CompletedNot Applicable

A Study of Parent and Child Emotions in Fetal Alcohol Spectrum Disorder (FASD)

United States118 participantsStarted 2018-08-13

Plain-language summary

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

Who can participate

Age range

4 Years – 12 Years

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: 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). Exclusion Criteria: * 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

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

Parent Awareness of Own Emotion Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)

Timeframe: baseline to immediate post-intervention (8 weeks)

Parent Acceptance of Own Expression Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)

Timeframe: baseline to immediate post-intervention (8 weeks)

Parent Regulation of Own Emotions Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)

Timeframe: baseline to immediate post-intervention (8 weeks)

Parent Awareness of Child Emotion Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)

Timeframe: baseline to immediate post-intervention (8 weeks)

Parent Acceptance of Child's Emotion Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)

Timeframe: baseline to immediate post-intervention (8 weeks)

Parent Emotion Coaching Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)

Timeframe: baseline to immediate post-intervention (8 weeks)

Trial details

NCT IDNCT03524664

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-30

Results submitted2022-08-31

View on ClinicalTrials.gov More Fetal Alcohol Spectrum Disorders trials