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

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.

Study Overview

• Status: Completed
• Conditions: Children at Risk for ASD
• Intervention / Treatment: Behavioral: Baby JASPER; Behavioral: Standard Baby Classroom

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • UCLA Semel Institue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing change in Parent Child Interaction (PCX) throughout the diverse time points.	10 minute unstructured free play assessment with caregiver and child measuring change over the duration of the study.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autism Diagnostic Observation Schedule Toddler module (ADOS-T)	Semi-structured, standardized assessment of communication, social interaction, play and imaginative use of materials	Prior to treatment commencing (Study Entry) and 10 months post treatment exit
Imitation Task		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)
Vineland Adaptive Behavior Scales (VABS)		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)
EEG/Event Related Potential (ERP)		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)
Mullen Scales of Early Learning (MSEL)		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)
Early Social Communication Scales (ESCS)		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)
Structured Play Assessment (SPA)		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)

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Publications and helpful links

General Publications

• Abidin, R. R. (1983). Parenting Stress Index manual. Charlottesville, VA: Pediatric Psychology Press.
• Adamson LB, Bakeman R, Deckner DF. The development of symbol-infused joint engagement. Child Dev. 2004 Jul-Aug;75(4):1171-87. doi: 10.1111/j.1467-8624.2004.00732.x.
• Akhtar N, Dunham F, Dunham PJ. Directive interactions and early vocabulary development: the role of joint attentional focus. J Child Lang. 1991 Feb;18(1):41-9. doi: 10.1017/s0305000900013283.
• Arnold, S. D., Elliot, M., Storoschuk, S., Pickles, A., Hellriegel, C., & Lord, C. (1993) Social directedness and prelinguistic vocalization in autism. Paper presented at the meeting of the American Academy of Child and Adolescent Psychiatry, San Antonio, TX.
• Bakeman R, Adamson LB. Coordinating attention to people and objects in mother-infant and peer-infant interaction. Child Dev. 1984 Aug;55(4):1278-89.
• Barnes S, Gutfreund M, Satterly D, Wells G. Characteristics of adult speech which predict children's language development. J Child Lang. 1983 Feb;10(1):65-84. doi: 10.1017/s0305000900005146. No abstract available.
• Baron-Cohen S. The autistic child's theory of mind: a case of specific developmental delay. J Child Psychol Psychiatry. 1989 Mar;30(2):285-97. doi: 10.1111/j.1469-7610.1989.tb00241.x.
• 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.
• Brereton, A., & Tonge, B. (2005). Pre-schoolers with autism: An education and skills training programme for parents. London, UK: Jessica Kingsley Publishers.
• Brown, R. (1973). A first language: The early stages. Cambridge, MA: Harvard University Press.
• Bruner, J.S. (1974/75). From communication to language: A psychological perspective. Cognition, 3, 255-287.
• Bryk, A., & Raudenbush, S. (1992). Hierarchical linear models: Applications and data analysis methods. Newborn Park, CA: Sage.
• Cross, T. G. (1977). Mother's speech adjustments: The contribution of selected child listener variables. In C. E. Snow and C. A. Ferguson (Eds.), Talking to children: Language input and acquisition. Cambridge: Cambridge University Press.
• Curcio F. Sensorimotor functioning and communication in mute autistic children. J Autism Child Schizophr. 1978 Sep;8(3):281-92. doi: 10.1007/BF01539631.
• D'Amico EJ, Neilands TB, Zambarano R. Power analysis for multivariate and repeated measures designs: a flexible approach using the SPSS MANOVA procedure. Behav Res Methods Instrum Comput. 2001 Nov;33(4):479-84. doi: 10.3758/bf03195405.
• Dawson, G., & Galpert, L. (1990). Mother's use of imitative play for facilitating social responsiveness and toy play in young autistic children. Development and Psychopathology, 2, 151-162.
• Dawson, G., & Osterling, J. (1997). Early intervention in autism: Effectiveness and common elements of current approaches. In Guralnick, M. J. (Ed.), The Effectiveness of Early Intervention: Second Generation Research (pp. 307-326). Balitmore, MD: Brookes.
• Donnellan, A & Kilman, B. (1986). Behavioral approaches to social skill development in autism: Strengths, misapplications, and alternatives. In E. Schopler & G. Mesibov (Eds.), Social behavior in autism, (pp. 213-236). New York: Plenum Press.
• Harding, C. G. (1983). Setting the stage for language acquisition: Communication in the first year. In R. M. Golinkoff (Ed.), The transition from prelinguistic to linguistic communication. Hillsdale, NJ: Erlbaum.
• Harris S, Kasari C, Sigman MD. Joint attention and language gains in children with Down syndrome. Am J Ment Retard. 1996 May;100(6):608-19.
• Hobson, R. P. (1989). On sharing experiences. Development and Psychopathology, 1, 197-203.
• Lovaas OI. Behavioral treatment and normal educational and intellectual functioning in young autistic children. J Consult Clin Psychol. 1987 Feb;55(1):3-9. doi: 10.1037//0022-006x.55.1.3. No abstract available.
