Condition category
Mental and Behavioural Disorders
Date applied
23/02/2018
Date assigned
05/03/2018
Last edited
07/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The Incredible Years preschool course is for parents with children aged 3-5 years who have behavioural problems. It helps parents to adopt a positive approach incorporating praise, play, use of incentives, predictable routines, boundaries and strategies to manage challenging behaviour. Parents learn how to prepare their children for school, working more closely with early years professionals to develop emotional regulation and social skills. The aim of this study is to find out whether the Incredible Years Programme is effective for families.

Who can participate?
Parents/carers with children aged 0-5 years who have attended the Incredible Years Programme, Incredible Years trained practitioners/Family Support Workers, Incredible Years operational and project leads, and Local Authority commissioners

What does the study involve?
Parents/carers attend 14 weekly sessions of 2.5 hours duration with childcare provided in local children’s centres. Incredible Years facilitators work with parents to improve emotional and social functioning and address, reduce and prevent aggression and behavioural problems. The course uses video clips depicting real life scenarios to encourage group discussion, problem solving and sharing of ideas and experiences. Parents receive manuals and group materials throughout the course in addition to home assignments. Interviews are also conducted with parents after the Programme to understand the extent to which they feel they have been helped. Incredible Years group facilitators, managers and local authority commissioners are interviewed regarding the implementation of Incredible Years.

What are the possible benefits and risks of participating?
Previous research suggests that Incredible Years helps parents to make positive changes in their family relationships. The interviews allow participants to give their views on Incredible Years. There are no anticipated risks, but there is a protocol in place to signpost parents to additional support/advice if required, and the researcher is available afterwards for debriefing if necessary.

Where is the study run from?
1. University of Bedfordshire (UK)
2. Flying Start (UK)

When is the study starting and how long is it expected to run for?
February 2016 to November 2018

Who is funding the study?
1. University of Bedfordshire (UK)
2. Flying Start (UK)

Who is the main contact?
Dr Rosemary Davidson
rosemary.davidson@beds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rosemary Davidson

ORCID ID

http://orcid.org/0000-0002-0010-4809

Contact details

Institute for Health Research
University of Bedfordshire
University Square
Luton
LU1 3JU
United Kingdom
+44 (0)7966676974
rosemary.davidson@beds.ac.uk

Type

Scientific

Additional contact

Prof Gurch Randhawa

ORCID ID

http://orcid.org/0000-0002-2289-5859

Contact details

Institute for Health Research
University of Bedfordshire
Putteridge Bury Campus
Hitchin Road
Luton
LU2 8LE
United Kingdom
-
gurch.randhawa@beds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FS_IY

Study information

Scientific title

Reduction and prevention of aggression and behavioural problems in disadvantaged pre-school children: a Process and Outcome Evaluation of the Incredible Years Programme, Luton, UK

Acronym

IY

Study hypothesis

Incredible Years aims to improve parent-child relationships through positive interaction. The Programme has been shown to prevent, reduce and treat aggression and emotional problems in other countries.

Ethics approval

University Research Ethics Committee, University of Bedfordshire, 07/06/2017, ref: UREC107

Study design

Process and outcome evaluation of a single-centre targeted intervention

Primary study design

Interventional

Secondary study design

Process evaluation

Trial setting

Community

Trial type

Prevention

Patient information sheet

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

Condition

Prevention, reduction and treatment of aggression and emotional problems in pre-school children

Intervention

The Incredible Years pre-school course is designed for families living in disadvantaged areas with children aged 3-5 years who are showing early onset behaviour problems. The programme consists of 14 weekly sessions of 2.5 hours duration with childcare provided. Incredible Years facilitators work with parents to improve emotional and social functioning and address, reduce and prevent aggression and behavioural problems. The course uses video clips depicting everyday scenarios to encourage group discussion, problem solving and sharing of ideas and experiences. Parents receive manuals and group materials throughout the course in addition to home assignments. Programme fidelity is maintained with a standardized training process involving peer review, videotape feedback and consultation.

The study design is a process and outcome evaluation using a mixed method approach. The process evaluation aims to understand how and why the intervention was adopted, drivers and barriers to implementation and the role of context. With respect to Incredible Years, this will involve semi-structured interviews with families, staff and stakeholders throughout the delivery of Incredible Years.

The outcome evaluation will measure the progress of families who attend the Incredible Years Programme. Pre and post Programme measures are: Children’s behaviour (Strengths and Difficulties questionnaire); Emotional well-being (Adult well-being scale); Parenting skills (Parenting Daily Hassles scale); Parental self-efficacy (TOPSE tool).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Measured pre and post Programme (14 weeks):
1. Children’s behaviour, assessed using the Strengths and Difficulties questionnaire
2. Emotional well-being, assessed using the Adult well-being scale
3. Parenting skills, assessed using the Parenting Daily Hassles scale
4. Parental self-efficacy, assessed using the TOPSE tool
5. Parent attendance, monitored by facilitators over the 14 week duration of the course and reasons for absence noted where possible

Secondary outcome measures

1. Positive and negative aspects, ways they can improve, group dynamics, and group reactions/responses, reviewed by Group Facilitators after each session
2. Overall impressions of Incredible Years including changes observed in parents and any challenges identified, reviewed by Facilitators at the end of the Programme
3. Parental feedback, collected with an anonymous appraisal at the end of the Programme

Overall trial start date

01/02/2016

Overall trial end date

01/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Parents/carers with children 0-5 years who have attended the Incredible Years Programme
2. Incredible Years trained practitioners/Family Support Workers
3. Incredible Years operational and project leads
4. Local Authority commissioners

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Persons with no experience of Incredible Years
2. Persons with no experience of working in the early years sector

Recruitment start date

01/03/2018

Recruitment end date

01/07/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute for Health Research
University of Bedfordshire University Square
Luton
LU1 3JU
United Kingdom

Trial participating centre

Flying Start
The TOKKO Building 7 Gordon Street
Luton
LU1 2PQ
United Kingdom

Sponsor information

Organisation

Institute for Health Research

Sponsor details

University of Bedfordshire
University Square
Luton
LU1 3JU
United Kingdom

Sponsor type

University/education

Website

Organisation

Flying Start Luton

Sponsor details

The TOKKO Building
7 Gordon Street
Luton
LU1 2QP
United Kingdom

Sponsor type

Government

Website

https://www.flyingstartluton.com

Funders

Funder type

University/education

Funder name

University of Bedfordshire

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

Flying Start Luton

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study protocol is available on request. Planned publication of one process article in a high-impact peer reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

15/08/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/06/2018: Prof Gurch Randhawa has been added as a scientific contact