Plain English Summary
Background and study aims:
Safe Families for Children (SFFC) is a volunteer-driven programme from the USA that provides respite, friendship and resources to families in crisis. SFFC has been piloted in the North East of England and will be rolled out to other areas in the UK in 2015. Although previous studies have been run, it is difficult to draw conclusions about SFFC. The aim of this study is to estimate its impact on children’s behavioural and emotional outcomes and parental anxiety.
Who can participate?
Participants will be the lead parent/carers of children (at least one child aged 10 years or under) referred to social services who would be accommodated under Section 20 of The Children Act (1989) if not referred onto SFFC. The referral must involve voluntary, short-term care of a child perceived to be in need of less than 14 nights care away from home. Families from 5 regions in England (East Midlands; Greater Manchester; Merseyside; North East; West Midlands and The Black Country) can participate.
What does the study involve?
For families with children defined as ‘on the edge of care’, the study will compare those who receive SFFC intervention with those who receive services as usual (i.e. temporary foster care), for the following:
• Child emotional and behavioural outcomes, as reported by parents
• Level of anxiety and general wellbeing reported by the children's parents
• Number of bed nights away from home
• Frequency of re-referral to the care system
• Period between initial referral and re-referral to the care system
Once a family is referred to SFFC by a local authority social worker, the consent procedure and initial assessments with the lead parent/carer contact will take place during a home visit.
What are the possible benefits and risks of participating?
The potential benefits to participating families are the reduction of child emotional and behavioural problems and parental anxiety, as well as improved interpersonal support. There are no known risks to participating families.
Where is the study run from?
The study is run from the Dartington Social Research Unit, UK. Families will be from 5 regions in England (East Midlands, Greater Manchester, Merseyside, North East, West Midlands and The Black Country).
When is the study starting and how long it is expected to run for?
The study is expected to start when the SFFC teams are ready to receive referrals, which will be from the week starting 18/05/2015 in some geographical hubs. The Department for Education Innovation Fund report is due to be produced by the end of March 2016. Overall May 2015 to March 2016.
Who is funding the study?
The Department for Education (UK) is funding the project as part of their Social Care Innovation Programme (from April 2015 to March 2016). Further funding will be sought after March 2016.
Who is the main contact?
Dr Georgina Warner
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effectiveness of Safe Families for Children in supporting families with children identified as on the edge of care: a randomised controlled trial
Acronym
ACE (Alternative to Care Evaluation)
Study hypothesis
The project will evaluate the effectiveness of SFFC, a volunteer-driven intervention from the USA that provides respite, friendship and resources to families in crisis. SFFC has been piloted in the North East of England and will be rolled out to other areas in the UK in 2015. To date, no impact evaluations of SFFC have been published. However, a descriptive evaluation of the SFFC programme in Illinois (USA) revealed that over a 3-year period there was a 136% increase in the number of children placed with SFFC and the majority of children (76.5%) went home to their parents at the end of the placement and relatively few entered the social care system (8.0%). Nonetheless, without outcome measures or comparison data from a control group, it is difficult to draw firm conclusions about the impact of the intervention. The current study will evaluate SFFC using experimental methods to estimate the impact on children’s behavioural and emotional outcomes and parental anxiety.
It is hypothesised that in families who have received Safe Families for Children (SFFC) intervention (the intervention arm), children will reportedly demonstrate less deterioration in emotional and behavioural difficulties and parents will report a lower level of anxiety, as well as a higher level of social support, at follow-up (c.8 weeks post- randomisation) than in families who have not received SFFC intervention (the control arm).
Ethics approval
Warren House Group Research Ethics Committee; 20/03/2015; ref. WHG2015-001
Study design
Two-arm randomised controlled parallel group superiority trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
www.dartington.org.uk/projects/ACE
Condition
Child emotional and behavioural difficulties and parental anxiety
Intervention
The SFFC intervention provides support for families who are going through crises. It is a faith-based charity that aims to keep the family together and to reduce the number of children coming into care. SFFC recruits volunteers from churches but offers support to people from all backgrounds in a number of ways. Firstly, it offers residential care for the children to provide respite for the families. Secondly, SFFC offers a befriending service where a volunteer will act as a mentor/befriender for the family in crisis and provides support. Thirdly, it offers financial support for the family in terms of goods or skills. The intervention arm will receive support from SFFC, which will involve temporary child placement with a volunteer family and an offer of family friendship (intervention support might also include the provision of resources, if required). The control arm will receive services as usual, which in this context means entrance to the social care system and temporary placement with a foster family.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
The study will primarily measure changes in children’s behaviour and emotional functioning and parental anxiety, both from the parents’ perspective (co-primary outcomes). These measures will be administered at baseline, then at follow-up c.8 weeks after randomisation.
1. Strengths and Difficulties Questionnaire- parent report (SDQ: Goodman 1997) (Total Difficulties score – this combines ratings of the child’s difficulties in four domains of functioning: emotional symptoms, conduct problems, hyperactivity, and peer relationship problems.)
2. Hospital Anxiety and Depression Scale (HADS, Snaith & Zigmond, 1983) (Anxiety score)
Secondary outcome measures
Secondary assessments will include a measure of interpersonal support. In addition, the number of bed nights spent away from home, frequency of re-referral and time lapse between referrals will be measured. The secondary outcome measure will be administered at baseline and at follow-up c.8 weeks after randomisation. The other data will be retrieved c.13 weeks after randomisation (for initial report) and a further 2 time points if the trial period is extended (c.25 weeks and c.50 weeks after randomisation).
1. Interpersonal Support Evaluation List (ISEL, Cohen & Hoberman, 1983). (Total support, tangible support, belonging support, self-esteem support and appraisal support.)
Overall trial start date
01/05/2015
Overall trial end date
31/03/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. At least one of the referred children within a family is aged 10 years or under (child outcome data will be collected for children aged 2 or above as per the validation of the outcome measure)
2. The referred children would be accommodated under Section 20 of The Children Act (1989) if not placed with a SFFC host family (voluntary arrangement)
3. The lead parent/carer contact has parental responsibility for the child(ren)
4. The referred children are perceived to be in need of less than 14 nights care
Participant type
Other
Age group
All
Gender
Both
Target number of participants
600 families (300 intervention; 300 control) (Based on service capacity for year 1; actual numbers for year 1 may be lower but the trial may be extended beyond year 1 if further funding is secured).
Participant exclusion criteria
1. It is reported by the referring local authority social worker that it would be unsafe for SFFC staff or volunteers to regularly visit the family home
2. It is reported by the referring local authority social worker that any family members (including children) would put SFFC staff or volunteers at risk
Recruitment start date
18/05/2015
Recruitment end date
31/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Safe Families for Children (North East)
Venture House, Aykley Heads
Durham
DH1 5TS
United Kingdom
Trial participating centre
Safe Families for Children (East Midlands)
-
United Kingdom
Trial participating centre
Safe Families for Children (Greater Manchester)
Manchester
M3 7BB
United Kingdom
Trial participating centre
Safe Families for Children (Merseyside)
Wirral
CH62 8PE
United Kingdom
Trial participating centre
Safe Families for Children (West Midlands and The Black Country)
Birmingham
B12 9JU
United Kingdom
Sponsor information
Organisation
Dartington Social Research Unit
Sponsor details
Lower Hood Barn
Dartington
TQ9 6AB
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Government
Funder name
Department for Education
Alternative name(s)
DfE
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
2017 evaluation report in: https://innovationcsc.co.uk/wp-content/uploads/2017/11/1.2.89-Safe_Families_IP_evaluation_report.pdf
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list