Plain English Summary
Background and study aims
Someone is said to have a learning disability (or ‘intellectual disability’ (ID)) if they have a reduced ability to understand new or complex information and to learn new skills, and a reduced ability to cope independently, which started before adulthood. People with ID are more likely to experience poor physical and mental health and on average die 15 to 20 years younger than the general population. This is not simply due to their ID or related medical conditions, but in large part to being more likely to experience low incomes, unemployment, poor housing, social isolation and loneliness, bullying and abuse. A recent report concludes that to improve lives and health outcomes for people with ID, more needs to be done to reduce stigma (negative stereotypes, prejudice and discrimination).
Stigma has been linked to lower self-esteem, quality of life, and mental health problems, including for people with ID. Efforts are being made to reduce ID stigma within society and among specific groups, such as health care providers. However, efforts to empower people with ID themselves to challenge stigma are lacking. We have developed Standing up for Myself (STORM), a new group-based programme to address this gap. STORM is designed for people with mild to moderate ID aged 16+ and seeks to give them the means to challenge stigma in their everyday lives. It consists of four 90-minute group sessions and a booster session and involves a range of activities, including watching films of people with ID talking about their experiences of prejudice and bullying, group discussions, and planning how to stand up to prejudice and discrimination in everyday life. STORM is delivered by staff in charities, colleges and other services that run groups for people with ID. Staff receive training in how to deliver STORM, how to look out for possible signs of distress in STORM participants and support them, and ongoing support (supervision). So far, we have developed STORM and piloted it with ten groups involving 67 people with ID. Feedback from group members and staff who led STORM groups has been very positive and indicates a great need for and interest in this intervention. We found initial positive effects of STORM on group members' self-esteem, mental health and confidence in challenging stigma.
We now need to address further important questions before we will know whether a large research test (a trial) of STORM is called for. We will ask 16 community organisations across South East England who run groups for people with ID to take part in the research. Of the 16, eight will be chosen at random to deliver STORM to one of their groups. The other eight (the “control group”) will carry on with their usual group meetings and will not complete STORM. The control group will have access to STORM after completion of all measures and interviews, as long as there is no suggestion of harm in the STORM arm. In total, we expect about 104 people with ID will take part in the research. We will examine how easy it is to recruit groups and participants, how many drop out, and how good facilitators are at delivering the sessions as they were trained to. We will also assess whether participants are willing and able to complete all outcome measures and whether STORM appears to improve mental wellbeing, self-esteem and confidence in standing up to stigma. STORM was developed with close input from people with ID and staff who run groups for people with ID. In the new research, self-advocates with ID and staff from three organisations who have worked on STORM already will be closely involved.
Who can participate?
Community and education sector organisations that work with groups of people with ID, and the people that attend them (aged 16 years or above)
What does the study involve?
Groups will be randomised to receive treatment as usual or the STORM intervention. Those who receive treatment as usual will be receive the STORM intervention after the study.
What are the possible benefits and risks of participating?
The possible benefits of participating are that participants may benefit from completing the STORM programmme, they might learn something new from taking part and that the research may help other people with learning disabilities. Participants may find some questions and tasks difficult. In such instances, we will make sure that they can talk to someone.
Where is the study run from?
Research Department of Clinical, Educational and Health Psychology, University College London, UK
When is the study starting and how long is it expected to run for?
March 2020 to September 2021
Who is funding the study?
National Institute for Health Research (NIHR), UK
Who is the main contact?
Dr Katrina Scior
k.scior@ucl.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Dr Katrina Scior
ORCID ID
http://orcid.org/0000-0002-4679-0090
Contact details
Research Dept of Clinical
Educational and Health Psychology
University College London
1-19 Torrington Place
London
WC1E 7HB
United Kingdom
+44 (0)2076791845
k.scior@ucl.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
NIHR PHR 17/149/03, CPMS 45284
Study information
Scientific title
The standing up for myself (STORM) psychological group intervention for young people and adults with intellectual disabilities: feasibility study
Acronym
STORM
Study hypothesis
The aim is to examine whether STORM can be delivered successfully to established groups of people with an intellectual disability (ID) in a range of community, social and educational settings, and in particular, whether it would be feasible to conduct a later definitive RCT of the effectiveness and cost-effectiveness of STORM. The study will assess recruitment and retention, fidelity of STORM delivery in accordance with the manual, acceptability of the intervention and proposed outcome measures, including completion rates for and sensitivity to change of measures not included in the pilot study (e.g., WEMWBS, EQ-5D, service use)
Ethics approval
Approved 05/12/2019, University College London Research Ethics Committee (Research Ethics Office, Office of the Vice-Provost (Research), University College London, 2 Taviton St, London WC1E 6BT; 020 7679 8717 extension 28717; ethics@ucl.ac.uk), ref: 0241/005
Study design
Cluster-randomized feasibility trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Intellectual disabilities (learning disability)
Intervention
Community and education sector organisations that work with groups of people with ID will be asked to identify one established group with an average of 6 to 7 members (average cluster size) for the trial. Groups will be randomised to STORM or the control arm on a 1:1 ratio using variable block randomisation in which unit of randomisation is the group. The control group will receive treatment as usual + access to STORM after the follow-up period (wait-list control). The proposed methods for economic evaluation will be tested and a process evaluation, using mixed methods, will be carried out to examine the delivery of the intervention and adherence, as well as stakeholder views on the acceptability of the intervention and on barriers and facilitators that may affect its future implementation and plans for a future definitive trial.
Standing up for Myself (STORM), is a psychosocial group intervention. STORM works directly with groups of young people and adults with intellectual disability (ID) to enhance their capacity to manage and resist stigma. STORM was designed from the outset to be scalable by being brief (4 sessions plus one booster session) and suitable for delivery by group facilitators with a modest amount of preparation and training but without requiring any specific qualifications. By being delivered within the context of established groups for people with ID, STORM provides a safe space to tackle a sensitive subject, maximises the potential for peer support, and does not require substantial new delivery mechanisms which would affect its potential future implementation. STORM’s theory of change draws on cognitive behavioural therapy, e.g. challenging negative beliefs and examining the benefits and disadvantages of different ways of responding to stigma; narrative therapy, e.g. by separating oneself from a problematised label and developing new stories about oneself; and liberation psychology, e.g. by explicitly acknowledging acts of oppression.
Total duration of treatment and follow-up is 12 months : 2 months for the intervention (4 months for the 4 core sessions plus a booster session one month after session 4) and 12 months from baseline for follow-up assessments.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Feasibility will be addressed using a qualitative/quantitative (mixed-methods) evaluation of the following at 12-months:
1. Recruitment of providers of groups for people with ID and of group facilitators: Can sufficient providers and group facilitators be recruited to run up to 10 STORM groups and have 10 groups in the control arm? What factors influence providers’ willingness to take part in the research? Can sufficient group facilitators be recruited and trained?
2. Recruitment of participants/groups: What are the most effective recruitment pathways to identify suitable groups for people with ID from a range of settings (educational, social/activity based, or self-advocacy groups)? What recruitment rate can be achieved in different settings? What are the characteristics of organisations/groups and participants approached and screened to recruit 16 groups (8 STORM, 8 Control) with an estimated 104 participants?
3. Acceptability of research design: Are organisations, facilitators and participants willing to be randomised within the context of an RCT?
4. Adherence: What proportion of groups and participants complete at least three of the five STORM sessions?
5. Retention: What proportion of groups and participants are retained in the study to the 12-month post-randomisation follow-up? Does retention differ between trial arms?
6. Fidelity of implementation: Can facilitators deliver STORM with a high degree of fidelity to the programme manual? Does fidelity differ by setting (i.e. usual primary purpose of participating groups)?
7. Usual practice (UP): What does UP consist of for young people and adults with mild to moderate ID? How is UP different from the STORM programme content?
8. Feasibility of outcome measures: Do participants complete the outcome measures for the study? Is there preliminary evidence of differences on these measures between the trial arms?
9. Feasibility of economic evaluation: What is the feasibility of collecting resource use and health related quality of life data from participants? What is the feasibility of collecting data on the cost of the intervention from providers?
10. Estimation of ICCs for the outcome measures and of other parameters needed to inform future sample size calculations, including average cluster size/coefficient of variation.
Secondary outcome measures
Measured at baseline and follow-up:
1. Mental wellbeing measured using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS), a 14-item scale validated for adolescents aged 13+ and adults, with some items simplified in line with other recent studies that have used the scale with people with ID
2. Self-esteem, measured using 6-item version of Rosenberg self-esteem scale (RSES), validated for people with ID
3. Self-Efficacy in Rejecting Prejudice (SERP), a single self-rated item used in our pilot: “At this moment, how confident do you feel about standing up to prejudice?”, rated on a 4-point scale (‘not at all confident’ to ‘very confident’)
4. Reactions to Discrimination (RtD) 4-item subscale of the ID Self-Stigma Scale, measuring emotional reactions to stigma in people with ID
5. Sense of Social Power (SSP): adapted 4-item version of the Sense of Power Scale, to date not yet validated for people with ID
All the above scales use 3 to 5-point Likert response scales.
6. We aim to develop a measure of stigma resistance that is sensitive to change and will pilot this during the proposed study. For this purpose, we will develop vignette-based scenarios of stigmatising interactions that people with ID may typically experience, and will ask participants how they would be most likely to respond in each situation, with their responses analysed thematically and also categorised as e.g., social withdrawal, ignoring, educating, or confronting. The scenarios, response formats and methods of analysis will be co-produced with our STORM Expert Advisors Panel (a Patient and Public Involvement (PPI) group) during the early stages of the study and subsequently piloted with all phase 2 participants
Overall trial start date
01/10/2019
Overall trial end date
30/09/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
For groups/organisations:
1. In place already, i.e. they are not specifically formed for the purposes of the intervention or the research
2. Intend to continue meeting as a group for at least three further months
3. Have at least four members with ID who wish to participate in the intervention, and no more than ten members to allow for full engagement in group discussions and other STORM activities
4. Willing to replace five of their usual meetings with STORM for the study
5. Have a group facilitator who consents to taking part and who is willing to facilitate the STORM intervention
6. The facilitator is willing to complete two 2-hour training sessions (a mix of on-line and face-to-face training) and to receive 2 to 3 hours of STORM supervision
7. Facilitators will also be expected to be willing to complete the study records, audio record sessions, and to participate in a qualitative interview 4 to 6 months from baseline
8. The organisation which hosts participating groups must have the resources to support the study and must be willing to free up the group facilitator for STORM training and supervision
For individuals:
1. Aged 16+ years
2. Have an ID as defined by an administrative definition, in terms of receipt of specialist services for people with ID within the education, social care, third or health sector
3. Be able to complete the outcome measures (with support), attend to short films, and engage in a discussion-based group programme – abilities likely to equate to mild to moderate ID (severity of ID will not be formally assessed as this is too resource intensive)
4. Have sufficient expressive and receptive communication skills in English (reading skills not required) to allow participation in STORM and completion of measures
5. Be a member of an established group for people with ID (educational, activity, social or self-advocacy focused)
6. Have capacity to provide informed consent to participation in the study
7. Provide informed consent to taking part in the study
8. Some individuals whose group is randomised to the intervention arm may not have capacity to consent to participating in the research but may wish to take part in STORM. In such cases, the individual will be included in the STORM group but not the research, presuming an assessment concludes that the potential benefits of taking part outweigh any risks and that participation in STORM is in the person’s best interests
Participant type
Other
Age group
Mixed
Gender
Both
Target number of participants
104
Participant exclusion criteria
For groups/organisations:
1. Run as part of NHS services
2. Some of their regular members decline taking part in STORM and it is not possible to find alternative meeting times to run STORM
For individuals:
1. Unable to communicate using English (and adaptations to meet their communication needs cannot be put in place for the respective group)
2. Do not have capacity to consent (see above)
Recruitment start date
26/03/2020
Recruitment end date
30/09/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
Research Department of Clinical, Educational and Health Psychology
1-19 Torrington Place
London
WC1E 7HB
United Kingdom
Sponsor information
Organisation
University College London
Sponsor details
Gower St
Bloomsbury
London
WC1E 6BT
United Kingdom
+44 (0)203 4475123
joe.mwanza@nhs.net
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The study results will be presented in a peer reviewed journal article (journal to be confirmed) and at the IASSID 2021 European Congress.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Intention to publish date
01/12/2021
Participant level data
Available on request
Basic results (scientific)
Publication list