Parent-Mediated Social Training for Developmental Delay
(IA Trial)

Recruiting in Palo Alto (17 mi)

Overseen byRebecca Landa, PhD, CCC-SLP

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This study is being done to examine the feasibility and impact of the Infant Achievements caregiver coaching treatment on caregiver child-engagement strategies used during play with their infant. The investigators will examine effects on infants' social and communication behavior. This randomized controlled trial will compare caregivers and infants in the Infant Achievements (IA) coaching group to caregivers and infants in the Caregiver Education (CE) no-coaching group. A total of 64 eligible participants (16 children plus their caregiver per group) will participate in the study.

Eligibility Criteria

This trial is for infants aged 8-12 months who may be at risk for autism or developmental delays, and their caregivers. Infants must show certain signs of communication or social challenges. Caregivers should primarily speak English at home. Infants with hearing/visual impairments, genetic disorders, low birth weight/prematurity, or severe trauma are excluded.

Inclusion Criteria

My child is between 8 and 12 months old.

My family speaks English at home most of the time.

Children must receive an AOSI concern score ≥7 OR a T-score of ≤39 on either the Mullen Receptive Language or Expressive Language subscale OR Score in the Concern range on either the Composite or Total Score of the parent-completed Communication and Symbolic Behavior Scales Developmental Profile (CSBS DP) Infant-Toddler Checklist

Exclusion Criteria

Any severe birth trauma

Cannot be living in foster care

I have a hearing or visual impairment.

+4 more

Participant Groups

The study tests a caregiver coaching program called Infant Achievements (IA) against a no-coaching education group (CE). It aims to improve how caregivers interact during play and enhance the infant's social and communication behaviors through direct comparison in a randomized controlled setup.

2Treatment groups

Experimental Treatment

Group I: Infant AchievementsExperimental Treatment1 Intervention

Families randomized to the IA condition will receive 17 in-home sessions. These include a one-time start up session followed by twice-weekly visits in which they will be coached on how to implement the IA strategies. Families will receive a set of developmentally appropriate toys.

Group II: Caregiver EducationExperimental Treatment1 Intervention

In this condition, parents will receive 17 sessions with a trained study team member focused on promoting child development and well-being. Sessions include a one-time start-up visit followed by one in-home visit and one phone contact per week. Families will receive a set of developmentally appropriate toys.