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

History of Changes

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:

MedlinePlus related topics: Autism Caregivers

U.S. FDA Resources

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

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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Autism Speaks

Investigators

Principal Investigator:

Connie Kasari, Ph.D

University of California, Los Angeles

More Information

Additional Information:

UCLA Center for Autism Research and Treatment Web Site This link exits the ClinicalTrials.gov site

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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 Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013

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