A Study of Parent and Child Emotions in Fetal Alcohol Spectrum Disorder (FASD)
Completed · Not applicable
Conditions studied: Fetal Alcohol Spectrum Disorders
In brief
The purpose of this study is to learn about the emotion regulation skills of children with fetal alcohol spectrum disorders (FASD) and different strategies that may improve these skills. This study is also testing whether a training program taught to caregivers is helpful. Children will be asked to: * Complete a brief measure of verbal and nonverbal problem-solving skills. * Play two computer games. * Have their heart rate measured while completing a task that is designed to be mildly disappointing. Two ECG pads are placed on the chest with a small recorder. * Play or relax with study staff while you are finishing caregiver activities. Caregivers will be asked to complete interviews and questionnaires about: * the child's background, including any past stressful experiences * the child's behavior and how s/he handles emotions * caregiver views on the child's emotions and their own * caregiver relationship with the child * Stress caregivers experience as a parent
Key facts
- Study ID
- NCT03524664
- Run by
- University of Rochester
- People needed
- 118
- Starts
- 2018-08-13
- Expected to finish
- 2021-09-30
- Last updated by the study team
- 2022-11-04
Who can join
Age: 4 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Families will be eligible for the study if they:
- Have a child between the age of 4 and 12 with a formal diagnosis of an FASD based on the Revised 2016 Hoyme criteria (Hoyme et al., 2016)
- The child is in some form of out of home care (e.g., adoptive, foster, relative, or other legal guardian)
- The child has resided with the primary caregiver for at least a year and be expected to remain in that placement for at least 6 months (study duration).
You may not qualify if…
- A history of other genetic, neurological, or significant medical conditions, traumatic brain injury, serious psychiatric illness or disability that would preclude data collection
- Child has a moderate to severe intellectual disability (IQ < 55)
- Child or caregiver has insufficient proficiency in English
- Caregiver is a biological parent of the child with FASD
Where it is running
- Mt. Hope Family Center — Rochester, New York, United States
Full record on ClinicalTrials.gov
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