Plain English Summary
Background and study aims
The aim of this study is to develop and test a new psychological intervention related to adult personality disorders and child emotional and behavioural difficulties. Personality disorder refers to the long-term problems that some people have in managing their feelings and in relating to others. People with a personality disorder are highly sensitive to stress and prone to extreme mood swings, self-harm, substance use and interpersonal challenges. Such difficulties affect 4% of all adults in the UK and 40% of adults in mental health services, with high costs to the NHS and social services. Emotional and behavioural problems affect nearly 1 in 10 children. Common examples are disruptive behaviour and anxiety. These can interfere with family life, friendships and school achievement, and increase long-term risks for poor adult mental health, substance use, unemployment and crime. The likelihood of severe and persistent problems is increased when a parent has a personality disorder. This is because personality difficulties can make it harder for a parent to provide the consistent care and nurture required for healthy child development. Having a child with emotional and behavioural difficulties is also stressful in itself, and may worsen a parents own mental health. Routinely available parenting interventions often achieve worse results when parents have mental health problems. Our study aims to improve care for families with needs in both of these areas. We will focus on psychoeducation, which is a widely used approach in healthcare that teaches service users and carers about the nature of health conditions and useful ways of managing symptoms and impacts. Other research has shown that psychoeducational support is generally effective at helping parents to manage childrens difficulties.
Who can participate?
Parents with personality disorders whose children have emotional and/or behavioural disorders. We will recruit participants from two NHS Mental Health Foundation Trusts in London that serve large and diverse populations with high rates of adult and child mental health problems. This will be augmented by additional fieldwork in children's social service teams operating within the same catchment areas.
What does the study involve?
We have previously developed and evaluated a promising psychoeducational treatment for adults with personality disorder, and another for parents with complex psychosocial needs. Phase 1 of the proposed study will combine these two existing treatments to create a new psychoeducational intervention manual. We will also produce a screening manual detailing suitable methods for identifying and selecting eligible parents. We will work closely with service users and clinicians to ensure that our methods are practical, acceptable to parents and alert to the ethical issues involved. In Phase 2, trained clinicians will deliver the intervention to 12 consenting parents. The parents will complete assessments and take part in interviews about their experiences. This information will then be used to refine our screening and intervention methods where necessary. Phase 3 will involve an initial study to compare the newly refined intervention with the usual care that parents receive. Seventy consenting parents will be allocated at random to receive the new intervention or usual care. Parents will complete follow-up assessments and interviews after the intervention and 6 months later. This study will carefully test research and clinical procedures to obtain reliable information about what is feasible, effective and acceptable for participants. The results will show whether the intervention can and should be tested in a larger, more definitive study with a view to wider use in the NHS.
What are the possible benefits and risks of participating?
The intervention may help to enhance parenting skills and confidence, improve parent-child relationships, and reduce child mental health difficulties. Parent participants will also learn strategies for managing stressful situations that may benefit their own mental health. It is possible that some participants might feel upset while discussing topics related to parental and child mental health, but therapists will be trained to provide appropriate practical and emotional support. Participants may be provided with information about other help as needed. Research assessments might be difficult for some parents if they have English as a second language or difficulties reading and writing. A researcher will be present during data collection in case a participant requires help or becomes distressed.
Where is the study run from?
The study is being run from South London and Maudsley NHS Foundation Trust and Central and North West London NHS Foundation Trust in the UK.
When is study starting and how long is it expected to run for?
The project will run for 37 months starting in June 2014
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)
Who is the main contact?
Dr Daniel Michelson
daniel.m.d.michelson@kcl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Crispin Day
ORCID ID
http://orcid.org/0000-0002-7655-7839
Contact details
Centre for Parent and Child Support
South London & Maudsley NHS Foundation Trust
CAMHS Research Unit
Institute of Psychiatry
King's College London
Michael Rutter Centre
De Crespigny Park
London
SE5 8AZ
United Kingdom
Type
Scientific
Additional contact
Ms Jackie Briskman
ORCID ID
Contact details
Research Coordinator
The 'Helping Families' Trial
CAMHS Research Unit
Department of Psychology (PO78)
Institute of Psychiatry
Psychology and Neuroscience
King's College London
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)207 848 0504
jackie.briskman@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 12/194/01
Study information
Scientific title
Helping Families: The Systematic Development and Pilot Randomised Controlled Trial of a Psychoeducational Intervention for Parents with Personality Disorders
Acronym
Study hypothesis
Does psychoeducational support for parental caregivers with personality disorders, who have children with severe emotional and behavioural problems, improve parental mental health and their children's emotional development?
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/1219401
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/118341/PRO-12-194-01.pdf
Ethics approval
The South East Coast - Brighton & Sussex Research Ethics Committee, 21/03/2016, REC ref: 16/LO/0199; IRAS project ID: 197474
Study design
Pragmatic phased design with iterative development of health technology; feasibility testing in linked case studies; and piloting in a two-arm parallel randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
In preparation
Condition
Personality disorders
Intervention
Two existing, validated psychoeducational health technologies will be used as the platform for the new technology:
1. Psycho-Education with Problem-Solving (PEPS), a psychoeducational programme for adults with personality disorder
2. The Helping Families Programme (HFP), a parenting programme for families with complex psychosocial difficulties
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Child mental health:
1. Strengths and Difficulties Questionnaire (SDQ)
2. Eyberg Child Behavior Inventory (ECBI)
3. Child Behavior Checklist-Internalising Scale (CBCL-Int)
4. Concerns About My Child (CAMC)
Parental mental health:
1. Symptom Checklist-27 (SCL-27)
Secondary outcome measures
1. Parenting satisfaction: Kansas Parental Satisfaction Scale (KPSS)
2. Parenting behaviour: Arnold-OLeary Parenting Scale
3. Treatment alliance: Working Alliance Inventory-Short-Revised (WAI-SR)
4. Quality-adjusted life years (QALYs): EQ-5D and EQ-5D-Y
5. Service use and costs: Client Service Receipt Inventory (CSRI)
Overall trial start date
01/06/2014
Overall trial end date
30/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Parent:
1. Primary parental caregiver for index child
2. Aged 18-65 years
3. Presence of any personality disorder
4. Proficient in written and spoken English
5. Capacity to provide informed consent to participate
Child:
1. Living at home with index parent
2. Aged 3-16 years
3. Presence of an emotional or behavioural disorder
4. Attending, or being considered for, CAMHS
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Pre-pilot feasibility study: N=12. Pilot RCT: N=70
Total final enrolment
48
Participant exclusion criteria
Parent:
1. Presence of psychosis
2. Engaged in individual or group psychotherapy directly related to personality disorder
3. Engaged in another structured parenting intervention
4. Receiving inpatient care
5. Insufficient language or cognitive abilities to participate fully in trial procedures
Child:
1. Presence of neurodevelopmental or psychotic disorder
2. Not residing with index parent
3. Considered for or subject to an application for care or supervision proceedings
Recruitment start date
01/04/2016
Recruitment end date
30/11/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
South London and Maudsley (SLaM) NHS Foundation Trust
London
SE5 8AZ
United Kingdom
Trial participating centre
Central and North West London NHS Foundation Trust
London
NW1 2PL
United Kingdom
Sponsor information
Organisation
South London & Maudsley NHS Foundation Trust (UK)
Sponsor details
Joint South London & Maudsley NHS Foundation Trust/Institute of Psychiatry Research Office
Room W1.11
Institute of Psychiatry
King's College London
De Crespigny Park
London
SE5 8AF
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme; ref. HTA 12/194/01
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Submission of peer-reviewed papers (to be made publicly available through open-access publication) and associated abstracts to relevant conferences, including scientific meetings of the British Psychological Society, Royal College of Psychiatrists, British and Irish Group for the Study of Personality Disorder (BIGSPD), and International Society for the Study of Personality Disorders (ISSPD). The trial protocol will also be published and made publicly available.
Research participants will receive an interim newsletter and final summary of findings. These will be co-produced by Service User Advisory Panel. We will also seek to disseminate findings through service user and public engagement events, such as national NIHR CRN events and local network meetings.
The Centre for Parent and Child Support (SLaM NHS Foundation Trust) will lead dissemination of outputs for services. Managers and practitioners will be invited to in-service seminars in the dissemination phase of the trial.
Intention to publish date
01/01/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32034024 (added 10/02/2020)
2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32174297 (added 17/03/2020)