The impact of systemic family therapy as an element of treatment for families following trauma
| ISRCTN | ISRCTN04094806 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04094806 |
| Protocol serial number | EAT/3196/05 |
| Sponsor | Belfast Health and Social Care Trust (UK) |
| Funder | Department of Health, Social Services and Public Safety for Northern Ireland (UK) (ref: 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 of protocol
Not provided at time of registration
Contact information
Mr Stephen Coulter
Scientific
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 |
|---|---|
| scoulter07@qub.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single-blind trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The impact of systemic family therapy as an element of treatment for families following trauma |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
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. |
| Key secondary outcome measure(s) |
The following assessments will be carried out at baseline and 6 months: |
| Completion date | 31/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 160 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 15/02/2007 |
| Date of final enrolment | 31/08/2008 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
Study participating centre
Institute of Child Care Research (ICCR)
Belfast
BT7 1LP
United Kingdom
BT7 1LP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/06/2017: No publications found, verifying study status with principal investigator
