Optimizing Social and Communication Outcomes for Toddlers With Autism

NCT00999778 | Completed DMC

• 1 other identifier: 1P50HD055784
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

Study Arms (2)

Caregiver Education Intervention

ACTIVE COMPARATOR

10 1:1,one hour sessions weekly for 10 weeks with parent and interventionist. Behavioral education strategies will be targeted

Behavioral: Caregiver-Education Intervention

Caregiver-Mediated Intervention

ACTIVE COMPARATOR

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

Interventions

Caregiver-Mediated Intervention BEHAVIORAL

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

Caregiver-Mediated Intervention

Caregiver-Education Intervention BEHAVIORAL

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

Caregiver Education Intervention

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• Autism Speaks: collaborator

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

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• Schlink A, Williams J, Pizzano M, Gulsrud A, Kasari C. Parenting stress in caregiver-mediated interventions for toddlers with autism: An application of quantile regression mixed models. Autism Res. 2022 Feb;15(2):353-365. doi: 10.1002/aur.2637. Epub 2021 Nov 19.

  PMID: 34797038 DERIVED

• Gulsrud AC, Hellemann G, Shire S, Kasari C. Isolating active ingredients in a parent-mediated social communication intervention for toddlers with autism spectrum disorder. J Child Psychol Psychiatry. 2016 May;57(5):606-13. doi: 10.1111/jcpp.12481. Epub 2015 Nov 3.

  PMID: 26525461 DERIVED

• Kasari C, Gulsrud A, Paparella T, Hellemann G, Berry K. Randomized comparative efficacy study of parent-mediated interventions for toddlers with autism. J Consult Clin Psychol. 2015 Jun;83(3):554-63. doi: 10.1037/a0039080. Epub 2015 Mar 30.

  PMID: 25822242 DERIVED

Related Links

• UCLA Center for Autism Research and Treatment Web Site

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Connie Kasari, Ph.D

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychological Studies in Education and Psychiatry

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 22, 2009
• Study Start: July 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 16, 2012

Record last verified: 2012-08

Locations

US (1)