Optimizing Social and Communication Outcomes for Toddlers With Autism
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|ClinicalTrials.gov Identifier: NCT00999778|
Recruitment Status : Completed
First Posted : October 22, 2009
Last Update Posted : August 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Caregiver-Mediated Intervention Behavioral: Caregiver-Education Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Optimizing Social and Communication Outcomes for Toddlers With Autism|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||August 2012|
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
- Cognitive Assessment - Mullen Scales of Early Learning (MSEL) [ Time Frame: Before treatment begins and at the 6 month follow up ]
- Language Assessment - Reynell Developmental Language Scales [ Time Frame: Before treatment begins and at 6 month follow up ]
- 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 ]
- 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 ]
- MacArthur Communicative Development Inventories [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: during intervention ]
- 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 ]
- ADI-R Clinical diagnostic instrument for assessing autism in children [ Time Frame: 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 [ Time Frame: Prior to interventin, at the end of intervention and 6 month follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999778
|United States, California|
|University of California Los Angeles|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Connie Kasari, Ph.D||University of California, Los Angeles|