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Interventions for Communication in Autism Network (ICAN)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Connie Kasari, Ph.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01018407
First received: November 20, 2009
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Autism
Behavioral: Discrete Trial Training
Behavioral: Interpersonal Developmental Approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multisite Randomized Control Treatment of Early Intervention for Spoken Communication in Autism

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Reynell Developmental Language Scale [ Time Frame: Pre-treatment, post-treatment, and 6 months later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Caregiver-child Interaction [ Time Frame: Pre-treatment, three times during active intervention, post-treatment, and 6-month follow up ] [ Designated as safety issue: No ]
  • Early Social Communication Scale [ Time Frame: Pre-treatment, post-treatment, and 6-month follow up ] [ Designated as safety issue: No ]
  • Structured Play Assessment [ Time Frame: Pre-treatment, post-treatment, and 6-month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 192
Study Start Date: December 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: IDA

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.

  Eligibility

Ages Eligible for Study:   33 Months to 54 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018407

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90024
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21211
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Connie Kasari, PhD University of California, Los Angeles
  More Information

Additional Information:
Publications:
Responsible Party: Connie Kasari, Ph.D., Professor of Psychological Studies in Education and Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01018407     History of Changes
Other Study ID Numbers: 1R01MH084864-01A109, 1R01MH084864, DDTR B2-MBA
Study First Received: November 20, 2009
Last Updated: May 5, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on November 27, 2014