NCT03634761

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 30, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

May 30, 2018

Last Update Submit

September 18, 2019

Conditions

Keywords

Program QualityIntervention SettingAutism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Ethics, Values and Allegiance (EVA)

    Baseline and follow-up (about 9 months from baseline)

  • Evidence Based Practices (EBP)

    Baseline and follow-up (about 9 months from baseline)

  • Autism Knowledge Questionnaire (AKQ)

    Baseline and follow-up (about 9 months from baseline)

  • Self-Efficacy and Stress Questionnaire (SESQ)

    Baseline and follow-up (about 9 months from baseline)

  • Goal Attainment Scale (GAS)

    Follow-up about 9 months after onset of study

  • +3 more secondary outcomes

Other Outcomes (1)

  • Social validity scale

    Follow-up about 9 months after onset of study

Study Arms (2)

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.

Behavioral: Competency based modelBehavioral: 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.

Behavioral: Comprehensive program

Interventions

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.

Experimental group

Comprehensive program of EIBI for Children with ASD supervised by external expert from habilitation center (treatment as usual)

Comparison groupExperimental group

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BanyanCenter

Stockholm, 11140, Sweden

Location

Autismcenter för Små Barn

Stockholm, 11869, Sweden

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
In total, 17 preschools, 17 children (one from each preschool), and 35 preschool staff (two from each preschool except from one preschool where three preschool staff participated) participated in the study. None of the participants were blind to their assigned condition.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 30, 2018

First Posted

August 16, 2018

Study Start

May 15, 2017

Primary Completion

May 30, 2019

Study Completion

May 30, 2019

Last Updated

September 20, 2019

Record last verified: 2019-09

Locations