Optimizing Social and Communication Outcomes for Toddlers With Autism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimizing Social and Communication Outcomes for Toddlers With Autism

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Caregiver-Mediated Intervention
* Behavioral: Caregiver-Education Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caregiver Education Intervention<br>10 1:1,one hour sessions weekly for 10 weeks with parent and interventionist. Behavioral education strategies will be targeted | Behavioral: Caregiver-Education Intervention<br>* 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<br>|
| Active Comparator: Caregiver-Mediated Intervention<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Assessment - Mullen Scales of Early Learning (MSEL) |  | Before treatment begins and at the 6 month follow up | 
| Language Assessment - Reynell Developmental Language Scales |  | Before treatment begins and at 6 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Prior to Intervention, two follow up points 3 month post intervention and 6 months post intervention | 
| Early Social-Communication Scales; frequencies of initiating and responses of joint attention behaviors to toys and l interaction - sessions will be video taped |  | Before intervention, at the end of intervention and at the 3 and 6 month follow up | 
| MacArthur Communicative Development Inventories |  | Before 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 child |  | Before 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 materials |  | Prior 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 & peers |  | Prior to intervention and once during each phase of intervention | 
| Coding of child behaviors in classroom - using time sampling procedure, four different contexts; direct instruction, structure play, circle-time, unstructured play |  | during intervention | 
| Caregiver-child interaction - A 10-minute interaction between parent and child |  | Pre-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 children |  | Prior 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 child |  | Prior to interventin, at the end of intervention and 6 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism, Social and Communication Deficits in Autism, Parent and Caregiver interventions with children with Autism, Autism Spectrum Disorder, ASD