Early Intervention Coaching for Infants at Risk of Autism

(PETAL Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Los Angeles

Must not be taking: Anti-seizure medications

Disqualifiers: Seizures, Surgery, Physical disorders, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 (incorporates JASPER intervention and Babble Bootcamp) 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.

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 data supports the effectiveness of the treatment Babble Bootcamp, Babble Bootcamp, Babble Plus, JASPER, Joint Attention Symbolic Play Engagement & Regulation 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 with autism. Additionally, involving parents in early intervention and tailoring the approach to each child's needs are effective strategies for supporting infants at risk of developmental challenges. ^{1 2 3 4 5}

Is the Early Intervention Coaching for Infants at Risk of Autism safe for humans?

The JASPER intervention, which is similar to Early Intervention Coaching, has been found to be feasible and acceptable for families, with no safety concerns reported in studies involving children with autism. ^{1 2 3 6 7}

How does the early intervention coaching treatment for infants at risk of autism differ from other treatments?

This treatment is unique because it is a parent-mediated, video-aided, and interaction-focused intervention that starts as early as 8-10 months of age, aiming to modify developmental trajectories by enhancing parent-infant social interactions and addressing atypical behaviors early on. ^{1 4 5 8 9}

Research Team

Eligibility Criteria

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

I am eligible for the study regardless of my gender.

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

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.

Exclusion Criteria

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

My infant is scheduled for surgery within the next year.

My baby was born before 34 weeks of pregnancy.

Trial Timeline

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)

Treatment Details

Interventions

• Babble Bootcamp (Behavioural Intervention)
• JASPER (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Thomas Rando

University of California, Los Angeles

Chief Medical Officer since 2023

MD from UCLA

Amir Naiberg

University of California, Los Angeles

Chief Executive Officer since 2024

JD from UCLA

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

Dr. Eric W. Dickson

University of Massachusetts, Worcester

Chief Executive Officer since 2013

MD from UMass Chan Medical School, Master's in Health Care Management from Harvard University

Dr. Andy Karson

University of Massachusetts, Worcester

Chief Medical Officer

MD

Findings from Research

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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intervention for infants at risk of developing autism: a case series. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Preschool based JASPER intervention in minimally verbal children with autism: pilot RCT. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Language outcome in autism: randomized comparison of joint attention and play interventions. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Early Indicators of Autism in Infants: Development of the IMES Screening Tool. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Intervening in infancy: implications for autism spectrum disorders. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Sensory and motor behaviors of infant siblings of children with and without autism. [2012]

7. England pubmed.ncbi.nlm.nih.gov

The effects of JASPER intervention for children with autism spectrum disorder: A systematic review. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Atypical object exploration in infants at-risk for autism during the first year of lifer. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Repetitive behavior with objects in infants developing autism predicts diagnosis and later social behavior as early as 9 months. [2023]