Early Intervention and Autism: Transformation From Research to Practice Through a Competency Based Model

Autism Spectrum Disorder Clinical Trial

— AUT-TID  

Official title:

Early Intervention and Autism: Transformation From Research to Practice Through a Competency Based Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634761
• Other study ID #: VR 2015-01212
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: May 30, 2019

Study information

• Verified date: September 2019
• Source: Stockholm University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

• Autism diagnosis

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• Competency based model
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
Comprehensive program of EIBI for Children with ASD supervised by external expert from habilitation center (treatment as usual)

Locations

Country	Name	City	State
Sweden	Autismcenter för Små Barn	Stockholm
Sweden	BanyanCenter	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Stockholm University	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social validity scale	A scale designed to asses the social validity of the goals targeted within the study	Follow-up about 9 months after onset of study
Primary	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.	Baseline and follow-up (about 9 months from baseline)
Secondary	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)	Baseline and follow-up (about 9 months from baseline)
Secondary	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)	Baseline and follow-up (about 9 months from baseline)
Secondary	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	Baseline and follow-up (about 9 months from baseline)
Secondary	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)	Baseline and follow-up (about 9 months from baseline)
Secondary	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)	Follow-up about 9 months after onset of study
Secondary	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)	Baseline and follow-up (about 9 months from baseline)
Secondary	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)	Baseline and follow-up (about 9 months from baseline)
Secondary	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)	Baseline and follow-up (about 9 months from baseline)