Effects of a Short-term Parent Mediated Social Training on Developmental Trajectories in Infants

NCT03404505 | Completed

• 2 other identifiers: IRB00065698R21DC015846
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Younger Sibling of Child With Autism Spectrum Disorder; Signs of Developmental Delay; Signs of Communication Delay; Signs of Social Delay

Keywords

infant; play; parents

Outcome Measures

Primary Outcomes (2)

• Change in parent behavior during the Parent-Child Play Sample

  This measure is a natural observation of parent and child unstructured playing, and will be used to assess change in caregiver's use of child-responsive engagement strategies

  Change from behavior at Baseline to behavior at 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention

• Change in child communication and social engagement sample during the Parent-Child Play Sample

  This outcome will be coded from the Parent-Child Play Sample

  Change from behavior at Baseline to behavior at 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention

Secondary Outcomes (3)

• Change in scores on the Mullen Scales of Early Learning Receptive and Expressive Language Raw Scores

  Change from Baseline to 8 weeks post-baseline and from Baseline to 8 weeks post-intervention

• Change in scores on the MacArthur-Bates Communication Development Inventory

  Change from Baseline to 8 weeks post-baseline and from Baseline to 8 weeks post-intervention

• Change in scores on the CSBS Behavior Sample

  Change from Baseline to 8 weeks post-baseline and from Baseline to 8 weeks post-intervention

Study Arms (2)

Infant Achievements

EXPERIMENTAL

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.

Behavioral: Infant Achievements

Caregiver Education

EXPERIMENTAL

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.

Behavioral: Caregiver Education (CE)

Interventions

Infant Achievements BEHAVIORAL

Play-based intervention for caregivers and infants. The efficacy of the Infant Achievements intervention for improving communication and social behavior in infants who are at risk for communication, social, or developmental delay.

Infant Achievements

Caregiver Education (CE) BEHAVIORAL

Parents in the CE group will be taught about child development and well-being in their home, weekly, with a weekly follow-up phone call by trained research staff.

Caregiver Education

Eligibility Criteria

• Age: 8 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child participants must be between the ages of 8 months and 12 months at the beginning of the study.
• Family must speak English at least 75% in the home.
• 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.

You may not qualify if:

• History of head injury, seizure disorder, severe aggression or self-injurious behavior, prenatal illicit drug or excessive alcohol exposure.
• Any hearing or visual impairment
• Any severe birth trauma
• Any birth defects or genetic disorders
• Gestational age \< 35 weeks and/or Birth weight less than 1,500g
• Cannot be living in foster care.
• Location of in-home visits \>35 miles of the Center for Autism and Related Disorders

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location

Related Publications (1)

• Landa RJ, Reetzke R, Hess CR. Infant Achievements Intervention Improves Caregiver Implementation Fidelity and Infant Social Communication Outcomes: A Preliminary Randomized Clinical Trial. Autism Res. 2025 May;18(5):1104-1116. doi: 10.1002/aur.70051. Epub 2025 May 2.

  PMID: 40318004 DERIVED

Study Officials

• Rebecca Landa, PhD, CCC-SLP

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: January 19, 2018
• Study Start: November 3, 2017
• Primary Completion: December 15, 2020
• Study Completion: January 15, 2021
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)