- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03634761
Early Intervention and Autism: Transformation From Research to Practice Through a Competency Based Model (AUT-TID)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Stockholm, Sweden, 11140
- BanyanCenter
-
Stockholm, Sweden, 11869
- Autismcenter för Små Barn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Autism diagnosis
- Receiving comprehensive program/EIBI implemented in preschool setting with supervision from habilitation center
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
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.
|
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 program of EIBI for Children with ASD supervised by external expert from habilitation center (treatment as usual)
|
|
Active Comparator: Comparison group
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.
|
Comprehensive program of EIBI for Children with ASD supervised by external expert from habilitation center (treatment as usual)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and follow-up (about 9 months from baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ethics, Values and Allegiance (EVA)
Time Frame: Baseline and follow-up (about 9 months from baseline)
|
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)
|
Baseline and follow-up (about 9 months from baseline)
|
|
Evidence Based Practices (EBP)
Time Frame: Baseline and follow-up (about 9 months from baseline)
|
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)
|
Baseline and follow-up (about 9 months from baseline)
|
|
Autism Knowledge Questionnaire (AKQ)
Time Frame: Baseline and follow-up (about 9 months from baseline)
|
A questionnaire designed to assess knowledge on ASD among preschool staff.
18 items/statements about autism, answered either yes/no/I dont know
|
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)
|
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)
|
Baseline and follow-up (about 9 months from baseline)
|
|
Goal Attainment Scale (GAS)
Time Frame: Follow-up about 9 months after onset of study
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
Baseline and follow-up (about 9 months from baseline)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social validity scale
Time Frame: Follow-up about 9 months after onset of study
|
A scale designed to asses the social validity of the goals targeted within the study
|
Follow-up about 9 months after onset of study
|
Collaborators and Investigators
Sponsor
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VR 2015-01212
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Autism Spectrum Disorder
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Istituto Clinico HumanitasRecruitingAutism | Autism Spectrum Disorder (ASD) | Autism DisorderItaly
-
The Children's Hospital of Zhejiang University...Not yet recruitingAutism | Autism Spectrum Disorder (ASD)China
-
Poznan University of Physical EducationCompletedAutism | Autism Spectrum Disorder (ASD)Poland
-
Greater Atlanta Integrative PediatricsRecruitingAutism Spectrum Disorder | Autism | ASD | Autism Spectrum Disorder (ASD)United States
-
Adia Med of Winter Park LLCRecruitingAutism Spectrum Disorder | Autism | ASD | Autism Spectrum Disorder (ASD)United States
-
Blinklab LimitedRecruitingAutism Spectrum Disorder | Autism | Neurodevelopmental Conditions | Autism Spectrum Disorder (ASD)United States
-
Poznan University of Physical EducationNational Science Centre, PolandCompletedAutism Spectrum Disorder | ASD | Autism Spectrum Disorder High-Functioning | Autism SpectrumPoland
-
National Cheng-Kung University HospitalCompletedAutism Spectrum Disorder (ASD) | Autism Spectrum Disorder High-FunctioningTaiwan
-
Stanford UniversityJohn and Marcia Goldman FoundationNot yet recruitingAutism | Autism Spectrum Disorder (ASD)United States
-
Stanford UniversityCalifornia Department of Developmental ServicesActive, not recruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
Clinical Trials on Competency based model
-
Matrouh UniversityCompleted
-
Yale UniversityAgency for Healthcare Research and Quality (AHRQ)CompletedProcedural Skill CompetencyUnited States
-
University of AarhusActive, not recruitingBurnout, Professional | Interprofessional Relations | Neonatal Care | Psychological SafetyDenmark
-
Vanderbilt University Medical CenterRecruitingChildhood ObesityUnited States
-
The University of Hong KongRecruitingSuicidal Ideation | Self-Harm, Deliberate | MasculinityHong Kong
-
Alvaro Castellanos OrtegaEuropean Society of Intensive Care Medicine; Generalitat ValencianaUnknownCompetency-Based EducationSpain
-
Istanbul University - CerrahpasaActive, not recruitingMetacognition | Flipped Education Model | Web Based Education | Self Directed LearningTurkey
-
University of North Carolina, CharlotteNorth Carolina Department of Health and Human Services; North Carolina Department...Enrolling by invitation
-
Stockholm UniversityKarolinska InstitutetCompletedAutism Spectrum Disorder | Social Communication ChallengesSweden
-
Kutahya Health Sciences UniversityGazi UniversityCompletedHysterectomy | Sexual Function | Sexual Health | PLISSIT Model | Sexual Health Quality of LifeTurkey (Türkiye)