Biomarkers of Developmental Trajectories and Treatment in Autism Spectrum Disorder (ASD) (BabyJ)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01874327
First received: October 28, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

The study will evaluate the efficacy of a novel intervention implemented in a classroom setting aimed at improving joint attention and joint engagement skills with infants who are at risk of developing an Autism Spectrum Disorder.


Condition Intervention
Children at Risk for Developing Autism
Behavioral: Baby JASPER
Behavioral: Standard Baby Classroom

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Joint Engagement in Infants at Risk for ASD: Integrating Treatment With Biomarkers

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Change in Parent Child Interaction (PCX) [ Time Frame: Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit) ] [ Designated as safety issue: No ]
    10 minute unstructured free play assessment with caregiver and child measuring change over the duration of the study.


Secondary Outcome Measures:
  • Autism Diagnostic Observation Schedule Toddler module (ADOS-T) [ Time Frame: Prior to treatment commencing (Study Entry) and 10 months post treatment exit ] [ Designated as safety issue: No ]
    Semi-structured, standardized assessment of communication, social interaction, play and imaginative use of materials

  • Imitation Task [ Time Frame: Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit) ] [ Designated as safety issue: No ]
  • Vineland Adaptive Behavior Scales (VABS) [ Time Frame: Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit) ] [ Designated as safety issue: No ]
  • EEG/Event Related Potential (ERP) [ Time Frame: Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit) ] [ Designated as safety issue: No ]
  • Mullen Scales of Early Learning (MSEL) [ Time Frame: Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit) ] [ Designated as safety issue: No ]
  • Early Social Communication Scales (ESCS) [ Time Frame: Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit) ] [ Designated as safety issue: No ]
  • Structured Play Assessment (SPA) [ Time Frame: Prior to treatment commencing (Study Entry), within treatment (3 and 6 weeks post entry), Exit (8-10 weeks post entry), and three further follow ups (2 months post exit, 4 months post exit and 10 months post exit) ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: January 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Baby JASPER
This classroom will spend the majority of the time focusing on social-communication goals
Behavioral: Baby JASPER
Intervention focuses on core deficits of joint attention, play, engagement, and regulation embedded within AEPS curriculum
Active Comparator: Standard Baby Classroom
This classroom will focus more heavily on developing motor and cognitive skills
Behavioral: Standard Baby Classroom
Assessment, Education and Programming System (AEPS) for Infants and Children curriculum focused on early developmental milestones in fine and gross motor, cognitive, adaptive and social areas

Detailed Description:

The proposed intervention adapts a parent-mediated intervention that successfully improved outcomes in toddlers with autism. The intervention model (a) targets the foundations of social-communication (joint attention, imitation, play), (b) uses naturalistic strategies to increase the rate and complexity of social-communication and (c) includes parents as implementers of the intervention to promote generalization across settings and activities and to ensure maintenance over time.

In addition to testing the primary effects of this early intervention on the developmental outcomes of children with signs of autism, we will examine whether this method is superior to an early intervention focused on global infant development. Because brain development occurs rapidly in infants and toddlers, we will use high density EEG to investigate (1) biomarkers of change in these infants as a result of intervention and (2) biomarkers predicting response to treatment, with focus on the neural correlates of social attention and learning from joint engagement.

Study Aims:

AIM 1: To examine the effects of the experimental intervention (Baby JASPER) on primary (joint attention) and secondary outcomes (receptive language, play, symbol-infused joint engagement and parent use of social communication support strategies).

AIM 2: To examine maintenance and generalization of the effects of the experimental intervention on children and their parents.

AIM 3: To examine electrophysiological biomarkers of change with treatment as well as predictors of social communication outcomes in children after intervention.

AIM 4 (exploratory): To examine the effect of potential child level and parent level moderators on the primary and secondary outcomes of the study across the two conditions.

  Eligibility

Ages Eligible for Study:   12 Months to 21 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have elevated scores on the ADOS-Toddler version and clinical concern from professional (Pediatrician, Psychologist, etc). Because of the young age of children, we expect to intervene with children who do not yet have a diagnosis of ASD but may only show some risk by virtue of elevated scores on the ADOS-T.
  • Have a parent available for parent-mediated sessions 2 times per week in the classroom
  • Do not have seizures
  • Do not have associated sensory or physical disorders
  • Are not co-morbid with other syndromes or diseases

Exclusion Criteria:

  • Other co-morbid syndromes or diseases
  • Seizure activity
  • Other sensory or physical disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874327

Contacts
Contact: Amanda Gulsrud, PhD 310-206-1268

Locations
United States, California
UCLA Semel Institue Recruiting
Los Angeles, California, United States, 90024
Contact: Elizabeth Karp, BA    310-206-1268    ekarp@mednet.ucla.edu   
Principal Investigator: Connie Kasari, PhD         
Sponsors and Collaborators
  More Information

Publications:
Baron-Cohen, S. (1993). From attention-goal psychology to belief-desire psychology: The development of a theory of mind and its dysfunction. In S. Baron-Cohen, H. Tager-Flusberg, & D. J. Cohen (Eds.), Understanding other minds: Perspectives from autism, Oxford, UK: Oxford University Press.
Lord, C., Storoschuk, S., Rutter, M. & Pickles, A. (1993). Using the ADI-R to diagnose autism in preschool children with autism. Infant Mental Health Journal, 14, 234-252.

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01874327     History of Changes
Other Study ID Numbers: 12-000607
Study First Received: October 28, 2012
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 30, 2014