Condition category
Mental and Behavioural Disorders
Date applied
18/03/2015
Date assigned
19/03/2015
Last edited
08/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Behavioural problems affect 5-10% of children, and children with established behavioural problems are at risk of significantly worse outcomes throughout their life. Parenting has been identified as a key mechanism of risk in the development of behavioural problems. Interventions (or treatments) that work with caregivers to improve parenting have been found to reduce behavioural problems, and have the potential to improve parental wellbeing. These interventions predominantly target mothers, despite accumulating evidence that interventions targeting two caregivers can be more effective than those involving just one. The proposed intervention, Video-Feedback Intervention to Promote Positive Parenting and Sensitive Discipline (ViPP-SD) is a brief video-feedback intervention derived from attachment and social learning theories. This is the first large-scale trial to test ViPP-SD in the UK. A key innovation is the extension of VIPP-SD to include both parents. The aim of the trial is to evaluate the effectiveness and cost-effectiveness of ViPP-SD in preventing enduring (long lasting) behavioural problems in young children aged 12-36 months.

Who can participate?
Parents of young children aged 12-36 months at risk of behavioural difficulties.

What does the study involve?
Participating families are randomly allocated into two groups. Those assigned to the intervention receive ViPP-SD and those assigned to the control group receive treatment as usual. In this study ViPP-SD is offered to two parents/caregivers, or one parent, depending on the family’s preferences. The programme is carried out in the participant’s home by trained professionals and involves six visits, lasting 90 minutes, at roughly fortnightly intervals. Each visit involves a video recording session, after which the recording from the previous visit is viewed and discussed with an emphasis on identifying and reinforcing positive interactions. Parents are supported in observing their child’s behaviour, empathising with their child, praising their child when they behave in a positive manner, and adopting optimal discipline strategies. Parents in both the intervention and control group are asked to meet with a member of the research team to complete assessments on three occasions: before they are assigned to a group, and four and twenty-four months after assignment. These assessments include questions about the child’s behaviour, parental wellbeing, and observations of parent-child interactions.

What are the possible benefits and risks of participating?
We cannot say with certainty that those families assigned to the intervention will benefit from the programme. However, parents in previous research have found it helpful and it has been shown to have a positive impact on parent-child interaction. There are no known risks to participation in the study. Participation does involve parents’ time for both the assessment and programme visits (both of which last about 90 minutes with some variation depending on whether one or two parents take part). The researchers and intervenors are trained to respond sensitively should parents feel uncomfortable or distressed for any reason. Participation is entirely voluntary and families can take a break or end their participation at any time.

Where is the study run from?
There are two NHS trusts that are currently participating: the lead site is Central and North West London (postcode of headquarters NW1 2PL and this includes two study sites Camden, and Hillingdon)and the second site is Whittington Health (postcode of headquarters N19 5NF).

When is the study starting and how long is it expected to run for?
April 2015 to October 2016

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

Who is the main contact?
Dr Christine O’Farrelly

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christine O'Farrelly

ORCID ID

Contact details

Imperial College London
Centre for Mental Health
Hamersmith Campus
Du Cane Road
London
W12 0NN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18423

Study information

Scientific title

Preventing enduring behavioural problems in young children through early psychological intervention: Healthy Start, Happy Start.

Acronym

Study hypothesis

Among children with high levels of behavioural problems aged 12-36 months, adding a brief video-feedback parenting intervention (ViPP-SD) to treatment as usual will reduce enduring behavioural problems measured at four months post-randomisation, using the Preschool Parent Account of Childhood Symptoms.

Ethics approval

NRES Riverside, 12/12/2014, ref: 14/LO/2071

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Children, Mental Health; Subtopic: All Diagnoses, Psychosis; Disease: Mental health issues personality and behavioural changes, All Diseases

Intervention

Video-Feedback Intervention to Promote Positive Parenting and Sensitive Discipline (ViPP-SD) aims to increase parental sensitivity and improve discipline practices in order to promote optimal parent-child interactions and prevent behavioural problems in young children. It has an established evidence base with positive treatment effects observed on parental sensitivity, discipline strategies, and child behaviour. The intervention is delivered in the home over six sessions at approximately fortnightly intervals. Each session involves filming parent-child interactions and giving parents feedback based on these video clips. There are four core sessions, which aim to enhance the caregiver’s capacity to identify the child’s exploratory behaviour and attachment cues and to respond to them appropriately. Two further booster sessions repeat the key messages using continuing video interaction material at each session. A key aspect of the intervention is its positive emphasis, and the intervention has been shown to have high levels of parental acceptability. The intervention will be delivered by trained, supervised health professionals, predominantly health visitors. Participants randomised to the intervention will be offered ViPP-SD for one or two caregivers.
Follow Up Length: 24 month(s); Study Entry : Single Randomisation only

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Child behaviour measured using the Preschool Parent Account of Childhood Symptoms.; Timepoint(s): Pre-treatment and four and twenty-four months post-treatment.

Secondary outcome measures

1. Child behaviour measured using the Child Behaviour Checklist; Timepoint(s): Pre-treatment and four and twenty-four months post-treatment
2. Child behaviour measured using the Strengths and Difficulties Questionnaire; Timepoint(s): Pre-treatment and four and twenty-four months post-treatment
3. Parental anxiety measured using the Generalized Anxiety Disorder 7; Timepoint(s): Pre-treatment and four and twenty-four months post-treatment
4. Parental couple functioning measured using the Revised Dyadic Adjustment Scale; Timepoint(s): Pre-treatment and four and twenty-four months post-treatment
5. Parental mood measured using the Patient Health Questionnaire 9; Timepoint(s): Pre-treatment and four and twenty-four months post-treatment
6. Parenting practices measured using the Parenting Scale; Timepoint(s): Pre-treatment and four and twenty-four months post-treatment
7. Resource use measured using a modified version of the Child and Adolescent Service Use Schedule; Timepoint(s): Pre-treatment and four and twenty-four months post-treatment

Overall trial start date

01/10/2014

Overall trial end date

31/03/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Child aged between 12-36 months
2. Child scores in the top 20% for behavioural problems on the Strengths and Difficulties Questionnaire (SDQ), based on population norms.
3. Written informed parental consent

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

Planned Sample Size: 300; UK Sample Size: 300; Description: 1. 150 receiving the intervention2. 150 receiving standard care/treatment as usual

Participant exclusion criteria

1. Child has severe sensory impairment or learning disability
2. Carer has insufficient English language to complete questionnaire assessments
3. Siblings participating in the trial
4. Families participating in active court proceedings

Recruitment start date

15/04/2015

Recruitment end date

31/10/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Central and North West London NHS trust
London
NW1 2PL
United Kingdom

Trial participating centre

Whittington Health NHS trust
N19 5NF
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
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

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes