Optimizing Social and Communication Outcomes for Toddlers With Autism

United States Department of Health and Human Services (HHS)

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Caregiver-Mediated Intervention; Behavioral: Caregiver-Education Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00999778

1P50HD055784

Details and patient eligibility

About

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

Full description

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Caregiver Education Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Caregiver-Education Intervention

Caregiver-Mediated Intervention

Active Comparator group

Description:

One hour 1:1 with parent, child and interventionist, each week, for 10 weeks social communication and joint engagement strategies will be targeted

Treatment:

Behavioral: Caregiver-Mediated Intervention