Enhancing Social and Emotional Health in the Early Years
| ISRCTN | ISRCTN11079129 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11079129 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/04/2015
- Registration date
- 11/05/2015
- Last edited
- 09/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Behavioural and mental illness has become a public health crisis. There is a strong link between parent and child wellbeing. Incredible Years (IY) group-based parent programmes aim to promote social and emotional wellbeing in children aged 0 to 12 years. Reliable evidence for IY children aged over 3 years demonstrates increased child social and emotional wellbeing, fewer behavioural difficulties and, importantly, a positive impact on parent wellbeing – a major risk factor for healthy child development. However, few programmes and little evidence exist for the 0 to 2 year age range. So, in this study we aim to investigate whether the IY-Infant and IY-Toddler (0 to 2 years) programmes are effective (and cost-effective) in enhancing child social and emotional wellbeing at 20 months of age compared to usual care.
Who can participate?
Parents and co-parents of children aged 0 to 2 months.
What does the study involve?
Before the main study we will conduct an 18-month pilot study across two areas in the UK. The main study will follow this, lasting 30 months and involving four areas of the UK. Participants will be allocated at random either to receive usual care, or to receive access to some part of the Incredible Years programme. All families on the study will be asked to complete surveys and be videoed with their child during visits to their home by researchers. Those allocated to receive a level of the Incredible Years programme will receive different levels/types of the programme depending on their level of need, which will be assessed by completion of a mental health questionnaire. Those allocated to receive Incredible Years will all get an Incredible Years (IY) book, and may be offered either or both of the IY-Infant (8 to 10 weeks; 2 hours per week) and IY-Toddler (12 weeks; 2 hours per week) programmes, depending on the results of the questionnaire. Involvement of families in the study will last 18 months (until the child is 20 months old) and at the last home visit parents and co-parents will be asked to complete the final surveys, including in relation to the child’s social and emotional well-being. Linked projects will take place during the pilot study and the main study to consider how best Incredible Years could be offered in the future, and to compare the results of our research with other similar research in the UK and abroad.
What are the possible benefits and risks of participating?
Through taking part in the study the parents and co-parents may benefit from learning new parenting skills, which could in turn improve the future health and wellbeing of their child. This research may also help to improve family and children’s services for other similar families both in their area and across the country. This is because the Incredible Years programmes will be available more widely if shown to be effective. We do not believe that there are any risks to families taking part in this study.
Where is the study run from?
University of York (UK)
When is the study starting and how long is it expected to run for?
February 2015 to June 2020
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Sarah Blower (sarah.blower@york.ac.uk)
Dr Tracey Bywater (tracey.bywater@york.ac.uk)
Contact information
Public
Department of Health Sciences
Seebohm Rowntree Building
University of York
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0002-9168-9995 |
|---|---|
| Phone | +44 (0)1904 328107 |
| sarah.blower@york.ac.uk |
Scientific
Department of Health Sciences
Seebohm Rowntree Building
University of York
York
YO10 5DD
United Kingdom
Study information
| Study design | Two-phase randomized controlled trial (RCT) comprising an 18-month internal pilot conducted in two research sites and a 30-month pragmatic two-arm RCT conducted in four sites (the original two pilot sites plus two additional sites) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Location-dependant participant information sheets available, please use the contact details to request copies |
| Scientific title | Enhancing Social-Emotional health and wellbeing in the Early Years: a community-based randomised controlled trial and economic evaluation of the Incredible Years infant and toddler (0-2) parenting programmes |
| Study acronym | E-SEE (Enhancing Social-Emotional health and wellbeing in the Early years) |
| Study objectives | The key research question is: are the Incredible Years Book and Infant (IY-I) and Toddler (IY-T) programmes, when delivered in dose proportionate to need and when compared to services as usual (SAU), effective and cost-effective in enhancing child social and emotional wellbeing at 20 months of age? |
| Ethics approval(s) | 1. University of York Education Ethics Committee, 10/08/2015, ref: FC15/03 2. UK NHS Research Ethics Committee Wales REC 5, 22/05/2015, ref: 15/WA/0178 |
| Health condition(s) or problem(s) studied | Children's mental health |
| Intervention | We plan an 18-month internal pilot randomised controlled trial (RCT) leading to a definitive 30-month RCT. Participants will be randomly allocated to Incredible Years (IY) or service as usual (SAU) according to level of need based on primary carer depression scores and gender of child and primary carer. Intervention parents will receive an IY-Infant (IY-I) book (universal level) followed by an IY-I programme (8 to 10 weeks; 2 hours/ week) and/or IY-Toddler (12 weeks; 2 hours/ week) dependent on level of need at data collection points 2 and 3. Control parents will receive services as usual. |
| Intervention type | Behavioural |
| Primary outcome measure | Child Primary Outcome (primary outcome for the study): Social and emotional wellbeing – to establish effectiveness at each and all Incredible Years dose levels, using parent report Ages & Stages Questionnaire – Social Emotional (ASQ:SE-2) (measured at baseline and 2, 9 and 18 months post-baseline) Parent Primary Outcome (key secondary outcome for the study): Depression – to establish effectiveness at each and all Incredible Years dose levels, using the parent report Patient Health Questionnaire (PHQ-9) (measured at baseline and 2, 9, and 18 months post-baseline) |
| Secondary outcome measures | Current secondary outcome measures as of 06/02/2020: Child Secondary Outcomes: 1. Behaviour – measured at 18-month follow-up using the Strengths and Difficulties Questionnaire (SDQ) 2. Attachment – using the CARE Index (measured at baseline and 2, 9, and 18 months post-baseline) 3. Cognitive development – measured at 18-month follow-up using parent report PedsQL Infant Scale 4. Health (quality of life) – measured at 18-month follow-up using parent report PedsQL Infant Scale 5. Service use –using parent report: Client Service Receipt Inventory (CSRI) (measured at baseline and 2, 9, and 18 months post-baseline) Parent Secondary Outcomes: 1. Carer-child attachment/interaction – measured at 18-month follow-up using parent report Maternal Postnatal Attachment Scale (MPAS) and/or Paternal Postnatal Attachment Scale (PPAS) 2. Parenting skill – using parent report Parent Sense of Competence (PSOC) (measured at baseline and 2, 9 and 18 months post-baseline) 3. Health Related Quality of Life (HRQoL) –using parent report EQ5D5L (measured at baseline and 2, 9 and 18 months post-baseline) 4. Service use – using parent report CSRI (measured at baseline and 2, 9, and 18 months post-baseline) 5. Demographics – using bespoke parent report demographics form capturing key information on age, ethnicity, religion, income, marital status, parent/co-parent education (measured at baseline and 2, 9 and 18 months post-baseline, with a shorter version used for all appointments except baseline). Measures for the economic evaluation: 1. Service use – using parent report CSRI (measured at baseline and 2, 9 and 18 months post-baseline) Measures for the process evaluation: 1. Facilitators’ adherence to core components – standard, weekly-completed, self-rated Incredible Years checklists 2. Implementation fidelity – researcher-rated Parent Programme Implementation Checklist (PPIC), which comprises indices for adherence, dose/exposure, quality of delivery and participant responsiveness, observations conducted at a random subset of meetings. 3. Parent/co-parent satisfaction – standard Incredible Years parent satisfaction questionnaires are also completed after each session, and at the end of each programme. 4. Acceptability and feasibility of the intervention - focus groups and semi-structured interviews with key stakeholders including parents and professionals, using developed topic guides, after the programmes have been delivered. _____ Previous secondary outcome measures: Child Secondary Outcomes: 1. Behaviour – measured at 18-month follow-up using parent report Eyberg Child Behaviour Inventory (ECBI) 2. Attachment – using the CARE Index (measured at baseline and 2, 9, and 18 months post-baseline) 3. Cognitive development – measured at 18-month follow-up using parent report PedsQL Infant Scale 4. Health (quality of life) – measured at 18-month follow-up using parent report PedsQL Infant Scale 5. Service use –using parent report: Client Service Receipt Inventory (CSRI) (measured at baseline and 2, 9, and 18 months post-baseline) Parent Secondary Outcomes: 1. Carer-child attachment/interaction – measured at 18-month follow-up using parent report Maternal Postnatal Attachment Scale (MPAS) and/or Paternal Postnatal Attachment Scale (PPAS) 2. Parenting skill – using parent report Parent Sense of Competence (PSOC) (measured at baseline and 2, 9 and 18 months post-baseline) 3. Health Related Quality of Life (HRQoL) –using parent report EQ5D5L (measured at baseline and 2, 9 and 18 months post-baseline) 4. Service use – using parent report CSRI (measured at baseline and 2, 9, and 18 months post-baseline) 5. Demographics – using bespoke parent report demographics form capturing key information on age, ethnicity, religion, income, marital status, parent/co-parent education (measured at baseline and 2, 9 and 18 months post-baseline, with a shorter version used for all appointments except baseline). Measures for the economic evaluation: 1. Service use – using parent report CSRI (measured at baseline and 2, 9 and 18 months post-baseline) Measures for the process evaluation: 1. Facilitators’ adherence to core components – standard, weekly-completed, self-rated Incredible Years checklists 2. Implementation fidelity – researcher-rated Parent Programme Implementation Checklist (PPIC), which comprises indices for adherence, dose/exposure, quality of delivery and participant responsiveness, observations conducted at a random subset of meetings. 