Condition category
Not Applicable
Date applied
05/09/2018
Date assigned
07/09/2018
Last edited
14/02/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Children from poorer backgrounds often start school with low language ability and attention difficulties, impacting on their school achievement, employment prospects and subsequently on their health. Teams of health professionals (speech and language therapists, occupational therapists, physiotherapists and behaviour specialists) provide school-based programmes to support children with these difficulties, but there is limited evidence of their effectiveness.
Recall to Enhance Children’s Attention, Language and Learning (RECALL) is an intervention that targets working memory (WM), attention and language skills in 4- 5 year olds. RECALL includes a range of small group and whole-class activities that have been shown to improve WM i.e. sound awareness tasks, complex WM tasks and fantastical play. The programme consists of six, 40-minute sessions that are repeated three times per week for 6 weeks (18 sessions in total). The first session each week will be delivered by the health professionals who will model the activities for the teachers so that they can deliver the two further practice sessions.
The aim of this study is to investigate whether it will be possible to conduct a large-scale research study to investigate the effectiveness of RECALL. In this feasibility study, we aim to investigate:
1. The acceptability of the novel RECALL programme to the health professionals and teachers who deliver it.
2. Whether the programme is delivered as frequently as required and in the way intended
3. Whether we can recruit enough participants to the study
4. Participants' views on the research process
5. Whether comparing RECALL to an existing intervention is appropriate
6. How WM, attention and language skills are typically supported in the classroom (education as usual)
7. Appropriateness and acceptability of the measures used to assess the children's WM, attention and language skills

Who can participate?
1. Health professionals from multi-disciplinary, school-based therapy teams in one region of the UK, Northern Ireland (NI)
2. Six schools in areas of low socio-economic status in NI that have expressed concerns about children's attention and language skills. In each school, one class of year one children (4- 5 year olds) their teachers and classroom assistants will take part.
3. Ten children in each class and their parents/guardians and teachers will be recruited. They will be purposefully selected as follows:
3.1. Five children about whom teachers have concerns around listening and communication skills but do not have a diagnosed developmental or learning difficulty
3.2. Two children with diagnosed developmental or learning difficulties
3.3. Three typically developing children who do not have any identified listening and communication problems

What does the study involve?
RECALL will be compared to an existing programme and to no-intervention (education as usual). The six participating classes will be randomly allocated as follows:
1. Two classes will receive RECALL
2. Two classes will receive a programme currently used by the multidisciplinary school-based teams in NI. This programme has the same number of sessions, duration and format as RECALL and will be delivered in the same way.
3. Two classes will receive their usual education with no additional programme
The teachers in the two intervention groups will not be informed about which programme they will receive. We will measure children’s WM, attention and language skills before and after the six-week programme using standardised assessments, a teacher rating of attention skills and a parent rating of communication skills. Direct assessments with the children will be administered by a trained research assistant who will not be told about which intervention they received. At the end of the study, we will explore the health professionals' and teachers' experiences of the programme using short interviews.

What are the possible benefits and risks of participating? (what can participants gain from enrolling, are there any side effects of the treatments and if so, what are the symptoms?)
Participation in this study has potential benefits for the health professionals, education staff and children involved. Prior to delivering the RECALL programme, the health professionals will attend a two-day course that is likely to develop their professional practice. Teachers' knowledge and skills should be enhanced through observing and collaborating with the health professionals. We anticipate that children's skills WM, attention and language skills will be improved by RECALL.
This is a low risk study and no additional potential harm is associated with the research compared to the everyday activity of the participants. Through the whole-class sessions, it is possible that children with neurodevelopmental difficulties may be identified by the health professionals. In this instance the teacher will be advised about an appropriate service to which the child could be referred and asked to seek parental consent prior for referral.

Where is the study run from?
Ulster University (Northern Ireland, UK)

When is the study starting and how long is it expected to run for?
January 2018 to June 2019

Who is funding the study?
Research and Development Division of the Public Health Agency, Northern Ireland (UK)

Who is the main contact?
Anita Rowe
harron-a@ulster.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Anita Rowe

ORCID ID

http://orcid.org/0000-0002-2758-5585

Contact details

Institute of Nursing and Health Research
Ulster University
Shore Road
Newtownabbey
Co Antrim
Northern Ireland.
Belfast
BT37 0QB.
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18/0036

Study information

Scientific title

A school-based intervention targeting working memory, attention and language skills in 4-5 year olds (RECALL): a cluster randomised feasibility trial

Acronym

RECALL

Study hypothesis

There has been speculation that working memory (WM) training, embedded within typical educational activities, may improve children’s WM skills and produce transfer effects to real-world skills such as attention and language. However, little is known about the effectiveness of this approach. ‘Recall to Enhance Children’s Attention, Language and Learning’ (RECALL) is a novel, six-week, whole-class intervention targeting WM, attention and language skills in 4–5 year olds. This feasibility study will explore the acceptability of RECALL to the health professionals and teachers who will deliver it and the feasibility of conducting a large-scale definitive randomised controlled trial of its effectiveness.

Ethics approval

Ulster University Research Ethics Committee, 06/06/2018, REC/18/0036

Study design

Interventional multi-centre three-arm cluster randomised feasibility trial

Primary study design

Interventional

Secondary study design

Cluster randomised feasibility trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

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

Condition

Working memory, attention and language difficulties in children

Intervention

Current:
Randomisation is at the school (cluster) level. The six schools will be randomised to each arm of the trial: 2 will receive RECALL, 2 will receive the active control intervention (ALP), and 2 will receive education as usual (control group). This will be conducted by the schools’ names being placed in opaque, sealed envelopes, which will be selected by an independent person from within the researchers’ institute. Randomisation will occur after baseline data collection with the children.
The school participants (principal, teachers and classroom assistants) and parents/guardians in the two intervention groups will be blinded to their group allocation. Blinding of the health professionals to the schools’ allocation will not be possible as the teams will inevitably know which intervention they are delivering. The risk of this influencing the outcomes will be minimised by the blinding of the research assistant (RA) who will be collecting the outcomes data.
The experimental RECALL and active control interventions both incorporate small group and whole-class activities designed to be fun for young children. The programmes are comparable in their structure, format and dosage (intervention frequency and duration). They consist of six, 40-minute sessions that are repeated three times per week for 6 weeks (18 sessions in total). The first session each week will be delivered by the health professionals who will model the activities for the teachers so that they can deliver the two further practice sessions.
The experimental RECALL programme is a theoretically underpinned, multi-component, manualised intervention that explicitly targets working memory (WM) skills. WM is the ability to hold in mind and mentally manipulate information for short periods of time in the face of distraction. RECALL incorporates evidence-based tasks that are all executive-loaded in nature i.e., the tasks require attentional and processing resources under executive control (not just the simple storage of information). The intervention tasks include: direct, complex WM training; phoneme awareness training; fantastical play; and games targeting inhibitory control.
The active control intervention does not explicitly target WM and is not underpinned by WM theory. It aims to improve children’s attention and listening skills through repeated practice at listening tasks. It focuses on teaching children the importance of listening and on the use of visual, verbal and behavioural strategies to support listening e.g., proximal praise. The tasks do not require the children to recall verbal or visuospatial information and they are not all executive-loaded.
To enhance the implementation of RECALL, the health professionals, who will be modelling the programme each week for the teachers, will attend a two-day training course prior to delivering it. To monitor compliance with the programme delivery and dosage, the health professionals and teachers will be asked to keep a simple log of their implementation (e.g., how often they delivered the programme and how long for). To monitor fidelity, three RECALL sessions in each school (one delivered by the health professional team and two by the teacher) will be observed by the research team.

Previous:
Randomisation is at the school (cluster) level. The six schools will be randomised to each arm of the trial: 2 will receive RECALL, 2 will receive the active control intervention (ALP), and 2 will receive education as usual (control group). This will be conducted by the schools’ names being placed in opaque, sealed envelopes, which will be selected by an independent person from within the researchers’ institute. Randomisation will occur after baseline data collection with the children.
The school participants (principal, teachers and classroom assistants) and parents/guardians in the two intervention groups will be blinded to their group allocation. Blinding of the health professionals to the schools’ allocation will not be possible as the teams will inevitably know which intervention they are delivering. The risk of this influencing the outcomes will be minimised by the blinding of the research assistant (RA) who will be collecting the outcomes data.
The experimental RECALL and active control interventions both incorporate small group and whole-class activities designed to be fun for young children. The programmes are comparable in their structure, format and dosage (intervention frequency and duration). They consist of six, 40-minute sessions that are repeated three times per week for 6 weeks (18 sessions in total). The first session each week will be delivered by the health professionals who will model the activities for the teachers so that they can deliver the two further practice sessions.
The experimental RECALL programme is a theoretically underpinned, multi-component, manualised intervention that explicitly targets working memory (WM) skills. WM is the ability to hold in mind and mentally manipulate information for short periods of time in the face of distraction. RECALL incorporates evidence-based tasks that are all executive-loaded in nature i.e., the tasks require attentional and processing resources under executive control (not just the simple storage of information). The intervention tasks include: direct, complex WM training; cognitively-demanding physical activity; phoneme awareness training; fantastical play; and games targeting inhibitory control.
The active control intervention does not explicitly target WM and is not underpinned by WM theory. It aims to improve children’s attention and listening skills through repeated practice at listening tasks. It focuses on teaching children the importance of listening and on the use of visual, verbal and behavioural strategies to support listening e.g., proximal praise. The tasks do not require the children to recall verbal or visuospatial information and they are not all executive-loaded.
To enhance the implementation of RECALL, the health professionals, who will be modelling the programme each week for the teachers, will attend a two-day training course prior to delivering it. To monitor compliance with the programme delivery and dosage, the health professionals and teachers will be asked to keep a simple log of their implementation (e.g., how often they delivered the programme and how long for). To monitor fidelity, three RECALL sessions in each school (one delivered by the health professional team and two by the teacher) will be observed by the research team.
There will be a 3 month follow-up period, at the end of which WM, attention and language skills will be assessed again.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Acceptability of RECALL in the school setting and feasibility of the trial processes, gathered throughout the trial and analysed in a process evaluation at the end of the study:
1. Compliance, assessed using implementation logs of the frequency and duration of programme delivery and recording of any reasons for non-delivery or modifications
2. Fidelity, assessed using 3 RECALL sessions in each school (1 delivered by the health professional team and 2 by the teacher), which will be observed by the first author. One of the health professional sessions and one of the teacher-delivered sessions will be observed simultaneously by a second member of the research team who will independently rate the delivery. Agreement between the raters will be checked by a third member of the team.
3. Acceptability, assessed using qualitative data on the health professionals' and teachers' experience of delivering RECALL, obtained in semi-structured interviews at the end of the study
4. Recruitment, consent and sampling procedures, assessed using the following:
4.1. Number and proportion of schools that meet the eligibility criteria
4.2. Number of schools approached
4.3. Number of schools where consent is obtained from principals and teachers
4.4. Number and proportion of children identified by teachers in each of the 3 sub-groups
4.5. Number and proportion of parents who consent
5. Attendance levels and loss to follow-up, assessed using the following:
5.1. Number of completed interventions
5.2. Number of completed standardised assessments, teacher rating scales and parent rating scales at post-intervention and three-month follow-up.
6. Acceptability of randomisation, assessed using the following:
6.1. Consent rates
6.2. Reasons given for participation and non-participation by school prinicipals
6.3. Qualitative data gathered in the semi-structured interviews, which will explore teacher's perspectives on random allocation
7. Acceptability of active control intervention as a comparator to RECALL, assessed using the following:
7.1. Health professionals’ perspectives on similarities/differences between the programmes, explored in the semi-structured interviews
7.2. Observations of delivery by research team
8. Exploration of education as usual: semi-structured interviews will be conducted with teachers in the no-intervention (education as usual) control arm of the study to explore the activities and strategies they have employed to support children's attention and language skills during the intervention period
9. Acceptability of outcome measures for the children, teachers and RISE teams, assessed using the following:
9.1. Number of completed assessments for each child at each time point
9.2. Number lost to follow-up and reasons why if possible
9.3. Qualitative data obtained in semi-structured interviews
10. Unexpected adverse effects, recorded by the health professionals and teachers
11. Whether blinding is maintained at end of study, investigated in the semi-structured interviews

Secondary outcome measures

Current:
Children’s working memory, attention and language skills, assessed pre-intervention, post-intervention and at the 3 month follow-up) using the following:
1. Standardised assessments administered directly with the children by a trained research assistant (RA) who will be blinded to group allocation. The children will be withdrawn individually from their classroom for approximately 1 hour at each time point to complete the following three standardised assessments:
1.1. The Automated Working Memory Assessment (AWMA), used to assess working memory
1.2. NEPSY – A Developmental Neuropsychological Assessment (NEPSY), used to assess attention
1.3. The New Reynell Developmental Language Scales (NRDLS), used to assess language skills
2. A teacher rating scale of the child’s attention in the classroom, assessed using the The Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P)
3. A parent rating scale of the child’s language and communication skills at home, assessed using the The Focus on Communication Outcomes Under Six (FOCUS)
4. Weekly monitoring of the child's performance on the trained tasks by the health professionals using a pro-forma provided by the research team

Previous:
Children’s working memory, attention and language skills, assessed pre-intervention, post-intervention and at the 3 month follow-up) using the following:
1. Standardised assessments administered directly with the children by a trained research assistant (RA) who will be blinded to group allocation. The children will be withdrawn individually from their classroom for approximately 1 hour at each time point to complete the following three standardised assessments:
1.1. The Automated Working Memory Assessment (AWMA), used to assess working memory
1.2. NEPSY – A Developmental Neuropsychological Assessment (NEPSY), used to assess attention
1.3. Clinical Evaluation of Language Fundamentals-Preschool, Second Edition (CELF-P2), used to assess language skills
2. A teacher rating scale of the child’s attention in the classroom, assessed using the The Strengths and Difficulties Questionnaire (SDQ)
3. A parent rating scale of the child’s language and communication skills at home, assessed using the The Focus on Communication Outcomes Under Six (FOCUS)
4. Weekly monitoring of the child's performance on the trained tasks by the health professionals using a pro-forma provided by the research team

Overall trial start date

15/01/2018

Overall trial end date

30/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Schools:
1. Situated in areas of low socio-economic status
2. Requested support from school-based therapy teams in relation to children’s attention and language skills

Education staff (teachers and classroom assistants):
1. Work with year one classes (4-5 year olds) in a school that meets the above criteria.

Health professionals:
1. Work in school-based teams in the two participating HSCT areas
2. Speech and language therapists, occupational therapists, physiotherapists, or behaviour specialists with experience in delivering whole-class programmes

Children:
1. Be in a year one class, aged 4–5 years, in a school that meets the above criteria. They may have diagnosed or undiagnosed learning or developmental difficulties.

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

At the cluster level, six schools will be recruited. One class of children in year one (n= ~30), their teacher and classroom assistant will participate in each cluster. A sample of 10 children in each class will be recruited to complete the outcome measures (n= 60). Health professionals (n= 4-8) will be recruited to deliver the experimental and active control interventions.

Participant exclusion criteria

Schools:
1. No separate year one class i.e. if all year one children are taught within a composite class with older/younger children

Education staff (teachers and classroom assistants):
1. Previously accessed the active control intervention

Health professionals:
1. Work in a team that was involved in the co-production of RECALL

Children:
1. English is not their first language

Recruitment start date

12/12/2018

Recruitment end date

31/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northern Health and Social Care Trust
Research Office Research and Development Office Bush House Antrim Area Hospital Bush Road
Antrim
BT41 2QB
United Kingdom

Trial participating centre

Western Health and Social Care Trust
Research and Development Office Clinical Translational Research & Innovation Centre (C-TRIC) Altnagelvin Area Hospital Glenshane Road
Londonderry
BT47 6SB
United Kingdom

Sponsor information

Organisation

Ulster University

Sponsor details

Research and Innovation
Room 01H12
Ulster University
Jordanstown Campus
Shore Road
BT37 0QB
United Kingdom

Sponsor type

University/education

Website

ulster.ac.uk

Funders

Funder type

Not defined

Funder name

Research and Development Division of the Public Health Agency, Northern Ireland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The findings will be disseminated to all of the participants at a local level through informal networks in the first instance. The results will be disseminated through conferences and publication in professional literature and international, peer-reviewed journals.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to the feasibility nature of this study. However, any requests for data or material should be made to the corresponding author and requests will be reviewed by the Trial Steering Committee.

Intention to publish date

30/06/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/02/2019: Recruitment ended on 31/01/2019. 16/01/2019: The recruitment start date has been changed from 15/11/2018 to 12/12/2018. 15/01/2019: The following changes have been made to the trial record: 1. The secondary outcome measures have been changed. 2. The recruitment end date has been changed from 30/12/2018 to 31/01/2019. 3. The intention to publish date has been changed from 30/10/2018 to 30/06/2020. 4. The interventions have been changed. 5. The plain English summary has been changed to allow for changes in the secondary outcome measures and interventions.