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Completed

NCT Number: NCT00999778

Optimizing Social and Communication Outcomes for Toddlers With Autism

This project will examine the efficacy of two different treatment approaches aimed at facilitating change in social and communications outcomes of toddlers with autism.

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Key information

Age range

18 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Los Angeles

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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-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

Primary outcomes

  1. Cognitive Assessment - Mullen Scales of Early Learning (MSEL)

    Time frame: Before treatment begins and at the 6 month follow up

  2. Language Assessment - Reynell Developmental Language Scales

    Time frame: Before treatment begins and at 6 month follow up

Secondary outcomes

  1. 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

  2. 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

  3. MacArthur Communicative Development Inventories

    Time frame: Before Intervention, after intervention at 3 month and 6 month follow ups

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. ADI-R Clinical diagnostic instrument for assessing autism in children

    Time frame: Prior to intervention to determine eligibility for participation in the study

  10. 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

Sponsors and collaborators

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nih

Collaborators

  • Autism Speaks

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 22, 2009
Registry last updated
Aug 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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