CClinicalTrials.gg
CompletedNCT01018407ICANUpdated Jun 14, 2024

Interventions for Communication in Autism Network

An interventional study of Discrete Trial Training and Interpersonal Developmental Approach in Autism, sponsored by University of California, Los Angeles. Completed at 3 sites in United States. Open to participants aged 33 Months to 54 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
33 Months to 54 Months
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Autism

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In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's enrollment of 192 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
33 Months to 54 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
192 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralDiscrete 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.

    Also known as: DTT

  • BehavioralInterpersonal 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.

    Also known as: IDA

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What researchers measure

Primary outcomes

  1. Reynell Developmental Language Scale

    Time frame: Pre-treatment, post-treatment, and 6 months later

Secondary outcomes

  1. McArthur-Bates Communicative Development Inventory (Word and Gestures Inventory and/or Words and Sentences Inventory)

    Time frame: Pre-treatment, post-treatment, and 6-month follow up

  2. Caregiver-child Interaction

    Time frame: Pre-treatment, three times during active intervention, post-treatment, and 6-month follow up

  3. Early Social Communication Scale

    Time frame: Pre-treatment, post-treatment, and 6-month follow up

  4. Structured Play Assessment

    Time frame: Pre-treatment, post-treatment, and 6-month follow up

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Study locations

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

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. PubMed 16712638 ↗
  • 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. PubMed 10934569 ↗
  • 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. PubMed 37070270 ↗
  • 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. PubMed 33211817 ↗
  • 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. PubMed 29383380 ↗
  • 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 Jun;17(6):1218-1229. doi: 10.1002/aur.3151. Epub 2024 May 27. PubMed 38803132 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01018407
Lead sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Connie Kasari, Ph.D. (Professor of Psychological Studies in Education and Psychiatry, University of California, Los Angeles) — Principal investigator
First posted
Nov 23, 2009
Start date
Dec 2009
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jun 14, 2024

Study contacts

Connie Kasari, PhD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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