Condition category
Mental and Behavioural Disorders
Date applied
22/05/2017
Date assigned
29/06/2017
Last edited
29/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Children in foster care have typically had a very difficult start in life and for these children it is often difficult to trust new adults, such as new carers. Some children in foster care have such severe problems in this area that they may qualify for a diagnosis called Reactive Attachment Disorder (RAD). The difficulties experienced by such children can limit the benefits they might otherwise get from foster care; it also places them at risk of longer-term behavioural and emotional problems. There is currently no evidence-based treatment available for children in foster care with these kinds of difficulties. The aim of this study is to conduct all of the preparatory steps necessary to pave the way for a full–scale trial of a Video feedback Intervention to Promote Positive Parenting (or 'VIPP') for children in foster care with RAD difficulties.

Who can participate?
Families made up of foster carers and fostered children with RAD.

What does the study involve?
Foster families are randomly allocated to either receive the VIPP-FC service (alongside the usual support they receive) or to just receive the usual support in their area (‘usual care’). When foster families are placed in the usual care group, they continue to receive the care they have from their GP, health visitor, or other professionals in the area. When foster families are placed in the VIPP-FC group, they still get the support they would normally, but also receive the VIPP-FC service from their local Child Adolescent Mental Health Service (CAMHS). As part of this service, a CAMHS practitioner who is specially trained to support children in foster care and their carers comes to visit families at home on six occasions, for about an hour and a half each visit. The visits involve both the foster carer and the foster child and start by video-recording both interacting. The carer then looks at this recording with the practitioner, and they discuss it and think together about ways of understanding the foster child’s behaviour and coming up with strategies to try out. Regardless of whether families are placed in the usual care group or the VIPP-FC group, the foster carer and foster child are seen by a researcher twice. During these research visits carers have the opportunity to talk about their foster child’s development and the researcher carries out a number of commonly used assessments of children’s behaviour and wellbeing. These include questionnaires, an interview and an observation to see how the foster child responds to meeting new people and how they respond when you step out of the room for a short period of time.

What are the possible benefits and risks of participating?
It is hoped that the study will be an interesting and enjoyable experience and if allocated to the VIPP-FC group families may also find this helpful. Also, the information obtained from this study will help to improve services to other foster families with young children in the future. Foster families are also given £30 per research visit to thank them for their time. Sometimes the questionnaires and interviews used in this study can be a bit upsetting because they include some questions asking about some social or emotional difficulties the foster child might be experiencing. The assessment of the foster child’s reaction to a new room and an unfamiliar person might also be a little upsetting to either the carer or the child. During all the assessments families are free to stop at any time and do not have to talk about anything that they don’t want to. The assessments do take some time (up to 1 and half hours) and that might be difficult if families are very busy.

Where is the study run from?
1. Dragon Parade Clinic CAMHS centre (UK)
2. Lime Trees CAMHS centre (UK)
3. Brompton House CAMHS centre (UK)
4. Waltham Forest CAMHS centre (UK)
5. Haringey First Step service (UK)

When is the study starting and how long is it expected to run for?
September 2015 to October 2019

Who is funding the study?
National Institute for Health Research, Health Technology Assessment Programme (UK)

Who is the main contact?
Prof. Pasco Fearon
p.fearon@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Pasco Fearon

ORCID ID

http://orcid.org/0000-0003-1847-8443

Contact details

University College London
545
Research Department of Clinical
Educational and Health Psychology
1-19 Torrington Place
London
WC1E 7HB.
United Kingdom
+44 (0)207 679 1244
p.fearon@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 15/118/01

Study information

Scientific title

A feasibility study and pilot trial of a modified video-feedback intervention for children and foster carers to improve mental health outcomes of children with reactive attachment disorder

Acronym

VIPP-FC

Study hypothesis

The aim of this study is to investigate the feasibility of conducting a randomised trial of VIPP for children in foster care with RAD by:
1. Modifying an existing clinical manual to meet the requirements of children with RAD in the UK foster care context
2. Testing the acceptability of the intervention from the point of view of practitioners and foster carers, and working with local authorities, foster carers, parents and young people to establish the optimal systems, procedures and ethical considerations required to identify and support children with RAD in UK foster care populations
3. Investigate the feasibility of a randomised trial of the modified intervention

Ethics approval

Not provided at time of registration

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Mental health

Intervention

In the first instance, a case series (phase 2) will be carried out involving 6 consenting families who will all receive VIPP-FC. In the pilot trial (phase 3), forty consenting families will be randomly allocated in a 1:1 ratio to either a treatment group (VIPP-FC & treatment as usual:TAU) or a control (TAU only) group.

Randomisation: Randomisation with minimization will be employed, with minimization factors age (<=4 versus >4), gender and site. Minimization will include a random factor, as implemented in the minimisation program Simin (Wade, Pan, Eaton, Pierro & Ong, 2006). Randomisation will be requested by a member of the research team following completion of all necessary screening and consent procedures, and will be performed by an unblinded member of the trial coordination team. The allocation list will be held in the Trial Master File. The foster carer, CAMHS team and the individual(s) giving consent on behalf of the child (the parent or local authority social worker with parental responsibility as appropriate) will be notified of the outcome by letter by the unblinded member of the trial coordination team. The foster carer and CAMHS team will also be contacted by telephone within 24 hours to ensure a timely initiation of intervention.

Treatment Arm: Video-Feedback to Promote Positive Parenting – Foster Care (VIPP-FC): VIPP is a brief home-based attachment and parenting intervention. Staff from the relevant NHS Trust that have received training in the intervention will visit families at home for six 90-min sessions over 4 months. Sessions 1 to 4 take place biweekly and focus on improving carer sensitivity to the child. Sessions 5 and 6 are booster sessions, and can take place approximately once a month and focus on consolidating the information provided in sessions 1 to 4 and teaching carers sensitive discipline skills. Sessions involve both carer and child and start by video-recording carer-child interactions, which provides the basis for themed discussion in the next session. Themes include recognising the child’s attachment signals and expressions, providing prompt and adequate responses to them, promoting empathy for the child, praising positive behaviour, and appropriate ignoring of negative behaviour. Carers are also given exercises and tips. Session content is consistent across families, although its presentation and the video feedback are tailored to the specific needs of each family. VIPP has recently been modified specifically for the foster care context by the developers of VIPP in the Netherlands. This modified programme (VIPP-Foster Care [VIPP-FC]) pays particular attention to the need to help carers recognise signals that are specific to foster children--that may be quite challenging and difficult to understand--so that they are better equipped to respond sensitively, and to support the child’s secure attachment to them as their carer. This service will be in addition to the usual support services offered to foster families.

Treatment as Usual (TAU): VIPP-FC will be compared to usual care, as there is no pre-existing integrated care pathway for children in foster care. Treatment as usual varies widely from locality to locality and good data is not recorded that would currently allow precise specification of TAU in a planned trial. Systematically documenting TAU is therefore a key objective of this study. Initial consultations with CAMHS teams in our study sites, identified several likely treatments that may be offered within TAU: Theraplay, 1-3 sessions of foster carer consultation, network consultation, Incredible Years, foster carer support, 6-12 sessions of psychotherapy, behaviour support, foster parent groups. The Child and Adolescent Service Use Schedule (CA-SUS) will be used to systematically describe and quantify the services received by children and carers in the comparator arm of the pilot trial.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The presence of disordered attachment is measured using the Disturbance of Attachment Interview (DAI) at baseline and 4 months

Secondary outcome measures

1. Attachment security is measured using the Strange Situation Procedure at baseline and 4 months
2. Carer well-being is measured by The Parent Stress Index (PSI; Abidin, 1990) and The Parenting Efficacy Scale (Woolgar et al., 2012) at baseline and 4 months
3. Quality of parenting is measured by the Emotional Availability Scales (Biringen, 2000) at baseline and 4 months
4. Child co-occurring disorders and difficulties measured by The Development and Well-Being Assessment (DAWBA) and the Child Behaviour Checklist (Achenbach, 2000) at baseline and 4 months

Overall trial start date

01/09/2015

Overall trial end date

01/10/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Parental figure:
1. Foster carer(s) who is primary carer for the child
2. Aged 18 years and over
3. Proficient in English

Child:
1. Living with foster carer(s) in a placement planned to be at least 4 months
2. Lived with foster carer for at least 4 weeks
3. Presence of DSM-5 defined Reactive Attachment Disorder (RAD)
4. Aged between 11 months and 6 years

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

46

Participant exclusion criteria

Parental figure:
Already engaged in a similar parenting intervention.

Child:
Severe developmental disability.

Recruitment start date

01/07/2017

Recruitment end date

01/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dragon Parade Clinic
CAMHS centre 2 Dragon Parade
Harrogate
HG1 5BY
United Kingdom

Trial participating centre

Lime Trees CAMHS centre
31 Shipton Road
York
YO30 5RE
United Kingdom

Trial participating centre

Brompton House
CAMHS Centre 22 Brompton Road
Northallerton
DL6 1EA
United Kingdom

Trial participating centre

Waltham Forest CAMHS
Child and Family Consultation Service Thorpe Coombe Site Shernhall Street
Walthamstow
E17 3EA
United Kingdom

Trial participating centre

Haringey First Step service
Bounds Green Health Centre 1a Gordon Road
London
N11 2PA
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

University College London
1st Floor
Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
+44 (0)20 3447 5199
david.wilson@ucl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research, Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Academic dissemination: This will include publication of the manual and its development process, a paper on the multiple test case series, a policy/implementation paper on practical barriers and solutions to running attachment-focused trials in the foster care setting, the pilot trial protocol, and the results of the pilot trial. Plans for members of the team to attend two international academic conferences.
2. Foster carer and general public audiences: Planned dissemination of findings through our institutional websites, a designated project website and through our partner organization the NSPCC. Members of the PPI group will attend, with members of the study team, two national foster care and/or social work conferences such as the British Association of Adoption and Fostering (BAAF). Findings will be fed back through local meetings with foster care and adoption organizations and agencies (e.g., By The Bridge Fostering, TACT Fostering, Coram), and local authority foster care groups.
3. Clinical and policy audiences: Within local services regular seminars will be held updating on the progress of the study and later reporting the outcomes of the study. The clinical manual will be made available to participating CAMHS and local authority teams during the study to facilitate dissemination and learning. On a national and international level, the research team will liaise closely with the NIHR, national organisations (especially the NSPCC) to ensure that national clinical and policy audiences are aware of the project. In addition to academic publications the researhcers aim to produce a summary publication in a peer-review article for community practitioners, such as Adoption and Fostering, and to create a short accessible summary of the findings for services, particularly social care services, GPs and CAMHS.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Paula Oliveira (paula.oliveira@ucl.ac.uk).

Intention to publish date

01/07/2020

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes