Intervention Effects of Intensity and Delivery Style for Toddlers With Autism

NCT ID: NCT02272192

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2019-07-01

Brief Summary

A multi-site randomized study of intensive treatment for toddlers with autism involving a three-site collaborative network plus a data coordinating center to evaluate the effects of intervention intensity and intervention style delivered for 12 months, on the progress of very young children with ASD ages 12-30 months old and their families, and the effect of children's developmental rates and autism severity on their response to intervention.

Detailed Description

High quality, intensive early intervention is a powerful treatment for ASD, improving IQ and language markedly in randomized controlled clinical trials (RCTs), though little long term follow-up data exists. Few core characteristics that affect child change have been tested. Two potential core characteristics that invoke considerable debate among parents, professionals, and administrators are the delivery style of intervention: play-based versus discrete trial teaching, and the intensity (dosage) of intervention. This ACE treatment network conducted an RCTs to answer the following question: what are the effects of intensity and delivery style on developmental progress of toddlers with ASD?

87 young children with ASD, mean age 23.4 months who live within a specified radius near the university at each site were enrolled in one of three national sites and randomized into one of four cells varying on two dimensions: dosage - 15 or 25 hours per week of 1:1 treatment; and discrete trial teaching or naturalistic developmental-behavioral intervention. Other aspects of intervention held constant were: use of the principles of applied behavior analysis, 1:1 adult:child ratios, parent coaching in the assigned treatment, and treatment location. Developmental progress was measured frequently allowing for growth curve analysis to examine fine-grained differences in groups as well as interactions among major child and family initial variables and these two experimental variables.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESDM15 hr/week

Children receive 15 hours a week of 1:1 intervention at home plus parent coaching using the Early Start Denver Model and following its manual

Group Type: EXPERIMENTAL

Early Start Denver Model (ESDM)

Intervention Type: BEHAVIORAL

The Early Start Denver Model (ESDM) is a comprehensive developmental and behavioral early intervention approach for children with autism, ages 12 to 48 months. The program encompasses a developmental curriculum that defines the skills to be taught at any given time and a set of teaching procedures based in applied behavioral analysis to deliver this content. The teaching format focuses on trained therapists delivering the intervention 1:1 by engaging reciprocally with children in typical toddler activities involving play or daily routines, adding additional structure for children who need it to progress well. Progress data is collected throughout each session and used to make decisions about teaching approaches.

ESDM 25 hr/week

Children receive 25 hours a week of 1:1 intervention at home plus parent coaching using the Early Start Denver Model and following its manual

Group Type: EXPERIMENTAL

Early Start Denver Model (ESDM)

Intervention Type: BEHAVIORAL

The Early Start Denver Model (ESDM) is a comprehensive developmental and behavioral early intervention approach for children with autism, ages 12 to 48 months. The program encompasses a developmental curriculum that defines the skills to be taught at any given time and a set of teaching procedures based in applied behavioral analysis to deliver this content. The teaching format focuses on trained therapists delivering the intervention 1:1 by engaging reciprocally with children in typical toddler activities involving play or daily routines, adding additional structure for children who need it to progress well. Progress data is collected throughout each session and used to make decisions about teaching approaches.

EIBI 15 hr/week

Children receive 15 hours per week of 1:1 intervention at home plus parent training using Early Intensive Behavioral Intervention (EIBI) and following the Manual "A Work in Progress"

Group Type: EXPERIMENTAL

Early Intensive Behavioral Intervention (EIBI)

Intervention Type: BEHAVIORAL

EIBI is a one-to-one instructional approach based in applied behavior analysis used to teach skills in a planned, controlled, and systematic manner. Each trial or teaching opportunity has a definite beginning and end, thus the descriptor discrete trial. Within DTT, the use of antecedents and consequences is carefully planned and implemented. Positive praise and/or tangible rewards are used to reinforce desired skills or behaviors. Trial by trial data collection is an important part of DTT and supports decision making by providing teachers/practitioners with information about beginning skill level, progress and challenges, skill acquisition and maintenance, and generalization of learned skills or behaviors.

EIBI 25 hr/week

Children receive 25 hours per week of 1:1 intervention at home plus parent training using EIBI and following the Manual "A Work in Progress"

Group Type: EXPERIMENTAL

Early Intensive Behavioral Intervention (EIBI)

Intervention Type: BEHAVIORAL

EIBI is a one-to-one instructional approach based in applied behavior analysis used to teach skills in a planned, controlled, and systematic manner. Each trial or teaching opportunity has a definite beginning and end, thus the descriptor discrete trial. Within DTT, the use of antecedents and consequences is carefully planned and implemented. Positive praise and/or tangible rewards are used to reinforce desired skills or behaviors. Trial by trial data collection is an important part of DTT and supports decision making by providing teachers/practitioners with information about beginning skill level, progress and challenges, skill acquisition and maintenance, and generalization of learned skills or behaviors.

Interventions

Early Start Denver Model (ESDM)

The Early Start Denver Model (ESDM) is a comprehensive developmental and behavioral early intervention approach for children with autism, ages 12 to 48 months. The program encompasses a developmental curriculum that defines the skills to be taught at any given time and a set of teaching procedures based in applied behavioral analysis to deliver this content. The teaching format focuses on trained therapists delivering the intervention 1:1 by engaging reciprocally with children in typical toddler activities involving play or daily routines, adding additional structure for children who need it to progress well. Progress data is collected throughout each session and used to make decisions about teaching approaches.

Intervention Type: BEHAVIORAL

Early Intensive Behavioral Intervention (EIBI)

EIBI is a one-to-one instructional approach based in applied behavior analysis used to teach skills in a planned, controlled, and systematic manner. Each trial or teaching opportunity has a definite beginning and end, thus the descriptor discrete trial. Within DTT, the use of antecedents and consequences is carefully planned and implemented. Positive praise and/or tangible rewards are used to reinforce desired skills or behaviors. Trial by trial data collection is an important part of DTT and supports decision making by providing teachers/practitioners with information about beginning skill level, progress and challenges, skill acquisition and maintenance, and generalization of learned skills or behaviors.

Intervention Type: BEHAVIORAL

Other Intervention Names

Naturalistic developmental-behavioral intervention (NDBI); ABA, DTT, Lovaas method

Eligibility Criteria

Inclusion Criteria

• 12-30 months of age at time of assessment;
• ambulatory and without impairments affecting hand use;
• meets criteria for Autistic Spectrum Disorder on the APA Diagnostic and Statistical Manual, 5th revision criteria and on the Autism Diagnostic Observation Schedule for Toddlers:
• clinical consensus of ASD diagnosis by 2 independent staff (including a licensed psychologist) based on observation as well as record review;
• developmental quotient of >35 on Mullen Scales of Early Learning;
• normal hearing and vision screen;
• caregiver agreement to comply with all project requirements, including regular videotaping at home with provided equipment.

Exclusion Criteria

• English not a primary language spoken at home;
• absence at 2 or more appointments without prior notice during the intake assessment;
• more than 10 hours per week of 1:1 ABA based treatment;
• other health or genetic conditions (i.e. fragile X syndrome, seizures, prematurity).

• Minimum Eligible Age: 15 Months
• Maximum Eligible Age: 30 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sally J Rogers, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UC Davis MIND Institute

Locations

UC Davis MIND Institute

Sacramento, California, United States

Vanderbilt University

Nashville, Tennessee, United States

University of Washington Autism Center

Seattle, Washington, United States

Countries

United States

References

Rogers SJ, Yoder P, Estes A, Warren Z, McEachin J, Munson J, Rocha M, Greenson J, Wallace L, Gardner E, Dawson G, Sugar CA, Hellemann G, Whelan F. A Multisite Randomized Controlled Trial Comparing the Effects of Intervention Intensity and Intervention Style on Outcomes for Young Children With Autism. J Am Acad Child Adolesc Psychiatry. 2021 Jun;60(6):710-722. doi: 10.1016/j.jaac.2020.06.013. Epub 2020 Aug 24.

Reference Type: DERIVED

PMID: 32853704 (View on PubMed)

Other Identifiers

406188

Identifier Type: -

Identifier Source: org_study_id