Clinical trial NCT00999778: Optimizing Social and Communication Outcomes for Toddlers With Autism
Official title: Optimizing Social and Communication Outcomes for Toddlers With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism
Social and Communication Deficits in Autism
Parent and Caregiver interventions with children with Autism
Autism Spectrum Disorder
ASD
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
Collaborators: name: Autism Speaks
First posted: 2009-10-22
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cognitive Assessment - Mullen Scales of Early Learning (MSEL)
timeFrame: Before treatment begins and at the 6 month follow up
measure: Language Assessment - Reynell Developmental Language Scales
timeFrame: Before treatment begins and at 6 month follow up
Secondary outcomes:
measure: 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
timeFrame: Prior to Intervention, two follow up points 3 month post intervention and 6 months post intervention
measure: Early Social-Communication Scales; frequencies of initiating and responses of joint attention behaviors to toys and l interaction - sessions will be video taped
timeFrame: Before intervention, at the end of intervention and at the 3 and 6 month follow up
measure: MacArthur Communicative Development Inventories
timeFrame: Before Intervention, after intervention at 3 month and 6 month follow ups
measure: Parent Expectancy/Belief in the Intervention - assesses caregiver beliefs that the intervention is appropriate and working for the child
timeFrame: Before intervention and once during each phase of the intervention for total of 3 ratings (during intervention)
measure: ADOS - The Autism Diagnostic Observation Schedule - semi-structured, standardized assessment of communication, social interaction, play and imaginative use of materials
timeFrame: Prior to intervention (determines eligibility) and 6 months post intervention
measure: Generalization of skills to classroom - Observational measure to determine whether child show generalization of skill to the classroom,and in interaction with teachers & peers
timeFrame: Prior to intervention and once during each phase of intervention
measure: Coding of child behaviors in classroom - using time sampling procedure, four different contexts; direct instruction, structure play, circle-time, unstructured play
timeFrame: during intervention
measure: Caregiver-child interaction - A 10-minute interaction between parent and child
timeFrame: Pre-intervention, 3 times turing active intervention, post treatment and at 3 and 6 months follow-up
measure: ADI-R Clinical diagnostic instrument for assessing autism in children
timeFrame: Prior to intervention to determine eligibility for participation in the study
measure: Parenting Stress - The Parenting Stress Index (PSI) measuring parents reported stress associated with the care of autistic child
timeFrame: Prior to interventin, at the end of intervention and 6 month follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Connie Kasari, Ph.D
role: PRINCIPAL_INVESTIGATOR
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