The impact of systemic family therapy as an element of treatment for families following trauma

ISRCTN	ISRCTN04094806
DOI	https://doi.org/10.1186/ISRCTN04094806
Secondary identifying numbers	EAT/3196/05

Submission date: 14/05/2008
Registration date: 09/06/2008
Last edited: 02/06/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Mr Stephen Coulter
Scientific

Institute of Child Care Research (ICCR)
School of Sociology, Social Policy and Social Work (SSSPSW)
Queen's University Belfast
6 College Park
Belfast
BT7 1LP
United Kingdom

Phone	+44 (0)2890 971488
Email	scoulter07@qub.ac.uk

Study information

Study design	Randomised single-blind trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The impact of systemic family therapy as an element of treatment for families following trauma
Study hypothesis	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.
Ethics approval(s)	Office for Research Ethics Committees Northern Ireland (ORECNI), 25/10/2006, ref: 06/nir02/106
Condition	Trauma
Intervention	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.
Intervention type	Behavioural
Primary outcome measure	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.
Secondary outcome measures	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
Overall study start date	15/02/2007
Overall study end date	31/08/2008

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	40 families
Participant inclusion criteria	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.
Participant exclusion criteria	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
Recruitment start date	15/02/2007
Recruitment end date	31/08/2008

Locations

Countries of recruitment

Northern Ireland
United Kingdom

Study participating centre

Institute of Child Care Research (ICCR)

Belfast
BT7 1LP
United Kingdom

Sponsor information

Belfast Health and Social Care Trust (UK)
Hospital/treatment centre

Knockbracken Healthcare Park
Saintfield Road
Belfast
BT8 8BH
Northern Ireland
United Kingdom

Phone	+44 (0)2890 960000
Email	info@belfasttrust.hscni.net
Website	http://www.belfasttrust.hscni.net
"ROR"	https://ror.org/02tdmfk69

Funders

Funder type

Government

Department of Health, Social Services and Public Safety for Northern Ireland (UK) (ref: EAT/3196/05)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

02/06/2017: No publications found, verifying study status with principal investigator