Interventions for Communication in Autism Network

NCT01018407 | Completed DMC

• 3 other identifiers: 1R01MH084864-01A1091R01MH084864DDTR B2-MBA
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Autism

Outcome Measures

Primary Outcomes (1)

• Reynell Developmental Language Scale

  Pre-treatment, post-treatment, and 6 months later

Secondary Outcomes (4)

• 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

Study Arms (2)

Discrete Trial Training

EXPERIMENTAL

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

Interpersonal Developmental Approach

EXPERIMENTAL

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

Discrete Trial Training BEHAVIORAL

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

Discrete Trial Training

Interpersonal Developmental Approach BEHAVIORAL

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

Interpersonal Developmental Approach

Eligibility Criteria

• Age: 33 Months - 54 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Chronological age between 33 and 54 months
• 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.
• 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)

You may not qualify if:

• 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
• 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.
• 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
• Exposure to English less than 50% of the time

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (6)

• 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.

  PMID: 16712638 BACKGROUND

• 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.

  PMID: 10934569 BACKGROUND

• 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.

  PMID: 37070270 RESULT

• 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.

  PMID: 33211817 RESULT

• 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.

  PMID: 29383380 RESULT

• 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.

  PMID: 38803132 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Connie Kasari, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychological Studies in Education and Psychiatry

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: November 23, 2009
• Study Start: December 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

US (3)