Autism Spectrum DisorderESDM-ISRNCT03362840
Integrating the ESDM in ASD Preschools in Israel
A study testing Early Start Denver Model and Eclectic preschool intervention in people with Autism Spectrum Disorder, run by Bar-Ilan University, Israel at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Early Start Denver Model and Eclectic preschool intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2016to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating the Early Started Denver Model in Israeli Autism Spectrum Disorder Preschools: A Controlled Trial
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).
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Early Start Denver Model, Eclectic preschool intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Start Denver ModelBehavioural
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
Eclectic preschool interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Eclectic preschool intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Pre-intervention, 8 months, 20 months
Secondary outcomes (4)
Change from baseline Parent Sense of Competence Scale (PSOC)
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).
Measured: Pre-intervention, 8 months, 20 months
Change from baseline Parenting Stress Index - Short Form (PSI\SF)
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).
Measured: Pre-intervention, 8 months, 20 months
Change from baseline parent-child interaction paradigm
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.
Measured: Pre-intervention, 8 months, 20 months
Change from baseline child-staff member interaction paradigm
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.
Measured: Pre-intervention, 8 months, 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Nov 2016
- Primary completion30 Sep 2017
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bar-Ilan University, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Association for Children at Risk
- Responsible party
- Principal investigator, Ofer Golan, Bar-Ilan University, Israel
- Investigators
- Irit Mor-Snir, MD, Principal investigator, Association for Children at Risk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362840
- Sponsor's protocol ID
- BarIlanU
- Acronym
- ESDM-ISR
- Status last verified
- Dec 2017
- First submitted
- 30 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
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.
PubMed 18240012Hall 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.
PubMed 21341964Vivanti 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.
PubMed 24974255Dawson 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.
PubMed 19948568
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating the Early Started Denver Model in Israeli Autism Spectrum Disorder Preschools: A Controlled Trial
- ClinicalTrials.gov ID
- NCT03362840
- Acronym / sponsor ID
- ESDM-ISR / BarIlanU
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Bar-Ilan University, IsraelUniversity, hospital or other
- Collaborators
- Association for Children at Risk
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Start Denver Model (ESDM) group | Experimental | Behavioral: Early Start Denver ModelThe 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. |
| Eclectic preschool intervention group | Active comparator | Behavioral: Eclectic preschool interventionThe 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Start Denver ModelThe 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 | Behavioural | Early Start Denver Model (ESDM) group |
| Eclectic preschool interventionThe 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. | Behavioural | Eclectic preschool intervention group |
Primary outcome
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).
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).
4 secondary outcomes
Change from baseline Parent Sense of Competence Scale (PSOC)
Time frame: Pre-intervention, 8 months, 20 months
Change from baseline Parenting Stress Index - Short Form (PSI\SF)
Time frame: Pre-intervention, 8 months, 20 months
Change from baseline parent-child interaction paradigm
Time frame: Pre-intervention, 8 months, 20 months
Change from baseline child-staff member interaction paradigm
Time frame: Pre-intervention, 8 months, 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- BackgroundAbidin, R. R. (1995). The Parenting Stress Index Professional Manual. Odessa, FL: Psychological Assessment Resources.
- BackgroundMullen, E. M. (1995). Mullen Scales of Early Learning (AGS ed.). Circle Pines, MN: Circle Pines, MN: American Guidance Service Inc.
- BackgroundRogers, S. J, & Dawson, G. (2010). Early Start Denver Model for Young Children with Autism. Promoting language, learning and engagement. New York: Guilford Press.
- BackgroundJohnston, C., & Mash, E. J. (1989). A measure of parenting satisfaction and efficacy. Journal of Clinical Child Psychology, 18(2), 167-175.
- BackgroundSparrow, S. S, Cicchetti, D. V, & Balla, D. A. (2005). Vineland-II Adaptive Behavior Scales: Survey Forms Manual. Circle Pines, MN: AGS Publishing.
- Background: PubMed 18240012Davis 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.
- Background: PubMed 21341964Hall 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.
- Results publication: PubMed 24974255Vivanti 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.
- Results publication: PubMed 19948568Dawson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irit Mor-Snir, MD principal investigator
Association for Children at Risk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Start Denver Model and Eclectic preschool intervention in people with Autism Spectrum Disorder, run by Bar-Ilan University, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Mullen Scales of Early Learning (MSEL) (time frame: Pre-intervention, 8 months, 20 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03362840, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.