Effectiveness evaluation of the Incredible Years Toddler programme
| ISRCTN | ISRCTN49991769 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49991769 |
| Secondary identifying numbers | 01 |
- Submission date
- 18/01/2023
- Registration date
- 03/04/2023
- Last edited
- 28/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
There is evidence to suggest that a poor parent-infant relationship is associated with the ability of a child to regulate their own behaviour. In addition, parent-child attachment and parental sensitivity are important for the development of children’s social and emotional competence, cognitive functioning, physical health, and mental health. Children with insecure attachments or experiences of low parental sensitivity are more at risk for negative outcomes in these domains.
The Incredible Years (IY) parent programmes (https://incredibleyears.com/) are parent education and training interventions which are informed by social learning theory and designed to enhance the social and emotional wellbeing of children aged 0-12 years. The more recently developed Toddler (IY-T) version, for 1-3-year-olds, is an adapted version of the preschool BASIC programme. Parents learn more effective strategies for dealing with unwanted child behaviour when they have opportunities to practise and perceive themselves as effective in using them. Effective parenting strategies help the child learn how to better manage his or her emotions and behaviour.
IY Toddler has an evidence rating of 2+ by the Early Intervention Foundation (EIF), which means it has evidence of improving a child outcome from a study involving at least 20 participants, representing 60% of the sample, using validated instruments. Previous research suggests that IY Toddler may have positive benefits for children and families. There have been two studies demonstrating immediate positive results. These studies looked at outcomes up to 12 months later. IY-T has relatively little evidence in comparison to the other IY programmes. Further, evaluation is required to understand the longitudinal effects of IY Toddler on child outcomes in England with an ethnically diverse, disadvantaged, population.
IY-T is currently being delivered by Barnardo’s in the Better Start Bradford (BSB) programme (https://www.betterstartbradford.org.uk/). Born in Bradford’s Better Start (BiBBS) is an interventional birth cohort study that runs in parallel to BSB, and is designed to support the evaluation of the effectiveness of early life interventions. All mothers and children in the BiBBS cohort have in-depth baseline data captured during pregnancy and consent to routine linkage to their health and education records. As a part of the consent to BiBBS, mothers agree to the information about them being used to evaluate interventions.
This study aims to:
1. Establish if IY-T is effective in improving child social and emotional development at age 5 (primary outcome) when compared to services as usual
2. Establish if IY-T is effective in improving children’s early years school skills at age 5 (secondary outcome) when compared to services as usual
3. Establish whether the impact of IY-T on the above outcomes is moderated by (a) child age, (b) programme delivery mode (online versus face to face), (c) socioeconomic status, and (d) ethnicity
4. Estimate the cost of the intervention (including delivery and training to deliver Incredible Years)
5. Provide a description of the costs and outcomes in the IY group and where possible a no-intervention comparator
Who can participate?
Parents of children aged between 12 and 36 months who have either enrolled or not enrolled in IY-T. To be eligible for this evaluation, participants must be in the BiBBS cohort. Whilst not all participants that enrol in the intervention will be BiBBS participants, all participants in the analysed intervention and matched comparison group will be BiBBS participants.
What does the study involve?
This study will compare outcomes for BiBBS children whose parents have taken part in IY-T to BiBBS children whose parents have not taken part in IY-T. It will explore the effects of IY-T on children’s Early Years Foundation Stage Profiles (EYFSP), and conduct an economic evaluation.
What are the possible benefits and risks of participating?
There are no anticipated additional risks or benefits as all processes are a part of standard midwifery care and all data collection has been undertaken as a part of the existing BiB/BiBBS studies. All study staff are trained in Good Clinical Practice and provide opportunities for signposting to relevant services.
Where is the study run from?
Better Start Bradford, Better Start Bradford Innovation Hub (UK)
When is the study starting and how long is it expected to run for?
September 2018 to August 2028
Who is funding the study?
1. The National Lottery Community Fund (UK)
2. National Institute for Health and Care Research (UK)
Who is the main contact?
