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

October 28, 2012
May 8, 2014
January 2013
January 2018   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01874327 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Biomarkers of Developmental Trajectories and Treatment in Autism Spectrum Disorder (ASD)
Joint Engagement in Infants at Risk for ASD: Integrating Treatment With Biomarkers

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Children at Risk for Developing Autism
  • Behavioral: Baby JASPER
    Intervention focuses on core deficits of joint attention, play, engagement, and regulation embedded within AEPS curriculum
  • 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
  • Active Comparator: Baby JASPER
    This classroom will spend the majority of the time focusing on social-communication goals
    Intervention: Behavioral: Baby JASPER
  • Active Comparator: Standard Baby Classroom
    This classroom will focus more heavily on developing motor and cognitive skills
    Intervention: Behavioral: Standard Baby Classroom

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
January 2018
January 2018   (final data collection date for primary outcome measure)

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
Both
12 Months to 21 Months
No
Contact: Amanda Gulsrud, PhD 310-206-1268
United States
 
NCT01874327
12-000607
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 2014

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