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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 16, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Nathan A. Call, Ph.D., BCBA-D, Emory University

Tracking Information
First Submitted Date  ICMJE November 5, 2013
First Posted Date  ICMJE November 15, 2013
Last Update Posted Date January 16, 2019
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2013)
  • Child's social communication [ Time Frame: End of treatment (9 months) ]
    Standardized measure of child's social communication: Communication and Symbolic Behavior Scales (CSBS)
  • Child's Autism Symptoms [ Time Frame: End of treatment (9 months) ]
    Standardized Measure of autism symptoms: Autism Diagnostic Observation Schedule (ADOS).
  • Child's Developmental Level [ Time Frame: End of treatment (9 months) ]
    Standardized measure of child development: Mullen Scales of Early Learning (MSEL)
  • Child's Adaptive Behavior [ Time Frame: End of treatment (9 months) ]
    Standardized measure of adaptive behavior: Vineland Adaptive Behavior Scales (VABS-II)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01985022 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2013)
Parent Report [ Time Frame: End of treatment (9 months) ]
Parent measures of family functioning, daily hassles, and treatment satisfaction.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Changing Developmental Trajectories Through Early Treatment
Official Title  ICMJE Autism Center of Excellence: Project 3 - Changing Developmental Trajectories Through Early Treatment
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorders
Intervention  ICMJE
  • 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.
  • Behavioral: IES
    Parents will receive information, education, and support. They once a week for 75 minutes.
Study Arms  ICMJE
  • Experimental: PII with IES
    The treatment condition that this group receives is PII with IES for 9 months.
    Intervention: Behavioral: PII with IES
  • Experimental: IES
    The treatment condition that this group receives is IES for 9 months.
    Intervention: Behavioral: IES
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2013)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Months to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nathan Call, PhD 404-785-9400 nathan.call@choa.org
Contact: Amy Wetherby, PhD
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01985022
Other Study ID Numbers  ICMJE IRB00064779
P50MH100029-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nathan A. Call, Ph.D., BCBA-D, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Nathan Call, PhD Emory University, Marcus Autism Center, Children's Healthcare of Atlanta
Study Director: Amy Wetherby, Ph.D. Florida State University
PRS Account Emory University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP