Effects of a Short-term Parent Mediated… | Clinical Trial

Key information

Conditions

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

Age range

8 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

Change in parent behavior during the Parent-Child Play Sample

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

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

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

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

Secondary outcomes

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

Time frame: Change from Baseline to 8 weeks post-baseline and from Baseline to 8 weeks post-intervention

Receptive Language score (score range 0-48); Expressive Language Score (score range 0-50); higher scores indicate better outcome for both scales
Change in scores on the MacArthur-Bates Communication Development Inventory

Time frame: Change from Baseline to 8 weeks post-baseline and from Baseline to 8 weeks post-intervention

Number of words understood (range 0-396); Number of words produced (0-396); Total actions & gestures (0-63); higher scores indicate better outcomes for all scales
Change in scores on the CSBS Behavior Sample

Time frame: Change from Baseline to 8 weeks post-baseline and from Baseline to 8 weeks post-intervention

Frequency of initiation of joint attention; frequency of communicative consonants (range 0-6), gestures (range 0-6) and words (range (0-6); higher scores indicate greater outcome on all scales

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Acronym: IA

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2021
First posted: Jan 19, 2018
Registry last updated: Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.