Children at Risk for ASDBabyJNCT01874327
Biomarkers of Developmental Trajectories and Treatment in Autism Spectrum Disorder (ASD)
A study testing Baby JASPER and Standard Baby Classroom in people with Children at Risk for ASD, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 21 months
- Conditions the study is for
- Children at Risk for ASD
- What is being tested?
- Baby JASPER and Standard Baby Classroom
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 2018
- 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 12 to 21 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Other co-morbid syndromes or diseases
- Seizure activity
- Other sensory or physical disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Children at Risk for ASD
- Being tested
- Baby JASPER, Standard Baby Classroom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby JASPERBehavioural
Intervention focuses on core deficits of joint attention, play, engagement, and regulation embedded within AEPS curriculum
Standard Baby ClassroomBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Baby JASPER | Active comparator | This classroom will spend the majority of the time focusing on social-communication goals Receives: Behavioral: Baby JASPER |
| Standard Baby Classroom | Active comparator | This classroom will focus more heavily on developing motor and cognitive skills Receives: Behavioral: Standard Baby Classroom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (7)
Autism Diagnostic Observation Schedule Toddler module (ADOS-T)
Semi-structured, standardized assessment of communication, social interaction, play and imaginative use of materials
Measured: Prior to treatment commencing (Study Entry) and 10 months post treatment exit
Imitation Task
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Children at Risk for ASDStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Connie Kasari, Ph.D., University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874327
- Sponsor's protocol ID
- 12-000607
- Acronym
- BabyJ
- Status last verified
- Oct 2018
- First submitted
- 28 Oct 2012
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
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.
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 2010504Arnold, 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.
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 2523408Baron-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.
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 11816450
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Engagement in Infants at Risk for ASD: Integrating Treatment With Biomarkers
- ClinicalTrials.gov ID
- NCT01874327
- Acronym / sponsor ID
- BabyJ / 12-000607
- Conditions
- Children at Risk for ASD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 11 Jun 2013 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baby JASPER | Active comparator | Behavioral: Baby JASPERThis classroom will spend the majority of the time focusing on social-communication goals |
| Standard Baby Classroom | Active comparator | Behavioral: Standard Baby ClassroomThis classroom will focus more heavily on developing motor and cognitive skills |
Who may qualify
- Ages
- 12 to 21 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Other co-morbid syndromes or diseases
- Seizure activity
- Other sensory or physical disorders
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 |
|---|---|---|
| Baby JASPERIntervention focuses on core deficits of joint attention, play, engagement, and regulation embedded within AEPS curriculum | Behavioural | Baby JASPER |
| Standard Baby ClassroomAssessment, 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 | Behavioural | Standard Baby Classroom |
Primary outcome
Assessing change in Parent Child Interaction (PCX) throughout the diverse time points.
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)
10 minute unstructured free play assessment with caregiver and child measuring change over the duration of the study.
7 secondary outcomes
Autism Diagnostic Observation Schedule Toddler module (ADOS-T)
Time frame: Prior to treatment commencing (Study Entry) and 10 months post treatment exit
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)
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)
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)
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)
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)
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)
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 10 Oct 2018.
- BackgroundAbidin, R. R. (1983). Parenting Stress Index manual. Charlottesville, VA: Pediatric Psychology Press.
- 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.
- BackgroundArnold, 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.
- 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.
- BackgroundBaron-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.
- BackgroundBrereton, A., & Tonge, B. (2005). Pre-schoolers with autism: An education and skills training programme for parents. London, UK: Jessica Kingsley Publishers.
- BackgroundBrown, R. (1973). A first language: The early stages. Cambridge, MA: Harvard University Press.
- BackgroundBruner, J.S. (1974/75). From communication to language: A psychological perspective. Cognition, 3, 255-287.
- BackgroundBryk, A., & Raudenbush, S. (1992). Hierarchical linear models: Applications and data analysis methods. Newborn Park, CA: Sage.
Related trials for Children at Risk for ASD
Not yet recruiting
Home Play-based Intervention for Parents and Infants
Attention-Deficit/Hyperactivity Disorder (ADHD), Autism Spectrum Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby JASPER and Standard Baby Classroom in people with Children at Risk for ASD, run by University of California, Los Angeles 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 5 inclusion and 3 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 10 Oct 2018. 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?
Assessing change in Parent Child Interaction (PCX) throughout the diverse time points. (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)). 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 NCT01874327, which also lists 50 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 10 Oct 2018.