Early Intervention and Autism: Transformation From Research to Practice Through a Competency Based Model (AUT-TID)

September 18, 2019 updated by: Lise Roll-Pettersson, Stockholm University
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.

Study Overview

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

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Stockholm, Sweden, 11140
        • BanyanCenter
      • Stockholm, Sweden, 11869
        • Autismcenter för Små Barn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Autism diagnosis
  • Receiving comprehensive program/EIBI implemented in preschool setting with supervision from habilitation center

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

May 30, 2019

Study Registration Dates

First Submitted

May 30, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (Actual)

August 16, 2018

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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