Condition category
Not Applicable
Date applied
17/07/2019
Date assigned
26/07/2019
Last edited
26/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Past research has demonstrated the importance of oral language skills and their link to learning to read. Children from low income backgrounds are at risk of delayed language development and educational disadvantage. Interventions that promote oral language in the early years have the possibility to improve children’s learning and development, particularly for those from deprived backgrounds. Parents and Children Together (PACT) is a parent-delivered early language teaching programme that aims to help preschool children learn new words, listen to and talk about stories, understand and tell stories, and enjoy books and reading. This study aims to evaluate how well the PACT programme works.

Who can participate?
Pre-school children (3-4 years old), their parents/carers, and nursery staff

What does the study involve?
Nursery children are randomly allocated to either a PACT group (who get the programme) or a comparison group (who do not get the programme). The children's language skills are tested at the start and end of the project to see if there was any difference between the two groups. The 30-week programme consists of six 5-week teaching ‘blocks’ that each encompass a different theme which aligns to common early-years themes including: (1) Animals, (2) The World Around Us, (3) Journeys, (4) The Body, (5) Home, and (6) Places and People. Each PACT ‘block’ includes four storybooks including traditional stories (e.g. The Gingerbread Man), well known modern classics (e.g. The Gruffalo), fact-based storybooks (e.g. The Pond) and books that may be new/unfamiliar to families (e.g. 5 Minutes Peace). Each book has an activity book including all activities and related resources to enable parents/carers to deliver a scripted 20 minutes interactive learning session, five times a week. Each block also contains a ‘Bringing it all Together’ activity book which features consolidation and theme-level activities. Each PACT session should last around 20 minutes and should include all listed activities and should follow a consistent structure and routine. The content of weeks 1-4 activities focuses on introducing new content, and week five encourages parents/carers and children to revise and build on learning from the previous 4 weeks. Nominated caregivers are requested to complete a daily record form through a mobile application to gauge session completion and whether the pair enjoyed it. In any cases where families are unable to use the mobile app, paper copies of this form will be provided.

What are the possible benefits and risks of participating?
Possible benefits include improving the language development, early literacy skills, home learning environment and school readiness of children aged 3-4 years old. There are no potential risks.

Where is the study run from?
The PACT developer team are based at Manchester and will be responsible for recruiting for the trial and running the PACT intervention. The PACT Evaluation team are based at Durham and University and are responsible for the implementation and process evaluation.

When is the study starting and how long is it expected to run for?
July 2018 to October 2021

Who is funding the study?
Education Endowment Foundation (UK)

Who is the main contact?
Helen Cramman
helen.cramman@durham.ac.uk

Trial website

https://sites.manchester.ac.uk/pct/

Contact information

Type

Public

Primary contact

Mrs Victoria Menzies

ORCID ID

Contact details

Caedmon Building
Durham University
Leazes Road
Durham
DH1 1TZ
United Kingdom
+44 (0)191 3344242
victoria.menzies@durham.ac.uk

Type

Public

Additional contact

Dr Helen Cramman

ORCID ID

Contact details

Caedmon Building
Durham University
Leazes Road
Durham
DH1 1TA
United Kingdom
+44 (0)191 3344242
Helen.cramman@durham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

RH2

Study information

Scientific title

Independent evaluation of Parents and Children Together

Acronym

PACT

Study hypothesis

Implementing PACT with children aged three and four years old has a positive impact on their early language skills, early reading skills, home learning environment and school readiness, compared to not offering the PACT programme.

Ethics approval

Approved 12/12/2018, Durham University School of Education Ethics Committee (School of Education, Durham University, Leazes Road, Durham, DH1 1TA, UK; Tel: +44 (0)191 33448403; Email: ed.ethics@durham.ac.uk)

Study design

Within-school two-armed randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Other

Patient information sheet

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

Condition

Nurseries attached to schools, located in areas of social deprivation (as identified by low Indices of Multiple Deprivation rankings)

Intervention

Randomisation will be implemented at pupil level. All children who have parental consent to participate will be tested prior to randomisation, at post-test and at 10-month delayed post-test.

The control group receives no intervention but will proceed with ‘business at usual’. Those pupils randomised into the intervention group will receive the PACT programme. The 30-week programme consists of six 5-week teaching ‘blocks’ that each encompass a different theme which aligns to common early-years themes including: (1) Animals, (2) The World Around Us, (3) Journeys, (4) The Body, (5) Home, and (6) Places and People.

Each PACT ‘block’ includes four storybooks including traditional stories. Each book has a corresponding activity book including all activities and related resources to enable parents/carers to deliver a scripted 20 minutes interactive learning session, five times a week. Each block also contains a ‘Bringing it all Together’ activity book which features consolidation and theme-level activities.

For five days every week, parents will deliver the prescribed PACT activity with their child. The activities follow the principles of dialogic reading; parents encourage their children to take an active role in reading through linking the story to the child's interests and asking questions. Parents help the children to re-tell the story, describe what is happening and learn new vocabulary from the story.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Language development assessed by the latent language variable combining Clinical Evaluation of Language Fundamentals Preschool 2 UK (CELF- Preschool UK – sentence structure and expressive vocabulary subscales), The British Picture Vocabulary Scale (BPVS-3), Action Picture Test (APT) and Listening Comprehension (created by developer team). These measures will be carried out at baseline (September 2019), post-test (June/July 2020) and 10-month delayed post-test (May 2021).

Secondary outcome measures

Assessments will be carried out during any of the following timepoints: Baseline (September 2019), post-test (June/July 2020) and 10 month delayed post-test (May 2021):
1. Child’s home learning environment assessed by the Home Learning Environment Index (HLE) at baseline and post-test
2. Language development measured by the CELF-PreSchool-2 at baseline, post-test and delayed post-test
3. Early literacy skills measured by letter sound knowledge, early word reading and sound deletion, taken from York Assessment for Reading Comprehension (or YARC). This will be measured at baseline, post-test and delayed post-test
4. School readiness measured by the Brief Early Skills & Support Index (BESSI) measured at delayed post-test only

Overall trial start date

01/07/2018

Overall trial end date

31/10/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Eligible nurseries must be state-funded
2. Eligible nurseries must be located in areas high scores on the Indices of Multiple Deprivation
3. Eligible nurseries must agree to the study requirements outlined in the Memorandum of Understanding (MoU)
4. Eligible nurseries must agree to and sign a project-specific Data Sharing Agreement
5. Eligible children must be three or due to turn three by September 2019, and pre-registered to start nursery in September 2019
6. Eligible children must have a member of the family with a basic level of English (so must be able to access resources)
7. Eligible children cannot have (step)sibling within the same academic year
8. Eligible children cannot have suspected or diagnosed developmental or learning difficulty

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

450 participants (45 schools)

Participant exclusion criteria

1. Schools who are not state-funded
2. Schools not in areas with high scores on Indices of Multiple Deprivation
3. Schools who do not agree to the Memorandum of Understanding
4. Schools who do not agree to and sign the project-specific Data Sharing Agreement
5. Children who are not three or due to turn three by September 2019, and pre-registered to start nursery in September 2019
6. Children who do not have have a member of the family with a basic level of English (so are unable to access resources)
7. Children with a (step)sibling within the same academic year
8. Children with suspected or diagnosed developmental or learning difficulty

Recruitment start date

10/01/2019

Recruitment end date

06/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Durham University
School of Education
Durham
DH1 1TA
United Kingdom

Sponsor information

Organisation

Education Endowment Foundation

Sponsor details

9th Floor
Millbank Tower
21-23 Millbank
London
SW1P 4QP
United Kingdom
+44 (0)207 802 1676
info@eefoundation.org.uk

Sponsor type

Charity

Website

https://educationendowmentfoundation.org.uk/

Funders

Funder type

Charity

Funder name

Education Endowment Foundation

Alternative name(s)

EEF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The protocol will be published on the webpage below. The Statistical Analysis Plan will be published online on the same webpage as the protocol within three months of randomisation (anticipated to be by February 2020).

https://educationendowmentfoundation.org.uk/projects-and-evaluation/projects/pact-parents-and-children-together/

The main report for the evaluation project will be published in December 2020 by the Education Endowment Foundation (EEF) and will be available on their website. The EEF will also publish a report addendum in December 2021.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a repository.
Repository name: Fischer Family Trust (FFT) and the UK Data Archive.
Type of data stored: The dataset stored in the Fischer Family Trust (FFT) Archive will include a pupil identifier, school identifier, information about pupil context (gender, date of birth/age at testing, Early Years Pupil Premium Status, treatment allocation (intervention or control), primary and secondary test outcomes at pre and post-test, and delayed post-test. Additionally, another dataset will be used for inclusion in a publicly available repository via the UK Data Archive. This will include ID for participant and school but care will be taken to remove any method of identifying individual schools and participants.
Data anonymization: Data going into the Fischer Family Trust (FFT) archive will not be anonymised. This will be used for long-term follow up of students and the impact of the intervention over time. The funder may also choose to carry out additional analyses on these data. Data going into the UK Data Archive will be anonymised; age at pre-test to the nearest month will be the only age identifier. Further information on the specifics of anonymisation and how this data will be accessed will be made available at a later date.
Whether consent from participants was obtained/any ethical or legal restrictions: The legal basis for data processing for this project is public task; however, ethically ‘consent’ will be sought from parents for their child’s information to be linked with the National Pupil Database (NPD) (held by the Department for Education) and shared with EEF, and their data contractor The FFT archive for long term follow up of pupil progress by EEF. No sensitive personal information will be shared outside of Durham University.

Intention to publish date

01/12/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

26/07/2019: Trial's existence confirmed by ethics committee.