Healthy Start, Happy Start: helping parents with children's behaviour
| ISRCTN | ISRCTN58327365 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58327365 |
| Secondary identifying numbers | 18423 |
- Submission date
- 18/03/2015
- Registration date
- 19/03/2015
- Last edited
- 20/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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 study to test ViPP-SD in the UK. A key innovation is the extension of VIPP-SD to include both parents. The aim of the study is to assess 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?
It is not known for certain 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?
Central and North West London and Whittington Health NHS Trusts (UK)
When is the study starting and how long is it expected to run for?
April 2015 to December 2021 (updated 25/01/2021, previously: December 2019)
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Christine O’Farrelly
Contact information
Scientific
Imperial College London
Centre for Mental Health, Hamersmith Campus
Du Cane Road
London
W12 0NN
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | Preventing enduring behavioural problems in young children through early psychological intervention: Healthy Start, Happy Start |
| 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(s) | NRES Riverside, 12/12/2014, ref: 14/LO/2071 |
| 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 |
| Primary outcome measure | 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 study start date | 01/10/2014 |
| Overall study end date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | Planned Sample Size: 300; UK Sample Size: 300; Description: 1. 150 receiving the intervention 2. 150 receiving standard care/treatment as usual |
| Total final enrolment | 300 |
| 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 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 | 31/07/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
NW1 2PL
United Kingdom
United Kingdom
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
RM13 8GQ
United Kingdom
Fulbourn Hospital
Cambridgeshire
CB21 5EF
United Kingdom
United Kingdom
Sponsor information
University/education
Joint Research Compliance Office
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/11/2017 | Yes | No | |
| Results article | SWAT results | 15/10/2020 | 22/10/2020 | Yes | No |
| Results article | results | 15/03/2021 | 16/03/2021 | Yes | No |
| Results article | 01/05/2021 | 24/05/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
20/09/2021: Internal review.
24/05/2021: Publication reference added.
16/03/2021: Publication reference added.
28/01/2021: The following changes were made to the trial record:
1. The participant level data was changed from ‘not expected to be available’ to ‘available on request’.
2. The publication and dissemination plan was added.
25/01/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2019 to 31/12/2021.
2. The intention to publish date
3. The plain English summary was updated to reflect these changes.
4. The total final enrolment was added.
5. The trial participating centre
22/10/2020: Publication reference added.
20/11/2017: Publication reference added.
31/07/2017: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2016 to 31/07/2017.
2. The overall trial end date was changed from 31/03/2019 to 31/12/2019.
