Condition category
Not Applicable
Date applied
17/11/2017
Date assigned
16/01/2018
Last edited
12/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A lot has been written about how to evaluate programmes to establish if they are effective in achieving their aims. However there is little guidance on how to actually work with organisations to identify which programmes they offer are suitable for evaluation and the steps involved in setting up those evaluations. Research evaluating programmes or interventions rarely discuss the steps involved prior to evaluation to identify suitable projects for evaluation and describe the steps required, often with academic institutions working in partnership with external organisations, to set up an evaluation. The aim of this study is to help determine the steps used to evaluate projects.

Who can participate?
Children under five as well as stakeholders working on the identified interventions.

What does the study involve?
Four interventions have been identified as a consequence of following the steps outlined in this protocol. Sign 4 Little Talkers/Big Feelings teaches sign language and stories for pre-school children during a two month intervention period. Data is collected at baseline and after two months. Follow-up visits are conducted up to three months post intervention delivery. The HENRY programme is an 8 week course for parents with children with concerns regarding weight and eating habits. Surveys containing a number of behavioural measures are completed at the end of the 8 week course and again after 3 months. Incredible Years is a 14 week programme for parents with children with behavioural problems. Parents fill in behavioural measures at the beginning and end of the course, and are followed up after 3 months. Parents as Partners is a 16 week course offering group counselling to parents to improve couple relationships to in turn improve child wellbeing and developmental outcomes. Relationship measures are taken at the beginning and end of the course and 3 months afterwards.

What are the possible benefits and risks of participating?
As this protocol details the stages required prior to setting up evaluations, participants are not involved and consequently there are no direct benefits or risks. Any impact on participants would be anticipated when each programme identified by the steps described in this protocol is described in detail in separate, forthcoming protocols.

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

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

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

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

Trial website

Contact information

Type

Public

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
+44 796 667 6974
rosemary.davidson@beds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UoB_FS_EvProto_4Projects

Study information

Scientific title

Steps to Process and Outcomes Evaluation: The Flying Start Luton approach

Acronym

STEPS

Study hypothesis

Much has been written about how to evaluate projects, yet there is little on the steps required prior to this to identify suitable projects for evaluation. This is particularly salient when working in the community with partner organisations who wish their provision to be evaluated in order to build an evidence base and rationale behind their work.

Ethics approval

This is a protocol to allow evaluators to get to the stage where they can identify projects and thereafter seek ethical approval to evaluate a specific project, therefore no ethical approval is needed at this stage. Ethical approval will be sought for the next stage of the evaluation, where the projects have been identified, allowing us to give specific details to ethics committees.

Study design

Observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Community

Trial type

Quality of life

Patient information sheet

No participant information sheet available, however forthcoming participant information sheets will be made available for each intervention identified as a consequence of this evaluation approach.

Condition

Early years health and well-being.

Intervention

Four interventions have been identified as a consequence of following the steps outlined in this protocol. Sign 4 Little Talkers/Big Feelings teaches sign language and stories for pre-school children during a two month intervention period. Data is collected at baseline and after two months. Follow-up visits are conducted up to three months post intervention delivery. The HENRY programme is an 8 week course for parents with children with concerns regarding weight and eating habits. Surveys containing a number of behavioural measures are completed at the end of the 8 week course and again after 3 months. Incredible Years is a 14 week programme for parents with children with behavioural problems. Parents fill in behavioural measures at the beginning and end of the course, and are followed up after 3 months. Parents as Partners is a 16 week course offering group counselling to parents to improve couple relationships to in turn improve child wellbeing and developmental outcomes. Relationship measures are taken at the beginning and end of the course and 3 months afterwards.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Sign 4
1. Listening and Attention, Speaking, Managing Feelings & Behaviour, and Understanding are measured using Early Years Outcomes at baseline and 6 month follow-up

HENRY
1. Self reported measures relating to parenting skills and healthy lifestyles are taken at baseline and 3 month follow-up.

Incredible Years
1. Children’s behaviour is measured using the Strengths & Difficulties questionnaire at baseline and 14 weeks

Parents as Partners
1. Parenting style is measured using the Revised Parenting Index at baseline and 16 weeks

Secondary outcome measures

Sign 4
1. Children’s well-being is measured using Leuven Well-being scales at baseline and 6 month follow-up.

HENRY
1. Group facilitator and parental views of HENRY sessions are measured using surveys and interviews at 8 weeks and 3 month follow-up

IY
1. Group facilitator and parental views of Incredible Years sessions are measured using surveys and interviews at 14 weeks

Parents as Partners
1. Group facilitator and parental views of Parents as Partners sessions are measured using surveys and interviews at 14 weeks

Overall trial start date

05/05/2016

Overall trial end date

01/11/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Participants are children under five as well as stakeholders working on the identified interventions.

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

200

Participant exclusion criteria

Any other human participants who do not fit the inclusion criteria detailed above.

Recruitment start date

05/05/2017

Recruitment end date

01/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Trial participating centre

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

Sponsor information

Organisation

University of Bedfordshire

Sponsor details

University Square
Luton
LU1 3JU
United Kingdom

Sponsor type

University/education

Website

https://www.flyingstartluton.com

Organisation

Flying Start Luton

Sponsor details

The TOKKO Building
7 Gordon Street
Luton
LU1 2QP
United Kingdom
+44 1582 548356
flyingstart@luton.gov.uk

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

Steps to Evaluation article submitted to BMC Medical Research Methodology awaiting response.
Two outcome and four process evaluation articles are planned from the subsequent evaluation of the projects selected in the above protocol.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rosemary Davidson (rosemary.davidson@beds.ac.uk).

Intention to publish date

16/01/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes