Condition category
Mental and Behavioural Disorders
Date applied
02/04/2015
Date assigned
11/05/2015
Last edited
05/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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?
From February 2015 to July 2019.

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)

Trial website

http://e-see-trial.org

Contact information

Type

Public

Primary contact

Dr Sarah Blower

ORCID ID

http://orcid.org/0000-0002-9168-9995

Contact details

Department of Health Sciences
Seebohm Rowntree Building
University of York
York
YO10 5DD
United Kingdom
+44 (0)1904 328107
sarah.blower@york.ac.uk

Type

Scientific

Additional contact

Prof Tracey Bywater

ORCID ID

Contact details

Department of Health Sciences
Seebohm Rowntree Building
University of York
York
YO10 5DD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

E-SEE (Enhancing Social-Emotional health and wellbeing in the Early years)

Study hypothesis

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

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

Study design

Two-phase randomised 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

Trial setting

Community

Trial type

Prevention

Patient information sheet

Location-dependant participant information sheets available, please use the contact details below to request copies

Condition

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

Phase

Drug names

Primary outcome measures

Child Primary Outcome:
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:
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

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 trial start date

01/02/2015

Overall trial end date

31/07/2019

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

869 parent-child dyads

Participant 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

Recruitment start date

05/11/2015

Recruitment end date

31/07/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Lancashire Care NHS Foundation Trust
Ingol Health Centre Village Green Lane
Preston
PR2 7DS
United Kingdom

Trial participating centre

Blackburn with Darwen Borough Council
Children's Services Department 10 Duke Street
Blackburn
BB2 1DH
United Kingdom

Trial participating centre

Action for Children
Care of Whipton Children's Centre Hill Lane Whipton
Exeter
EX1 3JP
United Kingdom

Trial participating centre

Virgin Care Ltd.
Capital Court Bittern Road Sowton
Exeter
EX2 7FW
United Kingdom

Sponsor information

Organisation

University of York

Sponsor details

Research Innovation Office
Innovation Centre
York Science Park
Heslington
York
YO10 5DG
United Kingdom

Sponsor type

University/education

Website

http://www.york.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.