Condition category
Mental and Behavioural Disorders
Date applied
22/04/2015
Date assigned
28/04/2015
Last edited
28/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

www.dartington.org.uk/projects/ACE

Contact information

Type

Scientific

Primary contact

Dr Georgina Warner

ORCID ID

Contact details

Office S67
Second Floor
New Wing
Somerset House
Strand
London
WC2R 1LA
United Kingdom

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 measures

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

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
Devon
TQ9 6AB
United Kingdom

Sponsor type

Charity

Website

www.dartington.org.uk

Funders

Funder type

Government

Funder name

Department for Education (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The Department for Education Innovation Fund report is due to be produced by the end of March 2016.

Intention to publish date

30/06/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes