Promoting Early Intervention Timing and Attention to Language

Conditions

• COACH
• MONITOR

Eligibility Criteria

Sex

ALL

Age

6 Months - 8 Months

Healthy Volunteers

Not accepted

Interventions

• JASPER Babble — BEHAVIORAL
  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 Details

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.

Key Dates

Start date

Nov 25, 2024

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 9 month coaching
  Participants receive JASPER Babble coaching at 9 months of age. Prior to 9 months, participants are just being monitored.
• Experimental: 12 month coaching
  Participants receive JASPER Babble coaching at 12 months of age. Prior to 12 months, participants are just being monitored.
• Experimental: 15 month coaching
  Participants receive JASPER Babble coaching at 15 months of age. Prior to 15 months, participants are just being monitored.

Primary Outcome Measure

Mullen Early Learning Scales (MSEL) [ Time Frame: child's 6,9,12,15,18 and 24 months of age ]

Central Contacts

• Connie Kasari, PhD
  310-825-8342
  [email protected]
• Consuelo Garcia, BS
  562-301-6141
  [email protected]

Locations (2)

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