Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT03404505
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.
Study:
NCT03404505
Study Brief:
Protocol Section:
NCT03404505