CompletedNot Applicable

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

United States38 participantsStarted 2017-11-03

Plain-language 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.

Who can participate

Age range

8 Months – 12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in parent behavior during the Parent-Child Play Sample

Timeframe: 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

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

Trial details

NCT IDNCT03404505

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-15

View on ClinicalTrials.gov More Younger Sibling of Child With Autism Spectrum Disorder trials

Plain-language summary

Who can participate

Age range

8 Months – 12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in parent behavior during the Parent-Child Play Sample

Timeframe: 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

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