N/A N=87 Randomized Single-blind Treatment

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

Fetal Alcohol Spectrum Disorders

Bottom Line

View on ClinicalTrials.gov: NCT03524664 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2022

Primary outcome: Primary: Parent Awareness of Own Emotion Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks) — 32.73; 32.37; 32.20; 32.47 score on a scale — p=.523

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Tuning In to kids intervention (Behavioral)
Age: Pediatric · 4+ yrs
Sex: All
Sponsor: University of Rochester
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Parent Awareness of Own Emotion Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)	32.73; 32.37; 32.20; 32.47	.523
PRIMARY Parent Acceptance of Own Expression Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)	26.07; 25.35; 26.83; 25.05	.173
PRIMARY Parent Regulation of Own Emotions Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)	23.43; 22.11; 23.47; 23.14	.140
PRIMARY Parent Awareness of Child Emotion Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)	29.40; 29.48; 29.97; 29.86	0.845
PRIMARY Parent Acceptance of Child's Emotion Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)	21.17; 19.98; 21.33; 21.29	.147
PRIMARY Parent Emotion Coaching Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)	21.33; 20.14; 21.03; 20.45	.429
PRIMARY Child Regulation Score for Sadness at Baseline and Immediate Post-intervention (8 Weeks)	23.20; 23.74; 24.10; 23.43	.208
PRIMARY Parent Awareness of Own Emotion Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)	33.74; 33.12; 34.10; 34.31	.300
PRIMARY Parent Acceptance of Own Expression Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)	24.65; 25.12; 25.65; 24.69	.099
PRIMARY Parent Regulation of Own Emotions Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)	21.52; 20.71; 21.81; 22.24	.105
PRIMARY Parent Awareness of Child Emotion Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)	31.48; 31.17; 31.10; 31.07	.699
PRIMARY Parent Acceptance of Child's Emotion Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)	16.71; 16.91; 16.94; 17.07	.945
PRIMARY Parent Emotion Coaching Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)	20.10; 19.88; 20.26; 20.24	.767
PRIMARY Child Regulation Score for Anger at Baseline and Immediate Post-intervention (8 Weeks)	18.61; 18.31; 18.71; 18.05	.682
PRIMARY Proportion of Observed Emotion Coaching Statements Using the Family Narrative Task at Baseline and Immediate Post-intervention (8 Weeks)	0.045; 0.052; 0.039; 0.046	.960
PRIMARY Proportion of Observed Emotion Dismissing Statements Using the Family Narrative Task at Baseline and Immediate Post-intervention (8 Weeks)	0.014; 0.011; 0.006; 0.006	.643
PRIMARY Child Emotion Regulation Using the Emotion Regulation Checklist at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up	24.14; 23.36; 23.22; 23.81; 23.43; 23.54	.118
PRIMARY Child Lability/Negativity Using the Emotion Regulation Checklist at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up	38.61; 40.64; 38.89; 41.00; 39.38; 40.74	.800
PRIMARY Intensity of Disruptive Behaviors Using the Eyberg Child Behavior Inventory at Baseline, Immediate Post-intervention, and 3-month Post-intervention Follow-up	64.00; 66.68; 63.20; 66.75; 63.40; 66.32	.863

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03524664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.