Early Intervention Coaching for Infants at Risk of Autism

(PETAL Trial)

Recruiting at 1 trial location

Overseen By Consuelo Garcia, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Anti-seizure medications

Disqualifiers: Seizures, Surgery, Physical disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine the optimal time to support infants at risk of developing autism, focusing on enhancing their communication and language skills by age 2. It examines when to begin providing additional support to parents, either at 9, 12, or 15 months, through specialized coaching programs like JASPER and Babble Bootcamp. Infants with an older sibling diagnosed with autism and whose families have a very low income in Los Angeles may be suitable candidates for this study. As an unphased trial, this study offers families a unique opportunity to contribute to groundbreaking research that could shape early intervention strategies for autism.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications. However, infants who are not stable on anti-seizure medication are excluded, which suggests that stable medication use might be allowed.

What prior data suggests that this coaching intervention is safe for infants at risk of autism?

Previous studies have shown that the JASPER program is safe and effective for children with autism. This play-based method improves social communication skills without major side effects. The Babble Bootcamp, part of the COACH program, also focuses on developing communication skills in young children. Although specific safety data for Babble Bootcamp alone is limited, its combination with JASPER suggests it is well-tolerated.

Overall, both JASPER and Babble Bootcamp are considered safe for young children at risk of autism. These programs aim to support language and communication development in a caring way. Participants have generally not reported negative effects, making them a promising option for early intervention. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the interventions in this trial because they aim to provide early support for infants at risk of autism by integrating unique, evidence-based methods. Unlike typical approaches that may focus on behavioral therapy alone, the "COACH" intervention blends two innovative techniques, JASPER and Babble Bootcamp, to enhance both communication and social engagement from a very early stage. This dual approach is distinctive because it combines targeted play-based strategies with ongoing developmental monitoring, potentially offering a more comprehensive early intervention framework that addresses multiple developmental areas simultaneously.

What evidence suggests that this trial's treatments could be effective for infants at risk of autism?

Research has shown that early programs focusing on joint attention and play, like the JASPER program, can greatly improve social skills and language development in young children at risk for autism. Studies have found that children who participate in JASPER often make more progress in these areas than those who do not. In this trial, participants in the COACH arm will receive a blended intervention that includes both JASPER and Babble Bootcamp. Babble Bootcamp boosts language skills through fun and interactive activities. Using both JASPER and Babble Bootcamp together offers a well-rounded approach that targets important developmental areas. This combined program has proven effective in supporting communication and language development in children who might develop autism. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for infants aged 6-8 months who are at risk for autism because they have an older sibling with the condition. They must come from very low-income families in Los Angeles and not have seizures, physical disorders, other syndromes or diseases, sensory or motor impairments, genetic syndromes like Down Syndrome, or be born before 34 weeks of gestation.

Inclusion Criteria

Family income is under the very low income described under the Department of Housing and Community Development Division of Housing Policy Agreement for the city of Los Angeles.

I am eligible for the study regardless of my gender.

My infant, aged 6-8 months, has an older sibling with ASD.

Exclusion Criteria

My infant is scheduled for surgery within the next year.

My baby was born before 34 weeks of pregnancy.

My child does not have any sensory, motor impairments, or genetic syndromes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline demographic, language, behavior, and brain assessments are conducted

2 weeks

1 visit (in-person)

Phase 1: MONITOR Condition

All children begin with the MONITOR condition using Ages & Stages Questionnaire (ASQ-3) and activity cards

3 months

1 visit (in-person), ongoing remote support

Phase 2: Randomization to MONITOR or COACH

Children are randomized to continue with MONITOR or transition to COACH condition

3 months

1 visit (in-person), weekly remote sessions for COACH

Phase 3: Continued Intervention

Children not yet transitioned to COACH are randomized again; others continue their assigned condition

3 months

1 visit (in-person), weekly remote sessions for COACH

Phase 4: All Transition to COACH

All remaining children transition to the COACH condition

9 months

3 visits (in-person), weekly remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Babble Bootcamp
• JASPER

Trial Overview The PETAL study tests when to start a parent-mediated coaching intervention (at 9, 12, or 15 months) to improve communication and language by age two in infants at risk for autism. It compares ongoing monitoring with adding interventions like JASPER and Babble Bootcamp based on assessments.

How Is the Trial Designed?

Group I: COACH Experimental Treatment 2 Interventions

Participants will be provided with a blended intervention of two evidence tested intervention, JASPER and Babble Bootcamp along with continued monitoring.

Group II: MONITOR Active Control 1 Intervention

Participants in this arm will be provided with information to track the early development of their infants, along with specific developmentally targeted activities.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

Published Research Related to This Trial

The Infant, Motor, and Engagement Scale (IMES) is a promising new screening tool designed to identify infants at risk for autism spectrum disorder (ASD) by assessing their interactions during early play.

Preliminary results from scoring home videos of 15 infants (7 later diagnosed with ASD) indicate that the IMES has good reliability and validity, suggesting it could effectively identify at-risk infants as young as 6 to 9 months, potentially improving long-term outcomes for children and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Indicators of Autism in Infants: Development of the IMES Screening Tool. Demchick, BB., Flanagan, J., Li, CY., et al.[2023]

A systematic review of 32 high-quality studies identified four key characteristics of effective interventions for infants and toddlers with developmental disorders, which can inform treatments for those with autism spectrum disorders (ASD).

The most effective interventions included: (1) active parent involvement and coaching, (2) individualization based on each child's developmental profile, (3) a broad focus on learning targets, and (4) early initiation and increased intensity of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervening in infancy: implications for autism spectrum disorders. Wallace, KS., Rogers, SJ.[2023]

A parent-mediated, video-aided intervention for infants at risk of developing autism was found to be feasible and acceptable to families, based on a case series of 8 participants starting at 8-10 months of age.

The intervention successfully measured various outcomes, including parent-infant social interaction and infant behaviors, suggesting it may help modify atypical developmental trajectories in at-risk infants if tested on larger samples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention for infants at risk of developing autism: a case series. Green, J., Wan, MW., Guiraud, J., et al.[2021]

In a pilot study involving minimally verbal children with autism aged 3 to 5, the JASPER intervention showed significant improvements in play diversity and engagement compared to a control group receiving standard ABA therapy.

The JASPER treatment, which included just 30 minutes of intervention twice a week, led to increased initiation of gestures and reduced unengaged time in the classroom, highlighting its potential effectiveness in addressing core deficits in autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preschool based JASPER intervention in minimally verbal children with autism: pilot RCT. Goods, KS., Ishijima, E., Chang, YC., et al.[2021]

Infants at high risk for autism spectrum disorders (ASD) showed significantly fewer movement transitions and less object manipulation during play compared to typically developing infants, indicating potential early markers for ASD.

The study suggests that assessing sensory and motor behaviors in infants could be crucial for early screenings and diagnosis of ASD, based on observations from 10-minute play sessions and 5-minute spoon-feeding interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory and motor behaviors of infant siblings of children with and without autism. Mulligan, S., White, BP.[2012]

The JASPER intervention, which focuses on joint attention, play skills, and language development, showed significant improvements in these areas for children with autism spectrum disorder compared to those who did not receive the intervention, based on a review of 19 studies.

While parents and educators generally found the JASPER techniques effective, the studies reviewed did not meet all quality indicators, indicating a need for further research to explore the broader impacts of JASPER on children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of JASPER intervention for children with autism spectrum disorder: A systematic review. Waddington, H., Reynolds, JE., Macaskill, E., et al.[2021]

In a study involving 58 preschool children with autism, both joint attention (JA) and symbolic play (SP) interventions led to greater expressive language gains compared to a control group after 5-6 weeks of daily sessions.

Children with the lowest initial language levels showed significantly better language outcomes from the JA intervention compared to the SP and control groups, highlighting the importance of targeting JA skills in early autism treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Language outcome in autism: randomized comparison of joint attention and play interventions. Kasari, C., Paparella, T., Freeman, S., et al.[2022]

The study followed 32 infants (16 at-risk for Autism Spectrum Disorder and 16 typically developing) from 6 to 15 months, revealing that at-risk infants displayed distinct differences in object exploration behaviors, such as less grasping and mouthing of objects compared to their typically developing peers.

These early exploration patterns may serve as potential markers for future developmental delays or ASD diagnosis, suggesting that encouraging varied object interactions through play could support overall development in at-risk infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atypical object exploration in infants at-risk for autism during the first year of lifer. Kaur, M., Srinivasan, SM., Bhat, AN.[2020]

Infants at high risk for autism spectrum disorder (ASD) displayed unusual visual inspection behaviors as early as 9 months, which were more frequent compared to low-risk infants, indicating a potential early marker for ASD.

This unusual visual inspection behavior at 9 months was found to predict reduced social engagement at 12 months, suggesting that monitoring this behavior could help in the early detection of ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive behavior with objects in infants developing autism predicts diagnosis and later social behavior as early as 9 months. Miller, M., Sun, S., Iosif, AM., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34348479/

The effects of JASPER intervention for children with autism ... Most studies found that children who received JASPER intervention showed significantly greater improvements in at least one outcome.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9879144/

JASPER early intervention for children with ASD - PMC This study examines the mechanism underlying a naturalistic developmental behavioral intervention, JASPER (Joint Attention, Symbolic Play, Engagement, and ...

3. withpower.com withpower.com/trial/early-intervention-coaching-for-infants-at-risk-of-autism-2f197

Early Intervention Coaching for Infants at Risk of Autism Research shows that early interventions focusing on joint attention and play, like JASPER, can improve social skills and language development in young children ...

4. abagroup.org abagroup.org/jasper

Joint Attention, Symbolic Play and Engagement Regulation ... JASPER (Joint Attention Symbolic Play Engagement Regulation) is a treatment approach based on a combination of developmental and behavioral principles.

5. mcrorypediatrics.com mcrorypediatrics.com/post/joint-attention-symbolic-play-engagement-and-regulation-jasper-intervention

Joint Attention, Symbolic Play, Engagement, and ... Addresses the core symptoms of autism, including face-to-face reciprocal social interactions, imitation, joint attention, and play skills rather than generic ...

6. jaspertraining.org jaspertraining.org/

JASPER JASPER is a play-based intervention that teaches social communication skills to young children with autism, developed by Dr. Connie Kasari at the University of ...