- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05509309
Promoting Inclusive Educational Environments for Children with Autism and Other Social-communication Challenges: Preschool Class and Primary School
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Stockholm, Sweden
- Stockholm Municipality
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental group
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). |
APERS-assessments followed by in-service training, APERS-feedback and on-site coaching to improve primary school classroom quality for students with ASD/SCC
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No Intervention: Comparison group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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Baseline and about 9 months from baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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).
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Baseline and approximately 9 months from baseline
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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
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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.
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Baseline and approximately 9 months from baseline
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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
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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.
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Baseline and approximately 9 months from baseline
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Change from baseline in teachers' global impression of the child in the classroom
Time Frame: Baseline and approximately 9 months from baseline
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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.
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Baseline and approximately 9 months from baseline
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Change in teachers' stress assessed with the Teachers' Stress Scale
Time Frame: Baseline and approximately 9 months from baseline
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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.
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Baseline and approximately 9 months from baseline
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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
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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.
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Baseline and approximately 9 months from baseline
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Change in teachers' work satisfaction assessed with the Teacher Work Satisfaction Questionnaire
Time Frame: Baseline and approximately 9 months from baseline
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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,
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Baseline and approximately 9 months from baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social validity assessed with the Social Validity Scale
Time Frame: Follow-up approximately 9 months after onset of study
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A scale designed to asses the social validity of the procedures, goals and outcomes of the study by participating school staff.
It consists of 12 items rated on a Likert scale from 0 to 5, where higher ratings indicate higher levels of perceived social validity.
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Follow-up approximately 9 months after onset of study
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Social responsiveness measured with the Social Responsiveness Scale 2 (SRS-2)
Time Frame: Baseline assessment
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The SRS-2 is a scale designed to identify the presence and severity of social impairment within the autism spectrum and to differentiate it from that which occurs in other conditions.
In the current study used to assess the level of social challenges for the participating "index children" (i.e.
children with autism or socio-communicative challenges participating in the study).
The scale contains 65 items and is rated by the children's parents.
Each item is rated on a scale from 1 to 4, where 1 is "not true" and 4 is "almost always true".
Higher scores indicate more severe social impairment associated with autism, while lower scores indicate the opposite.
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Baseline assessment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lise Pettersson Roll, PhD, Stockholm University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VR 2020-03267
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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