READ-IT feasibility study: Teaching early reading skills to adults with intellectual disabilities using a support worker/family carer mediated on-line reading programme

ISRCTN	ISRCTN11409097
DOI	https://doi.org/10.1186/ISRCTN11409097
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	271739
Protocol serial number	v1.0, IRAS 271739, CPMS 44540
Sponsor	University of Warwick
Funder	National Institute for Health Research

Submission date: 04/12/2019
Registration date: 07/01/2020
Last edited: 05/02/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Many people with intellectual disabilities (ID) (also called learning disabilities (LD)) find it difficult to learn to read. This limits their ability to do things independently. Instead, they often need other people to help them complete everyday activities. “Easy Read” is sometimes used to help make information easier to understand. But this “one-size-fits-all” does not work for everyone. Another way of helping may be to teach people with LD to read. If we can teach adults with LD to read, it is possible that they will be able to do more things by themselves and will have a better quality of life.

The researchers have developed a reading programme called 'Teaching early reading skills to adults with LD' (READ-IT) based on work that they have done teaching children with LD to read as well as a small project with adults with LD. With READ-IT, adults with LD will take part in an on-line reading programme with additional support from their support workers or family carers using a guide that they will help to produce.

Who can participate?
Any adult with a LD can take part if they can make the decision to take part and have some basic computer skills. They also need to have a support worker or family carer who is happy to support them. Everyone who takes part will be asked to complete some measures of things that may change during READ-IT.

What does the study involve?
Adults with LD will be put into one of two groups by chance. One group will be taught to read using READ-IT, the other will have no change to their day-to-day activities. The intervention consists of 80 online episodes delivered in sessions of approximately 20 – 25 minutes, and it's recommended that between 3 and 6 sessions taking 20 to 25 minutes are completed per week. READ-It will therefore be delivered on average over 16-20 weeks. Participants will complete questionnaires at the start and at a six month follow up.
After READ-IT has been completed, the researchers will also interview some of the adults with LD, their support workers and family carers, to find out why they decided to take part and about their experiences having taken part in the study.

What are the possible benefits and risks of participating?
The people with LD that take part in this research study who are put into the READ-It group will have an opportunity to learn to read and anyone supporting them will receive training in supporting others to learn to read. Those participants who are in the activity as usual group will be given an opportunity to learn to read once the study has been completed.
The risks to taking part in the study are minimal, participants will be asked to use some of their spare some time to fill out questionnaires, possibly take part in interviews, and to complete the intervention (if in the intervention arm). Should trial staff become concerned at any point about the well-being or safety of a participant or their support worker/family carer, they will be offered the opportunity to withdraw from the trial without any repercussions.

Where is the study run from?
University of Warwick, UK

When is the study starting and how long is it expected to run for?
December 2019 to January 2022 (updated 31/03/2021, previously: March 2021)

Who is funding the study?
National Institute for Health Research (NIHR), UK

Who is the main contact?
Dr Elinor Coulman, Johne1@cardiff.ac.uk

Contact information

Dr Elinor Coulman
Public

Research Fellow / Senior Trial Manager
7th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom

Phone	+44 (0)29 20687624
Email	johne1@cardiff.ac.uk

Dr Elinor Coulman
Scientific

Research Fellow / Senior Trial Manager
7th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF144YS
United Kingdom

Phone	+44 (0)2920687624
Email	johne1@cardiff.ac.uk

Study information

Primary study design	Interventional
Study design	Individually randomized feasibility study
Secondary study design	Randomised feasibility study
Study type	Participant information sheet
Scientific title	Teaching early reading skills to adults with intellectual disabilities (READ-IT) using a support worker/family carer mediated on-line reading programme – a feasibility study
Study acronym	READ-IT
Study objectives	Primary objective: To examine whether READ-IT can be delivered successfully by community support workers/family carers. Secondary objective: Whether it would be feasible to conduct a later definitive RCT of the effectiveness and cost effectiveness of READ-IT.
Ethics approval(s)	Approved 03/12/2019, NHS Health Research Authority, London - Camberwell St Giles Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH; +44 (0)207 104 8124; NRESCommittee.London-CamberwellStGiles@nhs.net), ref: 19/LO/1784
Health condition(s) or problem(s) studied	Adults with intellectual disabilities (ID) with poor reading abilities
Intervention	This will be an individually-randomised feasibility study of adults with ID. We will recruit individuals from family homes, independent living, and small group settings (e.g. supported living and residential homes) and randomise them 1:1 to receive the READ-IT intervention or usual practice. Individuals will be randomised in a 1:1 ratio using a randomisation programme developed by the Centre for Trials Research. The randomisation list will be prepared using the Stata command ‘ralloc’. Allocations will be balanced by setting type (family home vs. other social care setting). The Study Manager/Research Assistant will inform participants of their allocation by telephone and will provide all details of starting the READ-IT course to those allocated to the intervention arm. The study will be composed of three stages: STAGE 1: Intervention Refinement and Development: A new intervention (READ-IT) will be developed by further adapting the Headsprout® Early Reading program (HER®) support manual specifically for use with support workers and family carers. STAGE 2: Feasibility study: The intervention arm participants will participate in an online reading programme (READ-IT) supplemented by additional support strategies tailored for adults with ID. The control arm participants will experience usual practice in relation to the support of their reading. Baseline measures for all participants will be conducted prior to randomisation and repeated 6 months post-randomisation. Selected participants will be approached 6 months post-randomisation to take part in a qualitative study designed to address the progression criteria that will not otherwise be clear from other data collected. A placement assessment to assess where within the intervention the individual is best advised to start will be used for eligibility screening across all participants prior to baseline data collection (but during the same visit). If eligible and willing to take part, a baseline interview will be undertaken and informed consent and baseline measures are taken. STAGE 3: Logic model/full trial protocol: The findings from the feasibility study will be used to review and refine the logic model and, subject to the progression criteria being met will lead to the development of a protocol for a full trial. This will be achieved through additional Public and Patient Involvement (PPI) input and with the advisory group.
Intervention type	Other
Primary outcome measure(s)	The feasibility of using a range of established outcome measures, proposed to test the intervention in a main trial, will be assessed: 1. Literacy measured using dynamic Indicators of Basic Early Literacy Skills (DIBELS) questionnaire at baseline and six-month follow-up 2. Reading self-efficacy using a novel questionnaire designed as part of the Patient and Public Involvement (PPI) workshops at baseline and six-month follow-up 3. Carer efficacy in supporting the person to read using a novel questionnaire designed as part of the Patient and Public Involvement (PPI) workshops at baseline and six-month follow-up 4. Quality of Life measured using the EQ5D-5L at baseline and six-month follow-up 5. Wellbeing measured using the Personal Well-Being Index Intellectual Disability version, completed by the person with ID and the family member/support staff member at baseline and six-month follow-up 6. Costs measured using the Client Service Receipt Inventory (CSRI) at baseline and six-month follow-up 7. Adherence to the READ-IT intervention measured using software that tracks progress through the intervention through the study and at six-month follow-up 8. Fidelity of READ-IT intervention delivery measured using a READ-IT self-rating of adherence tool during follow-up
Key secondary outcome measure(s)	1. Recruitment rates measured via management data during recruitment 2. Feasibility of randomisation measured using qualitative interview post six-month follow-up 3. Retention rates measured via management data during follow-up to six months 4. Assessment of the barriers and facilitating factors for recruitment and engagement from the perspective of all stakeholders measured using qualitative interview post six-month follow-up 5. The acceptability of the established primary outcome measures measured using qualitative interview post six-month follow-up) 6. The views/experiences of adults with ID: regarding the READ-IT intervention and study processes measured using qualitative interview post six-month follow-up 7. The views/experiences of support workers and family carers delivering the READ-IT intervention and study processes measured using qualitative interview post six-month follow-up
Completion date	31/01/2022

Eligibility

Participant type(s)	Other
Age group	Adult
Sex	All
Target sample size at registration	48
Total final enrolment	36
Key inclusion criteria	1. Adults administratively defined as having an ID (i.e., through receipt of/being known to services) 2. Have the capacity to give informed consent 3. Have a level of competence in understanding English suitable to access Headsprout® Early Reading program (HER® [assessed using the HER® placement test]) 4. Can sound out words (although degree of articulation will not be a factor). (This is a requirement of the HER® component of the intervention) 5. Have access to appropriate internet-enabled technology 6. Either have basic mouse skills, or the capacity to be taught basic mouse skills 7. Are living in a setting in which they are getting daily living skills support supported by a support worker/family carer 8. Have access to a support worker who are themselves able to read and willing to support the individual for the duration of the study
Key exclusion criteria	1. Visual impairments severe enough to limit their access to computer-based technology even with adaptations
Date of first enrolment	13/01/2020
Date of final enrolment	31/05/2021

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Warwick

CEDAR
Westwood Campus
Kirby Corner Rd
University of Warwick
Coventry
CV4 7AL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Elinor Coulman, Johne1@cardiff.ac.uk. Data shared will be anonymised and available from 2023 until 2038 to staff of academic institutions.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/01/2025	05/02/2025	Yes	No
Protocol article		22/01/2022	24/01/2022	Yes	No
HRA research summary			26/07/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

05/02/2025: Publication reference added.
18/09/2023: The study contacts were replaced throughout the record.
14/03/2023: The intention to publish date has been changed from 31/03/2023 to 31/08/2023. Total final enrolment and IPD sharing statement added.
10/03/2022: The intention to publish date has been changed from 31/03/2022 to 31/03/2023.
24/01/2022: Publication reference added.
25/05/2021: The recruitment end date has been changed from 30/04/2021 to 31/05/2021.
31/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2020 to 30/04/2021.
2. The overall end date was changed from 31/03/2021 to 31/01/2022.
3. The plain English summary was updated to reflect these changes.
15/12/2020: The recruitment resumed.
09/04/2020: Due to current public health guidance, recruitment for this study has been paused.
13/01/2020: Internal review.
07/01/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).