Condition category
Mental and Behavioural Disorders
Date applied
20/11/2017
Date assigned
21/11/2017
Last edited
21/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Parents with a personality disorder have long-term severe difficulties in managing their emotions and their relationships with others. This can lead to problematic parenting and child protection concerns, and places their children at elevated risk of long-term social and mental health difficulties. By the time they are 18 months old, children who have a parent with personality disorder are six times more likely to have problems managing their emotions and behaviour than other children. By age 14, 45% have experienced a major depressive episode. Offering additional parenting support while their children are still infants could prevent their children developing mental health problems, disrupting the intergenerational cycle of difficulties. However, there is no evidence on what interventions could be helpful for parents with personality disorder. Research with other vulnerable families has shown a brief six-session video-feedback intervention can improve parenting skills and child behaviour problems, by helping parents understand and respond sensitively to their child’s behaviour. The present research will therefore establish whether parents with enduring difficulties in managing their emotions and relationships, consistent with a personality disorder, consent to and complete this video feedback intervention, how they think it could be improved, and whether it is feasible to test it in a larger trial in the future. We will first pilot the intervention in eight parents, then randomly assign 20 parents to receive video feedback in addition to their usual treatment, and 20 to receive usual treatment alone. We will interview the parents about their experiences of the intervention and the research, and use their feedback to decide how to adapt the intervention and whether to test it in a larger trial in the future. An advisory group of parents with personality disorder will oversee the research, providing guidance throughout. The aim of this study is to evaluate the feasibility and acceptability of conducting a randomised controlled trial of the video feedback intervention for Positive Parenting (ViPP) versus treatment as usual in parents experiencing difficulties in managing emotions and relationships consistent with a personality disorder and who are a primary caregiver of a child aged six-36 months.

Who can participate?
Adults aged 16 to 35 who are a primary caregiver of a child aged 6-36 months old who have experienced enduring difficulties in managing emotions and relationships, consistent with personality disorders.

What does the study involve?
In Phase 1 of the study, all participants receive six Baby Behaviour and Bonding sessions and the researchers give participants some questionnaires before and afterwards, and ask for participant’s feedback, in order to improve the way the Baby Behaviour and Bonding sessions and the research is done. In Phase 2 of the study, participants are randomly allocated to one of two groups. Those in the first group receive six Baby Behaviour and Bonding sessions. Those in the second group receive a Baby Behaviour and Bonding Information booklet. The researchers give participants some questionnaires before and afterwards, and ask for participant’s feedback, in order to improve the way the Baby Behaviour and Bonding sessions, the Baby Behaviour and Bonding Information booklet.

What are the possible benefits and risks of participating?
The research is at an early stage and therefore it cannot be said with certainty that taking part will be of benefit. However, the information given to participants and the Baby Behaviour sessions have been used in research studies previously and parents have found it helpful. The disadvantages of taking part are likely to be small. If a participant is allocated to receive the Baby Behaviour sessions they would need to put some time aside for these appointments. Some people can find it embarrassing to watch clips of themselves and can start to feel self-critical or worry that others will judge them. The health professionals conducting the visits are specially trained to be aware of this and to help participants deal with these feelings.

Where is the study run from?
This study is being run by the Centre for Psychiatry, Central and North West London NHS Foundation Trust and takes place in Mental Health Services in the greater London area.

When is the study starting and how long is it expected to run for?
June 2017 to May 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Kirsten Barnicot
k.barnicot@imperial.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Kirsten Barnicot

ORCID ID

Contact details

Senior Research Fellow
CNWL & Imperial College London
Centre for Psychiatry
Commonwealth Building
London
W12 0NN
United Kingdom
+44 7933 995 456
k.barnicot@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

34179

Study information

Scientific title

Boosting Baby Behaviour and Bonding: A feasibility trial of video feedback versus treatment as usual to reduce the risk of behaviour problems in the children of parents with enduring difficulties in managing their emotions and relationships, consistent with a personality disorder

Acronym

BOOST

Study hypothesis

The aim of this study is to evaluate the feasibility and acceptability of conducting a randomised controlled trial of the Video feedback intervention for Positive Parenting (ViPP) versus treatment as usual in parents experiencing difficulties in managing emotions and relationships consistent with a personality disorder and who are a primary caregiver of a child aged six-36 months.

Ethics approval

London - Camden & Kings Cross Research Ethics Committee, 22/05/2017, ref: 17/LO/0669

Study design

Randomised; Interventional; Design type: Treatment, Prevention, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

See additional files (Phase 2)

Condition

Specialty: Mental health, Primary sub-specialty: Personality Disorders; UKCRC code/ Disease: Mental Health/ Disorders of adult personality and behaviour

Intervention

The first phase of the research (Phase 1) uses an uncontrolled pilot trial design in which the Baby Behaviour and Bonding (ViPP) intervention is piloted in eight parents with enduring difficulties in managing their emotions and behaviour, consistent with a personality disorder, and their feedback is used to modify intervention delivery in order to increase the feasibility and acceptability of the intervention.

Once 8 parents have received the intervention and their feedback has been gained and used to modify the protocol for intervention delivery, Phase 2 will commence.

Phase 2 of the research uses a parallel group randomised controlled feasibility trial design in an additional 40 parents with enduring difficulties in managing their emotions and behaviour, consistent with a personality disorder. 20 parents are allocated to receive the intervention (Baby Behaviour and Bonding (ViPP) sessions, Behaviour and Bonding Information and treatment as usual) and 20 are allocated to the control condition (Baby Behaviour and Bonding Information and treatment as usual). This allows establishment of objective indices of feasibility and acceptability for the intervention: the proportions consenting, completing the intervention, and completing the trial, and the acceptability and variance of the proposed outcome measures.

Intervention condition: Six 90 minute Baby Behaviour and Bonding sessions using the Video-feedback Intervention to promote Positive Parenting (ViPP), to be delivered approximately every two weeks over a three to five month period. ViPP is a manualised intervention which provides parenting feedback based on videoed interactions between parent and child. ViPP helps parents to recognise, understand and respond sensitively to their child’s behaviour. Positive and non-judgemental feedback is used to focus on parents’ strengths and help them feel confident in their parenting. Additional elements are incorporated into the training for clinicians delivering the intervention, to help them focus on building trust and addressing parents’ concerns around feeling judged. Sessions are primarily delivered in participants’ homes but clinicians and participants may request to hold the sessions in the clinic if this is more feasible. The therapists receive monthly supervision from a certified ViPP supervisor. Participants receiving the intervention also access treatment as usual from perinatal, adult mental health and/or social services during the trial. Some participants may disengage from services during the trial, and in order to meet the ethical requirement to provide support given the potential difficulties faced by themselves and their children, all participants receive the Baby Behaviour and Bonding information booklets developed by the NSPCC (Handle with care: A guide to keeping your baby safe. NSPCC, 2013; All babies count: Support for parents, NSPCC, 2013; Encouraging better behaviour: A practical guide to positive parenting. NSPCC, 2013.) These booklets contain practical advice on holding babies, coping with crying, dealing with difficult behaviour, looking after your own emotional health, and where to go for additional help.

Control condition: Control participants are allocated to receive treatment as usual from perinatal, adult mental health and/or social services including medication management, monitoring and psychological therapy as deemed appropriate by the clinician responsible for their care. For the ethical reasons stated above, all participants also receive the Baby Behaviour and Bonding information booklets developed by the NSPCC (Handle with care: A guide to keeping your baby safe. NSPCC, 2013; All babies count: Support for parents, NSPCC, 2013; Encouraging better behaviour: A practical guide to positive parenting. NSPCC, 2013.) These booklets contain practical advice on holding babies, coping with crying, dealing with difficult behaviour, looking after your own emotional health, and where to go for additional help.

Participants are followed up at five months and eight months after randomisation to assess the feasibility of the study.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Percentage of participants in the treatment arm receiving and completing the intervention, measured as attending ≥ 4 sessions, by the time of the 8 month post-randomisation follow-up.

Secondary outcome measures

1. Percentage of potentially eligible participants consenting to be contacted by researchers, measured as the % of parents with a child aged 6 to 36 months who clinicians deem potentially eligible and give information about the research, who consent to be contacted by the researchers
2. Percentage of eligible participants consenting to participate, measured as the % of parents meeting the study inclusion criteria who consent to take part in the research
3. Percent completing the outcome measures at each follow-up, measured as the % of participants completing all outcome measures at the 5 month follow-up, and the % of participants completing all outcome measures at the 8 month follow-up
4. Pre-post effect sizes and confidence intervals on outcomes relating to child socioemotional health, parenting competencies and parental mental health for participants receiving ViPP versus participants receiving treatment as usual, assessed at the baseline, 5 month and 8 month follow-up using the Child Behaviour Checklist (for children aged >= 12 months only) , Brief Infant-Toddler Socio-emotional Assessment, Infant-Toddler Symptom Checklist, Parental Sense of Competence Scale, Parental Stress Scale, CORE, Emotional Availability Scale and Complex PTSD Scale

Overall trial start date

01/06/2017

Overall trial end date

31/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Experience enduring difficulties in managing emotions and relationships, consistent with personality disorder
2. Primary caregiver of a child aged 6-36 months
3. Capable of giving informed consent
4. Aged 16 to 65

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 48; UK Sample Size: 48

Participant exclusion criteria

1. A sibling or co-parent is participating in the trial
2. The eligible child has a clinical diagnosis of a learning difficulty, developmental disorder or sensory impairment
3. The eligible parent has English language or learning difficulties that are sufficiently severe to prevent them completing study measures even with assistance

Recruitment start date

01/06/2018

Recruitment end date

01/07/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College London
Centre for Psychiatry Central and North West London NHS Foundation Trust 7th Floor Commonwealth Building Du Cane Road
London
W12 0NN
United Kingdom

Trial participating centre

Hillingdon Perinatal Mental Health Service
Riverside Centre Pied Heath Road Uxbridge
London
UB8 3NN
United Kingdom

Trial participating centre

Northwick Park Hospital Antenatal Clinic
Brent & Harrow Perinatal Mental Health Service Watford Road Harrow
London
HA1 3UJ
United Kingdom

Trial participating centre

Coombe Wood Unit
Brent & Harrow Perinatal Mental Health Service Park Royal Mental Health Centre Acton Lane
London
NW10 7LF
United Kingdom

Trial participating centre

Kensington, Chelsea & Westminster Perinatal Mental Health Service
South Wharf Road
London
W2 1NY
United Kingdom

Trial participating centre

Hackney Perinatal Mental Health Service
Homerton Row
London
E9 6SR
United Kingdom

Sponsor information

Organisation

Central and North West London NHS Foundation Trust

Sponsor details

1st Floor Bloomsbury Building
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/05/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes