T0. from the timepoints
Brief summary : in reducing days of homelessness turn into in preventing recurrent loss of housing
|- RECORD||7-mei-2012 - 12-jul-2013|