Autism Spectrum DisorderAut-CARENCT07041502
Aut-CARE Intervention to Improve Cognitive and Emotional Functioning in Young Adults on the Autism Spectrum
An observational study of Autism Spectrum Disorder and Autism Spectrum Disorder With Absence of Functional Language, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Currently, many autistic youths struggle to adapt to academic programs or the workforce, often turning to third-sector organizations such as specialized associations and foundations. Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism Spectrum Disorder With Absence of Functional Language
- What is being tested?
- Aut-CARE
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 16 Oct 2024to 15 Sep 2026
- Phase
- Observational
- 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 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Individuals (females and males) aged 16 to 30 years with an ASD diagnosis, levels 1 and 2
Who may be able to join
- Subjects aged 16 to 30 years (male, female, and non-binary)
- Attending one or more services of the Friends Foundation (Prelaboral Friends, Laboral Friends, and EducaFriends).
- Diagnosed with ASD (according to DSM-5 criteria), levels 1 or 2, and without intellectual disability (IQ > 80).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041
Maria J Portella, Dr., +34935537836, mportella@santpau.cat
Júlia Carrasco, Mrs., +34935537837, jcarrasco@santpau.cat
About this study
Official title: Co-creation of the Aut-CARE Intervention to Improve the Cognitive and Emotional Functioning of Young Adults on the Autism Spectrum and Facilitate Their Socio-occupational Integration
Currently, many autistic youths struggle to adapt to academic programs or the workforce, often turning to third-sector organizations such as specialized associations and foundations. This may be due to factors such as emotional dysregulation and executive dysfunction, which interfere with their psychosocial adaptation abilities, leading to anxiety and depression. These challenges have a neurobiological basis tied to the unique complexities of the autistic brain, which experiences emotional and cognitive overload and lacks attentional filters. To address this issue, the emotional and executive functioning of autistic youths at the Friends Foundation will be assessed through objective and subjective assessments.
This data collection will serve as a foundation for conceptualizing and co-creating a more realistic affective-cognitive remediation program, integrating user perspectives (conceptualization of interventions for systematic implementation). The program aims to improve the socio-occupational and emotional adaptation difficulties that often contribute to mental health challenges within this underserved population. It is important to highlight that many existing programs focus on cognitive training and social skills, neglecting strategies for adaptation and emotional regulation. This project will stand out for its inclusive design, featuring a representative sample of both sexes, overcoming the usual limitation of male-centered approaches.
Read the detailed description
The mixed or hybrid sequential study design (quantitative → qualitative → quantitative) includes three parts:
- Assessment of socio-occupational, neuropsychological, and psychological variables to establish relationships between the degree of impairment and socio-occupational integration. Quantitative study.
- Focus groups to determine the contents of the intervention program, which will be co-created as the Aut-CARE program. Qualitative study.
- Pilot study of the Aut-CARE program to evaluate its format, content, feasibility, and acceptability.
Individuals aged 16 to 30 years with an ASD diagnosis, levels 1 and 2. The calculated sample size is 37 subjects for sub-study A; the minimum sample size for the focus groups (sub-study B) is 14; and a maximum of 10 participants for the pilot study (sub-study C).
- Being tested
- Aut-CARE
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aut-CAREOther
There is no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in emotion regulation scale (DERS)
The DERS is a measure of emotional dysregulation. The raw scores range from 36 to 180. Higher scores mean more difficulties.
Measured: 1 day
Battery of cognitive tests
A set of neuropsychological tests is administered: Trail Making Test-A, Trail Making Test-B, Digit Symbol Substitution Test, Digit Span, Letter and Numbers, and Phonetic Fluency (PMR). Scores will be t-transformed (mean=50, SD=10), so high scores mean better performance.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start16 Oct 2024
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041502
- Sponsor's protocol ID
- IIBSP-AUT-2024-102
- Acronym
- Aut-CARE
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-creation of the Aut-CARE Intervention to Improve the Cognitive and Emotional Functioning of Young Adults on the Autism Spectrum and Facilitate Their Socio-occupational Integration
- ClinicalTrials.gov ID
- NCT07041502
- Acronym / sponsor ID
- Aut-CARE / IIBSP-AUT-2024-102
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 27 Jun 2025 (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.
Currently, many autistic youths struggle to adapt to academic programs or the workforce, often turning to third-sector organizations such as specialized associations and foundations. This may be due to factors such as emotional dysregulation and executive dysfunction, which interfere with their psychosocial adaptation abilities, leading to anxiety and depression. These challenges have a neurobiological basis tied to the unique complexities of the autistic brain, which experiences emotional and cognitive overload and lacks attentional filters. To address this issue, the emotional and executive functioning of autistic youths at the Friends Foundation will be assessed through objective and subjective assessments.
This data collection will serve as a foundation for conceptualizing and co-creating a more realistic affective-cognitive remediation program, integrating user perspectives (conceptualization of interventions for systematic implementation). The program aims to improve the socio-occupational and emotional adaptation difficulties that often contribute to mental health challenges within this underserved population. It is important to highlight that many existing programs focus on cognitive training and social skills, neglecting strategies for adaptation and emotional regulation. This project will stand out for its inclusive design, featuring a representative sample of both sexes, overcoming the usual limitation of male-centered approaches.
Detailed description
The mixed or hybrid sequential study design (quantitative → qualitative → quantitative) includes three parts:
- Assessment of socio-occupational, neuropsychological, and psychological variables to establish relationships between the degree of impairment and socio-occupational integration. Quantitative study.
- Focus groups to determine the contents of the intervention program, which will be co-created as the Aut-CARE program. Qualitative study.
- Pilot study of the Aut-CARE program to evaluate its format, content, feasibility, and acceptability.
Individuals aged 16 to 30 years with an ASD diagnosis, levels 1 and 2. The calculated sample size is 37 subjects for sub-study A; the minimum sample size for the focus groups (sub-study B) is 14; and a maximum of 10 participants for the pilot study (sub-study C).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Individuals (females and males) aged 16 to 30 years with an ASD diagnosis, levels 1 and 2
Key inclusion criteria (3 listed)
- Subjects aged 16 to 30 years (male, female, and non-binary)
- Attending one or more services of the Friends Foundation (Prelaboral Friends, Laboral Friends, and EducaFriends).
- Diagnosed with ASD (according to DSM-5 criteria), levels 1 or 2, and without intellectual disability (IQ > 80).
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Aut-CAREThere is no intervention | Other | – |
Primary outcome
Difficulties in emotion regulation scale (DERS)
Time frame: 1 day
The DERS is a measure of emotional dysregulation. The raw scores range from 36 to 180. Higher scores mean more difficulties.
Battery of cognitive tests
Time frame: 1 day
A set of neuropsychological tests is administered: Trail Making Test-A, Trail Making Test-B, Digit Symbol Substitution Test, Digit Span, Letter and Numbers, and Phonetic Fluency (PMR). Scores will be t-transformed (mean=50, SD=10), so high scores mean better performance.
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 27 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Autism Spectrum Disorder With Absence of Functional Language, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 3 inclusion and 1 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 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 Alejandra Espinosa (+34 93 553 78 13, AEspinosaG@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in emotion regulation scale (DERS) (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2025; AzTrials last refreshed its copy on 1 Nov 2026.