Evaluation of the impact and implementation of the Parents and Children Together (PACT) programme

ISRCTN	ISRCTN16848772
DOI	https://doi.org/10.1186/ISRCTN16848772
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	RH2
Sponsor	Education Endowment Foundation
Funder	Education Endowment Foundation

Submission date: 17/07/2019
Registration date: 26/07/2019
Last edited: 10/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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?
Victoria Menzies
victoria.menzies@durham.ac.uk

Contact information

Mrs Victoria Menzies
Public

Caedmon Building
Durham University
Leazes Road
Durham
DH1 1TZ
United Kingdom

Phone	+44 (0)191 3344242
Email	victoria.menzies@durham.ac.uk

Study information

Primary study design	Interventional
Study design	Within-school two-armed randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Independent evaluation of Parents and Children Together
Study acronym	PACT
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	Nurseries attached to schools, located in areas of social deprivation (as identified by low Indices of Multiple Deprivation rankings)
Intervention	Current interventions: Randomisation will be implemented at the pupil level. All children with parental consent to participate will be tested before randomisation, at the post-test and at a 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 with 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. Due to Covid-19 restrictions which came into place during this trial, there was disruption to the delivery of the interventions from March 2019. There was a 2-month delay to the 6th pack of PACT materials being dispatched to the nurseries. There was also a change to the home environment for families in the trial both in the control and intervention groups during Covid-19 with children not attending school or other childcare and adults often working from home or being in the home being furloughed. Previous interventions: Randomisation will be implemented at the pupil level. All children with parental consent to participate will be tested before randomisation, at the post-test and at a 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 with 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
Primary outcome measure(s)	Current primary outcome measure: Due to Covid-19, there were changes to the primary outcome measure. It was impossible to collect any primary outcome data at the post-test due to Covid-19 restrictions. Instead, the primary outcome was collected only at delayed post-test and was changed to "Language Skills assessed by the latent language variable combining 4 subscales from the LanguageScreen Assessment (Expressive Vocabulary, Receptive Vocabulary, Listening Comprehension, Sentence Repetition)" using the initially planned baseline language latent variable described below. Previous 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).
Key secondary outcome measure(s)	Current secondary outcome measure: Due to Covid-19, there were changes made to the secondary outcome measures: 1. HLE was collected at Baseline and post-test but the measure had to be adapted to be suitable to the Covid-19 context when libraries were shut. An additional measure of the HLE was added in November 2020 after the intervention was complete. 2. It was not possible to collect CELF-PreSchool-2 data at post-test or delayed post-test. Instead, we used the individual subscales of the LanguageScreen assessment (Expressive Vocabulary, Receptive Vocabulary, Listening Comprehension, Sentence Repetition) as secondary outcomes at delayed post-test only. 3. It was not possible to collect any assessment of Early Literacy Skills as face-to-face visits to settings were not possible. 4. School readiness was measured by BESSI as planned at delayed post-test. Previous secondary outcome measure: 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
Completion date	31/10/2021

Eligibility

Participant type(s)	Other
Age group	Child
Sex	All
Target sample size at registration	450
Total final enrolment	450
Key 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
Key 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
Date of first enrolment	10/01/2019
Date of final enrolment	30/09/2019

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Durham University

School of Education
Durham
DH1 1TA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in repository
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Funder report results	results	15/12/2022	09/01/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 1.0	26/07/2019	01/09/2022	No	No
Protocol file	version 2.1	09/11/2021	01/09/2022	No	No
Statistical Analysis Plan	version 2.1	26/07/2021	01/09/2022	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN16848772_Protocol_v1.0_26Jul19.pdf: Protocol file
ISRCTN16848772_Protocol_v2.1_09Nov21.pdf: Protocol file
ISRCTN16848772_SAP_V2.1_26Jul21.pdf: Statistical Analysis Plan

Editorial Notes

10/01/2023: A public contact was removed.
09/01/2023: The following changes have been made:
1. Publication reference added.
2. The interventions have been changed.
3. The primary outcome measures have been changed.
4. The secondary outcome measures have been changed.
5. The main contact in the plain English summary has been updated.
6. The publication and dissemination plan has been changed.
7. The intention to publish date has been changed from 01/12/2020 to 01/06/2022.
01/09/2022: The following changes have been made:
1. The study protocol (not peer reviewed) has been uploaded as additional files.
2. The statistical analysis plan (not peer reviewed) has been uploaded as an additional file.
16/12/2019: The recruitment end date was changed from 06/09/2019 to 30/09/2019.
21/10/2019: Total final enrolment number added.
26/07/2019: Trial's existence confirmed by ethics committee.