Optimizing Social and Communication Outcomes for Toddlers With Autism

This study has been completed.
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Connie Kasari, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00999778
First received: October 21, 2009
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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 Intervention
Autism Spectrum Disorder
Behavioral: Caregiver-Mediated Intervention
Behavioral: Caregiver-Education Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Optimizing Social and Communication Outcomes for Toddlers With Autism

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Cognitive Assessment - Mullen Scales of Early Learning (MSEL) [ Time Frame: Before treatment begins and at the 6 month follow up ] [ Designated as safety issue: No ]
  • Language Assessment - Reynell Developmental Language Scales [ Time Frame: Before treatment begins and at 6 month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • MacArthur Communicative Development Inventories [ Time Frame: Before Intervention, after intervention at 3 month and 6 month follow ups ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • ADI-R Clinical diagnostic instrument for assessing autism in children [ Time Frame: Prior to intervention to determine eligibility for participation in the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: July 2008
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00999778

Locations
United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Autism Speaks
Investigators
Principal Investigator: Connie Kasari, Ph.D University of California, Los Angeles
  More Information

Additional Information:
Publications:
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
Bruner, J.S., From communication to language: A psychological perspective, Cognition, 3, 255-287, 1974/1975
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
Hobson, R.P., On sharing experiences, Development and Psychopathology, 1, 197-203, 1989
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
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
Morales, M., Mundy, P., & Rojas, J., Following the direction of gaze and language development in 6-month olds, Infant Behavior and Development, 21, 373-377, 1998
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
Ninio, A., & Bruner, J., The achievement and antecedents of labeling, Journal of Child Language, 5, 1-15, 1978
Nock, N.K., Kazdin, A.E., Parent expectancies for child therapy: Assessment and relation to participation in treatment, Journal of Child and Family Studies, 10, 155-189, 2001
Odom, S., & Strain, P., A comparison of peer-initiation and teacher-antecedent interventions for promoting reciprocal socal interaction of autistic preschoolers, Journal of applied Behavior Analysis, 18, 3-16, 1986
Ogletree, B.T., Communication intervention for a preverbal child with autism: A case study, Focus on Autistic Behavior, 7, 1-12, 1992
Rocissano, L., & Yatchmink, Y., Joint attention in mother-toddler interaction: A study of individual variation, Marril-Palmer Quarterly, 30, 11-31, 1984
Rogosa, D., & Willett, J.B., Understanding correlates of change by modeling individual differences in growth, Psychometrika, 50, 203-228, 1985
Rutter, M., Diagnosis and definitions of childhood autism, Journal of Autism and Childhood Schizophrenia, 8, 139-161, 1978
Seibert, J., Hogan, A., & Mundy, P., Assessing interactional competencies: The Early Social-Communication Scales, Infant Mental Health Journal, 3, 244-259, 1982
Seltzer, M., Frank, K., & Bryk, A., The metric matters: The sensitivity of conclusions concerning growth in student achievement to choice of metric, Education Evaluation and Policy Analysis, 16, 41-49, 1994
Sigman, M., & Karsari, C., Joint attention: Its origin and role in development, Erlbaum: Hilsdale, New Jersey, 189-203, 1995
Tomasello, M. Joint attention as social cognition, in C. Moore & P. Dunham (Eds), Joint attention: Its orgin and role in development Erlbaum: Hillsdale, New Jersey, 103-130, 1995
Tomasello, M., The role of joimt attentional processes in early language development, Language Sciences, 10, 69-88, 1998
Tomasello, M., Mannie, S., & Kruger, A.C., Linguistic enviornment of 1-to-2-year old twins, Developmental Psychology, 22, 169-176, 1986
Tomasello, M., & Todd, J., Joint attention and lexical acquisition style, First Language, 4, 197-211, 1983
Yoder, P.J., Warren, S.F., & McCathren, R.B., Determining spoken language prognosis in children with developmental disabilities, American Journal of Speech-Language Pathology, 7, 77-87, 1998

Responsible Party: Connie Kasari, Professor of Psychological Studies in Education and Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00999778     History of Changes
Other Study ID Numbers: 1-P50-HD-55784
Study First Received: October 21, 2009
Last Updated: August 14, 2012
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Autism
Social and Communication Deficits in Autism
Parent and Caregiver interventions with children with Autism
Autism Spectrum Disorder
ASD

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

ClinicalTrials.gov processed this record on October 22, 2014