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Infant Achievements for Social Delay (IA Trial)

N/A
Waitlist Available
Led By Rebecca Landa, PhD, CCC-SLP
Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child participants must be between the ages of 8 months and 12 months at the beginning of the study
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 8 weeks post-baseline, and from baseline to 8 weeks post-intervention
Awards & highlights

IA Trial Summary

This trial will compare the effects of infant coaching on social and communication behaviors.

Who is the study for?
This trial is for infants aged 8-12 months who may be at risk for autism or developmental delays, and their caregivers. Infants must show certain signs of communication or social challenges. Caregivers should primarily speak English at home. Infants with hearing/visual impairments, genetic disorders, low birth weight/prematurity, or severe trauma are excluded.Check my eligibility
What is being tested?
The study tests a caregiver coaching program called Infant Achievements (IA) against a no-coaching education group (CE). It aims to improve how caregivers interact during play and enhance the infant's social and communication behaviors through direct comparison in a randomized controlled setup.See study design
What are the potential side effects?
Since this trial involves educational interventions rather than medical treatments, there are no typical side effects like those seen with medications. However, participation could impact family routines or stress levels.

IA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is between 8 and 12 months old.

IA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 8 weeks post-baseline, and from baseline to 8 weeks post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 8 weeks post-baseline, and from baseline to 8 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in child communication and social engagement sample during the Parent-Child Play Sample
Change in parent behavior during the Parent-Child Play Sample
Secondary outcome measures
Change in scores on the CSBS Behavior Sample
Change in scores on the MacArthur-Bates Communication Development Inventory
Change in scores on the Mullen Scales of Early Learning Receptive and Expressive Language Raw Scores

IA Trial Design

2Treatment groups
Experimental Treatment
Group I: Infant AchievementsExperimental Treatment1 Intervention
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 II: Caregiver EducationExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
328 Previous Clinical Trials
178,232 Total Patients Enrolled
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
88 Previous Clinical Trials
24,874 Total Patients Enrolled
Rebecca Landa, PhD, CCC-SLPPrincipal Investigator - Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
7 Previous Clinical Trials
1,139 Total Patients Enrolled

Media Library

Social Delay Clinical Trial 2023: Caregiver Education Highlights & Side Effects. Trial Name: NCT03404505 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must individuals meet to take part in this clinical trial?

"Potential participants should manifest signs of developmental delay and fall in the 8 to 12 month age bracket. This research is recruiting a maximum of 64 children for its study cohort."

Answered by AI

Are there any available slots for prospective participants in this experiment?

"Per the latest data on clinicaltrials.gov, this trial is not presently registering participants; though it was initially posted in November 2017 and last updated December 5th 2022. Nevertheless, 254 other trials are actively recruiting right now."

Answered by AI

Does this trial include individuals who have surpassed the age of fifty?

"According to this trial's eligibility requirements, the youngest acceptable participant is 8 months old while the oldest allowed is 12 months."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effects of a Short-term Parent Mediated Social Training on Developmental Trajectories in Infants
Rebecca Landa 2017. "Effects of a Short-term Parent Mediated Social Training on Developmental Trajectories in Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03404505.
~5 spots leftby Nov 2024
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