Autism Spectrum DisorderNCT05509309
Promoting Inclusive Educational Environments for Children with Autism and Other Social-communication Challenges: Preschool Class and Primary School
A study testing APERS-based model in people with Autism Spectrum Disorder and Social Communication Challenges, run by Stockholm University at 1 site in Sweden.
Trial summary
This study evaluates the effect of using the Autism Program Environment Rating Scale (APERS) as the foundation for providing feedback, in-service training and coaching to teachers, to improve program quality for autistic (ASD) students and students with related social-communication challenges (SCC) in Swedish primary… Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Social Communication Challenges
- What is being tested?
- APERS-based model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 15 Aug 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- autism diagnosis
- socio-communicative challenges identified by parents and/or school staff
- attending a primary school classroom (i.e., from pre-school class to third grade)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effect of using the Autism Program Environment Rating Scale (APERS) as the foundation for providing feedback, in-service training and coaching to teachers, to improve program quality for autistic (ASD) students and students with related social-communication challenges (SCC) in Swedish primary school classrooms. In the current study half of the participating classrooms will receive the APERS-based model for program quality improvement, while the other half will receive services as usual.
It is hypothesized that the APERS-based model will improve primary school program quality for children with ASD and SCC, as well as improve functioning for students with ASD/SCC and self-perceived self-efficacy among participating teachers, compared to the study's comparison group.
- Being tested
- APERS-based model
- 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.
APERS-based modelBehavioural
APERS-assessments followed by in-service training, APERS-feedback and on-site coaching to improve primary school classroom quality for students with ASD/SCC
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | In the experimental group, in-service training on autism, program quality, and APERS will be provided to participating staff. Furthermore, APERS-rating to assess the program quality for students with ASD/SCC will be conducted. Pertaining feedback on program areas of strength and improvement will be provided by the APERS-raters to the classroom teachers.
Subsequently, assigned coaches (already employed at the school as special educators or equivalent) will based on the APERS-ratings develop an action plan to improve program quality for students with ASD and SCC, in collaboration with classroom teachers. Subsequently, the coach will provide weekly or bi-weekly coaching to promote program quality during the course of two school semesters (approximately 8-9 months). Receives: Behavioral: APERS-based model |
| Comparison group | No intervention | The classrooms in the comparison group will also be rated with the APERS, and feedback will provided to classroom teachers. However, no further support will be provided in transforming APERS-ratings with pertaining feedback into best practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in autism program quality assessed with the Autism Program Environment Rating Scale - Preschool and primary school (APERS-Fk/L-SE)
The APERS-Fk/L-SE is a rating scale designed to examine primary school program quality for autistic students in Sweden. It contains 10 domains including areas such as students' personal independence and competence, and challenging behaviors. The scale consists of 59 items rated on a five-point Likert-scale (1= low quality - 5 = high quality) resulting in individual item scores, subdomain scores, domain scores and a total score.
Measured: Baseline and about 9 months from baseline
Secondary outcomes (7)
Change from baseline in how children feel about their school assessed with How I Feel About My School (HIFAMS)
The HIFAMS is a questionnaire designed to assess the happiness and subjective well-being of children in school. It is to to be completed by all children in all participating classrooms in the study. The questionnaire is composed of seven questions which asks children how they feel about school life, which are scored using a three-point Likert "face" scale (sad face, neutral face, happy face).
Measured: Baseline and approximately 9 months from baseline
Change from baseline in parents ratings on their children's body functions, activities and participation and contextual factors assessed with the International Classification of Functioning, Disability and Health (ICF) Core Sets for Autism
the ICF Core Sets for Autism is a questionnaire for parents to complete about their children. It contains a number of statements about their children's body functions, activities and participation, and contextual factors that may affect their children's functioning rater on a Likert-scale from either 0 to 10, or -5 to 5 (contextual factors), where higher ratings indicate higher levels of functioning and participation.
Measured: Baseline and approximately 9 months from baseline
Change from baseline in children's self-regulation and academic behavior assessed with children's self-regulation and academic behavior questionnaire
The Children's self-regulation and academic behavior questionnaire is designed for teachers to rate children's self-regulation and academic behavior skills in various situations in the classroom, rated on a five-point Likert scale from 0 to 4, across 11 items, where higher ratings indicate more skills and better self-regulation.
Measured: Baseline and approximately 9 months from baseline
Change from baseline in teachers' global impression of the child in the classroom
Teachers' global impression of the child in school during the latest week. Rated on a four-point Likert scale from 0 to 3, across four items, where higher ratings indicate more well-being, participation, engagement and adaptive behaviors.
Measured: Baseline and approximately 9 months from baseline
Change in teachers' stress assessed with the Teachers' Stress Scale
The Teachers' Stress Scale is a questionnaire designed for teachers to complete about their perceived work-related stress. It consists of five items, and is rated on a six-point Likert scale from 0 to 6 where higher ratings are associated with more stress.
Measured: Baseline and approximately 9 months from baseline
Change in teachers' perceived self-efficacy for supporting students with autism using the Autism Self-Efficacy Scale for Teachers
The Autism Self-Efficacy Scale for Teachers is a questionnaire for teachers to complete about their perceived self-efficacy for supporting students with ASD and socio-communicative challenges in their classroom. It consists of 28 items, and is rated on a six-point Likert scale from 0 to 5. Higher ratings indicate more self-efficacy.
Measured: Baseline and approximately 9 months from baseline
Change in teachers' work satisfaction assessed with the Teacher Work Satisfaction Questionnaire
The Teacher Work Satisfaction Questionnaire is designed for teachers to complete about their work satisfaction. It contains three items that are rated on a six-point Likert scale from 0 to 5, where higher ratings indicate more work satisfaction,
Measured: Baseline and approximately 9 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start15 Aug 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stockholm University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Lise Roll-Pettersson, Stockholm University
- Investigators
- Lise Pettersson Roll, PhD, Principal investigator, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509309
- Sponsor's protocol ID
- VR 2020-03267
- Status last verified
- Jan 2025
- First submitted
- 31 May 2022
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Inclusive Educational Environments for Children with Autism and Other Social-communication Challenges: Preschool Class and Primary School
- ClinicalTrials.gov ID
- NCT05509309
- Acronym / sponsor ID
- VR 2020-03267
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stockholm UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 22 Aug 2022 (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.
This study evaluates the effect of using the Autism Program Environment Rating Scale (APERS) as the foundation for providing feedback, in-service training and coaching to teachers, to improve program quality for autistic (ASD) students and students with related social-communication challenges (SCC) in Swedish primary school classrooms. In the current study half of the participating classrooms will receive the APERS-based model for program quality improvement, while the other half will receive services as usual.
It is hypothesized that the APERS-based model will improve primary school program quality for children with ASD and SCC, as well as improve functioning for students with ASD/SCC and self-perceived self-efficacy among participating teachers, compared to the study's comparison group.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: APERS-based modelIn the experimental group, in-service training on autism, program quality, and APERS will be provided to participating staff. Furthermore, APERS-rating to assess the program quality for students with ASD/SCC will be conducted. Pertaining feedback on program areas of strength and improvement will be provided by the APERS-raters to the classroom teachers. Subsequently, assigned coaches (already employed at the school as special educators or equivalent) will based on the APERS-ratings develop an action plan to improve program quality for students with ASD and SCC, in collaboration with classroom teachers. Subsequently, the coach will provide weekly or bi-weekly coaching to promote program quality during the course of two school semesters (approximately 8-9 months). |
| Comparison group | No intervention | –The classrooms in the comparison group will also be rated with the APERS, and feedback will provided to classroom teachers. However, no further support will be provided in transforming APERS-ratings with pertaining feedback into best practice. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- autism diagnosis
- socio-communicative challenges identified by parents and/or school staff
- attending a primary school classroom (i.e., from pre-school class to third grade)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| APERS-based modelAPERS-assessments followed by in-service training, APERS-feedback and on-site coaching to improve primary school classroom quality for students with ASD/SCC | Behavioural | Experimental group |
Primary outcome
Change from baseline in autism program quality assessed with the Autism Program Environment Rating Scale - Preschool and primary school (APERS-Fk/L-SE)
Time frame: Baseline and about 9 months from baseline
The APERS-Fk/L-SE is a rating scale designed to examine primary school program quality for autistic students in Sweden. It contains 10 domains including areas such as students' personal independence and competence, and challenging behaviors. The scale consists of 59 items rated on a five-point Likert-scale (1= low quality - 5 = high quality) resulting in individual item scores, subdomain scores, domain scores and a total score.
7 secondary outcomes
Change from baseline in how children feel about their school assessed with How I Feel About My School (HIFAMS)
Time frame: Baseline and approximately 9 months from baseline
Change from baseline in parents ratings on their children's body functions, activities and participation and contextual factors assessed with the International Classification of Functioning, Disability and Health (ICF) Core Sets for Autism
Time frame: Baseline and approximately 9 months from baseline
Change from baseline in children's self-regulation and academic behavior assessed with children's self-regulation and academic behavior questionnaire
Time frame: Baseline and approximately 9 months from baseline
Change from baseline in teachers' global impression of the child in the classroom
Time frame: Baseline and approximately 9 months from baseline
Change in teachers' stress assessed with the Teachers' Stress Scale
Time frame: Baseline and approximately 9 months from baseline
Change in teachers' perceived self-efficacy for supporting students with autism using the Autism Self-Efficacy Scale for Teachers
Time frame: Baseline and approximately 9 months from baseline
Change in teachers' work satisfaction assessed with the Teacher Work Satisfaction Questionnaire
Time frame: Baseline and approximately 9 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lise Pettersson Roll, PhD principal investigator
Stockholm University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APERS-based model in people with Autism Spectrum Disorder and Social Communication Challenges, run by Stockholm University at 1 site in Sweden.
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 0 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: finished, as of the sponsor's last update on 24 Jan 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in autism program quality assessed with the Autism Program Environment Rating Scale - Preschool and primary school (APERS-Fk/L-SE) (time frame: Baseline and about 9 months from baseline). 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 24 Jan 2025.