3. Parent/co-parent satisfaction – standard Incredible Years parent satisfaction questionnaires are also completed after each session, and at the end of each programme. 4. Acceptability and feasibility of the intervention - focus groups and semi-structured interviews with key stakeholders including parents and professionals, using developed topic guides, after the programmes have been delivered. |
| Overall study start date | 01/02/2015 |
| Completion date | 30/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 869 parent-child dyads |
| Total final enrolment | 341 |
| Key inclusion criteria | 1. Have the main parental responsibility for a child <8 weeks at initial engagement 2. Be willing to participate in the research 3. Be willing to be randomised and, if allocated to intervention, be able to receive Incredible Years services offered 4. Not be enrolled on another group parent programme at sign-up |
| Key exclusion criteria | 1. The child has obvious or diagnosed organic or child developmental difficulties 2. Do not have the main parental responsibility for a child <8 weeks at initial engagement 3. Are not willing to participate in the research 4. Are not willing to be randomised and, if allocated to intervention, to receive Incredible Years services offered 5. Are enrolled on another group parent programme at sign-up |
| Date of first enrolment | 05/11/2015 |
| Date of final enrolment | 05/09/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Village Green Lane
Preston
PR2 7DS
United Kingdom
10 Duke Street
Blackburn
BB2 1DH
United Kingdom
Hill Lane
Whipton
Exeter
EX1 3JP
United Kingdom
Bittern Road
Sowton
Exeter
EX2 7FW
United Kingdom
Harrogate
HG2 7SX
United Kingdom
Southampton
SO16 4XE
United Kingdom
8 Russell Road
Ipswich
IP1 2BX
United Kingdom
Northallerton
DL7 8AD
United Kingdom
Sponsor information
University/education
Research Innovation Office
Innovation Centre
York Science Park
Heslington
York
YO10 5DG
England
United Kingdom
| Website | http://www.york.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/04m01e293 |
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 | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The E-SEE study has developed a publication policy and a core publication group. The publication policy contains guidelines on how to approach authorship and a publication plan. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 19/12/2018 | Yes | No | ||
| Results article | 04/04/2022 | 05/04/2022 | Yes | No | |
| Interim results article | pilot trial results | 12/06/2021 | 11/05/2022 | Yes | No |
| Plain English results | Video summary of findings | 11/05/2022 | No | Yes | |
| Other publications | economic evaluation | 23/06/2022 | 24/06/2022 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Dataset | 04/04/2022 | 05/06/2024 | No | No | |
| Results article | 01/06/2022 | 05/06/2024 | Yes | No | |
| Other publications | 30/12/2024 | 09/06/2025 | Yes | No |
Editorial Notes
09/06/2025: Publication reference added.
05/06/2024: Publication reference and dataset added.
24/06/2022: Publication reference added.
11/05/2022: The following changes have been made:
1. Publication reference added.
2. A plain English summary of the results of this trial has been uploaded.
3. The trial website has been changed from http://e-see-trial.org to https://www.york.ac.uk/healthsciences/research/public-health/projects/e-see-trial/.
05/04/2022: Publication reference added.
28/07/2021: The intention to publish date was changed from 31/07/2021 to 31/12/2021.
15/07/2020: The total final enrolment was added.
02/04/2020: The primary outcome measures were updated to clarify primary outcome and key secondary outcome for the study.
06/02/2020: The following changes were made to the trial record:
1. The secondary outcome measures were changed.
2. The trial participating centres were added: Harrogate District Hospital, Western Community Hospital, Suffolk County Council, North Yorkshire County Council Children and Young People's Service.
02/01/2019: Publication reference added.
23/10/2018: The recruitment end date has been changed from 10/08/2018 to 05/09/2018
03/08/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2018 to 10/08/2018.
2. The overall trial end date was changed from 31/07/2019 to 30/06/2020.
3. The intention to publish date was changed from 31/07/2020 to 31/07/2021.
16/04/2018: The recruitment end date was changed from 31/07/2017 to 30/06/2018.
05/04/2016: The study contact addresses have been updated and Virgin Care Ltd. has been added as a trial participating centre.
30/03/2016: Ethics approval information added. The recruitment start date has also been updated from 03/08/2015 to 05/11/2015.
