|- candidate number||8707|
|- NTR Number||NTR2622|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-nov-2010|
|- Secondary IDs||ESI-EVC-001 Movisie|
|- Public Title||Recognition of Acquired Competencies: Does is positively effect empowerment and vocational functioning in people with vulnerabilities?|
|- Scientific Title||TRACE: A multisite randomized controlled Trial on the Effectiveness of Recognition of Acquired Competencies for people who deal with long-term unemployment due to psychosocial problems.|
|- hypothesis||Guidance added by Recognition of Acquired Competencies results in better improvement in empowerment in people with vulnerabilities compared to usual guidance |
|- Healt Condition(s) or Problem(s) studied||Psychosiocial problems, Vulnerabilities, Long-term unemployment|
|- Inclusion criteria||1. Motivated for working with RAC-v;|
3. Client of a social agency targeted on long-term unemployed people;
4. Willingly to participate in the study and to sign informed consent;
5. Sufficiently understands Dutch language (or is supported by a translator made available by the agency involved).
|- Exclusion criteria||Currently undertaking a RAC-v trajectory (if the person involved has completed a RAC trajectory with a certificate, this has to be closed for at least a year before study admission).|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2009|
|- planned closingdate||30-nov-2012|
|- Target number of participants||300|
|- Interventions||Recognition of Acquired Competencies for volunteers (RAC-v), or in Dutch "Erkenning van Verworven Competenties voor vrijwilligers" (EVC-v). RAC-v is applied at 20 to 25 rehabilitation or social agencies. Professional workers of these agencies are being trained in RAC-v by trainers of the founding organization. These workers offer RAC-v to enrolled participants who are randomized to RAC-v. RAC-v generally takes six months to finish. It consists of several phases, including choosing core competencies, looking for evidence which confirms the participant actually possesses these competencies, making a portfolio that shows this process has been carried out and finally an authorization phase which ends in certification.|
People in the control condition sign in for a waiting list and are offered RAC-v after one year. All other (usual) guidance proceeds without modification for both groups.
|- Primary outcome||1. Empowerment:|
A. Improvement in mean score on empowerment, measured with the Dutch Empowerment scale (Boevink etal 2009); Time points 6 months and 12 months;
B. Improvement in mean score on hope measured with the Herth Hope Index (Herth 1989); Time points 6 months and 12 months.
2. Vocational functioning:
A. % of participants who show improvement in participation in 12 months; Time point 12 months;
B. Improvement in mean score on job search behavior (Schellekens 2007); Time point 12 months.
|- Secondary outcome||1. Improvement in mean score on mental health confidence); Time points 6 months and 12 months;|
2. Improvement in mean score on quality of life; Time points 6 months and 12 months;
3. Improvement in mean score (on perceived insight in personal competencies); Time points 6 months and 12 months.
|- Timepoints||1. T0;|
2. T6 months;
3. T12 months.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Manja Wezep, van|
|- CONTACT for SCIENTIFIC QUERIES||PhD. H. Michon|
|- Sponsor/Initiator ||Trimbos-institute - Netherlands Institute of Mental Health and Addiction|
(Source(s) of Monetary or Material Support)
|Movisie – Netherlands centre for social development|
|- Brief summary||TRACE is a multi-site pragmatic, parallel group randomised clinical trial evaluating effectiveness of Recognition of Acquired Competencies for volunteers (RAC-v). RAC-v is applied at rehabilitation or social agencies targeting people with a 'large distance' to the labour market because of social and psychological vulnerabilities. Professional workers of these agencies are being trained in RAC-v by trainers of the founding organization. These workers offer RAC-v to enrolled participants who are randomized to RAC-v. People in the control condition sign in for a waiting list and are offered RAC-v after one year. All other (usual) guidance proceeds without modification for both groups. Three time points are used: T0 (baseline) - T6 months - T12 months. Empowerment measured at T6 and T12 and vocational improvement measured at T12 are the primary outcomes.|
|- Main changes (audit trail)|
|- RECORD||25-nov-2010 - 25-mrt-2011|