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

NCT ID: NCT03404505

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-03
• Study Completion Date: 2021-01-15

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.

Detailed Description

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. Parents in the IA group will be coached, at home twice a week, to implement the intervention by trained research staff. 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. In both groups: Videotaped caregiver-child interaction data will be gathered in the home. Baseline, post-treatment and follow-up measures will also be collected at the investigators' child development research center.

Families with children between the ages of 8 and 12 months with developmental concerns may be eligible to participate. Developmental concerns are defined as infrequent production of specific communication or social behaviors, or in immature or qualitatively atypical forms. These concerns will be documented via the Autism Observation Scale for Infants, Communication and Symbolic Behavior Scale (CSBS) Infant-Toddler Checklist, and/or Mullen Scales of Early Learning. Recruitment will occur from the Kennedy Krieger Institute (KKI), community agencies, and community events. Recruitment flyers will be distributed within those programs. In addition, a social media blurb will be placed on the KKI and other relevant groups' Facebook pages, KKI Center for Autism and Related Disorders newsletter, KKI websites, and may be sent to relevant local newsletters/magazines for families of young children.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Infant Achievements

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 Type: EXPERIMENTAL

Infant Achievements

Intervention Type: 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.

Caregiver Education

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.

Group Type: EXPERIMENTAL

Caregiver Education (CE)

Intervention Type: 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.

Interventions

Infant Achievements

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.

Intervention Type: BEHAVIORAL

Caregiver Education (CE)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 8 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Landa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Landa, PhD, CCC-SLP

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Kennedy Krieger Institute

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40318004 (View on PubMed)

Other Identifiers

R21DC015846

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00065698

Identifier Type: -

Identifier Source: org_study_id