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A Randomized Clinical Trial for Toddlers With ASD

Primary Purpose

Autism Spectrum Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Social Communication

Social communication

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, language, social, toddlers

Eligibility Criteria

22 Months - 33 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants must be 22 to 33 months old
Children must meet criteria for ASD or autism on the ADOS plus receive a clinical judgment of PDD-NOS or autism by the study team
Children must have an age equivalent of 8 months or greater for non-verbal ability based on the Mullen Visual Reception and Fine Motor scales
Parents must agree to participate in the study and commit to having their child participate in the intervention to which they are randomized for 6 months
The parent (or other primary caregiver, such as grandparent) in the Parent-Mediated condition must agree to attend the training sessions three times per month
Parents must be between the ages of 16 and 50 years old
Families who qualify for medical assistance and/or have racial/ethnic minority backgrounds will be prioritized for recruitment and participation in this study. On the TSI, we will ask participants if they qualify for medical assistance or if they are of a racial minority or have a first degree relative of a racial minority. Families who do not fit these criteria will be notified that they may be eligible to participate if additional space is available.
It is not required that English be their primary language, but they must be fluent in English (or if the child is nonverbal he/she must hear English most of the time at home)

Exclusion Criteria:

Head injury prior to enrollment in the study
Major hearing or visual impairment after correction
Non-febrile seizures
PKU (Phenylketonuria)
Congenital Rubella (German measles)
Neurofibromatosis
Tuberous Sclerosis
Fragile X
A fall resulting in a loss of consciousness or other severe head injury
Velo-Cardio Facial Syndrome
Any other known genetic syndrome
No foster children may participate
The child must not be adopted

Sites / Locations

Kennedy Krieger Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Center-Based classroom intervention

Parent Training

Arm Description

Four days a week for 2.5 hours a day the child will participate in a classroom with peers in an attempt to increase social communication, language abilities, and other skills. Parents will also receive education sessions 1-3 times per month for 1-2 hours each. Treatment will last for 6 months.

Parents are taught strategies on how to interact with their children to increase their skills. Parent training sessions are given 2 times a month at our center and once a month at home for 60-90 minutes each. Treatment will last for 6 months.

Outcomes

Primary Outcome Measures

Communication and Symbolic Behavior Scales

Secondary Outcome Measures

Mullen Scales of Early Learning

Full Information

NCT ID

NCT01008800

First Posted

November 5, 2009

Last Updated

March 9, 2021

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Collaborators

HRSA/Maternal and Child Health Bureau

1. Study Identification

Unique Protocol Identification Number

NCT01008800

Brief Title

A Randomized Clinical Trial for Toddlers With ASD

Official Title

Parent-mediated vs Center-based Intervention for Toddlers With ASD: An RCT

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Collaborators

HRSA/Maternal and Child Health Bureau

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This research is being done to test the effectiveness of two treatments aimed at increasing language and social skills in children with autism spectrum disorder. If children show improvement in these treatments, we hope that the availability of public services for minority and low income families will be increased. Minority and low income families with children between 22 and 33 months of age with Autism Spectrum Disorders may join.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder, language, social, toddlers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

196 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Center-Based classroom intervention

Arm Type

Experimental

Arm Description

Arm Title

Parent Training

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Social Communication

Intervention Description

The Center-Based classroom intervention focuses on providing children with an invigorating, motivating learning environment in which emerging skills and knowledge are skillfully brought to a higher level of maturity, integrated with existing abilities, and used functionally. Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement week may offer the children experiences that they would not otherwise have (Ramey & Ramey, 1998). Parent training sessions will focus on strategies aimed at improving child social engagement and communication and on topics related to autism characteristics, learning styles, interventions, and resources.

Intervention Type

Behavioral

Intervention Name(s)

Social communication

Intervention Description

Parent training sessions will focus on teaching parents strategies for enhancing their child's social engagement and communication. Since parents will be using these strategies across all activities throughout the day, there is an increased likelihood of generalization. For parents of minority and underserved children, this may be the first exposure to responsive interaction strategies (Rudy & Grusec, 2001).

Primary Outcome Measure Information:

Title

Communication and Symbolic Behavior Scales

Time Frame

immediately after treatment ends and 6 months after treatment ends

Secondary Outcome Measure Information:

Title

Mullen Scales of Early Learning

Time Frame

immediately after treatment ends and 6 months after treatment ends

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Months

Maximum Age & Unit of Time

33 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants must be 22 to 33 months old Children must meet criteria for ASD or autism on the ADOS plus receive a clinical judgment of PDD-NOS or autism by the study team Children must have an age equivalent of 8 months or greater for non-verbal ability based on the Mullen Visual Reception and Fine Motor scales Parents must agree to participate in the study and commit to having their child participate in the intervention to which they are randomized for 6 months The parent (or other primary caregiver, such as grandparent) in the Parent-Mediated condition must agree to attend the training sessions three times per month Parents must be between the ages of 16 and 50 years old Families who qualify for medical assistance and/or have racial/ethnic minority backgrounds will be prioritized for recruitment and participation in this study. On the TSI, we will ask participants if they qualify for medical assistance or if they are of a racial minority or have a first degree relative of a racial minority. Families who do not fit these criteria will be notified that they may be eligible to participate if additional space is available. It is not required that English be their primary language, but they must be fluent in English (or if the child is nonverbal he/she must hear English most of the time at home) Exclusion Criteria: Head injury prior to enrollment in the study Major hearing or visual impairment after correction Non-febrile seizures PKU (Phenylketonuria) Congenital Rubella (German measles) Neurofibromatosis Tuberous Sclerosis Fragile X A fall resulting in a loss of consciousness or other severe head injury Velo-Cardio Facial Syndrome Any other known genetic syndrome No foster children may participate The child must not be adopted

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rebecca Landa, PhD, CCC-SLP

Organizational Affiliation

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kennedy Krieger Institute

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21211

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12212918

Citation

Sofronoff K, Farbotko M. The effectiveness of parent management training to increase self-efficacy in parents of children with Asperger syndrome. Autism. 2002 Sep;6(3):271-86. doi: 10.1177/1362361302006003005.

Results Reference

background

PubMed Identifier

1384566

Citation

Tannock R, Girolametto L, Siegel LS. Language intervention with children who have developmental delays: effects of an interactive approach. Am J Ment Retard. 1992 Sep;97(2):145-60.

Results Reference

background

Citation

McGee, G. G., Morrier, M. J., & Daly,T. (1999).An incidental teaching approach to early intervention for toddlers with autism. Journal of the Association for Persons with Severe Handicaps, 24, 133-146.

Results Reference

background

PubMed Identifier

670129

Citation

Rutter M. Diagnosis and definition of childhood autism. J Autism Child Schizophr. 1978 Jun;8(2):139-61. doi: 10.1007/BF01537863. No abstract available.

Results Reference

background

PubMed Identifier

16712638

Citation

Kasari C, Freeman S, Paparella T. Joint attention and symbolic play in young children with autism: a randomized controlled intervention study. J Child Psychol Psychiatry. 2006 Jun;47(6):611-20. doi: 10.1111/j.1469-7610.2005.01567.x. Erratum In: J Child Psychol Psychiatry. 2007 May;48(5):523.

Results Reference

background

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A Randomized Clinical Trial for Toddlers With ASD

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