Optimizing Social and Communication Outcomes for Toddlers With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

Optimizing Social and Communication Outcomes for Toddlers With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999778
• Other study ID #: 1P50HD055784
• Status: Completed
• Phase: N/A
• First received: October 21, 2009
• Last updated: August 14, 2012
• Start date: July 2008
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This project will examine the efficacy of two different treatment approaches aimed at facilitating change in social and communications outcomes of toddlers with autism.

Description:

The proposed research tests a theoretically and empirically derived treatment approach aimed at facilitating change in joint attention interactions between caregivers and their toddlers with autism. Young children with autism show impairments in engaging in joint attention skills such as pointing and showing. The importance of joint attention is underscored by data showing that these skills are important to later development of language. Yet these interaction and skills deficits have rarely been the focus of systematic intervention efforts, particularly with caregivers. Moreover, current interventions for young children wiht autism are behavioral in approach, therapist driven, and often exclude the lowest functioning and developmentally youngest children. Thus, targeting these deficits in developmentally young children using familiar caregivers may result in better language outcomes for these children.

The overarching goal of the proposed project is to rigorously test an intervention program for caregivers and their toddlers with autism that is developmentally informed, child-centered and focused on joint attention intervention with their toddlers versus mothers who receive parent education about autism and child development.

The Primary aims of this research are as follows:

• Aim 1: To determine if caregiver mediated intervention on joint engagement is superior to caregiver education on social communication and language outcomes in children.

• Aim 2: To determine if skill development in the context of caregiver child interaction transfers to interactions with classroom teachers and peers.

• Aim 3: To examine characteristics of families and children that best predict social-communication outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 36 Months

Eligibility

Inclusion Criteria:

• Child meets screening criteria for PDD

• Not currently enrolled in a pre-existing intervention program

• Parent is available for intervention

• Child must be ready to start in the Early Childhood Partial Hospitalization Program (ECPHP) at UCLA

Exclusion Criteria:

• Child does not have other sensory or genetic disorders

• Children already on medication on the outset, although we find few toddlers already on medication when they begin treatment. If children begin medication after treatment commences, then we will keep all informatin and data pertaining to possible medication effects and statistically convey medication use if necessary

• Co-morbidity, participant diagnosed with other diseases

• Family/participant unable to follow-up

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• Caregiver-Mediated Intervention
1 (two- 1/2 jour sessions weekly) hour of intervention per week for 10 weeks in which parents and their child meet with the interventionist together using the caregiver as a means to facilitate change in their child's development
• Caregiver-Education Intervention
The caregiver meets 1 time (1 hour each session) a week for 10 weeks with an interventionist - caregiver will receive information on child development and have the opportunity to ask questions and discuss the information vis-a-vis their own child

Locations

Country	Name	City	State
United States	University of California Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Autism Speaks

Country where clinical trial is conducted

United States, 

References & Publications (91)

Abidin RR. Parenting stress and the utilization of pediatric services. Child Health Care. 1983 Fall;11(2):70-3. — View Citation

Adamson LB, Bakeman R, Deckner DF. The development of symbol-infused joint engagement. Child Dev. 2004 Jul-Aug;75(4):1171-87. — View Citation

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. — View Citation

Arnold, SD., Elliot, M., Storoschuk, S., Pickles, A., Hellriegel, C., & Lord, C., Social Directedness and Prelinguistic Vocalization in Autism, Paper presented at the meeting of the American Academy of Child and Adolescent Psychiatry, San Antonio, TX, 1993

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. — View Citation

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. — View Citation

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. — View Citation

Baron-Cohen, S., From Attention-Goal Psychology to Belief-Desire Psychology: The Development of a Theory of Mind and its Dysfunction, In S. Baron-Cohen, H. Hager-Flusberg & DJ Cohen (Eds), Understanding other Minds: Perspectives from Autism, Oxford, UK: Oxford University Press, 1993

Brereton, A., & Tonge, B., Preschoolers with autism: An education and skills training programme for parents, London, UK: Jessica Kingsley Publishers, 2005

Brown, R., A first language: the early stages, Cambridge, MA: Harvard University Press, 1973

Bruner, J.S., From communication to language: A psychological perspective, Cognition, 3, 255-287, 1974/1975

Bryk, A., & Raudenbush, S., Hierarchial linear models: Applications and data analysis methods, Newborn Park, CA: Sage, 1992

Cross, T.G., 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, 1977

Curcio F. Sensorimotor functioning and communication in mute autistic children. J Autism Child Schizophr. 1978 Sep;8(3):281-92. — View Citation

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. — View Citation

Dawson, G., & Galpert, L., Mother's use of imitative play for facilitating social responsiveness and toy play in young autistic children, Development and Psychopathology, 2, 151-162, 1990

Donnellan, A., & Kilman, B., Behavioral approaches to social skill development in autism: Strengths, misapplications, and alternatives, In E. Schopler & G. Mesibov (Eds), Social behavior in autism,, New York: Plenum Press, 213-215, 1986

Fenson, L., Dale, P.S., Reznik, J.S., Thal, D., Bates, E., hartung, J.P., Pethick, S., & Reilly, J.S., The MacArthur communicative development inventories: User's guide and technical manual, San Diego, CA: Singular Publishing Group, 1993

Harding, C.G., 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, 1983

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. — View Citation

Hobson, R.P., On sharing experiences, Development and Psychopathology, 1, 197-203, 1989

Kaiser, A., Yoder, P., & Keetz, A., Evaluating milieu teaching, In S. Warren & J Reichel (Eds) Causes and effects in communication and language intervention, Baltimore, MD: Brookes, 9-47, 1992

Kanner, L., Autistic distrubances of affective contact, Nervous Child, 2, 273-280, 1943

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. Erratum in: J Child Psychol Psychiatry. 2007 May;48(5):523. — View Citation

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. — View Citation

Kasari C, Paparella T, Freeman S, Jahromi LB. Language outcome in autism: randomized comparison of joint attention and play interventions. J Consult Clin Psychol. 2008 Feb;76(1):125-37. doi: 10.1037/0022-006X.76.1.125. — View Citation

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. — View Citation

Kasari C, Sigman M, Mundy P, Yirmiya N. Caregiver interactions with autistic children. J Abnorm Child Psychol. 1988 Feb;16(1):45-56. — View Citation

Kasari C, Sigman M. Linking parental perceptions to interactions in young children with autism. J Autism Dev Disord. 1997 Feb;27(1):39-57. — View Citation

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. — View Citation

Kasari, C., Jahromi, L., Freeman, S., Paparella, T., Predictors of language growth in young children with autism. Paper presented at the Gatlinburg Conference, San Diego, CA, March 2006

Kasari, C., Sigman, M., & Yirmiya, N., Focused and social attention in caregiver-child interactions: A comparison of autistic, mentally retarded and nonretarded children, Development and Psychopathology, 5, 403-414, 1994

Kasari, C., Sigman, M., Yimiya, N., & Mundy, P., Affective Development and Communication in Children with Autism, In A.P. Kaiser & D.G. Gray (Eds) Enhancing Children's Commmunication: Research Foundations for Intervention, New York: Brookes 201-222 1993

Kasari, C., Sigman, M., Yirmiya, N., & Mundy, P., Affective development in children with autism, in A.P. Kaiser & D.B. Bray (Eds) Enhancing chilren's communication: Reseach foundations for intervention, New York: Brookes, 201-222, 1993

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. Erratum in: J Child Psychol Psychiatry 1994 Jul;35(5):983. — View Citation

Kirk, R.E., Experimental design: Procedures for the behavioral sciences (2nd ed), Pacific Grove, CA: Brooks/Cole, 1982

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. — View Citation

Koegel, R., & Koegel, L., Teaching children with autism, Baltimore: Paul H. Brookes, 1995

Lord, C., Rutter, M.D., DiLavore, P., & Risi, S., Autism diagnostic observation schedule manual, Los Angeles, CA: Western Psychological Services, 2001

Lord, C., Storoschuk, S., Rutter, M., & Pickles, A., Using the ADI-R to diagnose autism in preschool children with autism, Infant Mental Health Journal, 14, 234-252, 1993

Lovaas OI. Behavioral treatment and normal educational and intellectual functioning in young autistic children. J Consult Clin Psychol. 1987 Feb;55(1):3-9. — View Citation

Loveland KA, Landry SH. Joint attention and language in autism and developmental language delay. J Autism Dev Disord. 1986 Sep;16(3):335-49. — View Citation

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. — View Citation

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. — View Citation

Morales, M., Mundy, P., & Rojas, J., Following the direction of gaze and language development in 6-month olds, Infant Behavior and Development, 21, 373-377, 1998

Mullen, E., Infant Mullen Scales of Early Learning, Cranston RI: T.O.T.A.L. Child, Inc, 1989

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. — View Citation

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. — View Citation

Mundy P, Sigman M, Ungerer J, Sherman T. Nonverbal communication and play correlates of language development in autistic children. J Autism Dev Disord. 1987 Sep;17(3):349-64. — View Citation

Mundy, P., Gomes, A., Individual differences in joint attention skill development in the second year, Infant Behavior and Development, 21, 469-482, 1998

Mundy, P., Kasari, C., & Sigman, M., Nonverbal communiction, affective sharing and inter-subjectivity, Infant Behavior and Development, 15, 377-381, 1992

Mundy, P., Sigman, M., & Kasari, C., Nonverbal communication, developmental level and symptom presentation in autism, Development and Psychopathology, 6, 389-041, 1994

Mundy, P., Sigman, M., & Kasari, C., The theory of mind and joint-attention deficits in autism. ZIn S. Baron-Cohen, H. Tager-Flusberg, & D. Cohen (Eds), Understanding other minds: Perspectives form autism, New York: Oxford University Press, 181-203, 1993

Ninio, A., & Bruner, J., The achievement and antecedents of labeling, Journal of Child Language, 5, 1-15, 1978

Nock, N.K., Kazdin, A.E., Parent expectancies for child therapy: Assessment and relation to participation in treatment, Journal of Child and Family Studies, 10, 155-189, 2001

Odom SL, Strain PS. A comparison of peer-initiation and teacher-antecedent interventions for promoting reciprocal social interaction of autistic preschoolers. J Appl Behav Anal. 1986 Spring;19(1):59-71. — View Citation

Ogletree, B.T., Communication intervention for a preverbal child with autism: A case study, Focus on Autistic Behavior, 7, 1-12, 1992

Oke NJ, Schreibman L. Training social initiations to a high-functioning autistic child: assessment of collateral behavior change and generalization in a case study. J Autism Dev Disord. 1990 Dec;20(4):479-97. — View Citation

Osborne JW. Power analysis for multivariate and repeated measurements designs via SPSS: correction and extension of D'Amico, Neilands, and Zambarano (2001). Behav Res Methods. 2006 May;38(2):353-4. — View Citation

Paperalla, T., Pruitt, L., & Kasari, C., Joint attention in parent-autistic child dyads, Poster session at the meeting of the Society for Research in Child Development, Albuqeruqe, N, April 1999

Ratner N, Bruner J. Games, social exchange and the acquisition of language. J Child Lang. 1978 Oct;5(3):391-401. — View Citation

Reynell, J.K., Reynell developmental language scales (revised), Windsor, England: NFER Publishing Co, 1977

Ricks DM, Wing L. Language, communication, and the use of symbols in normal and autistic children. J Autism Child Schizophr. 1975 Sep;5(3):191-221. — View Citation

Rocissano, L., & Yatchmink, Y., Joint attention in mother-toddler interaction: A study of individual variation, Marril-Palmer Quarterly, 30, 11-31, 1984

Roeyers H, Van Oost P, Bothuyne S. Immediate imitation and joint attention in young children with autism. Dev Psychopathol. 1998 Summer;10(3):441-50. — View Citation

Rogers SJ, Lewis H. An effective day treatment model for young children with pervasive developmental disorders. J Am Acad Child Adolesc Psychiatry. 1989 Mar;28(2):207-14. — View Citation

Rogosa, D., & Willett, J.B., Understanding correlates of change by modeling individual differences in growth, Psychometrika, 50, 203-228, 1985

Rutter M. Cognitive deficits in the pathogenesis of autism. J Child Psychol Psychiatry. 1983 Oct;24(4):513-31. — View Citation

Rutter M. Diagnosis and definition of childhood autism. J Autism Child Schizophr. 1978 Jun;8(2):139-61. — View Citation

Schopler E, Short A, Mesibov G. Relation of behavioral treatment to "normal functioning": comment on Lovaas. J Consult Clin Psychol. 1989 Feb;57(1):162-4. — View Citation

Schriebman, L., Austims, Newbury Park, CA: Sage, 1988

Seibert, J., Hogan, A., & Mundy, P., Assessing interactional competencies: The Early Social-Communication Scales, Infant Mental Health Journal, 3, 244-259, 1982

Seltzer, M., Frank, K., & Bryk, A., The metric matters: The sensitivity of conclusions concerning growth in student achievement to choice of metric, Education Evaluation and Policy Analysis, 16, 41-49, 1994

Sigman M, Mundy P, Sherman T, Ungerer J. Social interactions of autistic, mentally retarded and normal children and their caregivers. J Child Psychol Psychiatry. 1986 Sep;27(5):647-55. — View Citation

Sigman M, Ungerer JA. Attachment behaviors in autistic children. J Autism Dev Disord. 1984 Sep;14(3):231-44. — View Citation

Sigman MD, Kasari C, Kwon JH, Yirmiya N. Responses to the negative emotions of others by autistic, mentally retarded, and normal children. Child Dev. 1992 Aug;63(4):796-807. — View Citation

Sigman, M., & Karsari, C., Joint attention: Its origin and role in development, Erlbaum: Hilsdale, New Jersey, 189-203, 1995

Sigman, M., & Ruskin, E., Soical competence in children with autism and Down's syndrome, (in preparation)

Tomasello M, Farrar MJ. Joint attention and early language. Child Dev. 1986 Dec;57(6):1454-63. — View Citation

Tomasello, M. Joint attention as social cognition, in C. Moore & P. Dunham (Eds), Joint attention: Its orgin and role in development Erlbaum: Hillsdale, New Jersey, 103-130, 1995

Tomasello, M., & Todd, J., Joint attention and lexical acquisition style, First Language, 4, 197-211, 1983

Tomasello, M., Mannie, S., & Kruger, A.C., Linguistic enviornment of 1-to-2-year old twins, Developmental Psychology, 22, 169-176, 1986

Tomasello, M., The role of joimt attentional processes in early language development, Language Sciences, 10, 69-88, 1998

Ungerer JA, Sigman M. Symbolic play and language comprehension in autistic children. J Am Acad Child Psychiatry. 1981 Spring;20(2):318-37. — View Citation

Warren SF, Kaiser AP. Incidental language teaching: a critical review. J Speech Hear Disord. 1986 Nov;51(4):291-9. Review. — View Citation

Wetherby AM, Prutting CA. Profiles of communicative and cognitive-social abilities in autistic children. J Speech Hear Res. 1984 Sep;27(3):364-77. — View Citation

Whalen C, Schreibman L. Joint attention training for children with autism using behavior modification procedures. J Child Psychol Psychiatry. 2003 Mar;44(3):456-68. — View Citation

Witte JS, Greenland S, Kim LL, Arab L. Multilevel modeling in epidemiology with GLIMMIX. Epidemiology. 2000 Nov;11(6):684-8. — View Citation

Wong, C., Play and joint attention of children with autism in the preschool classroom, University of California, Los Angeles, unpublished disseratation, 2006

Yirmiya N, Kasari C, Sigman M, Mundy P. Facial expressions of affect in autistic, mentally retarded and normal children. J Child Psychol Psychiatry. 1989 Sep;30(5):725-35. — View Citation

Yoder, P.J., Warren, S.F., & McCathren, R.B., Determining spoken language prognosis in children with developmental disabilities, American Journal of Speech-Language Pathology, 7, 77-87, 1998

* Note: There are 91 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Assessment - Mullen Scales of Early Learning (MSEL)		Before treatment begins and at the 6 month follow up	No
Primary	Language Assessment - Reynell Developmental Language Scales		Before treatment begins and at 6 month follow up	No
Secondary	Language Sample - The Caregiver Child Interaction will be coded at each timepoint to obtain a 10 minute sample of the child's language transcription will yield a measure of lexical density, type-token ration and mean length of utterances		Prior to Intervention, two follow up points 3 month post intervention and 6 months post intervention	No
Secondary	Early Social-Communication Scales; frequencies of initiating and responses of joint attention behaviors to toys and l interaction - sessions will be video taped		Before intervention, at the end of intervention and at the 3 and 6 month follow up	No
Secondary	MacArthur Communicative Development Inventories		Before Intervention, after intervention at 3 month and 6 month follow ups	No
Secondary	Parent Expectancy/Belief in the Intervention - assesses caregiver beliefs that the intervention is appropriate and working for the child		Before intervention and once during each phase of the intervention for total of 3 ratings (during intervention)	No
Secondary	ADOS - The Autism Diagnostic Observation Schedule - semi-structured, standardized assessment of communication, social interaction, play and imaginative use of materials		Prior to intervention (determines eligibility) and 6 months post intervention	No
Secondary	Generalization of skills to classroom - Observational measure to determine whether child show generalization of skill to the classroom,and in interaction with teachers & peers		Prior to intervention and once during each phase of intervention	No
Secondary	Coding of child behaviors in classroom - using time sampling procedure, four different contexts; direct instruction, structure play, circle-time, unstructured play		during intervention	No
Secondary	Caregiver-child interaction - A 10-minute interaction between parent and child		Pre-intervention, 3 times turing active intervention, post treatment and at 3 and 6 months follow-up	No
Secondary	ADI-R Clinical diagnostic instrument for assessing autism in children		Prior to intervention to determine eligibility for participation in the study	No
Secondary	Parenting Stress - The Parenting Stress Index (PSI) measuring parents reported stress associated with the care of autistic child		Prior to interventin, at the end of intervention and 6 month follow-up	No

External Links

•   UCLA Center for Autism Research and Treatment Web Site