|
Welcome
|
|
11 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Project SFP Cymru: evaluating the impact of the Strengthening Families 10-14 UK Programme on substance misuse |
| ISRCTN | ISRCTN63550893 |
| ClinicalTrials.gov identifier | |
| Public title | Project SFP Cymru: evaluating the impact of the Strengthening Families 10-14 UK Programme on substance misuse |
| Scientific title | Preventing substance misuse: a randomised controlled trial of the Strengthening Families 10-14 UK Programme |
| Acronym | N/A |
| Serial number at source | 2009/1-SPF |
| Study hypothesis |
Primary objectives:
To ascertain the impact of the Strengthening Families 10-14 UK Programme (SFP10-14 UK) on alcohol and drug misuse, and smoking behaviour in adolescents. Secondary objectives: To answer a number of other questions regarding other impacts of the SPF10-14 UK: 1. What impact does the SFP10-14 UK have on school performance, and mental health and well being? 2. What impact does the SFP10-14 UK have on protective factors for alcohol and tobacco use/misuse located in the family, such as family functioning, parenting and young people's peer resistance skills? 3. What are the costs associated with the SFP10-14 UK and to what extent can it be regarded as an efficient use of public funds? 4. How can SFP10-14 UK best be implemented and is there important variation in delivery and receipt? |
| Lay summary | |
| Ethics approval | Full approval pending from the Research Ethics Committee for Wales as of 04/12/2009 (ref: 09/MRE0953). Provisional opinion given following meeting held on 8th October 2009. |
| Study design |
Single-centre pragmatic randomised controlled effectiveness trial
|
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Substance misuse |
| Participants - inclusion criteria |
1. Families with a child aged 10 - 14 years, either sex
2. At least one parent/carer and one child are willing to attend the programme together 3. The ability to speak English (help can be provided for parents or children with low literacy levels). Some programmes may also be delivered through the medium of Welsh. 4. Families can self refer to the programme or be referred by a practitioner Any families deemed eligible to attend the Strengthening Families Programme will be included in the research trial, subject to their giving consent. |
| Participants - exclusion criteria |
1. Families with very high needs or challenges (such as serious substance misuse problems or family breakdown)
2. Situations where either a parent or child does not want to attend the programme 3. Families who do not live together e.g. the child/children are in care 4. Parents or children who cannot speak English Families deemed ineligible to attend the Strengthening Families Programme will not be included in the research trial. |
| Anticipated start date | 01/09/2009 |
| Anticipated end date | 31/03/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a participant information sheet |
| Target number of participants | 748 families |
| Interventions |
Participating families will be randomised to one of two treatment groups:
Control Group (C): Receive usual care with full access to existing services and a minimal information leaflet Intervention Group (I): Receive the SFP10-14 UK programme in addition to usual care There will not be a defined programme of usual care, and the existing variation in services available to participants across the six participating areas will continue throughout the trial period. Existing services include some peer education, brief interventions available through primary health care, and more intensive counselling interventions for individuals and families available through Drug and Alcohol Teams (DATs) and voluntary sector counselling services. The SFP10-14 UK addresses three broad areas: family functioning, including communication between parents and children; strengthening parental skills; and helping young people to develop new skills in relation to resisting peer pressure, stress management, and goal setting. It is designed for delivery to families with children aged 10 - 14 years, and in the Wales adaptation is targeted towards a mix of families with challenges (in relation to child behaviour and family functioning) and families from the general population. Each programme is open to families from a loosely defined and fairly large geographical area. The 'mixed families' approach aims to recruit about 4 families with challenges per group, and 6 - 8 families from the general population. Self referrals come forward from awareness raising in community and educational settings. Families are therefore drawn from the same area facilitating mutual support between sessions and at the end of the programme, but are not from a small or defined community such as a school or local neighbourhood. This recruitment model has worked well and achieved full programmes that have achieved high retention and engagement. The programme comprises seven weekly sessions of two hours and is delivered in a range of community venues by a multi-agency team of trained professionals. The SFP10-14 UK is a seven week intervention. In each session there is an hour during which parent sessions and young people sessions are conducted separately, followed by a second combined family hour. Typically, the first hour focuses on skills (e.g. peer resistance for the young people, parenting for the parents), with the second hour designed to enable parents and young people to focus on communication skills, recognise family strengths, and practice skills covered in the first hour. The last follow-up will be carried out 2 years after baseline. |
| Primary outcome measure(s) | Number of occasions that young people report ever having been really drunk. All outcomes will be measured at two-year follow-up. |
| Secondary outcome measure(s) |
All outcomes will be measured at two-year follow-up:
1. Reported use of cannabis (ever versus never) 2. Weekly smoking (yes versus no, validated by saliva cotinine) 3. General Certificate of Secondary Education (GCSE) performance (number of GCSEs passed at Grade C or above) |
| Sources of funding |
1. Medical Research Council (MRC) (UK) - manages funding from the National Prevention Research Initiative (ref: G0802128)
2. The Welsh Assembly Government (UK) - cover the costs of implementation and training support during the period to March 2011 |
| Trial website | http://www.cardiff.ac.uk/socsi/cishe/pages/projects/SFPCymru.html |
| Publications | |
| Contact name | Prof Laurence Moore |
| Address |
Cardiff Institute of Society, Health and Ethics
School of Social Sciences 1 - 3 Museum Place |
| City/town | Cardiff |
| Zip/Postcode | CF10 3BD |
| Country | United Kingdom |
| Sponsor | Cardiff University (UK) |
| Address | 30 - 36 Newport Road |
| City/town | Cardiff |
| Zip/Postcode | CF24 0DE |
| Country | United Kingdom |
| Sponsor website: | http://www.cardiff.ac.uk/ |
| Date applied | 03/12/2009 |
| Last edited | 05/02/2010 |
| Date ISRCTN assigned | 05/02/2010 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|