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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00065910
Other study ID # R21MH064927
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 1, 2003
Last updated June 28, 2007
Start date September 2001
Est. completion date January 2006

Study information

Verified date June 2003
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Toddlers with autism have poor joint attention skills. Joint attention skills include pointing to objects, following another person’s gaze, and responding to invitations to join in a social interaction. Improved joint attention skills may lead to better verbal ability as the child ages. This study teaches caregivers how to help their toddlers with autism develop joint attention skills.


Description:

Young children with autism show impairment in joint attention. The impairment affects their ability to sustain a shared interest in social interaction and to use specific joint attention skills, such as pointing and showing. The importance of joint attention is underscored by data suggesting these skills are important to later language skills. Targeting joint attention deficits in developmentally young children using familiar caregivers may result in better child language outcomes. This study will teach caregivers how to initiate and maintain episodes of joint engagement with their children.

Participants will be randomized to either the intervention group or to a wait list control group. Each caregiver and child in the intervention group will participate in 24 1-hour sessions, 3 times a week for 8 weeks. In these sessions, caregivers will be taught 10 different modules for teaching joint attention skills to their children. Outcome measures will include language and joint attention skills in the child and caregiver adherence to the intervention protocols. Children and caregivers will be assessed at baseline, during the course of the 8-week intervention, and 10 weeks after the end of the intervention. Participants assigned to the wait list group will begin the intervention at Week 12.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Months to 36 Months
Eligibility Inclusion Criteria

- Diagnosis of autism based on Autism Diagnostic Interview–Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS) criteria

Exclusion Criteria

- Seizures

- Medical or psychiatric diagnoses other than autism that potentially contribute to developmental delay (e.g., genetic syndromes)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Caregiver joint attention intervention


Locations

Country Name City State
United States University of California, Los Angeles Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

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