An interventional study of Caregiver-Mediated Intervention and Caregiver-Education Intervention in Autism Spectrum Disorder, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 1 site in United States. Open to participants aged 18 Months to 36 Months. Per ClinicalTrials.gov, last updated 2012-08-16.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Not applicable, Interventional, and Treatment
This project will examine the efficacy of two different treatment approaches aimed at facilitating change in social and communications outcomes of toddlers with autism.
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:
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 86 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
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Exclusion Criteria:
10 1:1,one hour sessions weekly for 10 weeks with parent and interventionist. Behavioral education strategies will be targeted
Behavioral: Caregiver-Education 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
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
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
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)