- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03404505
Effects of a Short-term Parent Mediated Social Training on Developmental Trajectories in Infants (IA)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21211
- Kennedy Krieger Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 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
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
|
Change from behavior at Baseline to behavior at 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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
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 from Baseline to 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention
|
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
|
Change from Baseline to 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rebecca Landa, PhD, CCC-SLP, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00065698
- R21DC015846 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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