Study of Adolescents' Family Experiences
| ISRCTN | ISRCTN27650478 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27650478 |
| Protocol serial number | N/A |
| Sponsor | King's College London (UK) |
| Funder | Department of Children, Schools and Families (UK) - The National Academy for Parenting Research |
- Submission date
- 23/03/2010
- Registration date
- 13/05/2010
- Last edited
- 22/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
PO85 De Crespigny Park
Institute of Psychiatry
London
SE5 8AF
United Kingdom
 ORCID ID |
0000-0003-3849-1629 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-arm randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Study of Adolescents' Family Experiences: a randomised controlled trial of functional family therapy with adolescent offenders and antisocial youth |
| Study acronym | SAFE |
| Study objectives | Aims and hypotheses: 1. Outcomes: The main aim is to evaluate the effectiveness of FFT compared to a dose control condition that includes treatment as usual plus non-specific treatment for young people. It is hypothesised that FFT will be associated with greater improvements in family relationships, parent relationships to the offending youth, youth mental health, and finally, greater reduction in youth re-offending. Effects will be assessed over a one year period. 2. Outcomes across diverse adolescents and their families: The second aim is to assess the effects of the program across the various adolescent, family, and quantity and quality of service provision variables. 3. Mechanisms of change: The third aim is to assess what are the essential 'active' ingredients of the programmes in terms of changes in family, and parent and child behaviours in the domains that FFT explicitly targets for change. It is hypothesised that change in family process variables and the parent relationship with the target youth are necessary conditions for change in ongoing youth antisocial behaviour. 4. Success of service provision in the UK YOT system; suitability for dissemination: Finally, we will assess the total and relative social acceptability, reach, and cost benefits of FFT into the UK YOT system. What proportion of parents can be induced to attend, that is it suitable for a minority or the majority of families? What are the characteristics of those who don't take up the programme? Are their differences across programmes? What is the acceptability of the programmes to parents, frontline practitioners, senior managers and commissioners? How well can practitioners be trained to implement the programme and thus produce change? |
| Ethics approval(s) | Kings College London Research Ethics Committee, 28/03/2008, ref: CREC/07/08-141 |
| Health condition(s) or problem(s) studied | Conduct disorder, antisocial behaviour |
| Intervention | 1. Functional Family Therapy group: FFT works by working improving outcomes for families by addressing a number of factors that may contribute to the likelihood of a young person offending. Key amongst these are family circumstances and styles of parenting, which have been shown to be correlated strongly with delinquency and anti-social behaviour. FFT aims to assist young people and their families to make meaningful changes in their functioning. This is accomplished by reducing negativity in the family and focusing on significant yet obtainable behavioural changes that will have a lasting impact on family relationships. These changes may have the immediate effect of changing a specific functional problem or difficulty and the longer term effect of empowering a family to continue to apply changes to future circumstances. A key duty of the therapist is to assume some of the functional duties of a "family case manager" to assist the family to identify and interact with relevant community resources that will help the family sustain their changes over time. In this way, FFT aims to increase the family's capacity to manage problems, enabling a reduced reliance on service providers and their resources. It is a home-based assertive outreach model. The intervention process involves, on average, 12 one hour sessions over a period of 3 to 4 months delivered in the family home, with more complex cases requiring up to 30 hours of direct service. Thus young people in the FFT group will receive treatment as usual as normally provided by agencies and FFT. Experienced family therapists have been hired to provide the intervention. They have been trained to the highest standard by the originator of the programme, Professor James Alexander, and will receive weekly supervision. Given that the SAFE project is an effectiveness trial the therapists will be located within, and will work as part of, the Brighton and Hove Youth Offending Team. 2. Dose Control group: The use of standard, no-treatment control groups in behavioural intervention research can be problematic for a number of reasons. In addition to ethical and legal considerations of denying treatment to this population, the use of no-treatment control groups may not control for a number of confounding factors. In particular, a treatment group may have improved outcomes, not because of the effectiveness of the intervention, but because they receive additional attention from a therapist. Whilst the use of dose control groups has become more widespread in clinical trials of interventions for depression it has been sorely lacking in evaluation trials of parenting programmes or family therapy. This study will address these issues by including treatment as usual as normally offered by agencies, and incorporating additional service provision in the control group that matches the amount of time and attention received by participants receiving FFT. Thus adolescents and their families will receive treatment as usual and an additional 12 hours of additional contact with, and support from, a caseworker not trained in FFT. |
| Intervention type | Other |
| Primary outcome measure(s) |
Young people's offending and antisocial behaviour: |
| Key secondary outcome measure(s) |
1. Peer relationships: |
| Completion date | 01/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Young people aged 10 - 17 years (either sex) and their families (mainly primary caregivers but also others with a parental role) 2. Clients of a CYPT agency being seen for offending or antisocial behaviour receiving a casework-based intervention |
| Key exclusion criteria | 1. Young people with a major developmental disability 2. Looked after young people (this does not include long term foster placements) 3. Young people not living in the family home |
| Date of first enrolment | 01/07/2008 |
| Date of final enrolment | 01/12/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
SE5 8AF
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? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/05/2017: Publication reference added.
