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



Status:Recruiting
Healthy:No
Age Range:Any
Updated:11/16/2018
Start Date:November 3, 2017
End Date:November 2021
Contact:Rebecca Landa, PhD, CCC-SLP
Email:landa@kennedykrieger.org
Phone:443-923-7551

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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.

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.

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
We found this trial at
1
site
707 North Broadway
Baltimore, Maryland 21205
443-923-9200
Principal Investigator: Rebecca Landa, PhD, CCC-SLP
Phone: 443-923-7551
Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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Baltimore, MD
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