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ISRCTN
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ISRCTN04094806
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ClinicalTrials.gov identifier
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Public title
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The impact of systemic family therapy as an element of treatment for families following trauma
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Scientific title
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Acronym
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N/A
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Serial number at source
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EAT/3196/05
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Study hypothesis
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A combination of systemic family therapy and trauma focused cognitive behavioural therapy (CBT) will improve outcomes compared to trauma focused CBT alone for families referred to a clinical service following trauma.
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Ethics approval
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Office for Research Ethics Committees Northern Ireland (ORECNI). Date of approval: 25/10/2006 (ref: 06/nir02/106)
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Study design
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Randomised, single-blind trial.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Trauma
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Participants - inclusion criteria
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1. Those who live in the study area at time of referral
2. One or more members of the family have suffered a traumatic event that is the primary reason for referral to the family trauma centre
3. Both males and females are eligible to participate. Measures are completed by those aged 13 and older who attend the initial assessment session.
Family will be offered an initial assessment interview at the family trauma centre between February 2007 and August 2008.
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Participants - exclusion criteria
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1. Not a trauma Case
2. Child sexual abuse case
3. Interpreter needed to facilitate therapy
4. Ongoing individual therapy with another service
5. New episode of treatment in an ongoing case
6. Very urgent response needed
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Anticipated start date
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15/02/2007
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Anticipated end date
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31/08/2008
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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40 families
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Interventions
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The families are randomly allocated to either of the following arms:
Arm 1: CBT and systemic family therapy
Arm 2: CBT only
The therapies are manualised and conducted by highly experienced mental health professionals including clinical psychologists, family therapists and CBT therapists. There are CBT and systemic consultants to the trial who review session checklists to ensure treatment fidelity. The family are invited to bring all who they deem relevant to the family therapy sessions. Family sessions last up to 90 mins and occur on a three weekly cycle. Individual therapy lasts for up to 60 mins and occurs on a 2 - 3 week cycle. The total number of therapy sessions per participant is not fixed, and some sessions may be missed for other family priorities. The number of sessions attended is recorded for each participant and therefore the dose effect for individuals and families can be included in the analysis.
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Primary outcome measure(s)
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McMaster family assessment device. This tool has seven subscales as follows: problem solving, communication, roles, affective responses, affective involvement, behavioural control and general functioning. This assessment will be carried out at baseline and 6 months.
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Secondary outcome measure(s)
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The following assessments will be carried out at baseline and 6 months:
1. Hospital anxiety and depression scale
2. Antonovsky's sense of coherence scale
3. Rosenberg self esteem scale
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Sources of funding
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Department of Health, Social Services and Public Safety for Northern Ireland (UK) (ref: EAT/3196/05)
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Trial website
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Publications
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Contact name
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Mr
Stephen
Coulter
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Address
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Institute of Child Care Research (ICCR)
School of Sociology, Social Policy and Social Work (SSSPSW)
Queen's University Belfast
6 College Park
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City/town
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Belfast
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Zip/Postcode
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BT7 1LP
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Country
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United Kingdom
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Tel
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+44 (0)2890 971488
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Email
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scoulter07@qub.ac.uk
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Sponsor
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Belfast Health and Social Care Trust (UK)
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Address
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Knockbracken Healthcare Park
Saintfield Road
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City/town
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Belfast
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Zip/Postcode
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BT8 8BH
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Country
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United Kingdom
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Tel
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+44 (0)2890 960000
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Fax
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+44 (0)2890 960099
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Email
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info@belfasttrust.hscni.net
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Sponsor website:
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http://www.belfasttrust.hscni.net
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Date applied
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14/05/2008
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Last edited
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09/06/2008
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Date ISRCTN assigned
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09/06/2008
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