The effects of a stress-monitoring smartphone application for autistic adults
| ISRCTN | ISRCTN17394910 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17394910 |
- Submission date
- 18/04/2023
- Registration date
- 19/04/2023
- Last edited
- 27/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Adults with autism consistently experience more daily stress compared to non-autistic adults. Regular stressful experiences can negatively affect one’s mental and physical health, which in turn may increase one’s susceptibility to experience even more stress. There is therefore a need for simple, widely accessible interventions that reduce the daily stress load of autistic adults by supporting them in recognizing, monitoring and managing their daily stress. This study aims to investigate the effectiveness of SAM-NAR, a stress-monitoring smartphone application for autistic adults.
Who can participate?
Adults (aged 16 years and older) with autism who are registered in the Netherlands Autism Register and who have a smartphone
What does the study involve?
Participants will be randomly distributed into two groups. One group will use the SAM-NAR smartphone application for 4 weeks, while the other group waits for 4 weeks before they also get access to the application. Both groups fill in online questionnaires at two timepoints: at the beginning of the study (before using the app) and 4 weeks after the start of the study (after one group used the app for 4 weeks). These assessments include questions on perceived stress, coping skills, and mental wellbeing.
What are the possible risks and benefits of participating?
Participants may benefit personally because the SAM-NAR app can give them more insight into their stress level and which factors contribute to this. Participants contribute to a science-led knowledge base on daily life factors which contribute to stress and well-being of adults with autism.
Participation requires time and effort. Using the SAM-NAR app takes between 4 and 12 minutes per day for a period of 4 weeks. Participants could experience more stress by using the app. If they find that this is the case, they can always choose to stop using the app. Participants may become more aware of their own stress or the stimuli that lead to more stress. This awareness can be perceived as annoying.
Where is the study run from?
The study is run from the Netherlands Autism Register at the Vrije Universiteit Amsterdam (Netherlands). However, all assessments and application usage will take place online and are thus not location-bound.
When is the study starting and how long is it expected to run for?
January 2023 to May 2023
Who is funding the study?
Dutch Research Council (NWO) (Netherlands)
Who is the main contact?
Dr Anke Scheeren, a.m.scheeren@vu.nl
Contact information
Principal Investigator
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
 ORCID ID |
0000-0001-7530-3354 |
|---|---|
| Phone | +31 (0)20 59 85399 |
| A.M.Scheeren@vu.nl |
Study information
| Study design | Interventional parallel non-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Telephone |
| Study type | Quality of life |
| Participant information sheet | https://nar.vu.nl/actueel_onderzoek/sam-stress-in-het-dagelijks-leven |
| Scientific title | Effectiveness of a smartphone application (SAM-NAR) compared to a waitlist-control in reducing stress in autistic adults: a randomized controlled trial |
| Study acronym | SAM-NAR |
| Study objectives | Research question: What is the effectiveness of the SAM-NAR application on the stress and well-being of autistic adults? Hypothesis: The intervention group that uses the SAM-NAR app for 4 weeks will show a stronger decrease in their stress level compared to the waitlist control group. |
| Ethics approval(s) | Approved 03/03/2023, the ethics committee of the Faculty of Behavior and Movement Sciences of the Vrije Universiteit Amsterdam (Van der Boechorststraat 7, 1081 BT Amsterdam, Netherlands; +31 (0)20 59 88732; vcwe.fgb@vu.nl), ref: VCWE‐2023‐024R1 |
| Health condition(s) or problem(s) studied | Stress reduction in adults with autism spectrum disorder |
| Intervention | Participants receive an email with a link to the baseline assessment (pre-test): an online questionnaire regarding stress and wellbeing. At the end of this questionnaire, randomization occurs automatically by a built-in “Randomizer” tool from Qualtrics (Qualtrics, Provo, UT). Participants are allocated to either the intervention group or a waitlist-control group. Participants are informed via email about their group status right after the baseline assessment. Additionally, participants in the intervention group receive instructions on how to download and use the SAM-NAR app, a stress-monitoring smartphone app designed specifically for autistic adults (please see below). Waitlist-control participants are informed that they can make use of the smartphone application after 4 weeks. Four weeks after the pre-test, all participants receive an automatic email with a link to the post-test. After the post-test, waitlist-control participants receive instructions on how to download and use the SAM-NAR app. Due to the nature of the study, no blinding of the participants or researchers could be realized. SAM-NAR application The SAM-NAR application is a mobile health application designed for autistic adults to help them recognize, monitor and manage their stress in everyday life. The Stress Autism Mate (SAM) app, a precursor app which is very similar to the SAM-NAR app, was developed by a project group consisting of mental health researchers of the Netherlands organization for applied scientific research (TNO), clinicians of Ggz Centraal, an organization for specialist mental health care in the Netherlands, and fifteen individuals with autism. The SAM-NAR is an extended version of the SAM-app, including additional questions developed by the Netherlands Autism Register (NAR). Using the SAM-NAR app involves filling in short questionnaires on a regular and daily basis. Users receive a request from the app to complete a short questionnaire at 2, 3, or 4 fixed moments each day (depending on the preference of the participant), with a 4-hour interval. Participants can set the time for the first questionnaire. Each questionnaire takes approximately 2 to 3 minutes to complete. On a daily basis, usage of the application therefore takes 4 to 12 minutes. Preferences with regard to layout, number of assessments per day, and timing of the first questionnaire can be altered at any time by the participant. During these brief daily assessments, the SAM-NAR app prompts the user with multiple-choice questions regarding their environment in the past 4 hours (e.g., being alone or with others), what activities they were doing in the past 4 hours, and how they felt during these activities. The app then asks questions about the presence of stressful feelings or thoughts in the past 4 hours, such as ‘Did you feel irritable?’ and ‘Were you dreading activities on your schedule?’. Answers to these stress-related questions are summed to create a total score corresponding to various intensities of stress: no stress, little stress, stress, much stress. With the use of an algorithm, an automatic report of the level of perceived stress is generated and available to the user directly after filling in the questions. The stress level of the user is then verified by asking if this report matches the user’s own perception of stress. Discrepancies between the user’s stress levels as assessed by the application and as perceived by themselves are registered. Please see Hoeberichts et al. (2022) for more information on the SAM application. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Level of perceived stress is measured via online questionnaires using the 10-item Perceived Stress Scale (PSS-10) at baseline (pretest: T0) and 4 weeks after baseline (post-test: T1) 2. Mental wellbeing will be assessed with the 14-item Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline (pretest: T0) and 4 weeks after baseline (post-test: T1) |
| Secondary outcome measures | Coping skills will be assessed with the 13-item Coping Self-Efficacy Scale (CSES) at baseline (pretest: T0) and 4 weeks after baseline (post-test: T1) |
| Overall study start date | 23/01/2023 |
| Completion date | 03/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 130 |
| Total final enrolment | 214 |
| Key inclusion criteria | To be eligible for this study, participants ought to: 1. Be at least 16 years old 2. Have a formal diagnosis of Autism Spectrum Disorder 3. Be a self-reporting participant in the Netherlands Autism Register 4. Be in possession of a smartphone or tablet for using the SAM-NAR application |
| Key exclusion criteria | 1. People who are not registered in the Netherlands Autism Register |
| Date of first enrolment | 14/03/2023 |
| Date of final enrolment | 04/04/2023 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Amsterdam
1081 BT
Netherlands
Sponsor information
University/education
De Boelelaan 1105
Amsterdam
1081 HV
Netherlands
| Phone | +31 (0)20 59 85000 |
|---|---|
| contact@vu.nl | |
| Website | https://vu.nl/en/about-vu/practical-matters |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Netherlands Organisation for Scientific Research, Dutch National Scientific Foundation, Dutch National Science Foundation, Dutch Research Council (Nederlandse Organisatie voor Wetenschappelijk Onderzoek), NWO:Nederlandse Organisatie voor Wetenschappelijk Onderzoek, Nederlandse Organisatie voor Wetenschappelijk Onderzoek (NWO), Dutch Research Council, Dutch Research Council, Netherlands, NWO
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in an international peer-reviewed journal specialising in autism spectrum disorder. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository. The Netherlands Autism Register will store the data non-publicly. The datasets generated during and/or analyses during the current study will be available upon request. Please note these data do not include individual user data collected with the help of the SAM-NAR app, but include survey data collected at pre- and post-test. Researchers who want to collaborate with the Netherlands Autism Register can fill out the form at the NAR website (https://nar.vu.nl/samenwerken_met_het_nar/werken_met_nar_data/) and/or contact the NAR via info@nederlandsautismeregister.nl. The data request will be reviewed by the NAR team. Once the NAR team has reviewed the request (typically within 2 weeks) the researchers will be informed of the outcome. If the request is not approved, researchers may be requested to revise the proposal and resubmit. Once the data request is approved, researchers will be asked to sign a data sharing agreement (DSA). Once the NAR team receives the signed data-sharing agreement, data management will prepare the dataset. A typical data request takes approximately 2 weeks to prepare. If the request is particularly complex or if the request comes at a very busy time, more time may be needed. If this is the case, researchers will be informed of this by NAR data management. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/06/2025 | 27/06/2025 | Yes | No |
Editorial Notes
27/06/2025: Publication reference added.
21/08/2024: The total final enrolment was changed from 225 to 214. The intention to publish date was changed from 01/02/2024 to 01/02/2025.
18/04/2023: Trial's existence confirmed by the ethics committee of the Faculty of Behavior and Movement Sciences of the Vrije Universiteit Amsterdam.
