Title: A pilot randomised controlled trial of one to one befriending by volunteers for people with intellectual disability (ID)
Funder: Department of Health and Social Care

Abstract: Background: People with intellectual disability (ID) are more likely to experience loneliness, social isolation, have fewer social networks and lower levels of social participation that can lead to low self esteem and increased vulnerability to depression. The aim of befriending is to provide friendship and emotional support, to reduce loneliness and promote social participation. Befriending has been shown to increase social satisfaction in people with ID and to reduce depressive symptoms in other populations, but randomised controlled trials, including pilot studies, have not been carried out in people with ID. Aim: to carry out a pilot randomised controlled trial of the one to one befriending by volunteers for people with ID, compared to Usual Care and a booklet of community resources. We will assess feasibility data on the recruitment rate of individuals with ID and volunteers, the number of successfully matched pairs and the drop-out rate at six and 12 months follow up. We will also examine the effect of befriending on outcome measures, adherence to the trial protocol, and acceptability of the intervention. Intervention: Face to face meetings between the volunteer and the individual once a week over a six month period. The volunteer will provide social support and help the individual to access activities in the community using a booklet of local resources and will be asked to keep a log of their activities. Control arm: Access to booklet of local resources only. Both groups will have access to Usual care, which will include multidisciplinary input from intellectual disability services, pharmacological and psychological treatments and day services. Inclusion criteria: Individuals aged 18 or over with mild or moderate ID, who have a score of 5 or more on the GDS-LD, not attending education/ day service for more than two days a week, will be recruited from referrals to befriending organisations. Exclusion criteria: severe ID, unable to communicate in English or provide consent. Volunteers will be aged 18 and over and will be recruited by the befriending organisations in their usual way. Those with a criminal record will be excluded. Study procedures: 50 participants with ID will be randomised using block randomisation and allocated to either the intervention or control arm. Forty two volunteers will need to be recruited (assuming a drop out rate of 40% before matching). Outcomes: Feasibility data on recruitment and drop out rates; Primary health outcome: symptoms of depression at 12 months; secondary outcomes: self esteem, quality of life, loneliness, social support, social participation, health related quality of life and service use costs. Outcomes will be recorded at baseline, end of the intervention (6 months), and at 12 months. In volunteers, self-esteem, emotional well-being, loneliness and attitudes towards people with ID before matching and at six and 12 months will be measured. A process evaluation using mixed methods will be carried out involving an assessment of adherence to the intervention, the nature and frequency of contacts and qualitative interviews with stake holders to identify aspects of the intervention that were/were not successful. Trial progression criteria: 70% of the target recruitment rate of individuals with ID is met; 70% are matched to a volunteer; there is less than 30% drop-out rate and the intervention is acceptable.

Lay abstract: There are 900,000 people with intellectual disability (ID) in England. They frequently experience stigma and are socially excluded. Many people have few friends and limited access to social support, which can lead to feelings of loneliness and isolation. This can have an adverse effect on self-esteem and lead to depression. The aim of befriending is to reduce isolation and encourage participation in social activities. Befriending has been found to be effective in reducing symptoms of depression in the general population, and may improve social satisfaction in people with ID. However, there have been no randomised controlled trials evaluating befriending in people with ID. We plan to carry out a pilot randomised controlled trial of one to one befriending by volunteers for people with intellectual disability (ID) compared to Usual care, with the aim of identifying whether it would be feasible and acceptable to carry out a full randomised controlled trial. A total of 50 participants with ID recruited from two community befriending organisations (Hackney,London and Suffolk) will be randomised to either one to one befriending by a volunteer or a control group (Usual Care). There will be 25 participants in each arm. In the intervention arm, the participants will be matched to a volunteer with similar interests who will meet with the individual a once a week for one hour, over a six month period. They will be given a booklet which will contain information about local activities that the pair can access together and they will be asked to keep a log of their activities. In the control arm, the participants will only receive the booklet. Both groups will have access to their usual care (medication, psychological therapies and contact with health professionals). We will examine information about the recruitment rate of participants with ID and volunteers, the number of participants with ID who are successfully matched to a volunteer and the number of volunteers or participants with ID who drop out of the study. We will explore if befriending reduces symptoms of depression at 12 months and impact on self esteem, quality of life, loneliness and social support/ participation, in people with ID and if it reduces health and social care costs. We will explore potential benefits to the volunteers and society such as whether befriending improves wellbeing and attitudes towards people with ID. These measures will be recorded at baseline, at the end of the intervention (6 months) and at 12 months. We will explore negative effects of befriending such as distress following the ending of the relationship. We will examine the log books and will interview participants, carers, volunteers and staff at the end of the study to explore what aspects of the befriending intervention were successful and what could be improved, which will enable us to consider factors that could be barrier to the main trial. We have consulted with befriending services, volunteers and befriendees with ID and an advisory group of carers and service users for their advice on the design of the study and relevant outcomes. Service users/carers will form a study advisory group and will be members of the trial management group. The results of the study will be made available to the participants and the organisations taking part. The results will be published in a scientific journal, presented at conferences and shared with stakeholders through a public engagement seminar.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: MENTAL HEALTH