Integrating the ESDM in ASD Preschools in Israel

NCT03362840 | Unknown DMC

• 1 other identifier: BarIlanU
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The current study evaluates the effectiveness of the Early Start Denver Model (ESDM) when integrated in existing community preschools for children with ASD. The study compares developmental gains made a group of children receiving preschool-based ESDM compared to a group of children receiving eclectic interventions in their preschools (treatment as usual).

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Change from baseline Mullen Scales of Early Learning (MSEL)

  A standardized measure of early development which is administered to children from birth to 68 months of age. The MSEL includes five subscales: receptive language, expressive language, visual reception, fine motor, and gross motor skills, for which a standard T score and age equivalents (AE) are computed, together with a total composite of intellectual ability. Administration time - 30-60 minutes (Mullen, 1995).

  Pre-intervention, 8 months, 20 months

• Change from baseline Vineland Adaptive Behavior Scales, Second Edition (VABS-II)

  A structured interview measuring adaptive behavior from birth to adulthood. This measure is divided into 11 sub-scales, clustered into four domains: communication, daily living skills, socialization and motors skills. Standard scores and age equivalents can be obtained from this measure, together with an adaptive behavior composite (ABC). The VABS-II may be administered via a structured interview with the caregiver or teacher, or using a self-report questionnaire filled out by the responder. In the current study, both forms of administration will be used, so that parents will be interviewed by a trained practitioner, and teachers will be given the self-report version of the test. Administration time - 45-60 minutes (Sparrow, Cicchetti \& Balla, 2005).

  Pre-intervention, 8 months, 20 months

Secondary Outcomes (4)

• Change from baseline Parent Sense of Competence Scale (PSOC)

  Pre-intervention, 8 months, 20 months

• Change from baseline Parenting Stress Index - Short Form (PSI\SF)

  Pre-intervention, 8 months, 20 months

• Change from baseline parent-child interaction paradigm

  Pre-intervention, 8 months, 20 months

• Change from baseline child-staff member interaction paradigm

  Pre-intervention, 8 months, 20 months

Study Arms (2)

Early Start Denver Model (ESDM) group

EXPERIMENTAL

The ESDM is a manualized comprehensive treatment model for young children (12-48 months). In the preschool based ESDM, learning objectives are guided by the ESDM curriculum checklist, which includes developmental skills in language, play, motor skills, personal independence, imitation and cognition.

Behavioral: Early Start Denver Model

Eclectic preschool intervention group

ACTIVE COMPARATOR

The eclectic approach consists of a combination of methods from several treatment-models. Individualized educational plans are based on multi-disciplinary assessment, and include objectives in several domains - communication, social-skills, play, emotional adjustment, adaptive daily skills, motor skills and cognition. They are presented to parents at the beginning of the year and are reviewed by the staff three times a year.

Behavioral: Eclectic preschool intervention

Interventions

Early Start Denver Model BEHAVIORAL

The ESDM is a manualized comprehensive treatment model for young children (12-48 months). In the preschool based ESDM, learning objectives are guided by the ESDM curriculum checklist, which includes developmental skills in language, play, motor skills, personal independence, imitation and cognition. The objectives are monitored for progress during each session The sessions are conducted according to ESDM principles, and include weekly parent-coaching session, in which parents observe the therapist interact with the child while applying various teaching techniques, and then implement these techniques during the interaction with their child. Additionally, parents get acquainted with the daily objective sheet and are encouraged to work on these objectives at home as well. Finally, in this model, therapist adherence to the ESDM practices are monitored according to the ESDM fidelity rating system

Early Start Denver Model (ESDM) group

Eclectic preschool intervention BEHAVIORAL

The eclectic approach consists of a combination of methods from several treatment-models. Individualized educational plans are based on multi-disciplinary assessment, and include objectives in several domains - communication, social-skills, play, emotional adjustment, adaptive daily skills, motor skills and cognition. They are presented to parents at the beginning of the year and are reviewed by the staff three times a year. Parents attend by-weekly counseling-sessions with a professional in order to receive input regarding their child's progress, and discuss issues concerning their child's functioning. All staff members receive supervision at various intensities. However, these usually do not adhere to a single structure and are not guided by official fidelity criteria.

Eclectic preschool intervention group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children learning in ASD schools with a diagnosis of ASD validated by the Autism Diagnostic Observation Schedule - 2nd edition.
• ESDM group: parents who have agreed to participate in weekly joint sessions at the preschool.

Sponsors & Collaborators

• Bar-Ilan University, Israel: lead
• Association for Children at Risk: collaborator

Study Sites (1)

Bar Ilan University

Ramat Gan, 5290002, Israel

Location

Related Publications (9)

• Abidin, R. R. (1995). The Parenting Stress Index Professional Manual. Odessa, FL: Psychological Assessment Resources.

  BACKGROUND

• Mullen, E. M. (1995). Mullen Scales of Early Learning (AGS ed.). Circle Pines, MN: Circle Pines, MN: American Guidance Service Inc.

  BACKGROUND

• Rogers, S. J, & Dawson, G. (2010). Early Start Denver Model for Young Children with Autism. Promoting language, learning and engagement. New York: Guilford Press.

  BACKGROUND

• Johnston, C., & Mash, E. J. (1989). A measure of parenting satisfaction and efficacy. Journal of Clinical Child Psychology, 18(2), 167-175.

  BACKGROUND

• Sparrow, S. S, Cicchetti, D. V, & Balla, D. A. (2005). Vineland-II Adaptive Behavior Scales: Survey Forms Manual. Circle Pines, MN: AGS Publishing.

  BACKGROUND

• Davis NO, Carter AS. Parenting stress in mothers and fathers of toddlers with autism spectrum disorders: associations with child characteristics. J Autism Dev Disord. 2008 Aug;38(7):1278-91. doi: 10.1007/s10803-007-0512-z. Epub 2008 Feb 1.

  PMID: 18240012 BACKGROUND

• Hall HR, Graff JC. The relationships among adaptive behaviors of children with autism, family support, parenting stress, and coping. Issues Compr Pediatr Nurs. 2011;34(1):4-25. doi: 10.3109/01460862.2011.555270.

  PMID: 21341964 BACKGROUND

• Vivanti G, Paynter J, Duncan E, Fothergill H, Dissanayake C, Rogers SJ; Victorian ASELCC Team. Effectiveness and feasibility of the early start denver model implemented in a group-based community childcare setting. J Autism Dev Disord. 2014 Dec;44(12):3140-53. doi: 10.1007/s10803-014-2168-9.

  PMID: 24974255 RESULT

• Dawson G, Rogers S, Munson J, Smith M, Winter J, Greenson J, Donaldson A, Varley J. Randomized, controlled trial of an intervention for toddlers with autism: the Early Start Denver Model. Pediatrics. 2010 Jan;125(1):e17-23. doi: 10.1542/peds.2009-0958. Epub 2009 Nov 30.

  PMID: 19948568 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Irit Mor-Snir, MD

  Association for Children at Risk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., PhD

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 5, 2017
• Study Start: November 1, 2016
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2018
• Last Updated: December 5, 2017

Record last verified: 2017-12

Locations

IL (1)