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Optimizing Social and Communication Outcomes for Toddlers With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00999778
Recruitment Status : Completed
First Posted : October 22, 2009
Last Update Posted : August 16, 2012
Autism Speaks
Information provided by (Responsible Party):
Connie Kasari, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Caregiver-Mediated Intervention Behavioral: Caregiver-Education Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Optimizing Social and Communication Outcomes for Toddlers With Autism
Study Start Date : July 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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

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
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

Primary Outcome Measures :
  1. Cognitive Assessment - Mullen Scales of Early Learning (MSEL) [ Time Frame: Before treatment begins and at the 6 month follow up ]
  2. Language Assessment - Reynell Developmental Language Scales [ Time Frame: Before treatment begins and at 6 month follow up ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. MacArthur Communicative Development Inventories [ Time Frame: Before Intervention, after intervention at 3 month and 6 month follow ups ]
  4. 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) ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. ADI-R Clinical diagnostic instrument for assessing autism in children [ Time Frame: Prior to intervention to determine eligibility for participation in the study ]
  10. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00999778

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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Autism Speaks
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Principal Investigator: Connie Kasari, Ph.D University of California, Los Angeles

Additional Information:
Abidin, RR, Parenting Stress Index Manual, Pediatric Psychology Press Charlottesville, VA 1983
Kasari, C., Sigman, M., Yimiya, N., & Mundy, P., Affective Development and Communication in Children with Autism, In A.P. Kaiser & D.G. Gray (Eds) Enhancing Children's Commmunication: Research Foundations for Intervention, New York: Brookes 201-222 1993
Arnold, SD., Elliot, M., Storoschuk, S., Pickles, A., Hellriegel, C., & Lord, C., Social Directedness and Prelinguistic Vocalization in Autism, Paper presented at the meeting of the American Academy of Child and Adolescent Psychiatry, San Antonio, TX, 1993
Baron-Cohen, S., From Attention-Goal Psychology to Belief-Desire Psychology: The Development of a Theory of Mind and its Dysfunction, In S. Baron-Cohen, H. Hager-Flusberg & DJ Cohen (Eds), Understanding other Minds: Perspectives from Autism, Oxford, UK: Oxford University Press, 1993
Brereton, A., & Tonge, B., Preschoolers with autism: An education and skills training programme for parents, London, UK: Jessica Kingsley Publishers, 2005
Brown, R., A first language: the early stages, Cambridge, MA: Harvard University Press, 1973
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Bryk, A., & Raudenbush, S., Hierarchial linear models: Applications and data analysis methods, Newborn Park, CA: Sage, 1992
Cross, T.G., Mother's speech adjustments: The contribution of selected child listener variables, in C.E. Snow and C.A. Ferguson (Eds), Talking to children: Language input and acquisition, Cambridge: Cambridge University Press, 1977
Dawson, G., & Galpert, L., Mother's use of imitative play for facilitating social responsiveness and toy play in young autistic children, Development and Psychopathology, 2, 151-162, 1990
Donnellan, A., & Kilman, B., Behavioral approaches to social skill development in autism: Strengths, misapplications, and alternatives, In E. Schopler & G. Mesibov (Eds), Social behavior in autism,, New York: Plenum Press, 213-215, 1986
Harding, C.G., Setting the stage for language acquisition: Communication in the first year, In R. M. Golinkoff (Ed), The transition from prelinguistic to linguistic communication, Hillsdale, NJ: Erlbaum, 1983
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Kaiser, A., Yoder, P., & Keetz, A., Evaluating milieu teaching, In S. Warren & J Reichel (Eds) Causes and effects in communication and language intervention, Baltimore, MD: Brookes, 9-47, 1992
Kanner, L., Autistic distrubances of affective contact, Nervous Child, 2, 273-280, 1943
Kasari, C., Jahromi, L., Freeman, S., Paparella, T., Predictors of language growth in young children with autism. Paper presented at the Gatlinburg Conference, San Diego, CA, March 2006
Kasari, C., Sigman, M., Yirmiya, N., & Mundy, P., Affective development in children with autism, in A.P. Kaiser & D.B. Bray (Eds) Enhancing chilren's communication: Reseach foundations for intervention, New York: Brookes, 201-222, 1993
Kasari, C., Sigman, M., & Yirmiya, N., Focused and social attention in caregiver-child interactions: A comparison of autistic, mentally retarded and nonretarded children, Development and Psychopathology, 5, 403-414, 1994
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Koegel, R., & Koegel, L., Teaching children with autism, Baltimore: Paul H. Brookes, 1995
Lord, C., Rutter, M.D., DiLavore, P., & Risi, S., Autism diagnostic observation schedule manual, Los Angeles, CA: Western Psychological Services, 2001
Lord, C., Storoschuk, S., Rutter, M., & Pickles, A., Using the ADI-R to diagnose autism in preschool children with autism, Infant Mental Health Journal, 14, 234-252, 1993
Fenson, L., Dale, P.S., Reznik, J.S., Thal, D., Bates, E., hartung, J.P., Pethick, S., & Reilly, J.S., The MacArthur communicative development inventories: User's guide and technical manual, San Diego, CA: Singular Publishing Group, 1993
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Mundy, P., Gomes, A., Individual differences in joint attention skill development in the second year, Infant Behavior and Development, 21, 469-482, 1998
Mundy, P., Kasari, C., & Sigman, M., Nonverbal communiction, affective sharing and inter-subjectivity, Infant Behavior and Development, 15, 377-381, 1992
Mundy, P., Sigman, M., & Kasari, C., The theory of mind and joint-attention deficits in autism. ZIn S. Baron-Cohen, H. Tager-Flusberg, & D. Cohen (Eds), Understanding other minds: Perspectives form autism, New York: Oxford University Press, 181-203, 1993
Mundy, P., Sigman, M., & Kasari, C., Nonverbal communication, developmental level and symptom presentation in autism, Development and Psychopathology, 6, 389-041, 1994
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Sigman, M., & Karsari, C., Joint attention: Its origin and role in development, Erlbaum: Hilsdale, New Jersey, 189-203, 1995
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Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Connie Kasari, Professor of Psychological Studies in Education and Psychiatry, University of California, Los Angeles Identifier: NCT00999778     History of Changes
Other Study ID Numbers: 1P50HD055784 ( U.S. NIH Grant/Contract )
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: August 16, 2012
Last Verified: August 2012
Keywords provided by Connie Kasari, University of California, Los Angeles:
Social and Communication Deficits in Autism
Parent and Caregiver interventions with children with Autism
Autism Spectrum Disorder
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders