Autism Spectrum DisorderOPASNCT06127472
Psychoeducation for Older Adults With Autism
A study testing Training in detection and diagnosis of ASD and PE program in people with Autism Spectrum Disorder, run by Tilburg University at 11 sites in Netherlands.
Trial summary
Until recently, autism in older adults went unrecognised. Although there has been more attention to autism in older adults in recent years, there is still a lot of unfamiliarity with the phenomenon and underdiagnosis in (mental) health care. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Training in detection and diagnosis of ASD and PE program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 11 sitesNetherlands
- Study dates
- 12 Sep 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- minimum of 55 years old.
- diagnosed with ASD or a probability diagnosis by a multidisciplinary team according to the Dutch multidisciplinary guideline, as confirmed by the DSM-5 interview for ASD (Spek, n.d.), or the Netherlands Interview for Diagnosis of ASD in adults (NIDA; Vuijk, 2023)
Who cannot join
- comorbid mental disorder that needs acute treatment and severely interferes with a group treatment (for example psychosis),
- a major neurocognitive disorder (for example dementia or acquired brain injury),
- substance abuse disorder, that requires detoxification, and/or
- an IQ below 70.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Netherlands11 sites, 2 recruiting
- Active, not recruiting
Reinier van Arkel
's-Hertogenbosch, North Brabant, 5223 GZ
- Active, not recruiting
GGNet Ouderen (Elderly)
Apeldoorn, Gelderland, 7334 DZ
- Recruiting
Dimence
Deventer
Silvia Filart-Heuven, +31546684000, s.filart@dimence.nl
Ileen Verbeek, MSc, LLM, +31880162636, i.c.verbeek@tilburguniversity.edu
- Active, not recruiting
GGzE Nestor
Eindhoven, North Brabant, 5623 KW
- Active, not recruiting
SeneVita GGZ
Eindhoven, North Brabant, 5632 CW
- Active, not recruiting
GGz Mediant
Enschede, Overijssel, 7546 TA
- Active, not recruiting
GGz WNB Ouderen (Elderly)
Halsteren, North Brabant, 4661AA
- Active, not recruiting
Mondriaan Ouderen (Elderly)
Heerlen, Limburg, 6419PJ
- Active, not recruiting
GGz NHN Frailty
Hoorn, North Holland, 1624 NP
- Recruiting
GGz Breburg PersonaCura
Tilburg, North Brabant, 5025JE
A. (Arjan) C. Videler, Dr.
- Active, not recruiting
Vincent van Gogh Ouderen (Elderly)
Venray, Limburg, 5804 AV
About this study
Official title: Support With Psychoeducation for Older Adults With Autism Study
Until recently, autism in older adults went unrecognised. Although there has been more attention to autism in older adults in recent years, there is still a lot of unfamiliarity with the phenomenon and underdiagnosis in (mental) health care. Many care providers are reluctant to diagnose autism in later life, due to a lack of knowledge about autism in older adults and because there is still very little scientific knowledge available for this target group. Although several multidisciplinary guidelines for autism in adults prescribe that after the diagnosis psycho-education is the first step in treatment, psycho-education is still only offered in a few places in the Netherlands. Psycho-education is important to help older people gain knowledge about their autism, to help them understand and accept this diagnosis, in order to subsequently make the treatment of the problems, with which they turn to the mental health care, more appropriate and effective.
The aim of this study is to contribute to better recognition and diagnosis of autism among older adults. This research also aims to improve a psycho-education program for older adults and investigate its effects.
The scientific research question is whether training in ASD for health care professionals results in better recognition and detection of ASD in older adults, and whether participation in the psycho-education course for older adults, who have been diagnosed with autism, or have received a probability diagnosis ASD, contributes to improvement of mental health and quality of life.
Read the detailed description
The detection of autism spectrum disorder (ASD) in older adults in Dutch (specialised) mental health care is improving, but underdiagnosis remains. Older adults with ASD experience a low quality of life (QoL) and a high rate of psychopathology across the life span and into old age. Additionally, Dutch and international treatment guidelines advocate psychoeducation (PE) as the first intervention after patients have been diagnosed with ASD. However, as PE for older patients with ASD is hardly available in the Netherlands, access to PE is severely limited for these older adults. Hence, it is important to improve detection and diagnosis of ASD and increase the availability of PE for older adults. The hypotheses of this study are 1) that detection and diagnosis of ASD in older adults will significantly increase following training of professionals and 2) that delivering an adapted and improved PE program for older adults will result in more knowledge and recognition of ASD, a better acceptance of the diagnosis, improved coping with ASD, improved resilience and comorbid general psychological distress, and ultimately in higher quality of life, compared to those patients with ASD that receive no PE.
The aim of this study on the one hand is to gain insight into: 1) the effects of providing training and education to mental health care providers in detection and diagnosis of ASD in older adults, with the expectation that this contributes to an increase in the number and proportion of ASD diagnoses in older adults in the Netherlands; 2) the effects of a PE program for older adults with ASD in terms of knowledge and recognition of ASD and traits, a better acceptance of the diagnosis, improved coping with ASD, improved resilience and comorbid general psychological distress - and ultimately higher quality of life; and 3) the experiences of older adults with ASD following the PE program.
Study design: The effects of training and education in detection and diagnosis of ASD in older adults, and the effects of the PE program will be evaluated in a Stepped Wedge Trial Design (SWTD), with the intervention sequentially rolled-out in eleven (specialised) mental healthcare organisations. Furthermore, a pre-post design will be used to compare the situation before the roll-out period with the situation after the roll-out period in terms of diagnosis and individual outcomes such as knowledge regarding ASD. Qualitative measures will be used to assess the experiences of older adults with ASD who participated in the PE program.
Study population: Older adults - aged 55 and over diagnosed with ASD or a probability diagnosis by a multidisciplinary team according to the Dutch multidisciplinary guidelines, as confirmed by the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) interview for ASD, or the Netherlands Interview for Diagnosis of ASD in adults (NIDA) as well as a proxy (an individual who provides reports on behalf of, or about, a study participant).
The intervention consists of education in detection and diagnosis of ASD in older adults for mental health professionals and of an adapted PE program for older adults with a (probability) diagnosis of ASD. The PE program consists of eight, two hour group meetings on a weekly basis.
Primary study parameter concerns clinical outcomes measuring effects of the psycho-education course in terms of quality of life, acceptance of the diagnosis, knowledge of ASD, recognition of ASD traits, coping with ASD, quantitative autistic traits, resilience, and comorbid psychological distress. Quality of life is assessed by the MHQoL-7 (Mental Health Quality of Life Questionnaire). Acceptance of the diagnosis, knowledge and coping with ASD are assessed with use of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA). Acceptance of ASD (-diagnosis) is further assessed through the Acceptance Questionnaire (AQ). Autistic traits are assessed through the Social Responsiveness Scale-Adults (SRS-A). Comorbid psychological distress is assessed by the Brief Symptom Inventory (BSI). All these assessments are performed (1) at baseline (following diagnosis and informed consent); (2) before the patient starts with PE (on average three months after baseline; participants in the control group will receive this three months after baseline; (3) after the PE (on average two months after the start of the PE program; participants in the control group will receive this measurement 6 months after baseline); (4) at 9-months follow-up (nine months after second measurement). A proxy, chosen by the study participant, will additionally inform on acceptance, knowledge, recognition, coping and ASD traits through measurements on the VKHAA for informants (VKHAA-N) and SRS-A for informants (SRS-A-N) at two moments that overlap with measurements 2 and 3 of study participants.
Secondary study parameters is the number and proportion of ASD diagnoses in the participating centres (collected from the information and registration systems of the mental health care centres) from one year before, during the project, and at one year follow-up.
For patients, benefits will be considerable as they will receive a PE program that is recommended by the Dutch multidisciplinary guideline for ASD in adults, and although being the recommended first intervention by treatment guidelines, is not provided to them momentarily. The benefits account for patients who provide informed consent to participate in the research and patients who do not give their consent, since the same treatment will be available for both. The investigators consider the burden of participating in the research, which consists of filling out questionnaires and inviting a proxy of their choice to fill out two of the same questionnaires, to be limited. Firstly, because this will be done in the context of treatment that fits the recommended first intervention by treatment guidelines and thus does not provide an extra mental burden. Moreover, the time needed to fill out these questionnaires is limited: approximately 40 to 60 minutes per measurement point, and there are no indications that risks are involved with regard to the topics of these questionnaires; specifically in a similar study by the study's research group, no adverse events or risks were observed.
Additional potential benefits exist in the form of increased detection and diagnosis of ASD in older adults across participating organisations, while the burden of participating in the study hardly exceeds time and effort spent in diagnostic efforts as usual, yet lightens efforts spent on informing patients with an ASD diagnosis as this can be done in a group format rather than on an individual basis. The only extra effort is limited to informing patients about the study with verbal and written information.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Training in detection and diagnosis of ASD, PE program
- Keywords
- autism, older adults
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in detection and diagnosis of ASDOther
To improve detection and diagnosis of ASD the participating mental health institutes will be trained by the research group on how to detect and diagnose autism in older adults. The basis of the ASD training involves two separate training sessions. Part one focuses on recognition and detection of ASD, specifically in older adults, and will be offered to the entire teams of the participating centres. The second part of the training focuses on the diagnosis of ASD and as such is offered primarily to diagnosticians. Follow up will consist of monthly recurring options for online consultation during the entire project to discuss clinical cases by experts in ASD in older adults from PersonaCura, clinical centre of excellence for personality and developmental disorders in older adults (dr. A. Videler and R. Wilting).
PE programOther
An adapted PE program for older adults with a (probability) diagnosis of ASD. The PE program consists of eight, two-hour group meetings on a weekly basis.
| Study group | Role | What they receive |
|---|---|---|
| ASD trained | Other | Periods in the SWTD after receiving training in detection and diagnosis of ASD. Receives: Other: Training in detection and diagnosis of ASD |
| ASD training - control | Other | Periods in the SWTD before receiving training in detection and diagnosis of ASD. Receives: Other: Training in detection and diagnosis of ASD |
| PE program | Other | Periods in the SWTD after receiving the PE program. Receives: Other: PE program |
| PE program - control | Other | Periods in the SWTD before receiving the PE program. Receives: Other: PE program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (MHQoL-7)
Quality of life as measured with the Mental Health Quality of Life-7 (MHQoL-7) a standardized quality of life questionnaire specifically aimed at people with mental health problems. The MHQoL-7D index score can vary from 0 to 21, with higher scores indicating better quality of life.
Measured: minimum of 9 to maximum of 15 months with four measurements over this period.
Acceptance of the diagnosis
Acceptance of the diagnosis is based on the combined scores from patients and their chosen proxy on item 31 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA and VKHAA-N for proxies). The score on this item is binary with either yes or no scores. Scores thus range from 0 to 1, with a score of 1 reflecting acceptance as opposed to a score of 0 (no acceptance). This data further is aggregated with measurements of patients' acceptance of the diagnosis as evaluated with the Acceptance Questionnaire (AQ), a questionnaire with scores ranging from 0 to 33 and higher scores reflecting higher diagnosis acceptance. Total acceptance scores thus have a range from 0 - 35 and higher scores indicating more acceptance.
Measured: minimum of 9 to maximum of 15 months with four measurements over this period.
Acceptance of the diagnosis from proxy perspective
Acceptance of the diagnosis as reflected by proxies is based on item 31 from the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies (VKHAA-N). The score on this item is binary with either yes or no scores. Scores thus range from 0 to 1, with a score of 1 reflecting acceptance as opposed to a score of 0 (no acceptance).
Measured: 8 weeks with two measurements over this period.
Knowledge of ASD
Knowledge of ASD is based on measurements on items 1-18 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA). Scores range from 0 to 54 with higher scores indicating more knowledge of ASD.
Measured: minimum of 9 to maximum of 15 months with four measurements over this period.
Knowledge of ASD from proxy perspective
Knowledge of ASD as reflected by proxy perspective is based on measurements on items 1-18 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies (VKHAA-). Scores range from 0 to 54 with higher scores indicating more knowledge of ASD.
Measured: 8 weeks with two measurements over this period.
Recognition of ASD traits
Recognition of ASD is based on measurements on items 20-25 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA). Minimum to maximum values are 0 through 24, with higher scores reflecting more recognition of ASD.
Measured: minimum of 9 to maximum of 15 months with four measurements over this period.
Recognition of ASD traits from proxy perspective
Recognition of ASD as reflected by the proxy perspective is based on measurements on items 20-25 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies (VKHAA-N). Minimum to maximum values are 0 through 24, with higher scores reflecting more recognition of ASD.
Measured: 8 weeks with two measurements over this period.
Coping with ASD
Coping with ASD is based on measurements on items 19 and 28-30 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA). Scores range from 0 to 15, with higher scores indicating better coping with ASD.
Measured: minimum of 9 to maximum of 15 months with four measurements over this period.
Coping with ASD from proxy perspective
Coping with ASD from the proxy perspective is based on measurements on items 19 and 28-30 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies (VKHAA-N). Scores range from 0 to 15, with higher scores indicating better coping with ASD.
Measured: 8 weeks with two measurements over this period.
Quantitative autistic traits
Autistic traits are evaluated with use of the Social Responsiveness Scale-Adults (SRS-A). The questionnaire consists of 4 subscales: Social Awareness (SA), Social Communication (SC), Social Motivation (SM) and Repetitiveness and Rigidity (RR). Scores on the SRS-A range from 64 to 256 with higher scores reflecting more autistic traits.
Measured: minimum of 9 to maximum of 15 months with four measurements over this period.
Quantitative autistic traits from proxy perspective
Autistic traits from the proxy perspective are evaluated with use of the Social Responsiveness Scale-Adults for proxies, the SRS-A-N. The questionnaire consists of 4 subscales: Social Awareness (SA), Social Communication (SC), Social Motivation (SM) and Repetitiveness and Rigidity (RR). Scores on the SRS-A-N range from 64 to 256 with higher scores reflecting more autistic traits.
Measured: 8 weeks with two measurements over this period.
Resilience
Resilience will be assessed with a 10-item questionnaire, the Connor-Davidson Resilience Scale (CD-RISC-10). Scores range from 0 - 40 with higher scores indicating greater resilience.
Measured: minimum of 9 to maximum of 15 months with four measurements over this period.
Comorbid psychological distress
Comorbid psychological distress will be assessed through the Brief Symptom Inventory (BSI). BSI is a 53-item questionnaire with 9 subscales for somatic complaints, cognitive problems, interpersonal sensitivity, depressive mood, anxiety, hostility, phobia, paranoia and psychoticism. Scores range from 0 - 212 with higher scores indicating higher presence of psychological complaints.
Measured: minimum of 9 to maximum of 15 months with four measurements over this period.
Secondary outcomes (2)
Number of ASD diagnoses
The number of ASD diagnoses collected from the information and registration systems of the participating mental health care centres.
Measured: Collection of data concerns numbers per month, starting from one year before, during the expected 18 months of the roll out of the ASD training intervention, and at one year follow-up following roll out of this training in the last cluster of the SWTD.
Proportion of ASD diagnoses
The proportion of ASD diagnoses collected from the information and registration systems of the participating mental health care centres.
Measured: Collection of data concerns numbers per month, starting from one year before, during the expected 18 months of the roll out of the ASD training intervention, and at one year follow-up following roll out of this training in the last cluster of the SWTD.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start12 Sep 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The effects of the adapted PE program will be evaluated in a Stepped Wedge Trial Design (SWTD), with the intervention sequentially rolled-out in eleven (specialised) mental healthcare organisations. Furthermore, a pre-post design will be used to compare the situation before the roll-out period with the situation after the roll-out period. A second intervention, training and education in detection and diagnosis of ASD in older adults, is rolled out in de same SWTD. The effects of this intervention will also be assessed further in pre-post design.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tilburg University
- Sponsor type
- University, hospital or other
- Collaborators
- GGZ Breburg
- Responsible party
- Sponsor
- Investigators
- Arjan Videler, Dr., Principal investigator, Tilburg University, GGz Breburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127472
- Sponsor's protocol ID
- NL84067.028.23
- Acronym
- OPAS
- Status last verified
- May 2026
- First submitted
- 26 Oct 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be saved on the secured server of Tranzo, Tilburg University, for 15 years. Three years after the research project is completed, other researchers may apply to use the research data. This concerns only processed and fully anonymized data. Only applications for research that has a purpose similar to the purpose of the current study may be approved. Participants that do not want their data used for this purpose can indicate so on their consent form. They will still be able to participate in the study and will receive the same treatment in that case.
Publications
Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.
PubMed 18157881de Beurs, E. (2011). Brief Symptom Inventory-BSI. Handleiding herziene editie 2011. Leiden: PITS BV.
Cage E, Di Monaco J, Newell V. Experiences of Autism Acceptance and Mental Health in Autistic Adults. J Autism Dev Disord. 2018 Feb;48(2):473-484. doi: 10.1007/s10803-017-3342-7.
PubMed 29071566van Krugten FCW, Busschbach JJV, Versteegh MM, Hakkaart-van Roijen L, Brouwer WBF. The Mental Health Quality of Life Questionnaire (MHQoL): development and first psychometric evaluation of a new measure to assess quality of life in people with mental health problems. Qual Life Res. 2022 Feb;31(2):633-643. doi: 10.1007/s11136-021-02935-w. Epub 2021 Jul 9.
PubMed 34241821Verbeek, I.C., Wedjelek, J., Elfeddali, I., & Videler, A.C. (2023). Acceptance Questionnaire Dutch translation. In development.
Verbeek, I.C., Lenders, M.A.C.., van Alphen, S.P.J., Elfeddali, I., & Videler, A.C., (2023a). Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis. In development.
Verbeek, I.C., Lenders, M.A.C, van Alphen, S.P.J., Elfeddali, I., & Videler, A.C., (2023b). Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies. In development.
Constantino, J.N., & Gruber, C.P. (2016). SRS-A Screeningslijst voor autismespectrumstoornissen: Handleiding. Hogrefe. [Dutch Handbook for the Social Responsiveness Scale for Adults]
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support With Psychoeducation for Older Adults With Autism Study
- ClinicalTrials.gov ID
- NCT06127472
- Acronym / sponsor ID
- OPAS / NL84067.028.23
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, older adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tilburg UniversityUniversity, hospital or other
- Collaborators
- GGZ Breburg
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Until recently, autism in older adults went unrecognised. Although there has been more attention to autism in older adults in recent years, there is still a lot of unfamiliarity with the phenomenon and underdiagnosis in (mental) health care. Many care providers are reluctant to diagnose autism in later life, due to a lack of knowledge about autism in older adults and because there is still very little scientific knowledge available for this target group. Although several multidisciplinary guidelines for autism in adults prescribe that after the diagnosis psycho-education is the first step in treatment, psycho-education is still only offered in a few places in the Netherlands. Psycho-education is important to help older people gain knowledge about their autism, to help them understand and accept this diagnosis, in order to subsequently make the treatment of the problems, with which they turn to the mental health care, more appropriate and effective.
The aim of this study is to contribute to better recognition and diagnosis of autism among older adults. This research also aims to improve a psycho-education program for older adults and investigate its effects.
The scientific research question is whether training in ASD for health care professionals results in better recognition and detection of ASD in older adults, and whether participation in the psycho-education course for older adults, who have been diagnosed with autism, or have received a probability diagnosis ASD, contributes to improvement of mental health and quality of life.
Detailed description
The detection of autism spectrum disorder (ASD) in older adults in Dutch (specialised) mental health care is improving, but underdiagnosis remains. Older adults with ASD experience a low quality of life (QoL) and a high rate of psychopathology across the life span and into old age. Additionally, Dutch and international treatment guidelines advocate psychoeducation (PE) as the first intervention after patients have been diagnosed with ASD. However, as PE for older patients with ASD is hardly available in the Netherlands, access to PE is severely limited for these older adults. Hence, it is important to improve detection and diagnosis of ASD and increase the availability of PE for older adults. The hypotheses of this study are 1) that detection and diagnosis of ASD in older adults will significantly increase following training of professionals and 2) that delivering an adapted and improved PE program for older adults will result in more knowledge and recognition of ASD, a better acceptance of the diagnosis, improved coping with ASD, improved resilience and comorbid general psychological distress, and ultimately in higher quality of life, compared to those patients with ASD that receive no PE.
The aim of this study on the one hand is to gain insight into: 1) the effects of providing training and education to mental health care providers in detection and diagnosis of ASD in older adults, with the expectation that this contributes to an increase in the number and proportion of ASD diagnoses in older adults in the Netherlands; 2) the effects of a PE program for older adults with ASD in terms of knowledge and recognition of ASD and traits, a better acceptance of the diagnosis, improved coping with ASD, improved resilience and comorbid general psychological distress - and ultimately higher quality of life; and 3) the experiences of older adults with ASD following the PE program.
Study design: The effects of training and education in detection and diagnosis of ASD in older adults, and the effects of the PE program will be evaluated in a Stepped Wedge Trial Design (SWTD), with the intervention sequentially rolled-out in eleven (specialised) mental healthcare organisations. Furthermore, a pre-post design will be used to compare the situation before the roll-out period with the situation after the roll-out period in terms of diagnosis and individual outcomes such as knowledge regarding ASD. Qualitative measures will be used to assess the experiences of older adults with ASD who participated in the PE program.
Study population: Older adults - aged 55 and over diagnosed with ASD or a probability diagnosis by a multidisciplinary team according to the Dutch multidisciplinary guidelines, as confirmed by the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) interview for ASD, or the Netherlands Interview for Diagnosis of ASD in adults (NIDA) as well as a proxy (an individual who provides reports on behalf of, or about, a study participant).
The intervention consists of education in detection and diagnosis of ASD in older adults for mental health professionals and of an adapted PE program for older adults with a (probability) diagnosis of ASD. The PE program consists of eight, two hour group meetings on a weekly basis.
Primary study parameter concerns clinical outcomes measuring effects of the psycho-education course in terms of quality of life, acceptance of the diagnosis, knowledge of ASD, recognition of ASD traits, coping with ASD, quantitative autistic traits, resilience, and comorbid psychological distress. Quality of life is assessed by the MHQoL-7 (Mental Health Quality of Life Questionnaire). Acceptance of the diagnosis, knowledge and coping with ASD are assessed with use of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA). Acceptance of ASD (-diagnosis) is further assessed through the Acceptance Questionnaire (AQ). Autistic traits are assessed through the Social Responsiveness Scale-Adults (SRS-A). Comorbid psychological distress is assessed by the Brief Symptom Inventory (BSI). All these assessments are performed (1) at baseline (following diagnosis and informed consent); (2) before the patient starts with PE (on average three months after baseline; participants in the control group will receive this three months after baseline; (3) after the PE (on average two months after the start of the PE program; participants in the control group will receive this measurement 6 months after baseline); (4) at 9-months follow-up (nine months after second measurement). A proxy, chosen by the study participant, will additionally inform on acceptance, knowledge, recognition, coping and ASD traits through measurements on the VKHAA for informants (VKHAA-N) and SRS-A for informants (SRS-A-N) at two moments that overlap with measurements 2 and 3 of study participants.
Secondary study parameters is the number and proportion of ASD diagnoses in the participating centres (collected from the information and registration systems of the mental health care centres) from one year before, during the project, and at one year follow-up.
For patients, benefits will be considerable as they will receive a PE program that is recommended by the Dutch multidisciplinary guideline for ASD in adults, and although being the recommended first intervention by treatment guidelines, is not provided to them momentarily. The benefits account for patients who provide informed consent to participate in the research and patients who do not give their consent, since the same treatment will be available for both. The investigators consider the burden of participating in the research, which consists of filling out questionnaires and inviting a proxy of their choice to fill out two of the same questionnaires, to be limited. Firstly, because this will be done in the context of treatment that fits the recommended first intervention by treatment guidelines and thus does not provide an extra mental burden. Moreover, the time needed to fill out these questionnaires is limited: approximately 40 to 60 minutes per measurement point, and there are no indications that risks are involved with regard to the topics of these questionnaires; specifically in a similar study by the study's research group, no adverse events or risks were observed.
Additional potential benefits exist in the form of increased detection and diagnosis of ASD in older adults across participating organisations, while the burden of participating in the study hardly exceeds time and effort spent in diagnostic efforts as usual, yet lightens efforts spent on informing patients with an ASD diagnosis as this can be done in a group format rather than on an individual basis. The only extra effort is limited to informing patients about the study with verbal and written information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The effects of the adapted PE program will be evaluated in a Stepped Wedge Trial Design (SWTD), with the intervention sequentially rolled-out in eleven (specialised) mental healthcare organisations. Furthermore, a pre-post design will be used to compare the situation before the roll-out period with the situation after the roll-out period. A second intervention, training and education in detection and diagnosis of ASD in older adults, is rolled out in de same SWTD. The effects of this intervention will also be assessed further in pre-post design.
| Arm | Type | Receives |
|---|---|---|
| ASD trained | Other | Other: Training in detection and diagnosis of ASDPeriods in the SWTD after receiving training in detection and diagnosis of ASD. |
| ASD training - control | Other | Other: Training in detection and diagnosis of ASDPeriods in the SWTD before receiving training in detection and diagnosis of ASD. |
| PE program | Other | Other: PE programPeriods in the SWTD after receiving the PE program. |
| PE program - control | Other | Other: PE programPeriods in the SWTD before receiving the PE program. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- minimum of 55 years old.
- diagnosed with ASD or a probability diagnosis by a multidisciplinary team according to the Dutch multidisciplinary guideline, as confirmed by the DSM-5 interview for ASD (Spek, n.d.), or the Netherlands Interview for Diagnosis of ASD in adults (NIDA; Vuijk, 2023)
Key exclusion criteria (4 listed)
- comorbid mental disorder that needs acute treatment and severely interferes with a group treatment (for example psychosis),
- a major neurocognitive disorder (for example dementia or acquired brain injury),
- substance abuse disorder, that requires detoxification, and/or
- an IQ below 70.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training in detection and diagnosis of ASDTo improve detection and diagnosis of ASD the participating mental health institutes will be trained by the research group on how to detect and diagnose autism in older adults. The basis of the ASD training involves two separate training sessions. Part one focuses on recognition and detection of ASD, specifically in older adults, and will be offered to the entire teams of the participating centres. The second part of the training focuses on the diagnosis of ASD and as such is offered primarily to diagnosticians. Follow up will consist of monthly recurring options for online consultation during the entire project to discuss clinical cases by experts in ASD in older adults from PersonaCura, clinical centre of excellence for personality and developmental disorders in older adults (dr. A. Videler and R. Wilting). | Other | ASD trained, ASD training - control |
| PE programAn adapted PE program for older adults with a (probability) diagnosis of ASD. The PE program consists of eight, two-hour group meetings on a weekly basis. | Other | PE program, PE program - control |
Primary outcome
Quality of life (MHQoL-7)
Time frame: minimum of 9 to maximum of 15 months with four measurements over this period.
Quality of life as measured with the Mental Health Quality of Life-7 (MHQoL-7) a standardized quality of life questionnaire specifically aimed at people with mental health problems. The MHQoL-7D index score can vary from 0 to 21, with higher scores indicating better quality of life.
Acceptance of the diagnosis
Time frame: minimum of 9 to maximum of 15 months with four measurements over this period.
Acceptance of the diagnosis is based on the combined scores from patients and their chosen proxy on item 31 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA and VKHAA-N for proxies). The score on this item is binary with either yes or no scores. Scores thus range from 0 to 1, with a score of 1 reflecting acceptance as opposed to a score of 0 (no acceptance). This data further is aggregated with measurements of patients' acceptance of the diagnosis as evaluated with the Acceptance Questionnaire (AQ), a questionnaire with scores ranging from 0 to 33 and higher scores reflecting higher diagnosis acceptance. Total acceptance scores thus have a range from 0 - 35 and higher scores indicating more acceptance.
Acceptance of the diagnosis from proxy perspective
Time frame: 8 weeks with two measurements over this period.
Acceptance of the diagnosis as reflected by proxies is based on item 31 from the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies (VKHAA-N). The score on this item is binary with either yes or no scores. Scores thus range from 0 to 1, with a score of 1 reflecting acceptance as opposed to a score of 0 (no acceptance).
Knowledge of ASD
Time frame: minimum of 9 to maximum of 15 months with four measurements over this period.
Knowledge of ASD is based on measurements on items 1-18 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA). Scores range from 0 to 54 with higher scores indicating more knowledge of ASD.
Knowledge of ASD from proxy perspective
Time frame: 8 weeks with two measurements over this period.
Knowledge of ASD as reflected by proxy perspective is based on measurements on items 1-18 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies (VKHAA-). Scores range from 0 to 54 with higher scores indicating more knowledge of ASD.
Recognition of ASD traits
Time frame: minimum of 9 to maximum of 15 months with four measurements over this period.
Recognition of ASD is based on measurements on items 20-25 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA). Minimum to maximum values are 0 through 24, with higher scores reflecting more recognition of ASD.
Recognition of ASD traits from proxy perspective
Time frame: 8 weeks with two measurements over this period.
Recognition of ASD as reflected by the proxy perspective is based on measurements on items 20-25 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies (VKHAA-N). Minimum to maximum values are 0 through 24, with higher scores reflecting more recognition of ASD.
Coping with ASD
Time frame: minimum of 9 to maximum of 15 months with four measurements over this period.
Coping with ASD is based on measurements on items 19 and 28-30 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis (VKHAA). Scores range from 0 to 15, with higher scores indicating better coping with ASD.
Coping with ASD from proxy perspective
Time frame: 8 weeks with two measurements over this period.
Coping with ASD from the proxy perspective is based on measurements on items 19 and 28-30 of the Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies (VKHAA-N). Scores range from 0 to 15, with higher scores indicating better coping with ASD.
Quantitative autistic traits
Time frame: minimum of 9 to maximum of 15 months with four measurements over this period.
Autistic traits are evaluated with use of the Social Responsiveness Scale-Adults (SRS-A). The questionnaire consists of 4 subscales: Social Awareness (SA), Social Communication (SC), Social Motivation (SM) and Repetitiveness and Rigidity (RR). Scores on the SRS-A range from 64 to 256 with higher scores reflecting more autistic traits.
Quantitative autistic traits from proxy perspective
Time frame: 8 weeks with two measurements over this period.
Autistic traits from the proxy perspective are evaluated with use of the Social Responsiveness Scale-Adults for proxies, the SRS-A-N. The questionnaire consists of 4 subscales: Social Awareness (SA), Social Communication (SC), Social Motivation (SM) and Repetitiveness and Rigidity (RR). Scores on the SRS-A-N range from 64 to 256 with higher scores reflecting more autistic traits.
Resilience
Time frame: minimum of 9 to maximum of 15 months with four measurements over this period.
Resilience will be assessed with a 10-item questionnaire, the Connor-Davidson Resilience Scale (CD-RISC-10). Scores range from 0 - 40 with higher scores indicating greater resilience.
Comorbid psychological distress
Time frame: minimum of 9 to maximum of 15 months with four measurements over this period.
Comorbid psychological distress will be assessed through the Brief Symptom Inventory (BSI). BSI is a 53-item questionnaire with 9 subscales for somatic complaints, cognitive problems, interpersonal sensitivity, depressive mood, anxiety, hostility, phobia, paranoia and psychoticism. Scores range from 0 - 212 with higher scores indicating higher presence of psychological complaints.
2 secondary outcomes
Number of ASD diagnoses
Time frame: Collection of data concerns numbers per month, starting from one year before, during the expected 18 months of the roll out of the ASD training intervention, and at one year follow-up following roll out of this training in the last cluster of the SWTD.
Proportion of ASD diagnoses
Time frame: Collection of data concerns numbers per month, starting from one year before, during the expected 18 months of the roll out of the ASD training intervention, and at one year follow-up following roll out of this training in the last cluster of the SWTD.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 18157881Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.
- Backgroundde Beurs, E. (2011). Brief Symptom Inventory-BSI. Handleiding herziene editie 2011. Leiden: PITS BV.
- Background: PubMed 29071566Cage E, Di Monaco J, Newell V. Experiences of Autism Acceptance and Mental Health in Autistic Adults. J Autism Dev Disord. 2018 Feb;48(2):473-484. doi: 10.1007/s10803-017-3342-7.
- Background: PubMed 34241821van Krugten FCW, Busschbach JJV, Versteegh MM, Hakkaart-van Roijen L, Brouwer WBF. The Mental Health Quality of Life Questionnaire (MHQoL): development and first psychometric evaluation of a new measure to assess quality of life in people with mental health problems. Qual Life Res. 2022 Feb;31(2):633-643. doi: 10.1007/s11136-021-02935-w. Epub 2021 Jul 9.
- BackgroundVerbeek, I.C., Wedjelek, J., Elfeddali, I., & Videler, A.C. (2023). Acceptance Questionnaire Dutch translation. In development.
- BackgroundVerbeek, I.C., Lenders, M.A.C.., van Alphen, S.P.J., Elfeddali, I., & Videler, A.C., (2023a). Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis. In development.
- BackgroundVerbeek, I.C., Lenders, M.A.C, van Alphen, S.P.J., Elfeddali, I., & Videler, A.C., (2023b). Questionnaire Knowledge, Recognition and Acceptance of Autism Diagnosis for Proxies. In development.
- BackgroundConstantino, J.N., & Gruber, C.P. (2016). SRS-A Screeningslijst voor autismespectrumstoornissen: Handleiding. Hogrefe. [Dutch Handbook for the Social Responsiveness Scale for Adults]
- Individual participant dataSharing planned: No. Data will be saved on the secured server of Tranzo, Tilburg University, for 15 years. Three years after the research project is completed, other researchers may apply to use the research data. This concerns only processed and fully anonymized data. Only applications for research that has a purpose similar to the purpose of the current study may be approved. Participants that do not want their data used for this purpose can indicate so on their consent form. They will still be able to participate in the study and will receive the same treatment in that case.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arjan Videler, Dr. principal investigator
Tilburg University, GGz Breburg
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in detection and diagnosis of ASD and PE program in people with Autism Spectrum Disorder, run by Tilburg University at 11 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arjan Videler, Dr. (+3188-0162336 ext. +31 (NL), a.c.videler@tilburguniversity.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (MHQoL-7) (time frame: minimum of 9 to maximum of 15 months with four measurements over this period.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06127472, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.