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 range4 Years – 12 Years

SexALL

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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

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)

Child Regulation Score for Sadness at Baseline and 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