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Optimizing Social and Communication Outcomes for Toddlers With Autism

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ClinicalTrials.gov Identifier: NCT00999778
Recruitment Status : Completed
First Posted : October 22, 2009
Last Update Posted : August 16, 2012
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Connie Kasari, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE October 21, 2009
First Posted Date  ICMJE October 22, 2009
Last Update Posted Date August 16, 2012
Study Start Date  ICMJE July 2008
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2009)
  • Cognitive Assessment - Mullen Scales of Early Learning (MSEL) [ Time Frame: Before treatment begins and at the 6 month follow up ]
  • Language Assessment - Reynell Developmental Language Scales [ Time Frame: Before treatment begins and at 6 month follow up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2009)
  • Language Sample - The Caregiver Child Interaction will be coded at each timepoint to obtain a 10 minute sample of the child's language transcription will yield a measure of lexical density, type-token ration and mean length of utterances [ Time Frame: Prior to Intervention, two follow up points 3 month post intervention and 6 months post intervention ]
  • Early Social-Communication Scales; frequencies of initiating and responses of joint attention behaviors to toys and l interaction - sessions will be video taped [ Time Frame: Before intervention, at the end of intervention and at the 3 and 6 month follow up ]
  • MacArthur Communicative Development Inventories [ Time Frame: Before Intervention, after intervention at 3 month and 6 month follow ups ]
  • Parent Expectancy/Belief in the Intervention - assesses caregiver beliefs that the intervention is appropriate and working for the child [ Time Frame: Before intervention and once during each phase of the intervention for total of 3 ratings (during intervention) ]
  • ADOS - The Autism Diagnostic Observation Schedule - semi-structured, standardized assessment of communication, social interaction, play and imaginative use of materials [ Time Frame: Prior to intervention (determines eligibility) and 6 months post intervention ]
  • Generalization of skills to classroom - Observational measure to determine whether child show generalization of skill to the classroom,and in interaction with teachers & peers [ Time Frame: Prior to intervention and once during each phase of intervention ]
  • Coding of child behaviors in classroom - using time sampling procedure, four different contexts; direct instruction, structure play, circle-time, unstructured play [ Time Frame: during intervention ]
  • Caregiver-child interaction - A 10-minute interaction between parent and child [ Time Frame: Pre-intervention, 3 times turing active intervention, post treatment and at 3 and 6 months follow-up ]
  • ADI-R Clinical diagnostic instrument for assessing autism in children [ Time Frame: Prior to intervention to determine eligibility for participation in the study ]
  • Parenting Stress - The Parenting Stress Index (PSI) measuring parents reported stress associated with the care of autistic child [ Time Frame: Prior to interventin, at the end of intervention and 6 month follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing Social and Communication Outcomes for Toddlers With Autism
Official Title  ICMJE Optimizing Social and Communication Outcomes for Toddlers With Autism
Brief Summary This project will examine the efficacy of two different treatment approaches aimed at facilitating change in social and communications outcomes of toddlers with autism.
Detailed Description

The proposed research tests a theoretically and empirically derived treatment approach aimed at facilitating change in joint attention interactions between caregivers and their toddlers with autism. Young children with autism show impairments in engaging in joint attention skills such as pointing and showing. The importance of joint attention is underscored by data showing that these skills are important to later development of language. Yet these interaction and skills deficits have rarely been the focus of systematic intervention efforts, particularly with caregivers. Moreover, current interventions for young children wiht autism are behavioral in approach, therapist driven, and often exclude the lowest functioning and developmentally youngest children. Thus, targeting these deficits in developmentally young children using familiar caregivers may result in better language outcomes for these children.

The overarching goal of the proposed project is to rigorously test an intervention program for caregivers and their toddlers with autism that is developmentally informed, child-centered and focused on joint attention intervention with their toddlers versus mothers who receive parent education about autism and child development.

The Primary aims of this research are as follows:

  • Aim 1: To determine if caregiver mediated intervention on joint engagement is superior to caregiver education on social communication and language outcomes in children.
  • Aim 2: To determine if skill development in the context of caregiver child interaction transfers to interactions with classroom teachers and peers.
  • Aim 3: To examine characteristics of families and children that best predict social-communication outcome.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE
  • Behavioral: Caregiver-Mediated Intervention
    1 (two- 1/2 jour sessions weekly) hour of intervention per week for 10 weeks in which parents and their child meet with the interventionist together using the caregiver as a means to facilitate change in their child's development
  • Behavioral: Caregiver-Education Intervention
    The caregiver meets 1 time (1 hour each session) a week for 10 weeks with an interventionist - caregiver will receive information on child development and have the opportunity to ask questions and discuss the information vis-a-vis their own child
Study Arms  ICMJE
  • Active Comparator: Caregiver Education Intervention
    10 1:1,one hour sessions weekly for 10 weeks with parent and interventionist. Behavioral education strategies will be targeted
    Intervention: Behavioral: Caregiver-Education Intervention
  • Active Comparator: Caregiver-Mediated Intervention
    One hour 1:1 with parent, child and interventionist, each week, for 10 weeks social communication and joint engagement strategies will be targeted
    Intervention: Behavioral: Caregiver-Mediated Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2012)
86
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2009)
80
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Child meets screening criteria for PDD
  • Not currently enrolled in a pre-existing intervention program
  • Parent is available for intervention
  • Child must be ready to start in the Early Childhood Partial Hospitalization Program (ECPHP) at UCLA

Exclusion Criteria:

  • Child does not have other sensory or genetic disorders
  • Children already on medication on the outset, although we find few toddlers already on medication when they begin treatment. If children begin medication after treatment commences, then we will keep all informatin and data pertaining to possible medication effects and statistically convey medication use if necessary
  • Co-morbidity, participant diagnosed with other diseases
  • Family/participant unable to follow-up
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Months to 36 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00999778
Other Study ID Numbers  ICMJE 1P50HD055784( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Connie Kasari, University of California, Los Angeles
Study Sponsor  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators  ICMJE Autism Speaks
Investigators  ICMJE
Principal Investigator: Connie Kasari, Ph.D University of California, Los Angeles
PRS Account Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP