MONITORPETALNCT05853861
Promoting Early Intervention Timing and Attention to Language
A study testing JASPER Babble in people with MONITOR and COACH, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
The proposed study (PETAL: Promoting Early intervention Timing and Attention to Language) aims to determine the timing of intervention among infants with Increased Likelihood for Autism (ILA; at risk for autism by virtue of having an older sibling with autism) on communication and language outcomes at 24 months. Read more about this study
- Who is it for?
- Ages 6 to 8 months
- What is being tested?
- JASPER Babble
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Nov 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- This study will recruit approximately 140 infants ages 6-8 months of age who are younger siblings of children with ASD.
- Both males and females are eligible for study participation and will be recruited.
- Family income is under the very low income described under the Department of Housing and Community DevelopmentDivision of Housing Policy Agreement for the city of Los Angeles.
Who cannot join
- Infants who have seizures and are not stable on anti-seizure medication
- Infant is expected to have surgery over the next year
- Infant has associated physical disorders, and/or co-morbid with other syndromes or diseases.
- All of the children will be free of additional sensory or motor impairments (e.g., Visual or hearing impairment) and othergenetic syndromes (e.g., Down Syndrome).
- In addition, infants who are premature or less than 34 weeks (gestational age <34 weeks) will be excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UCLA
Los Angeles, California, 90095
Connie Kasari, PhD
Connie Kasari, PhD
- Recruiting
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655-0002
Sarabeth Broder-Fingert, MD, sarabeth.broderfingert1@umassmed.edu
About this study
The proposed study (PETAL: Promoting Early intervention Timing and Attention to Language) aims to determine the timing of intervention among infants with Increased Likelihood for Autism (ILA; at risk for autism by virtue of having an older sibling with autism) on communication and language outcomes at 24 months. Results of this study will determine when (9 vs 12 vs 15 months), and based on which measures (brain, language, or their combination) to augment parental support with a specialized parent-mediated coaching intervention for optimal outcomes on communication and language at 24 months.
Children will be recruited at 6-8 months of age and will begin with entry assessments. All children will first begin with the MONITOR condition (using Ages \& Stages Questionnaire (ASQ-3) and activity cards. Then when the child is 9 months, they will be randomized to continue with MONITOR condition or COACH condition (i.e. JASPER Babble) after second set of assessments. There are a total of 6 assessment timepoints (6-8 months of age, 9 months of age, 12 months of age, 15 months of age, 18 months of age, and 24 months of age). At time points of 9months and 12 months, the child will be randomized to COACH or MONITOR conditions. Once the child is randomized to COACH condition, they will continue with that condition until they terminate the study at 24 months. At the 15 months timepoint, there will no longer be a randomization. Children that were in the MONITOR condition will change to the COACH condition until they terminate the study.
Read the detailed description
A total of 140 infants aged 6-8 months old who are siblings of children with ASD will participate, with an expected 30-60infants recruited each year for 3 years. We expect to recruit a diverse sample of ILA infants and families in two sites, Los Angeles area and Boston area; many will be from traditionally marginalized and minoritized families, mostly low income. Referrals will be elicited from community partners with which both sites have a long history, including school systems, federally qualified health centers, local clinics, family resource centers, and family support groups.
This study will use a four phase, Sequential Multiple Assignment Randomized Trial (SMART) design to examine the effectiveness of transitioning to more intensive early intervention prior to 15 months of age, and to inform clinical decision-making concerning the optimal time to transition to more intensive intervention based on the specific characteristics of the child. Phase 1 begins at age 6 months; after baseline demographic, language, behavior and brain assessments, all children are offered the MONITOR intervention. Phase 2 begins at age 9 months; after language, behavior and brain assessments, all children are randomly assigned to transition to MONITOR plus COACH (with probability 1/3) versus continue with MONITOR (with probability 2/3). Phase 3 begins at age 12 months; following language, behavior, and brain assessments, children who have not yet transitioned to MONITOR plus COACH are randomly assigned (with equal probability) to transition to MONITOR plus COACH versus continue with MONITOR. Phase 4 begins at age 15 months; following language and behavior assessments, all remaining children will transition to MONITOR plus COACH.
The MONITOR condition consists will take a global, general domain approach to providing parents with information to track the early development of their infants, along with specific developmentally targeted activities. The well validated Ages and Stages-3+ screening tool along with activity cards will provide information to parents at each age. All parents will receive these materials at 3-month intervals, along with a developmentally chosen toy and book for their infant. We will provide an appropriate toy/book given we expect a diverse sample including many low resourced families. The questionnaire takes 10- 15 minutes to complete and covers developmental domains of communication, motor, problem-solving and personal-social, and is available in English, Spanish, and several other languages. We will drop off or mail the specific form and activity card (plus toy and book) to families at each of our specified ages---6, 9, 12, 15, 18, 21 and 24months. The intervention activities card includes suggestions for games and other fun events for parent- infant dyads. Moreover, each family will have access to the intervention team (text, call, zoom) on an as needed protocol, and we will keep track of all contact. The MONITOR intervention continues for all infants and parents throughout the study period even after receiving COACH intervention.
The COACH condition consists of JASPER Babble, which is an evidence-based intervention. Infant-parent dyads will be randomized to receive COACH (JASPER Babble) at 9, 12 or 15 months. JASPER Babble addresses early parent-child social communication by helping to close the 'feedback loop'. When parents talk and play with their infant, the infant increases their developmental behaviors which serve to provide more opportunities for parents to respond. JASPER Babble targets on babbling specifically will be incorporated into this feedback loop, and the importance of the blended intervention should be underscored, providing both context and targets. For infant-parentdyads randomized to COACH, we will set up once weekly remote (zoom) 1-hour coaching sessions in between assessment visits each 3 months. Similar to the ASQ-3+ monitoring intervention, parents will have access to the intervention team on as needed basis throughout the study if they request more input, and we will track this contact. Once randomized to COACH, parents will continue to receive the remotely delivered intervention throughout the study period.
Assessments will be administered at 6 timepoints. At entry (when child is 6-8 months), parents will sign consent, fill out demographic forms, treatment history form, Mullen, PCX, LENA, and EEG.
At the 9 months and 12 months timepoints, the Mullen, PCX, LENA, and EEG will be administered again.
At 15, 18, and 24 months, the Mullen, PCX, LENA will be administered. An ADOS-2 will also be administered at 24months only.
- Being tested
- JASPER Babble
- Keywords
- autism, siblings, JASPER, speech, intervention
- Medical subject headings
- Autistic Disorder, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JASPER BabbleBehavioural
JASPER Babble is an evidence based early intervention that focuses on the core social communication and engagement skills of young children that are important to improvements in communication and language.
| Study group | Role | What they receive |
|---|---|---|
| 9 month coaching | Experimental | Participants receive JASPER Babble coaching at 9 months of age. Prior to 9 months, participants are just being monitored. Receives: Behavioral: JASPER Babble |
| 12 month coaching | Experimental | Participants receive JASPER Babble coaching at 12 months of age. Prior to 12 months, participants are just being monitored. Receives: Behavioral: JASPER Babble |
| 15 month coaching | Experimental | Participants receive JASPER Babble coaching at 15 months of age. Prior to 15 months, participants are just being monitored. Receives: Behavioral: JASPER Babble |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mullen Early Learning Scales (MSEL)
The MSEL provides expressive language scale T-scores. We will compare the changes in T-scores throughout the different time points, expecting improvement throughout each time point.
Measured: child's 6,9,12,15,18 and 24 months of age
Secondary outcomes (3)
Parent-Child Interaction (PCX)
A 15-minute parent-child play-based interaction will be collected at every time point. Expressive language (canonical babble ratio, number of different consonants, vocalizations and number of words), communicative gestures, joint engagement, and object play will be measured and compared at each time point.
Measured: child's 6,9,12,15,18 and 24 months of age
LENA
Parents will collect day-long naturalistic recordings of their child's language environment. We will compare them throughout each time point.
Measured: child's 6,9,12,15,18 and 24 months of age
Resting electroencephalogram test (EEG)
EEG data (L Fronto-Temporal (alpha, gamma)- coherence) will be recorded in the participants' home. They will be compared at the distinct time frames they are collected.
Measured: child's 6,9,12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start25 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MONITORStudies 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
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Responsible party
- Principal investigator, Connie Kasari, Ph.D., University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853861
- Sponsor's protocol ID
- 22-001637
- Acronym
- PETAL
- Status last verified
- Mar 2026
- First submitted
- 25 Apr 2023
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Early Intervention Timing and Attention to Language
- ClinicalTrials.gov ID
- NCT05853861
- Acronym / sponsor ID
- PETAL / 22-001637
- Keywords
- autism, siblings, JASPER, speech, intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 11 May 2023 (actual)
- 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 proposed study (PETAL: Promoting Early intervention Timing and Attention to Language) aims to determine the timing of intervention among infants with Increased Likelihood for Autism (ILA; at risk for autism by virtue of having an older sibling with autism) on communication and language outcomes at 24 months. Results of this study will determine when (9 vs 12 vs 15 months), and based on which measures (brain, language, or their combination) to augment parental support with a specialized parent-mediated coaching intervention for optimal outcomes on communication and language at 24 months.
Children will be recruited at 6-8 months of age and will begin with entry assessments. All children will first begin with the MONITOR condition (using Ages \& Stages Questionnaire (ASQ-3) and activity cards. Then when the child is 9 months, they will be randomized to continue with MONITOR condition or COACH condition (i.e. JASPER Babble) after second set of assessments. There are a total of 6 assessment timepoints (6-8 months of age, 9 months of age, 12 months of age, 15 months of age, 18 months of age, and 24 months of age). At time points of 9months and 12 months, the child will be randomized to COACH or MONITOR conditions. Once the child is randomized to COACH condition, they will continue with that condition until they terminate the study at 24 months. At the 15 months timepoint, there will no longer be a randomization. Children that were in the MONITOR condition will change to the COACH condition until they terminate the study.
Detailed description
A total of 140 infants aged 6-8 months old who are siblings of children with ASD will participate, with an expected 30-60infants recruited each year for 3 years. We expect to recruit a diverse sample of ILA infants and families in two sites, Los Angeles area and Boston area; many will be from traditionally marginalized and minoritized families, mostly low income. Referrals will be elicited from community partners with which both sites have a long history, including school systems, federally qualified health centers, local clinics, family resource centers, and family support groups.
This study will use a four phase, Sequential Multiple Assignment Randomized Trial (SMART) design to examine the effectiveness of transitioning to more intensive early intervention prior to 15 months of age, and to inform clinical decision-making concerning the optimal time to transition to more intensive intervention based on the specific characteristics of the child. Phase 1 begins at age 6 months; after baseline demographic, language, behavior and brain assessments, all children are offered the MONITOR intervention. Phase 2 begins at age 9 months; after language, behavior and brain assessments, all children are randomly assigned to transition to MONITOR plus COACH (with probability 1/3) versus continue with MONITOR (with probability 2/3). Phase 3 begins at age 12 months; following language, behavior, and brain assessments, children who have not yet transitioned to MONITOR plus COACH are randomly assigned (with equal probability) to transition to MONITOR plus COACH versus continue with MONITOR. Phase 4 begins at age 15 months; following language and behavior assessments, all remaining children will transition to MONITOR plus COACH.
The MONITOR condition consists will take a global, general domain approach to providing parents with information to track the early development of their infants, along with specific developmentally targeted activities. The well validated Ages and Stages-3+ screening tool along with activity cards will provide information to parents at each age. All parents will receive these materials at 3-month intervals, along with a developmentally chosen toy and book for their infant. We will provide an appropriate toy/book given we expect a diverse sample including many low resourced families. The questionnaire takes 10- 15 minutes to complete and covers developmental domains of communication, motor, problem-solving and personal-social, and is available in English, Spanish, and several other languages. We will drop off or mail the specific form and activity card (plus toy and book) to families at each of our specified ages---6, 9, 12, 15, 18, 21 and 24months. The intervention activities card includes suggestions for games and other fun events for parent- infant dyads. Moreover, each family will have access to the intervention team (text, call, zoom) on an as needed protocol, and we will keep track of all contact. The MONITOR intervention continues for all infants and parents throughout the study period even after receiving COACH intervention.
The COACH condition consists of JASPER Babble, which is an evidence-based intervention. Infant-parent dyads will be randomized to receive COACH (JASPER Babble) at 9, 12 or 15 months. JASPER Babble addresses early parent-child social communication by helping to close the 'feedback loop'. When parents talk and play with their infant, the infant increases their developmental behaviors which serve to provide more opportunities for parents to respond. JASPER Babble targets on babbling specifically will be incorporated into this feedback loop, and the importance of the blended intervention should be underscored, providing both context and targets. For infant-parentdyads randomized to COACH, we will set up once weekly remote (zoom) 1-hour coaching sessions in between assessment visits each 3 months. Similar to the ASQ-3+ monitoring intervention, parents will have access to the intervention team on as needed basis throughout the study if they request more input, and we will track this contact. Once randomized to COACH, parents will continue to receive the remotely delivered intervention throughout the study period.
Assessments will be administered at 6 timepoints. At entry (when child is 6-8 months), parents will sign consent, fill out demographic forms, treatment history form, Mullen, PCX, LENA, and EEG.
At the 9 months and 12 months timepoints, the Mullen, PCX, LENA, and EEG will be administered again.
At 15, 18, and 24 months, the Mullen, PCX, LENA will be administered. An ADOS-2 will also be administered at 24months only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 9 month coaching | Experimental | Behavioral: JASPER BabbleParticipants receive JASPER Babble coaching at 9 months of age. Prior to 9 months, participants are just being monitored. |
| 12 month coaching | Experimental | Behavioral: JASPER BabbleParticipants receive JASPER Babble coaching at 12 months of age. Prior to 12 months, participants are just being monitored. |
| 15 month coaching | Experimental | Behavioral: JASPER BabbleParticipants receive JASPER Babble coaching at 15 months of age. Prior to 15 months, participants are just being monitored. |
Who may qualify
- Ages
- 6 to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- This study will recruit approximately 140 infants ages 6-8 months of age who are younger siblings of children with ASD.
- Both males and females are eligible for study participation and will be recruited.
- Family income is under the very low income described under the Department of Housing and Community DevelopmentDivision of Housing Policy Agreement for the city of Los Angeles.
Key exclusion criteria (5 listed)
- Infants who have seizures and are not stable on anti-seizure medication
- Infant is expected to have surgery over the next year
- Infant has associated physical disorders, and/or co-morbid with other syndromes or diseases.
- All of the children will be free of additional sensory or motor impairments (e.g., Visual or hearing impairment) and othergenetic syndromes (e.g., Down Syndrome).
- In addition, infants who are premature or less than 34 weeks (gestational age <34 weeks) will be excluded.
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 |
|---|---|---|
| JASPER BabbleJASPER Babble is an evidence based early intervention that focuses on the core social communication and engagement skills of young children that are important to improvements in communication and language. | Behavioural | 12 month coaching, 15 month coaching, 9 month coaching |
Primary outcome
Mullen Early Learning Scales (MSEL)
Time frame: child's 6,9,12,15,18 and 24 months of age
The MSEL provides expressive language scale T-scores. We will compare the changes in T-scores throughout the different time points, expecting improvement throughout each time point.
3 secondary outcomes
Parent-Child Interaction (PCX)
Time frame: child's 6,9,12,15,18 and 24 months of age
LENA
Time frame: child's 6,9,12,15,18 and 24 months of age
Resting electroencephalogram test (EEG)
Time frame: child's 6,9,12 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JASPER Babble in people with MONITOR and COACH, run by University of California, Los Angeles at 2 sites 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Connie Kasari, PhD (310-825-8342, kasari@gseis.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mullen Early Learning Scales (MSEL) (time frame: child's 6,9,12,15,18 and 24 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2026.