Interventions for Communication in Autism Network (ICAN)

Multisite Randomized Control Treatment of Early Intervention for Spoken Communication in Autism

The goal of this project is to compare the efficacy of two interventions for improving spoken language and reducing symptoms of autism.

Study Overview

• Status: Completed
• Conditions: Autism
• Intervention / Treatment: Behavioral: Discrete Trial Training; Behavioral: Interpersonal Developmental Approach

Detailed Description

While significant progress has been made toward identifying effective interventions for preschool-age children with autism (National Research Council, 2001), few scientifically rigorous studies have compared active ingredients of these interventions or examined outcomes focused on core deficits. To address these areas of need, this collaborative, multi-site project combines the expertise of investigators experienced in randomized controlled clinical trials (RCTs), in the study of core deficits in young children with autism, and in data management and analysis of multi-site clinical trials.

The goal of this project is to compare the efficacy of two interventions for improving spoken language and reducing symptoms of autism: (1) Discrete trial training (DTT)--an applied behavior analysis approach emphasizing highly structured teaching of school readiness skills (match-to-sample, imitation, functional play, and receptive and expressive language) and (2) Interpersonal developmental approach (IDA): a visually supported, child-focused, flexible engagement, social communicative engagement approach on joint attention, symbolic play, and the use of conventional symbols within socially valid communicative contexts.

Children will be randomly assigned to DTT or IDA. In each condition, children's ongoing early intervention programs will be augmented with two 30-minute sessions daily of the study intervention (DTT or IDA) conducted by supervised therapists for 4 months, with transition to home therapy for 2 months.

Potential moderators (e.g., initial mental age and language age) and mediators (e.g. parent synchronization of joint attention and changes in parental expectancies) on treatment outcome will also be examined.

The assessment measures will include diagnostic and developmental measures. There are three sets of assessments. The first set of assessments is to determine whether the child is eligible for the study. If the child is eligible, we will complete the next set of assessments, which are completed at three points: (1) prior to entry into the treatment (this is a baseline measurement conducted just before the start of the treatment phase); (2) at exit; and (3) at a 6 month follow-up. Several assessments will also be completed after 2 months, 4 months, and 6 months.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • University of California, Los Angeles
  • Maryland
    • Baltimore, Maryland, United States, 21211
      • Kennedy Krieger Institute
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 4 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. Diagnosis of an autism spectrum disorder (Autistic Disorder or Pervasive Developmental Disorder Not Otherwise Specified) from a licensed doctoral-level clinician, confirmed by the Autism Diagnostic Observation Schedule and clinical judgment.
2. Chronological age between 33 and 54 months
3. Must be receiving at least 12.5 hours per week of early intervention or preschool developmental services, some of which must be provided in a school setting.

4. Cognitive and language requirements (at least two of the following three criteria must be met:

   • >12 months for visual reception (as determined by Mullen Scales of Early Learning) or receptive language (as determined by Mullen or Reynell Developmental Language Scales)
   • a score of 1,2 or 3 on the ADOS Module 1
   • <30 spontaneous communicative words, as determined by behavior assessments (Mother- Child Interaction, Early Social Communication Scales, and Structured Play Assessment)

Exclusion criteria:

1. Major medical conditions other than autism, specifically (a) genetic disorders such as Fragile X, Down syndrome, or tuberous sclerosis, (b) sensory disabilities such as blindness or deafness, and (c) motor disabilities such as cerebral palsy
2. Nonverbal mental age < 12 months, based on a nonverbal score from the Mullen Scales of Early Learning (Mullen, 1995), as reliability of a diagnosis of autism is questionable at this developmental level.
3. Expressive language level that exceeds the First Words level, as evidenced by an age equivalent of 24 months or greater on the Expressive Language Scale of the Reynell
4. Exposure to English less than 50% of the time

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Discrete Trial Training; Targets nonverbal imitation, match-to-sample, verbal imitation, imitation of play activities, receptive language, and expressive language. 5 hours per week of individual instruction for 4 months (Two 30-minute sessions per day, five days per week) with reductions in classroom pull out sessions in months 5 and 6 with implementation of 1 hour per week of in-home parent training for the last 2 months.	Behavioral: Discrete Trial Training; UCLA model, developed by Lovaas and colleagues (Smith, Groen & Wynn, 2000). Two 30-minute sessions daily (5 hours/week) of 1:1 intervention focusing on imitation, match-to-sample, receptive and expressive language. Using operant conditioning, the therapist works individually with a child in a distraction-free setting and administers approximately 10 trials in a sitting, with breaks between sittings. During months 5 and 6, we will provide parents with training in an apprenticeship format one day per week for an hour per day. The clinician will demonstrate a DTT instructional program, then the parent will take a turn implementing it. The clinician and parent will give each other feedback on their implementation of the program.; Other Names: DTT
Experimental: Interpersonal Developmental Approach; Targets Joint Attention and Symbolic Play. 5 hours per week of individual instruction for 4 months (Two 30-minute sessions per day, five days per week) with reductions in classroom pull out sessions in months 5 and 6 with implementation of 1 hour per week of in-home parent training for the last 2 months.	Behavioral: Interpersonal Developmental Approach; Focus on teaching joint attention and symbolic play developmentally via floor play milieu teaching approach. Principles applied include following the child's lead and interest in activities, talking about what the child is doing, repeating back what the child says, expanding on what child says, giving corrective feedback, sitting close to the child and making eye-contact, and making environmental adjustments to engage the child (Kasari et al., 2006). Parents will be incorporated into the treatment to encourage joint engagement with their child and to focus specifically on joint attention and play skills in their interactions. Each home session will last one hour (once a week) during month 5 and 6 and will involve therapist modeling, and coaching of parent in child-directed activities.; Other Names: IDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reynell Developmental Language Scale	Pre-treatment, post-treatment, and 6 months later

Secondary Outcome Measures

Outcome Measure	Time Frame
McArthur-Bates Communicative Development Inventory (Word and Gestures Inventory and/or Words and Sentences Inventory)	Pre-treatment, post-treatment, and 6-month follow up
Caregiver-child Interaction	Pre-treatment, three times during active intervention, post-treatment, and 6-month follow up
Early Social Communication Scale	Pre-treatment, post-treatment, and 6-month follow up
Structured Play Assessment	Pre-treatment, post-treatment, and 6-month follow up

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Connie Kasari, PhD, University of California, Los Angeles

Publications and helpful links

General Publications

• Kasari C, Freeman S, Paparella T. Joint attention and symbolic play in young children with autism: a randomized controlled intervention study. J Child Psychol Psychiatry. 2006 Jun;47(6):611-20. doi: 10.1111/j.1469-7610.2005.01567.x. Erratum In: J Child Psychol Psychiatry. 2007 May;48(5):523.
• Smith T, Groen AD, Wynn JW. Randomized trial of intensive early intervention for children with pervasive developmental disorder. Am J Ment Retard. 2000 Jul;105(4):269-85. doi: 10.1352/0895-8017(2000)1052.0.CO;2. Erratum In: Am J Ment Retard 2000 Nov;105(6):508. Am J Ment Retard 2001 May;106(3):208.
• Kasari C, Shire S, Shih W, Landa R, Levato L, Smith T. Spoken language outcomes in limited language preschoolers with autism and global developmental delay: RCT of early intervention approaches. Autism Res. 2023 Jun;16(6):1236-1246. doi: 10.1002/aur.2932. Epub 2023 Apr 18.
• Brady NC, Romine RES, Holbrook A, Fleming KK, Kasari C. Measuring Change in the Communication Skills of Children With Austim Spectrum Disorder Using the Communication Complexity Scale. Am J Intellect Dev Disabil. 2020 Nov 1;125(6):481-492. doi: 10.1352/1944-7558-125.6.481.
• Brady NC, Fleming K, Romine RS, Holbrook A, Muller K, Kasari C. Concurrent Validity and Reliability for the Communication Complexity Scale. Am J Speech Lang Pathol. 2018 Feb 6;27(1):237-246. doi: 10.1044/2017_AJSLP-17-0106.
• Pizzano M, Shire S, Shih W, Levato L, Landa R, Lord C, Smith T, Kasari C. Profiles of minimally verbal autistic children: Illuminating the neglected end of the spectrum. Autism Res. 2024 May 27. doi: 10.1002/aur.3151. Online ahead of print.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: November 20, 2009
• First Submitted That Met QC Criteria: November 20, 2009
• First Posted (Estimated): November 23, 2009

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: 1R01MH084864-01A109; DDTR B2-MBA (Other Grant/Funding Number: National Institute of Mental Health); 1R01MH084864 (U.S. NIH Grant/Contract)