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Optimizing Social and Communication Outcomes for Toddlers With Autism

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caregiver-Mediated Intervention
Caregiver-Education Intervention
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism, Social and Communication Deficits in Autism, Parent and Caregiver interventions with children with Autism, Autism Spectrum Disorder, ASD

Eligibility Criteria

18 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Caregiver Education Intervention

Caregiver-Mediated Intervention

Arm Description

10 1:1,one hour sessions weekly for 10 weeks with parent and interventionist. Behavioral education strategies will be targeted

One hour 1:1 with parent, child and interventionist, each week, for 10 weeks social communication and joint engagement strategies will be targeted

Outcomes

Primary Outcome Measures

Cognitive Assessment - Mullen Scales of Early Learning (MSEL)
Language Assessment - Reynell Developmental Language Scales

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
Early Social-Communication Scales; frequencies of initiating and responses of joint attention behaviors to toys and l interaction - sessions will be video taped
MacArthur Communicative Development Inventories
Parent Expectancy/Belief in the Intervention - assesses caregiver beliefs that the intervention is appropriate and working for the child
ADOS - The Autism Diagnostic Observation Schedule - semi-structured, standardized assessment of communication, social interaction, play and imaginative use of materials
Generalization of skills to classroom - Observational measure to determine whether child show generalization of skill to the classroom,and in interaction with teachers & peers
Coding of child behaviors in classroom - using time sampling procedure, four different contexts; direct instruction, structure play, circle-time, unstructured play
Caregiver-child interaction - A 10-minute interaction between parent and child
ADI-R Clinical diagnostic instrument for assessing autism in children
Parenting Stress - The Parenting Stress Index (PSI) measuring parents reported stress associated with the care of autistic child

Full Information

First Posted
October 21, 2009
Last Updated
August 14, 2012
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Autism Speaks
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1. Study Identification

Unique Protocol Identification Number
NCT00999778
Brief Title
Optimizing Social and Communication Outcomes for Toddlers With Autism
Official Title
Optimizing Social and Communication Outcomes for Toddlers With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Autism Speaks

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism, Social and Communication Deficits in Autism, Parent and Caregiver interventions with children with Autism, Autism Spectrum Disorder, ASD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caregiver Education Intervention
Arm Type
Active Comparator
Arm Description
10 1:1,one hour sessions weekly for 10 weeks with parent and interventionist. Behavioral education strategies will be targeted
Arm Title
Caregiver-Mediated Intervention
Arm Type
Active Comparator
Arm Description
One hour 1:1 with parent, child and interventionist, each week, for 10 weeks social communication and joint engagement strategies will be targeted
Intervention Type
Behavioral
Intervention Name(s)
Caregiver-Mediated Intervention
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Caregiver-Education Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Cognitive Assessment - Mullen Scales of Early Learning (MSEL)
Time Frame
Before treatment begins and at the 6 month follow up
Title
Language Assessment - Reynell Developmental Language Scales
Time Frame
Before treatment begins and at 6 month follow up
Secondary Outcome Measure Information:
Title
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
Title
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
Title
MacArthur Communicative Development Inventories
Time Frame
Before Intervention, after intervention at 3 month and 6 month follow ups
Title
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)
Title
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
Title
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
Title
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
Title
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
Title
ADI-R Clinical diagnostic instrument for assessing autism in children
Time Frame
Prior to intervention to determine eligibility for participation in the study
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie Kasari, Ph.D
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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http://www.Autism.ucla.edu
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UCLA Center for Autism Research and Treatment Web Site

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