Condition category
Mental and Behavioural Disorders
Date applied
14/05/2008
Date assigned
09/06/2008
Last edited
02/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Stephen Coulter

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EAT/3196/05

Study information

Scientific title

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

Acronym

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

Office for Research Ethics Committees Northern Ireland (ORECNI), 25/10/2006, ref: 06/nir02/106

Study design

Randomised single-blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

15/02/2007

Overall trial end date

31/08/2008

Reason abandoned

Eligibility

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 type

Patient

Age group

Other

Gender

Both

Target number of participants

40 families

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

United Kingdom

Trial participating centre

Institute of Child Care Research (ICCR)
Belfast
BT7 1LP
United Kingdom

Sponsor information

Organisation

Belfast Health and Social Care Trust (UK)

Sponsor details

Knockbracken Healthcare Park
Saintfield Road
Belfast
BT8 8BH
United Kingdom
+44 (0)2890 960000
info@belfasttrust.hscni.net

Sponsor type

Government

Website

http://www.belfasttrust.hscni.net

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes