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Integrating the ESDM in ASD Preschools in Israel (ESDM-ISR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362840
Recruitment Status : Unknown
Verified December 2017 by Ofer Golan, Bar-Ilan University, Israel.
Recruitment status was:  Active, not recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Collaborator:
Association for Children at Risk
Information provided by (Responsible Party):
Ofer Golan, Bar-Ilan University, Israel

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).

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Early Start Denver Model Behavioral: Eclectic preschool intervention Not Applicable

Detailed Description:

The Early Start Denver Model is a comprehensive treatment model for young children with Autism Spectrum Disorders (ASD), which builds upon behavioral, relationship, play-based and developmental theories and practices. Utilizing the plasticity of the young brain, while managing social attention, employing multi-modal teaching, and tapping into the child's motivation, the ESDM aims to alter the child's developmental trajectories by creating rich and meaningful learning experiences in daily and naturalistic routines. This model focuses on all areas of development, with significant stress on communication, language, social skills, play and imitation. In the ESDM, parents are seen as a main motivational factor for the child, and a focal part in planning and implementing key components of the intervention.

Currently, community preschool settings are the main providers of intervention programs for children with ASD in Israel. The prevalent mode of intervention in these settings is a multi-disciplinary eclectic model, in which professionals from various disciplines deliver intervention comprising several theories and practices. While quite ubiquitous, this type of intervention was shown in previous research as less effective than specialized, comprehensive treatment models.

The ESDM was previously shown efficacious in intensive home-based delivery, and effective as a center-based group model. However, there are currently no studies that assess the effectiveness of the ESDM when integrated in existing community preschool settings. Additionally, previous research in center-based group delivery of the ESDM did not focus on the effects of routine parental involvement in child treatment (when delivered in a preschool setting) on child and parental outcomes. The current study aims to explore the effects of ESDM implementation in community preschool settings, together with incorporation of parents in the treatment process.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrating the Early Started Denver Model in Israeli Autism Spectrum Disorder Preschools: A Controlled Trial
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : September 30, 2017
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Start Denver Model (ESDM) group
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
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

Active Comparator: Eclectic preschool intervention group
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

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.





Primary Outcome Measures :
  1. Change from baseline Mullen Scales of Early Learning (MSEL) [ Time Frame: Pre-intervention, 8 months, 20 months ]
    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).

  2. Change from baseline Vineland Adaptive Behavior Scales, Second Edition (VABS-II) [ Time Frame: Pre-intervention, 8 months, 20 months ]
    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).


Secondary Outcome Measures :
  1. Change from baseline Parent Sense of Competence Scale (PSOC) [ Time Frame: Pre-intervention, 8 months, 20 months ]
    A 16 item self- report questionnaire designed to measure parental sense of efficacy and satisfaction in parenting. The 16 items of the inventory are rated on a 6 point Likert scale, with higher scores indicating to higher sense of efficacy and satisfaction. The PSOC was reported by the authors to have adequate internal reliability for both subscales. Additionally, the PSOC was found to be negatively correlated with measures of child behavior problems (Johnston & Mash, 1989).

  2. Change from baseline Parenting Stress Index - Short Form (PSI\SF) [ Time Frame: Pre-intervention, 8 months, 20 months ]
    A 36 item questionnaire assessing parenting distress, parent-child dysfunctional interactions, and perception of child as difficult to manage. Items are rated on a 5 point Likert scale, with higher scores pointing to higher parental stress. The PSI\SF (Abidin, 1995) was used in several studies assessing stress in parents to children with autism, and was reported to have high internal consistency and test-retest reliability (for example, Davis-Ornstein & Carter, 2008; Hall & Graff, 2011).

  3. Change from baseline parent-child interaction paradigm [ Time Frame: Pre-intervention, 8 months, 20 months ]
    In this paradigm, parents and children will be video-recorded during a 7 minute free-play interaction, in order to assess changes in child social-communication, play and restrictive-repetitive behaviors, and parental interactive behaviors. The video-records will be then coded micro-analytically using the Noldus Observer software, to capture moment to moment changes in child-parent interaction measures.

  4. Change from baseline child-staff member interaction paradigm [ Time Frame: Pre-intervention, 8 months, 20 months ]
    In this paradigm, the child will be video recorded with a staff member from his preschool during 7 minutes of free play, in order to measure child social-communication, play and restrictive-repetitive behaviors. The video-records will be then coded micro-analytically using the Noldus Observer software, to capture moment to moment changes in child behaviors.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362840


Locations
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Israel
Bar Ilan University
Ramat Gan, Israel, 5290002
Sponsors and Collaborators
Bar-Ilan University, Israel
Association for Children at Risk
Investigators
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Principal Investigator: Irit Mor-Snir, MD Association for Children at Risk
Publications of Results:
Other Publications:
Abidin, R. R. (1995). The Parenting Stress Index Professional Manual. Odessa, FL: Psychological Assessment Resources.
Mullen, E. M. (1995). Mullen Scales of Early Learning (AGS ed.). Circle Pines, MN: Circle Pines, MN: American Guidance Service Inc.
Rogers, S. J, & Dawson, G. (2010). Early Start Denver Model for Young Children with Autism. Promoting language, learning and engagement. New York: Guilford Press.
Johnston, C., & Mash, E. J. (1989). A measure of parenting satisfaction and efficacy. Journal of Clinical Child Psychology, 18(2), 167-175.
Sparrow, S. S, Cicchetti, D. V, & Balla, D. A. (2005). Vineland-II Adaptive Behavior Scales: Survey Forms Manual. Circle Pines, MN: AGS Publishing.

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Responsible Party: Ofer Golan, Prof., PhD, Bar-Ilan University, Israel
ClinicalTrials.gov Identifier: NCT03362840    
Other Study ID Numbers: BarIlanU
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders