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Changing Developmental Trajectories Through Early Treatment

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ClinicalTrials.gov Identifier: NCT01985022
Recruitment Status : Recruiting
First Posted : November 15, 2013
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Nathan A. Call, Ph.D., BCBA-D, Emory University

Brief Summary:
The major purpose of this study is to directly compare two parent intervention conditions for children diagnosed with autism spectrum disorders at 18 months of age to document the effectiveness.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Behavioral: PII with IES Behavioral: IES Not Applicable

Detailed Description:
Previous research has suggested that earlier intervention may contribute to better outcomes in autism. Answering the question "how early?" has significant health and educational implications for age of screening for autism spectrum disorders (ASD) and age of entry into early intervention for children with ASD. With the increased number of young children identified with ASD, there is a pressing need for evidence-based, manualized intervention that is accessible to and implemented by parents within their natural environments. This collaborative project is directed by Dr. Amy Wetherby at Florida State University and Dr. Nathan Call at Emory University to compare the effectiveness of parent implemented intervention for toddlers with autism spectrum disorders (ASD). The major objective is to directly compare two parent intervention conditions: 1) a parent-implemented intervention (PII) offered in a 2-3 weekly sessions to teach parents treatment strategies to support social communication skills within everyday routines, activities, and places for 25 hours a week; and 2) an information, education and support group (IES) offered twice monthly. Ninety-two children who 12 months of age and are at risk for developing an ASD because they have an older sibling who has an identified ASD will participate. Participants will be recruited from those children who are part of prerequisite studies on ASD in infancy that are also being conducted at Emory University. Families will be randomly assigned to either PII or IES at 12 months of age for a total of 9 months of intervention. The effectiveness of PII and IES will be examined with growth trajectories of social communication and autism symptoms and group outcomes on developmental level and adaptive behavior. The findings of this study will provide evidence of the effects of parent implemented intervention beginning at 12 months of age and substantiate that autism screening for toddlers is crucial for families to access early intervention.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autism Center of Excellence: Project 3 - Changing Developmental Trajectories Through Early Treatment
Study Start Date : May 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PII with IES
The treatment condition that this group receives is PII with IES for 9 months.
Behavioral: PII with IES
This is an individualized parent-implemented intervention (PII) offered weekly to teach parents how to embed strategies to support social communication skills for 25 hours a week within everyday routines, activities, and places for 9 months. In addition parent will receive twice weekly the IES condition of the study.

Experimental: IES
The treatment condition that this group receives is IES for 9 months.
Behavioral: IES
Parents will receive information, education, and support. They once a week for 75 minutes.




Primary Outcome Measures :
  1. Child's social communication [ Time Frame: End of treatment (9 months) ]
    Standardized measure of child's social communication: Communication and Symbolic Behavior Scales (CSBS)

  2. Child's Autism Symptoms [ Time Frame: End of treatment (9 months) ]
    Standardized Measure of autism symptoms: Autism Diagnostic Observation Schedule (ADOS).

  3. Child's Developmental Level [ Time Frame: End of treatment (9 months) ]
    Standardized measure of child development: Mullen Scales of Early Learning (MSEL)

  4. Child's Adaptive Behavior [ Time Frame: End of treatment (9 months) ]
    Standardized measure of adaptive behavior: Vineland Adaptive Behavior Scales (VABS-II)


Secondary Outcome Measures :
  1. Parent Report [ Time Frame: End of treatment (9 months) ]
    Parent measures of family functioning, daily hassles, and treatment satisfaction.



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Ages Eligible for Study:   9 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants will be recruited who have already completed Project 1 and Project 2 of the Emory Autism Center of Excellence project.
  • Participants will be the younger siblings of children with a diagnosed ASD
  • Positive screen on 2 of 3 measures of risk for an autism spectrum disorder before treatment 15 months of age or younger by the start of treatment
  • Normal hearing and adequate motor control to make simple actions (giving, reaching)
  • Families agree to twice monthly play group sessions for 9 months and 2-3 intervention sessions per week for 9 months (usually within work-day hours)
  • Families agree to monthly evaluations and videotaping of intervention sessions and weekly or monthly video check during the 18 months of treatment

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985022


Contacts
Contact: Nathan Call, PhD 404-785-9400 nathan.call@choa.org
Contact: Amy Wetherby, PhD

Locations
United States, Georgia
Marcus Autism Center Recruiting
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Nathan Call, PhD Emory University, Marcus Autism Center, Children's Healthcare of Atlanta
Study Director: Amy Wetherby, Ph.D. Florida State University

Responsible Party: Nathan A. Call, Ph.D., BCBA-D, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01985022     History of Changes
Other Study ID Numbers: IRB00064779
P50MH100029-02 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Keywords provided by Nathan A. Call, Ph.D., BCBA-D, Emory University:
autism
autism spectrum disorders
pervasive developmental disorders
toddlers
intervention

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders