Autism Spectrum DisorderNCT00999778
Optimizing Social and Communication Outcomes for Toddlers With Autism
A study testing Caregiver-Mediated Intervention and Caregiver-Education Intervention in people with Autism Spectrum Disorder, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 36 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Caregiver-Mediated Intervention and Caregiver-Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90095
About this study
This project will examine the efficacy of two different treatment approaches aimed at facilitating change in social and communications outcomes of toddlers with autism.
Read the detailed 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Caregiver-Mediated Intervention, Caregiver-Education Intervention
- Keywords
- Autism, Social and Communication Deficits in Autism, Parent and Caregiver interventions with children with Autism, Autism Spectrum Disorder, ASD
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver-Mediated InterventionBehavioural
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 InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Caregiver Education Intervention | Active comparator | 10 1:1,one hour sessions weekly for 10 weeks with parent and interventionist. Behavioral education strategies will be targeted Receives: Behavioral: Caregiver-Education Intervention |
| Caregiver-Mediated Intervention | Active comparator | One hour 1:1 with parent, child and interventionist, each week, for 10 weeks social communication and joint engagement strategies will be targeted Receives: Behavioral: Caregiver-Mediated Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Assessment - Mullen Scales of Early Learning (MSEL)
Measured: Before treatment begins and at the 6 month follow up
Language Assessment - Reynell Developmental Language Scales
Measured: Before treatment begins and at 6 month follow up
Secondary outcomes (10)
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
Measured: Prior to Intervention, two follow up points 3 month post intervention and 6 months post intervention
Early Social-Communication Scales; frequencies of initiating and responses of joint attention behaviors to toys and l interaction - sessions will be video taped
Measured: Before intervention, at the end of intervention and at the 3 and 6 month follow up
MacArthur Communicative Development Inventories
Measured: Before Intervention, after intervention at 3 month and 6 month follow ups
Parent Expectancy/Belief in the Intervention - assesses caregiver beliefs that the intervention is appropriate and working for the child
Measured: Before intervention and once during each phase of the intervention for total of 3 ratings (during intervention)
ADOS - The Autism Diagnostic Observation Schedule - semi-structured, standardized assessment of communication, social interaction, play and imaginative use of materials
Measured: Prior to intervention (determines eligibility) and 6 months post intervention
Generalization of skills to classroom - Observational measure to determine whether child show generalization of skill to the classroom,and in interaction with teachers & peers
Measured: Prior to intervention and once during each phase of intervention
Coding of child behaviors in classroom - using time sampling procedure, four different contexts; direct instruction, structure play, circle-time, unstructured play
Measured: during intervention
Caregiver-child interaction - A 10-minute interaction between parent and child
Measured: Pre-intervention, 3 times turing active intervention, post treatment and at 3 and 6 months follow-up
ADI-R Clinical diagnostic instrument for assessing autism in children
Measured: Prior to intervention to determine eligibility for participation in the study
Parenting Stress - The Parenting Stress Index (PSI) measuring parents reported stress associated with the care of autistic child
Measured: Prior to interventin, at the end of intervention and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startJul 2008
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (94)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Autism Speaks
- Responsible party
- Principal investigator, Connie Kasari, University of California, Los Angeles
- Investigators
- Connie Kasari, Ph.D, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999778
- Sponsor's protocol ID
- 1P50HD055784
- Status last verified
- Aug 2012
- First submitted
- 21 Oct 2009
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abidin, RR, Parenting Stress Index Manual, Pediatric Psychology Press Charlottesville, VA 1983
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.
PubMed 15260871Akhtar 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.
PubMed 2010504Bakeman R, Adamson LB. Coordinating attention to people and objects in mother-infant and peer-infant interaction. Child Dev. 1984 Aug;55(4):1278-89.
PubMed 6488956Barnes 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.
PubMed 6841502Baron-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.
PubMed 2523408Curcio F. Sensorimotor functioning and communication in mute autistic children. J Autism Child Schizophr. 1978 Sep;8(3):281-92. doi: 10.1007/BF01539631.
PubMed 690064D'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.
PubMed 11816450Harris 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.
PubMed 8735574Lovaas 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.
PubMed 3571656Kasari 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.
PubMed 16712638Kasari 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.
PubMed 2143659Kasari 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.
PubMed 9018581Kasari 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.
PubMed 8463373Kasari 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.
PubMed 2139025
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Social and Communication Outcomes for Toddlers With Autism
- ClinicalTrials.gov ID
- NCT00999778
- Acronym / sponsor ID
- 1P50HD055784
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism, Social and Communication Deficits in Autism, Parent and Caregiver interventions with children with Autism, Autism Spectrum Disorder, ASD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- Autism Speaks
- Study start
- Jul 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will examine the efficacy of two different treatment approaches aimed at facilitating change in social and communications outcomes of toddlers with autism.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregiver Education Intervention | Active comparator | Behavioral: Caregiver-Education Intervention10 1:1,one hour sessions weekly for 10 weeks with parent and interventionist. Behavioral education strategies will be targeted |
| Caregiver-Mediated Intervention | Active comparator | Behavioral: Caregiver-Mediated InterventionOne hour 1:1 with parent, child and interventionist, each week, for 10 weeks social communication and joint engagement strategies will be targeted |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregiver-Mediated Intervention1 (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 | Behavioural | Caregiver-Mediated Intervention |
| Caregiver-Education InterventionThe 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 | Behavioural | Caregiver Education Intervention |
Primary outcome
Cognitive Assessment - Mullen Scales of Early Learning (MSEL)
Time frame: Before treatment begins and at the 6 month follow up
Language Assessment - Reynell Developmental Language Scales
Time frame: Before treatment begins and at 6 month follow up
10 secondary outcomes
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
Time frame: Prior to Intervention, two follow up points 3 month post intervention and 6 months post intervention
Early Social-Communication Scales; frequencies of initiating and responses of joint attention behaviors to toys and l interaction - sessions will be video taped
Time frame: Before intervention, at the end of intervention and at the 3 and 6 month follow up
MacArthur Communicative Development Inventories
Time frame: Before Intervention, after intervention at 3 month and 6 month follow ups
Parent Expectancy/Belief in the Intervention - assesses caregiver beliefs that the intervention is appropriate and working for the child
Time frame: Before intervention and once during each phase of the intervention for total of 3 ratings (during intervention)
ADOS - The Autism Diagnostic Observation Schedule - semi-structured, standardized assessment of communication, social interaction, play and imaginative use of materials
Time frame: Prior to intervention (determines eligibility) and 6 months post intervention
Generalization of skills to classroom - Observational measure to determine whether child show generalization of skill to the classroom,and in interaction with teachers & peers
Time frame: Prior to intervention and once during each phase of intervention
Coding of child behaviors in classroom - using time sampling procedure, four different contexts; direct instruction, structure play, circle-time, unstructured play
Time frame: during intervention
Caregiver-child interaction - A 10-minute interaction between parent and child
Time frame: Pre-intervention, 3 times turing active intervention, post treatment and at 3 and 6 months follow-up
ADI-R Clinical diagnostic instrument for assessing autism in children
Time frame: Prior to intervention to determine eligibility for participation in the study
Parenting Stress - The Parenting Stress Index (PSI) measuring parents reported stress associated with the care of autistic child
Time frame: Prior to interventin, at the end of intervention and 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
- BackgroundAbidin, RR, Parenting Stress Index Manual, Pediatric Psychology Press Charlottesville, VA 1983
- Background: PubMed 15260871Adamson 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.
- Background: PubMed 2010504Akhtar 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.
- Background: PubMed 6488956Bakeman R, Adamson LB. Coordinating attention to people and objects in mother-infant and peer-infant interaction. Child Dev. 1984 Aug;55(4):1278-89.
- Background: PubMed 6841502Barnes 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.
- Background: PubMed 2523408Baron-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.
- Background: PubMed 690064Curcio F. Sensorimotor functioning and communication in mute autistic children. J Autism Child Schizophr. 1978 Sep;8(3):281-92. doi: 10.1007/BF01539631.
- Background: PubMed 11816450D'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.
- Background: PubMed 8735574Harris 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.
- Background: PubMed 3571656Lovaas 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.
- Background: PubMed 16712638Kasari 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.
- Background: PubMed 2143659Kasari 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.
- UCLA Center for Autism Research and Treatment Web SiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie Kasari, Ph.D principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver-Mediated Intervention and Caregiver-Education Intervention in people with Autism Spectrum Disorder, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Assessment - Mullen Scales of Early Learning (MSEL) (time frame: Before treatment begins and at the 6 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00999778, which also lists 94 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2012.