• Kaiser, A., Yoder, P., & Keetz, A. (1992). Evaluating milieu teaching. In S. Warren & J. Reichle (Eds.), Causes and effects in communication and language intervention. (pp. 9-47). Baltimore, MD: Brookes.
• Kanner L. Autistic disturbances of affective contact. Acta Paedopsychiatr. 1968;35(4):100-36. No abstract available.
• 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.
• Kasari C, Mundy P, Yirmiya N, Sigman M. Affect and attention in children with Down syndrome. Am J Ment Retard. 1990 Jul;95(1):55-67.
• Kasari C, Sigman M. Linking parental perceptions to interactions in young children with autism. J Autism Dev Disord. 1997 Feb;27(1):39-57. doi: 10.1023/a:1025869105208.
• Kasari C, Sigman MD, Baumgartner P, Stipek DJ. Pride and mastery in children with autism. J Child Psychol Psychiatry. 1993 Mar;34(3):353-62. doi: 10.1111/j.1469-7610.1993.tb00997.x.
• Kasari C, Sigman M, Mundy P, Yirmiya N. Caregiver interactions with autistic children. J Abnorm Child Psychol. 1988 Feb;16(1):45-56. doi: 10.1007/BF00910499.
• Kasari C, Sigman M, Mundy P, Yirmiya N. Affective sharing in the context of joint attention interactions of normal, autistic, and mentally retarded children. J Autism Dev Disord. 1990 Mar;20(1):87-100. doi: 10.1007/BF02206859.
• Kasari, C., Sigman, M., Yirmiya, N., & Mundy, P. (1993). Affective development and communication in children with autism. In A.P. Kaiser & D.B. Gray (Eds.), Enhancing children's communication: Research foundations for intervention (pp. 201-222). New York: Brookes.
• Kasari, C., Sigman, M., & Yirmiya, N. (1994). Focused and social attention in caregiver-child interactions: A comparison of autistic, mentally retarded and nonretarded children. Development and Psychopathology, 5, 403-414.
• Kellam SG, Rebok GW, Ialongo N, Mayer LS. The course and malleability of aggressive behavior from early first grade into middle school: results of a developmental epidemiologically-based preventive trial. J Child Psychol Psychiatry. 1994 Feb;35(2):259-81. doi: 10.1111/j.1469-7610.1994.tb01161.x. Erratum In: J Child Psychol Psychiatry 1994 Jul;35(5):983.
• Kirk, R.E. (1982). Experimental design: Procedures for the behavioral sciences. (2nd ed). Pacific Grove CA: Brooks/Cole.
• Koegel RL, Firestone PB, Kramme KW, Dunlap G. Increasing spontaneous play by suppressing self-stimulation in autistic children. J Appl Behav Anal. 1974 Winter;7(4):521-8. doi: 10.1901/jaba.1974.7-521.
• Koegel, R., & Koegel, L. (1995). Teaching children with autism. Baltimore: Paul H. Brookes.
• Lord, C., Rutter, M.D., DiLavore, P. & Risi, S. (2001). Autism diagnostic observation schedule manual. Los Angeles, CA: Western Psychological Services.
• 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.
• Loveland KA, Landry SH. Joint attention and language in autism and developmental language delay. J Autism Dev Disord. 1986 Sep;16(3):335-49. doi: 10.1007/BF01531663.
• Fenson, L., Dale, P. S., Reznick, J. S., Thal, D., Bates, E., Hartung, J. P., Pethick, S., & Reilly, J. S. (1993). The Macarthur communicative development inventories: User's guide and technical manual. San Diego, CA: Singular Publishing Group.
• McEachin JJ, Smith T, Lovaas OI. Long-term outcome for children with autism who received early intensive behavioral treatment. Am J Ment Retard. 1993 Jan;97(4):359-72; discussion 373-91.
• Miller JF, Chapman RS. The relation between age and mean length of utterance in morphemes. J Speech Hear Res. 1981 Jun;24(2):154-61. doi: 10.1044/jshr.2402.154.
• Morales, M., Mundy, P., & Rojas, J. (1998). Following the direction of gaze and language development in 6-month-olds. Infant Behavior & Development, 21, 373-377.
• Mullen, E. (1989). Infant Mullen Scales of Early Learning. Cranston, RI: T.O.T.A.L. Child, Inc. Mundy, P., & Gomes, A. (1998). Individual differences in joint attention skill development in the second year. Infant Behavior & Development, 21, 469-482.
• Mundy, P., Kasari, C. & Sigman, M. (1992). Nonverbal communication, affective sharing, and intersubjectivity. Infant Behavior and Development, 15, 377-381.
• Mundy P, Sigman M, Kasari C. A longitudinal study of joint attention and language development in autistic children. J Autism Dev Disord. 1990 Mar;20(1):115-28. doi: 10.1007/BF02206861.
• Mundy, P., Sigman, M. & Kasari, C. (1993). The theory of mind and joint-attention deficits in autism. In S. Baron-Cohen, H. Tager-Flusberg, & D. Cohen (Eds.), Understanding other minds: Perspectives from autism (pp. 181-203). New York: Oxford University Press.
• Mundy, P., Sigman, M., & Kasari, C. (1994). Nonverbal communication, developmental level and symptom presentation in autism. Development and Psychopathology, 6, 389-401.
• Mundy P, Sigman M, Ungerer J, Sherman T. Defining the social deficits of autism: the contribution of non-verbal communication measures. J Child Psychol Psychiatry. 1986 Sep;27(5):657-69. doi: 10.1111/j.1469-7610.1986.tb00190.x.
• Sterrett K, Magana MT, Gulsrud A, Paparella T, Kasari C. Predictors of Attrition in a Randomized Trial of a Social Communication Intervention for Infant-Toddlers at Risk for Autism. J Autism Dev Disord. 2022 Jun 9. doi: 10.1007/s10803-022-05616-w. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: October 28, 2012
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 12-000607