Clinical trial NCT01018407: Interventions for Communication in Autism Network
Official title: Multisite Randomized Control Treatment of Early Intervention for Spoken Communication in Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-11-23
Enrollment: 192
Sex: ALL
Minimum age (years): 33
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Reynell Developmental Language Scale
timeFrame: Pre-treatment, post-treatment, and 6 months later
Secondary outcomes:
measure: McArthur-Bates Communicative Development Inventory (Word and Gestures Inventory and/or Words and Sentences Inventory)
timeFrame: Pre-treatment, post-treatment, and 6-month follow up
measure: Caregiver-child Interaction
timeFrame: Pre-treatment, three times during active intervention, post-treatment, and 6-month follow up
measure: Early Social Communication Scale
timeFrame: Pre-treatment, post-treatment, and 6-month follow up
measure: Structured Play Assessment
timeFrame: Pre-treatment, post-treatment, and 6-month follow up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of California, Los Angeles
name: Connie Kasari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.