NCT00760812

Brief Summary

This study will compare the effectiveness of two parent-based programs for helping young children at risk of autism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

July 27, 2022

Status Verified

February 1, 2014

Enrollment Period

6.1 years

First QC Date

September 25, 2008

Last Update Submit

July 25, 2022

Conditions

Autistic Disorder

Keywords

AutismAutism Spectrum DisordersPervasive Developmental DisordersToddlersIntervention

Outcome Measures

Primary Outcomes (1)

  • Child measures of autism symptoms, social communication, developmental level, and adaptive behavior

    Measured before treatment, at crossover, and after treatment; some of these measures also will be taken every other month

Secondary Outcomes (1)

  • Parent report measures of family functioning, daily hassles, and treatment satisfaction

    Measured before treatment, at crossover, and after treatment

Study Arms (2)

ESI--Individual PII First Condition

EXPERIMENTAL

This group will first receive the Early Social Interaction (ESI) model individual parent-implemented intervention (PII) for 9 months, followed by the ESI model group information, education, and support (IES) intervention for 9 months.

Behavioral: Early Social Interaction Project- PIIBehavioral: Early Social Interaction Project- IES

ESI--Group IES First Condition

EXPERIMENTAL

The group will first receive ESI group IES condition for 9 months, followed by ESI individual PII for 9 months.

Behavioral: Early Social Interaction Project- PIIBehavioral: Early Social Interaction Project- IES

Interventions

Early Social Interaction Project- PIIBEHAVIORAL

The PII is an intensive, individualized treatment that teaches parents how to support social communication skills in children with autism by embedding skills practice within everyday routines, activities, and places. Participants will have three 75-minute sessions weekly with study administrators for the first 7 months of the study. Participants will then have two sessions per week for the final 2 months of the study. Children will also practice socialization embedded in normal activities for 25 hours a week outside of study visits.

ESI--Group IES First ConditionESI--Individual PII First Condition
Early Social Interaction Project- IESBEHAVIORAL

The IES intervention provides access to a support group meeting twice monthly for children with autism and their parents. The support group provides information to families and a playgroup where parents may practice intervention strategies under the supervision of study officials knowledgeable about autism spectrum disorders.

ESI--Group IES First ConditionESI--Individual PII First Condition

Eligibility Criteria

Age16 Months - 20 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Presence of autism risk factors and a clinical diagnosis of autism spectrum disorder based on a diagnostic evaluation conducted by the project team
  • Families agree to twice monthly play group sessions for 9 months and two to three intervention sessions per week for 9 months, usually to be scheduled within workday hours
  • Families agree to monthly evaluations, videotaping of intervention sessions, and weekly or monthly video checks during the 18 months of treatment

You may not qualify if:

  • Child does not have normal hearing or adequate motor control to make simple actions, such as giving and reaching gestures
  • Primary language of family is not English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Florida State University

Tallahassee, Florida, 32306, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Wetherby AM, Guthrie W, Woods J, Schatschneider C, Holland RD, Morgan L, Lord C. Parent-implemented social intervention for toddlers with autism: an RCT. Pediatrics. 2014 Dec;134(6):1084-93. doi: 10.1542/peds.2014-0757. Epub 2014 Nov 3.

    PMID: 25367544DERIVED

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum DisorderChild Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Amy M. Wetherby, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

  • Catherine Lord, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Research Professor

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

April 1, 2007

Primary Completion

May 1, 2013

Study Completion

January 1, 2014

Last Updated

July 27, 2022

Record last verified: 2014-02

Locations

US(2)