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Optimizing Social and Communication Outcomes for Toddlers With Autism

Optimizing Social and Communication Outcomes for Toddlers With Autism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00999778
Enrollment
86
Registered
2009-10-22
Start date
2008-07-31
Completion date
2012-08-31
Last updated
2012-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Autism, Social and Communication Deficits in Autism, Parent and Caregiver interventions with children with Autism, Autism Spectrum Disorder, ASD

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.

Interventions

BEHAVIORALCaregiver-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

BEHAVIORALCaregiver-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

Sponsors

Autism Speaks
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Months to 36 Months
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

Design outcomes

Primary

MeasureTime frame
Cognitive Assessment - Mullen Scales of Early Learning (MSEL)Before treatment begins and at the 6 month follow up
Language Assessment - Reynell Developmental Language ScalesBefore treatment begins and at 6 month follow up

Secondary

MeasureTime frame
MacArthur Communicative Development InventoriesBefore Intervention, after intervention at 3 month and 6 month follow ups
Parent Expectancy/Belief in the Intervention - assesses caregiver beliefs that the intervention is appropriate and working for the childBefore intervention and once during each phase of the intervention for total of 3 ratings (during intervention)
ADOS - The Autism Diagnostic Observation Schedule - semi-structured, standardized assessment of communication, social interaction, play and imaginative use of materialsPrior to intervention (determines eligibility) and 6 months post intervention
Generalization of skills to classroom - Observational measure to determine whether child show generalization of skill to the classroom,and in interaction with teachers & peersPrior to intervention and once during each phase of intervention
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 utterancesPrior to Intervention, two follow up points 3 month post intervention and 6 months post intervention
Caregiver-child interaction - A 10-minute interaction between parent and childPre-intervention, 3 times turing active intervention, post treatment and at 3 and 6 months follow-up
ADI-R Clinical diagnostic instrument for assessing autism in childrenPrior to intervention to determine eligibility for participation in the study
Parenting Stress - The Parenting Stress Index (PSI) measuring parents reported stress associated with the care of autistic childPrior to interventin, at the end of intervention and 6 month follow-up
Coding of child behaviors in classroom - using time sampling procedure, four different contexts; direct instruction, structure play, circle-time, unstructured playduring intervention
Early Social-Communication Scales; frequencies of initiating and responses of joint attention behaviors to toys and l interaction - sessions will be video tapedBefore intervention, at the end of intervention and at the 3 and 6 month follow up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026