Engaging young service users with neurodevelopmental conditions in shaping their daily living support – a preliminary evaluation of a new tool
| ISRCTN | ISRCTN40551389 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40551389 |
- Submission date
- 24/10/2023
- Registration date
- 25/10/2023
- Last edited
- 28/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The transition from adolescence to adulthood can be particularly challenging for people with neurodevelopmental conditions. In Sweden, young adults with autism spectrum condition or attention deficit hyperactivity disorder are increasingly accessing housing support, a form of practical, educational, and social support in daily living provided by the municipalities. Some municipalities have recently started delivering this support remotely, with support workers expressing both positive experiences and concerns. There is a limited understanding of the practical and emotional barriers that support workers and their young service users might encounter in implementing and receiving support remotely. In addition, the support needs, preferences, and values of the young service users are not fully understood. Service user engagement will therefore be necessary to ensure that the service is person-centred and of high quality. A new tool has been developed to help young service users with neurodevelopmental conditions develop a structure for their own support in close collaboration with their support worker. The tool was co-produced with young service users with autism spectrum conditions or attention deficit hyperactivity disorder and support workers. The aim of this study is to evaluate the feasibility of this tool in practice.
Who can participate?
People with an autism spectrum condition or attention deficit hyperactivity disorder who are aged between 18 and 29 years old and granted housing support service.
What does the study involve?
All participants will be offered the tool in conjunction with the support they already receive. The tool is text-based, consisting of a series of questions to help the service user think about their support and how they feel that it should be structured to meet their needs and preferences. Three themes are explored: personal aspects and preferences, how the support ideally should be structured in different support areas and productive ways of communicating remotely. The service user can read through and think about the questions in advance, and then continue the discussion with their support worker. Based on these questions, the service user and support worker decide how they should continue with the support. Participants will rate their quality of life, self-efficacy, and perceived participation before they use the tool and 4 weeks later. They will also be asked to complete a survey on the usefulness and relevance of the tool and to take part in a brief interview on the same topic.
What are the possible benefits and risks of participating?
The tool can help service users engage in their support service, to make it more responsive to their needs, values, and preferences. As with other interventions, it is unlikely that all participants will benefit from this tool. There are no known risks of participating, but it cannot be ruled out that some participants will experience some transient emotional distress related to some of the personal aspects raised by the tool, and that some expectations might not be realized.
Where is the study run from?
Karolinska Institutet (Sweden)
When is the study starting and how long is it expected to run for?
July 2021 to September 2024
Who is funding the study?
FORTE: Swedish Research Council for Health, Working Life and Welfare (Forskningsrådet om Hälsa, Arbetsliv och Välfärd) (Sweden)
Who is the main contact?
Dr Ulf Jonsson, ulf.jonsson@ki.se (Sweden)
Contact information
Public, Scientific, Principal Investigator
Karolinska Institutet
Center of Neurodevelopmental Disorders at Karolinska Institutet (KIND)
Gävlegatan 22
Stockholm
SE-113 30
Sweden
 ORCID ID |
0000-0002-5761-2943 |
|---|---|
| Phone | +46 (0)73 806 43 37 |
| ulf.jonsson@ki.se |
Study information
| Study design | Non-randomized single-arm mixed methods feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Other, Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Feasibility and acceptability of a tool for engaging young service users with neurodevelopmental conditions in designing their daily living support: a non-randomised mixed methods study |
| Study objectives | The aim of this study is to assess the feasibility and acceptability of a new tool for engaging young service users with neurodevelopmental conditions in designing their daily living support. The study is not designed for formal hypothesis testing. However, within-group changes in quality of life, self-efficacy, and perceived participation will be assessed. |
| Ethics approval(s) |
Approved 25/01/2022, Swedish Ethical Review Authority (Etikprövningsmyndigheten Box 2110, Uppsala, SE-750 02, Sweden; +46104750800; registrator@etikprovning.se), ref: Dnr 2021-06924-01 |
| Health condition(s) or problem(s) studied | Service user engagement among young adults with autism spectrum condition or attention deficit hyperactivity disorder. |
| Intervention | This feasibility study will employ a single-arm design, where all participating service users will be offered the tool for increased service user engagement in conjunction with their support as usual. Housing support is a form of practical, educational, and social support provided by the municipalities in Sweden for people who live independently but have support needs in their daily living. Outcome measures will be collected at baseline and after 4 weeks (post-intervention). The tool was co-produced in a series of workshops with young service users and support workers. The text-based tool consists of three separate sections, each consisting of a series of questions designed to help the service user think about their support and how it should be structured to meet their specific needs and preferences. Each of the three sections explores a theme: 1. Personal aspects and preferences (e.g., style of communication, stressful situations, what type of initiatives the service user wants the support worker to take, and daily routines). 2. How the service user prefers the support to be structured within different support areas (e.g., remote, in-person, or blended). 3. Productive ways of communicating remotely (e.g., agreements about how to communicate on the phone or through text messages). The service user will be asked to review and think about the questions in advance, and then continue the discussion with their support worker. Based on these questions, the service user and their support worker jointly will decide how they should continue with the support. |
| Intervention type | Behavioural |
| Primary outcome measure | Feasibility/acceptability: 1. Recruitment rate, uptake, and retention will be measured using information collected continuously over the course of the study 2. Characteristics of the included and retained samples (e.g., diagnoses, age, gender, housing/residence) and current needs, and preferences related to daily living support will be measured using information collected at pre-intervention 3. Usefulness and relevance of the tool will be measured using an evaluation form post-intervention 4. Participation/involvement will be measured using the Patient Participation and Rehabilitation Questionnaire pre-and post-intervention 5. Overall feasibility/acceptability will be measured using in-depth interviews with participating service users and their support workers post-intervention |
| Secondary outcome measures | Preliminary effects: 1. Quality of life measured using the Assessment of Quality of Life (AQoL-8D) tool pre- and post-intervention 2. Self-efficacy measured using the Generalized Self-Efficacy Scale (GSE) pre- and post-intervention |
| Overall study start date | 01/07/2021 |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 29 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 15 |
| Key inclusion criteria | 1. Aged 18 to 29 years old 2. Autism spectrum condition or attention deficit hyperactivity disorder 3. Currently accessing housing support 4. Sufficient proficiency in Swedish |
| Key exclusion criteria | Not meeting the participant inclusion criteria |
| Date of first enrolment | 01/11/2023 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Stockholm
SE-113 30
Sweden
Sponsor information
University/education
Karolinska Institutet
Stockholm
SE-171 77
Sweden
| Phone | +46 (0)80 524 865 95 |
|---|---|
| registrator@ki.se | |
| Website | https://ki.se/en |
"ROR" |
https://ror.org/056d84691 |
Funders
Funder type
Research council
Government organisation / Local government
- Alternative name(s)
- Swedish Research Council for Health, Working Life and Welfare, FORTE
- Location
- Sweden
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Not expected to be made available |
| Publication and dissemination plan | 1. Planned publication in a peer-reviewed open access journal 2. Dissemination of findings to Swedish municipalities and other stakeholders 3. No additional documents are available for this feasibility study |
| IPD sharing plan | The datasets generated during the current study are not expected to be made available, to ensure the anonymity of the participants. The datasets will be stored in a non-publicly available repository at Karolinska Institutet. |
Editorial Notes
28/06/2024: The following changes were made to the trial record:
1. The overall end date was changed from 30/06/2024 to 30/09/2024.
2. The intention to publish date was changed from 31/12/2024 to 30/06/2025.
3. The plain English summary was updated to reflect these changes.
4. The total final enrolment was added.
25/10/2023: Study's existence confirmed by the Swedish Ethical Review Authority.