Kate E Mooney, kate.mooney@york.ac.uk
Contact information
Principal Investigator
Department of Health Sciences
Seebohm Rowntree Building
University of York
York
YO30 5DD
United Kingdom
 ORCID ID |
0000-0002-9168-9995 |
|---|---|
| Phone | +44 (0)1904 321312 |
| sarah.blower@york.ac.uk |
Public
Department of Health Sciences
Seebohm Rowntree Building
University of York
York
YO10 5DD
United Kingdom
| ORCID ID |
0000-0003-4231-1643 |
|---|---|
| Phone | +44 (0)1904 321312 |
| kate.mooney@york.ac.uk |
Scientific
Department of Health Sciences
Seebohm Rowntree Building
University of York
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 321312 |
|---|---|
| kate.mooney@york.ac.uk |
Study information
| Study design | Quasi-experimental longitudinal study design using an intervention and matched control group in a single centre |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Quasi-experimental evaluation of the Incredible Years Toddler programme for improving children's socioemotional development at age 5: a Born in Bradford's Better Start (BiBBS) cohort study |
| Study objectives | 1. Establish if the Incredible Years Toddler programme (IY-T) is effective at improving child social and emotional development at age 5 (primary outcome) when compared to services as usual 2. Establish if IY-T is effective in improving children’s early years school skills at age 5 (secondary outcome) when compared to services as usual 3. Establish whether the impact of IY-T on the above outcomes is moderated by (a) child age, (b) programme delivery mode (online versus face to face), (c) socioeconomic status, and (d) ethnicity 4. Estimate the cost of the intervention (including delivery and training to deliver Incredible Years) 5. A description of the costs and outcomes in the IY group and where possible a no-intervention comparator |
| Ethics approval(s) | Approved 02/11/2015, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (Room 001, Jarrow Business Centre, Viking Industrial Park Rolling Mill Road, Jarrow, NE32 3DT, UK; +44 (0)207 104 8083, +44 (0)207 104 8210; bradfordleeds.rec@hra.nhs.uk), ref: 15/YH/0455 |
| Health condition(s) or problem(s) studied | Prevention of parental distress resulting in child conduct and behavioural disorder |
| Intervention | This study will compare outcomes for BiBBS children whose parents have taken part in IY-T to BiBBS children whose parents have not taken part in IY-T. It will explore the effects of IY-T on children’s Early Years Foundation Stage Profiles (EYFSP), and conduct an economic evaluation. Within Incredible Years Toddler (IY-T), parents learn how to help their toddlers feel loved and secure, encourage social and emotional development, and establish strategies for developing routines, handling separation, and managing misbehaviour (The Incredible Years, 2013). Parents/carers receive three promotional contacts prior to the beginning of the group via assertive outreach, consisting of telephone contact and at least one home visit. The initial telephone contact introduces the parents to the project and Group Facilitators and aims to build the participants' confidence in attending. The home visits are intended to create a sense of rapport between the family and Group Facilitators and alleviate any barriers that families might have in accessing the group such as crèche, language difficulties or concerns about what the group might involve. For more detail on the content and delivery of the IY-T intervention, please see the online information and materials here: https://incredibleyears.com/programs/. The IY-T theory of change and logic model developed by Barnardo’s states that IY-T will result in improvements in child social and emotional development over the medium and long term. This is thought to translate into children entering school with improved language and communication skills. Following this, children would have better literacy and language throughout school, and better achievement on leaving primary school. This logic model was developed the reflex the local BSB implementation. The intervention will be delivered in a combination of face-to-face and virtual formats (dependent on lockdown rules in place at the time of the study and participant needs). |
| Intervention type | Behavioural |
| Primary outcome measure | The primary outcome is the child’s Early Years Foundation Stage (EYFS) profile which will be linked to individual BiBBS children through their routine education records. The EYFS profile is completed by teachers for children when they reach age 5 years of age, at the end of their term in reception. It contains 17 Early Learning Goals (ELGs) relating to different areas of learning (Department for Education, 2021). Children are assigned a score of either “Emerging” (not reaching expected levels) or “Expected” (reaching expected levels) for each ELG. For the primary outcome (child social and emotional development), the researchers will examine only the most relevant ELGs to IY-T. These are the ‘communication and language’ and ‘personal, social, and emotional’ development areas, with a total of five goals. The binary responses for each of these six goals will be summed to generate a summary score between 0 and 5. |
| Secondary outcome measures | Child early years development: the binary responses for each of the 17 ELGs will be used to generate a summary score, where a total score between 0 and 17 will indicate how many of all the ELGs were assigned a score of ‘expected’. Measured when children reach age 5 years of age. |
| Overall study start date | 01/09/2018 |
| Completion date | 31/08/2028 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1336 (ratio of 1:3, intervention:control) |
| Key inclusion criteria | Eligibility criteria for the intervention group: 1. Consented to be a part of BiBBS 2. Parent consented to a referral and enrolled in IY-T Eligibility for the matched comparison group: 1. Consented to be a part of BiBBS 2. Parent of a child aged between 12 and 36 months at any time in the duration of service delivery (to ensure that matched cases are comparable) 3. Parent has not been referred or enrolled in IY-T at any timepoint |
| Key exclusion criteria | Participant is not currently enrolled in BiBBS cohort study |
| Date of first enrolment | 01/08/2018 |
| Date of final enrolment | 31/05/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
BD5 9NP
United Kingdom
Sponsor information
Hospital/treatment centre
Research Management and Support Office
Bradford Institute for Health Research
Duckworth Lane
Bradford
BD9 6RJ
England
United Kingdom
| Phone | +44 (0)1274382575 |
|---|---|
| jane.dennison@bthft.nhs.uk | |
| Website | https://bradfordhospitals.nhs.uk |
"ROR" |
https://ror.org/05gekvn04 |
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Big Lottery Fund
- Location
- United Kingdom
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 | 01/08/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | A protocol for this study is being submitted for publication in the coming months. It will be uploaded to ISRCTN if published. An academic publication in a peer-reviewed journal is planned. Findings will also be shared at relevant conferences where possible. Policy briefings will be collated for local services, commissioners, and national policymakers to share key findings. Summary findings for the community and participants will be co-produced with the Community Research Advisory Group to ensure accessibility. Different modes of sharing will be considered (e.g. videos, social media, local press channels). |
| IPD sharing plan | Researchers are encouraged to make use of the BiB data, which are available through a system of managed open access. Before contacting the researchers, please read the Guidance for Collaborators (https://borninbradford.nhs.uk/research/guidance-for-collaborators/). The BiB executive review proposals on a monthly basis and will endeavour to respond to requests as soon as possible. Find out about the different datasets in the Data Dictionary (https://borninbradford.github.io/datadict/) or contact a member of the BiB team (borninbradford@bthft.nhs.uk). Once you have formulated your request please complete the ‘Expression of Interest’ form available here (https://borninbradford.nhs.uk/wp-content/uploads/BiB_EoI_v3.1_10.05.21.doc) and send it to borninbradford@bthft.nhs.uk. If the request is approved you will be asked to sign a Data Sharing Contract (https://borninbradford.nhs.uk/wp-content/uploads/BIHR-Data-Sharing-Contract.docx) and a Data Sharing Agreement (https://borninbradford.nhs.uk/wp-content/uploads/BIHR-Data-Sharing-Agreement.docx), and if the request involves biological samples you will need to complete a material transfer agreement (https://borninbradford.nhs.uk/wp-content/uploads/BiB-Material-Transfer-Agreement-v4-0.docx). Born in Bradford (BiB) is a longitudinal research project. The aim of BiB is to work out why some people have good health or well-being, while others have difficulties. To do this, BiB collects information from participants about all aspects of their lives at different ages using surveys, research clinics and other assessments. BiB also gathers information about families from other sources, such as health records, or environmental records. BiB processes the data to make sure it is accurate, well organised, and to make it so that no person can be identified from the data. BiB then shares this processed data with scientists conducting research with potential public benefit. These scientists can be based anywhere in the world. The data that is available to be shared can be seen here: https://borninbradford.github.io/datadict/bibbs/ |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 27/09/2023 | 28/09/2023 | Yes | No |
Editorial Notes
28/09/2023: Publication reference added.
23/01/2023: Trial's existence confirmed by Better Start Bradford.
