Autism Spectrum DisorderAUT-TIDNCT03634761
Early Intervention and Autism: Transformation From Research to Practice Through a Competency Based Model
A study testing Competency based model and Comprehensive program in people with Autism Spectrum Disorder, run by Stockholm University at 2 sites in Sweden.
Trial summary
This study evaluates the effect of a competency based model on program quality in Swedish preschools for Children with autism spectrum disorder (ASD). Half of the participating preschools will receive "treatment as usual" (Early Intensive Behavioral Intervention (EIBI) provided to a Child with ASD in the preschool… Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Competency based model and Comprehensive program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesSweden
- Study dates
- 15 May 2017to 30 May 2019
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Autism diagnosis
- Receiving comprehensive program/EIBI implemented in preschool setting with supervision from habilitation center
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
BanyanCenter
Stockholm, 11140
Autismcenter för Små Barn
Stockholm, 11869
About this study
This study evaluates the effect of a competency based model on program quality in Swedish preschools for Children with autism spectrum disorder (ASD). Half of the participating preschools will receive "treatment as usual" (Early Intensive Behavioral Intervention (EIBI) provided to a Child with ASD in the preschool, supervised by an external supervisor from a habilitation center), while the other half will receive the above as well as, in-service training and monthly on-site coaching sessions also involving preschool staff other than the paraprofessional (competency based model). It is hypothesized that the competency based model will improve program quality, child's engagement, preschool staff knowledge, allegiance and self-efficacy compared to the comparison group.
Read the detailed description
Almost all children in Sweden between two and five years attend preschool including children with Autism spectrum disorder (ASD). High quality and structured early intervention programs grounded in the principles and procedures of applied behavior analysis have been found in numerous research studies and reviews to significantly improve developmental outcomes, adaptive behaviors and learning outcomes of preschool children with ASD.
A prerequisite of which is a high quality learning environment that includes both the physical set-up, learning climate and competence of staff. The primary purpose of this project is to improve program quality for preschool children with ASD through a competency based model grounded in ecological systems theory sustainable over time and applicable within the Swedish service support system. In total approximately 16 preschools will participate, half of which will receive "treatment as usual" EIBI to a Child with ASD in the preschool, supervised by an external supervisor from a habilitation center), while the other half will also receive obtain in-service training and monthly on-site coaching through habilitation. Involved habilitation specialists will obtain in-service training prior to the onset of the study on how to use the Autism Program Environment Rating Scale (APERS), the basic tenets of coaching based on the concept of reflective and collaborative dialogues in which the preschool teachers knowledge of the child and context are taken into account.
It is hypothesized that the competency based model will improve program quality, child's engagement, adaptive behavior, increase preschool staff knowledge, allegiance and self-efficacy compared to the comparison group only receiving supervision in implementing a comprehensive program.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Competency based model, Comprehensive program
- Keywords
- Program Quality, Intervention Setting, Autism
- 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.
Competency based modelBehavioural
Qualified Learning course and workshop to preschool staff combined with monthly on-site coaching at preschool sites to improve overall intervention setting quality and use of evidence bases practices, provided by external expert from habilitation center.
Comprehensive programBehavioural
Comprehensive program of EIBI for Children with ASD supervised by external expert from habilitation center (treatment as usual)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Preschools/Children in this group will receive EIBI supervised by an external expert from the habilitation center on a regular basis. In addition, preschool staff in this group are provided with in-service training consisting of a one full day (onset of project) and a half day (middle of project) on autism, applied behavior analysis, evidence-based practices, engagement, participation, inclusion and overall quality factors when working with Children with autism in preschool settings. Preschool staff are also provided with monthly on-site coaching in implementing evidence based practices, goal setting and working with overall intervention setting, through coaching from the habilitation center. Receives: Behavioral: Competency based model; Behavioral: Comprehensive program |
| Comparison group | Active comparator | Preschools/Children are in this group receive "treatment as usual", which is EIBI supervised by an external expert from the habilitation center at the habilitation center directed toward the paraprofessional. At the offset of the project preschool staff are offered to participate in a one-day learning course/workshop on autism, applied behavior analysis, evidence-based practices, engagement, participation, inclusion and overall quality factors when working with children with autism in preschool settings. Receives: Behavioral: Comprehensive program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall program quality measured by the Autism Program Environment Rating Scale (APERS-P-SE)
The APERS-P-SE is a rating scale designed to examine the preschool teaching environment of children with ASD in Sweden. It is used to assess overall intervention setting quality over 10 domains including areas such as Personal Independence and Functional Behavior. It consists of 56 items rated on a 5 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 follow-up (about 9 months from baseline)
Secondary outcomes (8)
Ethics, Values and Allegiance (EVA)
A questionnaire used to assess attitude and allegiance to EIBI among preschool staff. 11 items/statements rated on a five point scale (I don't agree at all, to I highly agree)
Measured: Baseline and follow-up (about 9 months from baseline)
Evidence Based Practices (EBP)
A questionnaire designed to assess knowledge, use and implementation skills of evidence based practices for Children with autism among preschool staff. 15 items rated on a 4 point Likert-scale (0 = no knowledge, 3 = high knowledge)
Measured: Baseline and follow-up (about 9 months from baseline)
Autism Knowledge Questionnaire (AKQ)
A questionnaire designed to assess knowledge on ASD among preschool staff. 18 items/statements about autism, answered either yes/no/I dont know
Measured: Baseline and follow-up (about 9 months from baseline)
Self-Efficacy and Stress Questionnaire (SESQ)
A questionnaire designed to assess stress and self-efficacy among preschool staff working with children with autism. A total of 34 items/statements rated on a 6 point Likert-scale (0 = i don't agree at all, 5 = i fully agree)
Measured: Baseline and follow-up (about 9 months from baseline)
Goal Attainment Scale (GAS)
An ordinal scale designed to assess level of goal attainment for participating Children in the study rated from 0 (baseline), 1 (initial objective), 2 (secondary objective), 3 (annual goal), 4 (exceeds annual goal)
Measured: Follow-up about 9 months after onset of study
Clinical Global Impression-autism (CGI-AUT)
An instrument designed to assess the symptom severity of preschool aged children with ASD rated on a scale between 1 and 7 (1 = no autism symptoms, 7 = maximum symptom severity)
Measured: Baseline and follow-up (about 9 months from baseline)
Children's Engagement Questionnaire (CEQ)
A scale designed to assess children's level of engagement in various situations in and outside the preschool. It consists of 31 items/situations, rated on a 4 point scale (not at all typical, to very typical)
Measured: Baseline and follow-up (about 9 months from baseline)
Vineland Adaptive Behavior Scales - Second Edition (Vineland-II) - Teacher ratings
A scale designed to assess the adaptive functioning for children within various domains such as independence and Communication skills. Rated on a 3 point scale (0 = never occurs, 2 = occurs often)
Measured: Baseline and follow-up (about 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 posted16 Aug 2018
- Study start15 May 2017
- Primary completion30 May 2019
- Study completion30 May 2019
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study used a staggered design where three waves of preschools were recruited and assigned to either the experimental or the control group. The first wave of preschools (n = 6) were divided into two groups, where group assignment was made to make the two groups comparable in regards to three variables: supervisors' experience of comprehensive programs, APERS-P-SE baseline scores, and children's adaptive behavior (Vineland II ratings). Originally, the plan was to then randomize which of these two matched groups would be the experimental group, but because of unforeseen circumstances one of the groups was made the control group because there was a lack of resources for one of the preschools to be able to be in the experimental group. However, for the following two waves of recruitment, the participating preschools (n = 11) were divided into matched pairs (based only on supervisor experience), which were then randomly assigned either as the control or the experimental group.
- Masking
- None (open label)
- Enrolment
- 17 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634761
- Sponsor's protocol ID
- VR 2015-01212
- Acronym
- AUT-TID
- Status last verified
- Sep 2019
- First submitted
- 30 May 2018
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention and Autism: Transformation From Research to Practice Through a Competency Based Model
- ClinicalTrials.gov ID
- NCT03634761
- Acronym / sponsor ID
- AUT-TID / VR 2015-01212
- Conditions
- Autism Spectrum Disorder
- Keywords
- Program Quality, Intervention Setting, Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Stockholm UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 15 May 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 16 Aug 2018 (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 a competency based model on program quality in Swedish preschools for Children with autism spectrum disorder (ASD). Half of the participating preschools will receive "treatment as usual" (Early Intensive Behavioral Intervention (EIBI) provided to a Child with ASD in the preschool, supervised by an external supervisor from a habilitation center), while the other half will receive the above as well as, in-service training and monthly on-site coaching sessions also involving preschool staff other than the paraprofessional (competency based model). It is hypothesized that the competency based model will improve program quality, child's engagement, preschool staff knowledge, allegiance and self-efficacy compared to the comparison group.
Detailed description
Almost all children in Sweden between two and five years attend preschool including children with Autism spectrum disorder (ASD). High quality and structured early intervention programs grounded in the principles and procedures of applied behavior analysis have been found in numerous research studies and reviews to significantly improve developmental outcomes, adaptive behaviors and learning outcomes of preschool children with ASD.
A prerequisite of which is a high quality learning environment that includes both the physical set-up, learning climate and competence of staff. The primary purpose of this project is to improve program quality for preschool children with ASD through a competency based model grounded in ecological systems theory sustainable over time and applicable within the Swedish service support system. In total approximately 16 preschools will participate, half of which will receive "treatment as usual" EIBI to a Child with ASD in the preschool, supervised by an external supervisor from a habilitation center), while the other half will also receive obtain in-service training and monthly on-site coaching through habilitation. Involved habilitation specialists will obtain in-service training prior to the onset of the study on how to use the Autism Program Environment Rating Scale (APERS), the basic tenets of coaching based on the concept of reflective and collaborative dialogues in which the preschool teachers knowledge of the child and context are taken into account.
It is hypothesized that the competency based model will improve program quality, child's engagement, adaptive behavior, increase preschool staff knowledge, allegiance and self-efficacy compared to the comparison group only receiving supervision in implementing a comprehensive program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study used a staggered design where three waves of preschools were recruited and assigned to either the experimental or the control group. The first wave of preschools (n = 6) were divided into two groups, where group assignment was made to make the two groups comparable in regards to three variables: supervisors' experience of comprehensive programs, APERS-P-SE baseline scores, and children's adaptive behavior (Vineland II ratings). Originally, the plan was to then randomize which of these two matched groups would be the experimental group, but because of unforeseen circumstances one of the groups was made the control group because there was a lack of resources for one of the preschools to be able to be in the experimental group. However, for the following two waves of recruitment, the participating preschools (n = 11) were divided into matched pairs (based only on supervisor experience), which were then randomly assigned either as the control or the experimental group.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Competency based model, Behavioral: Comprehensive programPreschools/Children in this group will receive EIBI supervised by an external expert from the habilitation center on a regular basis. In addition, preschool staff in this group are provided with in-service training consisting of a one full day (onset of project) and a half day (middle of project) on autism, applied behavior analysis, evidence-based practices, engagement, participation, inclusion and overall quality factors when working with Children with autism in preschool settings. Preschool staff are also provided with monthly on-site coaching in implementing evidence based practices, goal setting and working with overall intervention setting, through coaching from the habilitation center. |
| Comparison group | Active comparator | Behavioral: Comprehensive programPreschools/Children are in this group receive "treatment as usual", which is EIBI supervised by an external expert from the habilitation center at the habilitation center directed toward the paraprofessional. At the offset of the project preschool staff are offered to participate in a one-day learning course/workshop on autism, applied behavior analysis, evidence-based practices, engagement, participation, inclusion and overall quality factors when working with children with autism in preschool settings. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Autism diagnosis
- Receiving comprehensive program/EIBI implemented in preschool setting with supervision from habilitation center
Key exclusion criteria (1 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 |
|---|---|---|
| Competency based modelQualified Learning course and workshop to preschool staff combined with monthly on-site coaching at preschool sites to improve overall intervention setting quality and use of evidence bases practices, provided by external expert from habilitation center. | Behavioural | Experimental group |
| Comprehensive programComprehensive program of EIBI for Children with ASD supervised by external expert from habilitation center (treatment as usual) | Behavioural | Comparison group, Experimental group |
Primary outcome
Change in overall program quality measured by the Autism Program Environment Rating Scale (APERS-P-SE)
Time frame: Baseline and follow-up (about 9 months from baseline)
The APERS-P-SE is a rating scale designed to examine the preschool teaching environment of children with ASD in Sweden. It is used to assess overall intervention setting quality over 10 domains including areas such as Personal Independence and Functional Behavior. It consists of 56 items rated on a 5 Point Likert-scale (1= low quality - 5 = high quality) resulting in individual item scores, subdomain scores, domain scores and a total score.
8 secondary outcomes
Ethics, Values and Allegiance (EVA)
Time frame: Baseline and follow-up (about 9 months from baseline)
Evidence Based Practices (EBP)
Time frame: Baseline and follow-up (about 9 months from baseline)
Autism Knowledge Questionnaire (AKQ)
Time frame: Baseline and follow-up (about 9 months from baseline)
Self-Efficacy and Stress Questionnaire (SESQ)
Time frame: Baseline and follow-up (about 9 months from baseline)
Goal Attainment Scale (GAS)
Time frame: Follow-up about 9 months after onset of study
Clinical Global Impression-autism (CGI-AUT)
Time frame: Baseline and follow-up (about 9 months from baseline)
Children's Engagement Questionnaire (CEQ)
Time frame: Baseline and follow-up (about 9 months from baseline)
Vineland Adaptive Behavior Scales - Second Edition (Vineland-II) - Teacher ratings
Time frame: Baseline and follow-up (about 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 20 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Competency based model and Comprehensive program in people with Autism Spectrum Disorder, run by Stockholm University at 2 sites 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 2 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: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 in overall program quality measured by the Autism Program Environment Rating Scale (APERS-P-SE) (time frame: Baseline and follow-up (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 20 Sep 2019.